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Improving Diabetes Care in Family CarePractice: A Quality Improvement Project
Item Type text; Electronic Dissertation
Authors Chavez, Maria Magdalena
Publisher The University of Arizona.
Rights Copyright © is held by the author. Digital access to this materialis made possible by the University Libraries, University of Arizona.Further transmission, reproduction or presentation (such aspublic display or performance) of protected items is prohibitedexcept with permission of the author.
Download date 11/05/2018 19:07:47
Link to Item http://hdl.handle.net/10150/593612
IMPROVING DIABETES CARE IN FAMILY CARE PRACTICE:
A QUALITY IMPROVEMENT PROJECT
by
Maria Magdalena Chavez
________________________
A DNP Project Submitted to the Faculty of the
COLLEGE OF NURSING
In Partial Fulfillment of the Requirements For the Degree of
DOCTOR OF NURSING PRACTICE
In the Graduate College
THE UNIVERSITY OF ARIZONA
2 0 1 5
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THE UNIVERSITY OF ARIZONA GRADUATE COLLEGE
As members of the DNP Project Committee, we certify that we have read the DNP Project
prepared by Maria Magdalena Chavez entitled “Improving Diabetes Care in Family Care
Practice: A Quality Improvement Project” and recommend that it be accepted as fulfilling the
DNP Project requirement for the Degree of Doctor of Nursing Practice.
_______________________________________________ Date: November 4, 2015 Marylyn M. McEwen, PhD, PHCNP-BC, FAAN _______________________________________________ Date: November 4, 2015 Jane M. Carrington, PhD, RN _______________________________________________ Date: November 4, 2015 Audrey Russell-Kibble, DNP, FNP-C Final approval and acceptance of this DNP Project is contingent upon the candidate’s submission of the final copies of the DNP Project to the Graduate College. I hereby certify that I have read this DNP Project prepared under my direction and recommend that it be accepted as fulfilling the DNP Project requirement. _______________________________________________ Date: November 4, 2015 DNP Project Director: Marylyn M. McEwen, PhD, PHCNP-BC, FAAN
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STATEMENT BY AUTHOR
This DNP Project has been submitted in partial fulfillment of requirements for an advanced degree at The University of Arizona and is deposited in the University Library to be made available to borrowers under rules of the Library.
Brief quotations from this DNP Project are allowable without special permission, provided that accurate acknowledgment of source is made. Requests for permission for extended quotation from or reproduction of this manuscript in whole or in part may be granted by the head of the major department or the Dean of the Graduate College when in his or her judgment the proposed use of the material is in the interests of scholarship. In all other instances, however, permission must be obtained from the author.
SIGNED: __Maria Magdalena Chavez__________________
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ACKNOWLEDGMENTS
I would like to express my deepest gratitude to my committee chair, Dr. Marylyn
McEwen, for her endless guidance and patience. Without her positivity and persistent help this
project would not have been possible. I would like to thank my wonderful committee members,
Dr. Jane Carrington and Dr. Audrey Russell-Kibble for their support.
I would like to thank my parents for all the sacrifices they made so that I could achieve
my dreams. My mother has always been there as a shoulder to lean on and pushing me when I
felt like giving up. She spent long hours caring for my sons, cooking meals, and caring for my
home so I could complete my schoolwork. My father left everything he knew behind so I could
achieve greatness in this beautiful country.
Finally, I would like to thank my loving husband for supporting me and believing in my
abilities throughout my educational endeavor.
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DEDICATION
I dedicate this DNP project to my sons, Rogelio and Jose Francisco. May I inspire you
both to dream big and believe in yourselves.
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TABLE OF CONTENTS
LIST OF FIGURES .........................................................................................................................8
LIST OF TABLES ...........................................................................................................................9
ABSTRACT ...................................................................................................................................10
INTRODUCTION .......................................................................................................................11
Background Knowledge ..............................................................................................................11 Pathophysiology of Diabetes Mellitus ............................................................................11 Deficits in T2DM Care .....................................................................................................12
Project Purpose ............................................................................................................................13 Aims ...............................................................................................................................................14 Standards of Medical Care in Diabetes – 2015 .........................................................................14
Foundations of Care ........................................................................................................14 Glycemic Targets .............................................................................................................15 Cardiovascular Disease and Risk Management ............................................................16 Foot Care ..........................................................................................................................18
Local Problem ..............................................................................................................................19 Expected Outcomes ......................................................................................................................21 Summary .......................................................................................................................................22 METHODS ...................................................................................................................................22 Ethical Issues ................................................................................................................................22 Setting............................................................................................................................................25 Planning the Intervention ...........................................................................................................25
Recruitment ......................................................................................................................27 Plan-Do-Study-Act (PDSA) Cycle ..............................................................................................27
Plan ....................................................................................................................................28 Do .......................................................................................................................................30
Planning the Study of the Intervention ......................................................................................31 Study .................................................................................................................................31
Analysis .........................................................................................................................................32 Act ......................................................................................................................................33
Summary .......................................................................................................................................33
RESULTS .....................................................................................................................................33 Nature of Setting and Improvement Intervention ....................................................................34
PDSA Cycle .......................................................................................................................35 Plan. .......................................................................................................................35 Proposed changes. ................................................................................................38
Changes in Process of Care and Patient Outcomes Associated with the Intervention ..........40 Do .......................................................................................................................................40 Study .................................................................................................................................43 Act ......................................................................................................................................46
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TABLE OF CONTENTS – Continued
Summary .......................................................................................................................................46 DISCUSSION ...............................................................................................................................46 Relation to Other Evidence .........................................................................................................47 Limitations ....................................................................................................................................51 Strengths .......................................................................................................................................52 Interpretation ...............................................................................................................................52 Conclusion ....................................................................................................................................54 Significance to Nursing ................................................................................................................54
APPENDIX A: LETTER OF APPROVAL FROM MACHUCA FAMILY MEDICINE ...........56
APPENDIX B: IRB REVIEW NOT REQUIRED LETTER .......................................................58
APPENDIX C: ADA (2015) STANDARDS IN DIABETES FOR QI PROJECT ......................60
APPENDIX D: IMPLEMENTATION OT T2DM DECISION SUPPORT TOOL TRAINING
SHEET ................................................................................................................62
REFERENCES ..............................................................................................................................64
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LIST OF FIGURES
FIGURE 1. Plan-Do-Study-Act (PDSA) Cycle ........................................................................28
FIGURE 2. Run Chart Example ................................................................................................31
FIGURE 3. Fishbone Diagram Template ..................................................................................36
FIGURE 4. Fishbone Diagram ..................................................................................................38
FIGURE 5. A1C Testing Run Chart .........................................................................................42
FIGURE 6. LDL Testing Run Chart .........................................................................................42
FIGURE 7. Foot Exams Run Chart ...........................................................................................43
FIGURE 8. A1C Testing Median Comparison .........................................................................44
FIGURE 9. LDL Testing Median Comparison .........................................................................44
FIGURE 10. Foot Exams Median Comparison ...........................................................................45
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LIST OF TABLES
TABLE 1. T2DM Statistics at National and Local Level. .......................................................19
TABLE 2. T2DM Decision Support Tool. ...............................................................................29
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ABSTRACT
Type 2 diabetes mellitus (T2DM) is a chronic and debilitating disease contributing to the
rise in healthcare associated costs in the United States (ADA, 2013a; USDHHS, 2013). T2DM
management is complex and requires an ongoing multi-system approach (Goderis et al., 2010).
In this quality improvement project, the DNP student led a team in a family care practice setting
through a systematic quality improvement process, the PDSA cycle, for the improvement of
performance rates of quality indicators including A1C testing, LDL testing, and performance of
comprehensive foot examinations. The QI team developed a multi-component intervention to
include utilization of an electronic type 2 diabetes mellitus (T2DM) decision support tool. The
expected outcome was to increase current performance rates of A1C testing, LDL testing, and
comprehensive foot examinations at a family care practice by at least 10% within four weeks of
implementing the intervention. A1C testing improved from a pre-intervention median of 70.97%
to a post-intervention median of 91.38%, an increase of 20.41%. LDL testing improved from a
pre-intervention median of 74.19% to a post-intervention median of 91.38%, an increase of
17.19%. Comprehensive foot examinations improved from a pre-intervention median of 58.06%
to a post-intervention median of 84.48%, an increase of 26.42%. While results demonstrate a
trend of improvement, the duration of the intervention was insufficient for statistical
significance. The QI project served as a first systematic change process for the family care
practice and a model for future change processes at the clinic. This project highlights the DNP's
role in utilizing evidence-based research and applying a systematic change model for quality
improvement in the primacy care practice setting.
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INTRODUCTION
Background Knowledge
Diabetes mellitus (DM) is a prevalent health issue in the United States (U.S.) affecting an
estimated 25.8 million people, or 8.3% of the U.S. population (Centers for Disease Control and
Prevention [CDC], 2013a). Each year, an alarming 1.9 million adults are diagnosed with DM.
Both the incidence and prevalence of DM have more than tripled from 1980 to 2011 (CDC,
2013b). The estimated direct medical cost from DM is approximately $176 billion a year and an
additional $69 billion due to indirect costs such as disability (American Diabetes Association
[ADA], 2013a). DM has become a leading cause of death and hospitalizations in the U.S. (CDC,
2013a; U.S. Department of Health and Human Services [USDHHS], 2013). DM is a chronic and
debilitating disease with risk for complications and co-morbidities such as diabetic nephropathy,
neuropathy, retinopathy, and cardiovascular disease significantly contributing to the rise in
healthcare associated costs (ADA, 2013a; USDHHS, 2013). These complications from DM are a
leading cause of kidney failure, non-traumatic lower-limb amputations, and new cases of
blindness among adults in the U.S. (CDC, 2013a).
Pathophysiology of Diabetes Mellitus
Diabetes mellitus (DM) is a group of diseases characterized by abnormally elevated
blood glucose levels. Glucose metabolism is normally regulated by a feedback loop consisting of
pancreatic islet beta cells and insulin-sensitive tissues including the liver, muscle and adipose
tissue (Grossman, 2014; Kahn, Cooper, & Del Prato, 2014). Pancreatic beta cells produce insulin
in response to elevated glucose levels. Insulin mediates the uptake of glucose by insulin-sensitive
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tissues and suppresses glucose production in the liver. The amount of insulin produced is
regulated by feedback information about the need for insulin by these insulin-sensitive tissues.
In type 1 diabetes mellitus (T1DM) the pancreas is unable to produce insulin due to
destruction of pancreatic beta cells. Without insulin, tissues are unable to uptake glucose causing
severe hyperglycemia. Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder
characterized by insulin resistance and impaired insulin secretion that results in hyperglycemia
(Grossman, 2014; Kahn, Cooper, & Del Prato, 2014). Insulin resistance is a diminished tissue
response to insulin due to abnormalities in the insulin-receptor signal pathway and defects in
insulin-receptor function. This initially causes a state of compensatory hyperinsulinemia, or
higher than normal insulin levels produced by beta cells. Over time beta cells are unable to
compensate for increased glucose levels and begin to lose ability to produce adequate amounts of
insulin. This insulin deficiency then causes a state of hyperglycemia. This QI project will focus
on T2DM.
Deficits in T2DM Care
While the overall quality of healthcare in the United States is improving, T2DM care
continues to be inadequate (Gannon, Qaseem, & Snow, 2010; USDHHS, 2013). The National
Healthcare Quality Report (U.S. Department of Health and Human Services, 2013) and the
Institute of Medicine (IOM) (2001) have identified T2DM as a target condition for quality
improvement as T2DM care and health outcomes continue to be suboptimal. According to the
CDC (2012), only about 68.5% of adults with diagnosed DM received the recommended two or
more A1C tests in 2010 (Table 1). Glucose control was poor as only 52% of adults age 40 and
over with diagnosed DM achieved an A1C at or less than the recommended 7% in 2007 - 2010
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(USDHHS, 2013). Inadequate DM management is evident in the continued high hospital
admission rates and incidence of end-stage renal disease, heart disease, and stroke in patients
with diagnosed diabetes (CDC, 2013b).
T2DM management is complex and requires an ongoing multi-system approach (Goderis
et al., 2010). In addition to glycemic control, adequate control of blood pressure, cholesterol, and
receiving appropriate preventive care practices can help reduce the risk of complications from
T2DM (CDC, 2013a; Tricco et al., 2012; USDHHS, 2013). Standards of care help guide
clinicians on evidence based recommendations for screening, diagnostic and therapeutic
measures for improved patient outcomes and prevention of complications (ADA, 2015;
USDHHS, 2013). Despite evidence-based guidelines, nationally DM care continues to be
suboptimal as adherence to the guidelines is deficient and evidence-based practice goals are not
achieved (Gannon, Qaseem, & Snow, 2010; Tricco et al., 2012). A gap remains between
recommended practices and the actual care patients receive in the primary care setting (Tricco et
al., 2012).
Project Purpose
The purpose of this DNP quality improvement project was to develop and implement a
quality improvement (QI) project with Machuca Family Medicine Clinic in Las Vegas, Nevada
to improve the diabetes clinical management of patients with T2DM specific to standards of A1C
testing, LDL testing, and comprehensive foot examinations.
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Aims
The primary aim of the QI project was to increase performance rates of A1C testing, LDL
testing, and comprehensive foot examinations for patients with T2DM by at least 10%. The aim
was to be met within four weeks of implementing the QI project.
Standards of Medical Care in Diabetes – 2015
The ADA (2015) sets standards of care, evidence based recommendations, to guide
clinicians in screening, diagnosing, treating and preventing complications in patients with DM.
The standards of care include guidelines for foundations of care: education, nutrition, physical
activity, smoking cessation, psychosocial care, and immunization. Standards also include
glycemic targets, cardiovascular disease and risk management, and foot care.
Foundations of Care
Recommendations under foundations of care include education, nutrition, physical
activity, smoking cessation, psychosocial care, and immunization (ADA, 2015). Education refers
to diabetes self-management education (DSME) and diabetes self-management support (DSMS).
Patients with DM should receive evidence based DSME and DSMS at diagnosis and throughout
the disease process. DSME and DSMS are on-going processes that facilitate effective patient
self-management of DM. For nutrition therapy, the ADA (2015) recommends that all patients
with DM actively participate in the development of an individualized eating plan. People with
DM should receive ongoing individualized medical nutrition therapy, preferably by a registered
dietitian, to meet and address individual needs (ADA, 2015). The recommendations for physical
activity in adults with DM include performing at least 150 minutes a week of moderate intensity
aerobic physical activity over three days a week (ADA, 2015). There should be no more than two
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consecutive days without exercise. Unless contraindicated, adults with DM should perform
resistance training at least twice a week. Sedentary time should be limited by breaking up time
sitting greater than 90 minutes. The smoking cessation recommendations include advising all
patients not to smoke or use tobacco products and including smoking cessation counseling as
part of routine care (ADA, 2015). Recommendations for psychosocial care include ongoing
assessment and screening of the patient's psychological and social situation as part of ongoing
medical management of DM (ADA, 2015). This may include exploring patient attitudes about
the illness, expectations, quality-of-life, resources and psychiatric history. Screening for
depression should be routine especially in older adults and those with co-morbidities.
Immunization recommendations include providing routine vaccinations for all individuals with
DM (ADA, 2015). Individuals with DM six months of age and older should receive an influenza
vaccination annually. Patients two years of age and older with DM should receive a
pneumococcal polysaccharide vaccine 23. Adults 65 years of age and older should receive the
pneumococcal conjugate vaccine 13 and the pneumococcal polysaccharide vaccine 23 series.
The Hepatitis B vaccination should be administered to unvaccinated adults with DM aged 19 to
59 years of age and considered in adults with DM 60 years of age and older.
Glycemic Targets
Assessment of glycemic control may be performed through patient self-monitoring of
blood glucose and provider monitoring of A1C. The ADA (2015) recommends patient self-
monitoring of blood glucose as a component of self-management and to help guide treatment
decisions. A1C testing is a quality indicator used to determine glycemic control in patients with
T2DM. A1C levels reflect average blood glucose levels over the past three months (ADA, 2015;
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National Diabetes Information Clearinghouse, 2014). The A1C test is a standardized measure of
the amount of glucose attached to hemoglobin in red blood cells (National Diabetes Information
Clearinghouse, 2014). As red blood cells live approximately three months, the A1C levels
provide an average of glucose levels over the last few months. A1C levels are reported as a
percentage. A1C levels below 5.7% are considered normal in people without diabetes. Pre-
diabetes correlates with A1C levels between 5.7% and 6.4%. A1C levels at and above 6.5% are
consistent with diabetes.
The ADA has set a glycemic goal in adults with T2DM to an A1C level below or around
7% (2015). An A1C level of 7% correlates with a mean plasma glucose of 154mg/dl. A1C levels
are a strong predictive value for risk of complications in patients with T2DM. Maintaining A1C
levels below 7% has shown to help reduce the risk of diabetes complications (ADA, 2015;
National Diabetes Information Clearinghouse, 2014). A less stringent A1C level may be set for
patients with certain conditions such as a history of severe hypoglycemia, limited life
expectancy, advanced complications, or extensive co-morbidities (ADA, 2015). The ADA
recommends obtaining A1C testing twice a year in patients meeting stable glycemic control
(2015). For patients who do not meet glycemic control, the ADA recommends quarterly A1C
testing until goal is met. Pharmacologic therapy for DM is beyond the scope of this project.
Cardiovascular Disease and Risk Management
Components of cardiovascular disease and risk management recommendations set by the
ADA (2015) include hypertension/blood pressure control, dyslipidemia/lipid management,
antiplatelet agents, and coronary heart disease. The ADA (2015) recommends measuring blood
pressure at every routine visit. Individuals with an elevated blood pressure should have the blood
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pressure confirmed on a separate visit. Individuals with DM and hypertension should be treated
to have a systolic blood pressure of less than 140 mmHg and a diastolic blood pressure of less
than 90 mmHg. Certain patients, such as younger patients, may tolerate a lower target including
a systolic blood pressure of less than 130 mmHg and a diastolic blood pressure of less than 80
mmHg. Consideration of aspirin therapy is recommended in patients with DM at increased
cardiovascular risk, 10 year risk a greater than 10% (ADA, 2015). Aspirin is recommended in
patients with DM and a history of cardiovascular disease. Routine screening for coronary artery
disease is not recommended in asymptomatic patients. Treatment and pharmacological
management recommendations of high blood pressure and coronary artery disease are beyond
the scope of this project.
LDL levels are used as a quality indicator as they help determine risk for cardiovascular
disease and complications in patients with T2DM. In people with DM, there are increased
amounts of small dense low-density lipoproteins that are considered atherogenic, cause arterial
wall thickening. (Nesto, 2008; Ng, 2013). Arterial wall thickening is associated with
cardiovascular complications such as heart attack and stroke. Individuals with diabetes have an
increased risk for cardiovascular events and heart disease mortality (Nesto, 2008). For patients
with T2DM, glucose control alone is insufficient in decreasing cardiovascular complications.
The ADA (2015) recommends lipid monitoring and statin treatment based on risk status
rather than LDL cholesterol levels to help decrease cardiovascular disease risks and
complications. This is an update from previous ADA (2013b) recommendations targeting LDL
levels in patients with T2DM. Cardiovascular disease risk factors include LDL cholesterol
greater than or equal to 100 mg/dL, high blood pressure, smoking, and overweight and obesity
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(ADA, 2015). Initial lipid screening is recommended at the time of DM diagnosis, at an initial
medical evaluation, and/ or at age 40 years and periodically. For individuals on a statin, LDL
testing may be considered on an individual basis, for example every year. Statin therapy and
dosing is based on cardiovascular disease risk factors.
Foot Care
T2DM is one of the leading causes of lower limb ulceration and lower extremity
amputation in the United States (National Diabetes Education Program, 2000). Decreased
sensation and poor healing from peripheral neuropathy and peripheral vascular disease are
associated with the development of foot ulcerations (Praxel, Ford, & Vanderboom, 2011). An
ulcer precedes about 70% to 80% of amputations in people with T1DM and T2DM. Performing
recommended foot exams are essential in identifying foot problems in patients with T2DM and
may help prevent foot ulceration and amputations (National Diabetes Education Program, 2000;
Praxel, Ford, & Vanderboom, 2011). The ADA (2015) recommends an annual comprehensive
foot examination in patients with T2DM for early recognition and management of risk factors
that may help, prevent or delay ulcerations and lower extremity amputations. Patients with
decreased sensation, foot deformities, and ulcers should have feet examined at every visit.
General foot self-care education should be provided to all patients with DM.
While there are multiple recommendations for oversight of the care with patients with
diabetes, the DNP student focused on quality indicators chosen by the providers at the project
setting to include A1C testing, low-density lipoprotein (LDL) testing, and performance of
comprehensive foot exams.
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Local Problem
Patterns of healthcare quality vary across the nation with southern states typically having
lower performance (USDHHS, 2013). The state of Nevada, the setting for this DNP project, is in
the lowest quality quartile for overall quality of healthcare and in the second lowest quality
quartile for chronic care compared to the rest of the U.S. (USDHHS, 2013). Such patterns
become apparent when examining quality indicators for DM in the state of Nevada. The
percentage of adults with diagnosed DM in Nevada (Table 1) is similar to the national average at
about 8.1% (CDC, 2013b). Only about 63% of adult Nevada residents with diagnosed DM
received at least two A1C tests per year compared to the national average of 68.5% in 2010
(USDHHS, 2013). This indicates an urgency to improve the quality of diabetes care nationally,
and specifically for Machuca Family Medicine clinic in Nevada, to reduce the risk of
complications from diabetes.
TABLE 1. T2DM Statistics at National and Local Level.
Quality Indictors U.S. Nevada Machuca Family Medicine
Adults with Diagnosed DM 8.3% 8.1% 7.8% A1C at or Less than 7% 52% Unavailable 34% A1C Testing at Least Once a Year*
68.5% 63% 66%
LDL testing at Least Yearly* Unavailable Unavailable 72% Comprehensive Foot Exam at Least Yearly*
67.5% 57% 62%
*In patients with diagnosed DM
Providers at Machuca Family Medicine Clinic, a physician and an advanced practice
registered nurse (APRN) provide primary care at the family practice clinic located in an urban
community in Nevada. The providers identified a need for improvement in the delivery of care to
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adult patients with T2DM within their practice. The clinic providers reviewed health insurance
provider report cards and ran reports from the electronic health record on all adult patients
diagnosed with T2DM to analyze implementation of DM quality indicators.
One of Machuca Family Medicine Clinic’s largest health insurance providers has focused
on improving healthcare outcomes in patients with T2DM. The rationale for the focus on T2DM
was seen as important because of the high rate of insurance claims related to T2DM creating an
economic burden on the patients. The insurance provider prepares report cards for each practice
with quality indicator scores for patients with T2DM that address A1C levels, LDL levels, rates
of A1C testing, rates of LDL testing, rates of comprehensive foot examinations, rates of
influenza vaccinations given, and rates of referrals for eye examinations. Health care practices
with consistently low performance scores are at risk of losing their contract with the insurance
provider. In this manner, the insurance provider holds healthcare providers accountable for
quality patient care and patient outcomes. Deficits specific to adult patients with T2DM who
received their care at Machuca Family Medicine Clinic included A1C levels, A1C testing, LDL
testing, and performance of comprehensive foot examinations.
Machuca Family Medicine Clinic providers reviewed the quality indicator reports for
patients with T2DM who were seen within the last year (2014) to determine the care practices
needing improvement. A1C measures were suboptimal as only 34% of patients with T2DM had
an A1C at or below 7% (Table 1). This was far less than the national average of 52%. Of those
patients with uncontrolled T2DM, about 66% received recommended quarterly A1C testing. In
addition to A1C levels, LDL tests were analyzed for patients with T2DM at Machuca Family
Medicine Clinic. About 72% of patients with T2DM had an LDL test within the last year.
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Another quality indicator is frequency of foot examinations in patients with T2DM. Only about
62% of patients at Machuca Family Medicine Clinic with T2DM had a comprehensive foot
examination in the last year.
The providers with Machuca Family Medicine chose to initially address current deficits
in A1C testing, LDL testing, and comprehensive foot examinations. The rationale for focusing
on these indicators is due to below goal performance rates, less than 90%. Furthermore, changes
in performance rates may be measured on a weekly basis versus every three months for lab
results. Monitoring A1C and LDL levels helps providers determine glycemic control and
potential risk of complications such as diabetic nephropathy, neuropathy, retinopathy, and
cardiovascular disease (ADA, 2015). Comprehensive foot examinations helps providers identify
decreased sensation in feet and determine patient’s risk for foot ulcerations (ADA, 2015). Once
practice goals are met for these quality indicators, additional standards that require improvement
may be addressed.
Patients with T2DM increasingly depend on primary care practices such as Machuca
Family Medicine Clinic for care. Addressing the clinical management of patients with T2DM is
a crucial initial step for improving chronic disease quality indicators (Guzek, Guzek, Murphy,
Gallacher, & Lesneski, 2009). Monitoring quality indicators in patients with T2DM helps
providers determine adequacy of treatment plans and need for changes in interventions such as
medication management.
Expected Outcomes
Machuca Family Medicine Clinic has set a goal of meeting ADA standards at 90% in the
implementation rates of A1C testing, LDL testing and comprehensive foot examinations for
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patients with T2DM. For this QI project, the objective was to increase current performance rates
of A1C testing, LDL testing, and comprehensive foot examinations by at least 10% within four
weeks of implementing the project.
Summary
In this chapter, the prevalence and incidence of diabetes and the financial burden from
direct and indirect medical costs from diabetes and diabetes-related complications were
discussed. The pathophysiology of diabetes and the chronicity and complexity of disease
management were presented. The inadequacy of diabetes care at the national and local levels
despite available standards for care and evidence based guidelines, were deliberated. The project
purpose - to develop and implement a QI project with Machuca Family Medicine Clinic to
improve the diabetes clinical management specific to standards of A1C testing, LDL testing, and
comprehensive foot examinations for patients with diagnosed T2DM - and aims were presented.
The rationale for the proposed QI project was supported with an overview of the selected
performance rates at Machuca Family Medicine Clinic. Lastly, the expected outcome from the
proposed QI project, to increase current performance rates by at least 10% within four weeks of
implementing the project, was articulated.
METHODS
Ethical Issues
Nurse practitioners (NPs) provide patients with comprehensive chronic disease care and
focus on continually improving the quality of care in their healthcare setting (American
Association of Nurse Practitioners, 2015). QIs are systematic, data-guided activities aimed at
bringing about immediate improvements in quality indicators such as efficiency, effectiveness,
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performance, accountability, and outcomes that improve the health of the community (Minnesota
Department of Health, 2014). Ethical standards were followed in the development and
implementation of this QI project. The DNP student considered seven ethical requirements for
the protection of human participants in this QI project: (a) social or scientific value; (b) scientific
validity; (c) fair participation selection; (d) favorable risk-benefit ratio; (e) respect for
participants; (f) informed consent; and (g) independent review (Taylor, Pronovost, Faden, Kass,
& Sugarman, 2010).
To ensure the social and scientific value of QI activity, the DNP student based the
interventions on evidence-based standards set by the ADA (2015). These standards are aimed at
reducing risk of disease complications and improving patient outcomes in patients with T2DM
(ADA, 2015). Another ethical requirement is scientific validity, having a methodologically
structured project. The conceptual framework for this QI project is the Plan-Do-Study-Act
(PDSA) cycle, a systematic QI model used for improving processes and carrying out change
(Minnesota Department of Health, 2014). The intervention was applied to all adult patients 18
years and older with a diagnosis of T2DM receiving care at Machuca Family Medicine Clinic
during the time of the project, to ensure patients received fair and equitable care.
QI projects should be designed to limit risks while maximizing potential benefits to meet
a favorable risk-benefit ratio (Taylor, Pronovost, Faden, Kass, & Sugarman, 2010). QI projects
are typically congruent with patient interests and present lower risk than continuing with usual
care. The aim of this improvement project was to increase current performance rates of A1C
testing, LDL testing, and comprehensive foot exams by at least 10% within four weeks of
implementing the project at Machuca Family Medicine Clinic. The potential to improve
24
performance rates by 10% posed a lower risk than continuing the usual care - performance rates
below the clinic goal of 90%.
The DNP student maintained respect for participants through the QI process by protecting
privacy and maintaining confidentiality. In the collection of data, privacy was maintained by
using de-identified queries from the EHR that were used to evaluate performance rates. The DNP
student only received de-identified raw data prepared by the data specialist at Machuca Family
Medicine Clinic. The DNP student did not perform any data collection on her own. Informed
consent was waived in accordance with IRB as the QI did not expose the patients to additional
risks beyond those in standard clinical care. Performance of A1C testing, LDL testing, and
comprehensive foot examination per ADA guidelines is part of standard care at the Machuca
Family Medicine Clinic, though not consistently implemented by the healthcare providers for
patients with T2DM. Informed consent may be waived if the QI project poses no more than
minimal risk, is not practical, and all data are collected as part of routine care (Baker & Persell,
2015). Patients had the right to decline any tests or measures recommended by the provider as
they do with the usual care.
The DNP student obtained approval from The University of Arizona Human Subjects
Protection Program (HSPP) to conduct the QI project (Appendix A). HSPP determined that the
project did not require Institutional Review Board approval as the project activity was to assess,
analyze, critique, and improve current processes of health care delivery in an institutional setting.
Furthermore, the activity involved data-guided, systematic activities designed to bring about
prompt improvements in health care delivery in the Machuca Family Medicine Clinic.
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Setting
Machuca Family Medicine Clinic is a private family care practice with two locations in
Las Vegas, Nevada. The primary provider, a physician, owns the clinics. The DNP obtained
permission to conduct the QI project (Appendix B). The DNP student, an APRN, lead the QI
project at the smaller clinic location. The clinic is staffed by an APRN, an office manager, a
medical assistant, and a receptionist. Each staff member is equipped with a laptop with access to
Practice Fusion, the electronic health record implemented in the clinic. The clinic serves patients
with Medicare, Medicaid, private insurance, and no insurance. About 7.8% of patients have a
diagnosis of T2DM. Patients typically visit one clinic for routine visits, usually choosing the
closest location to patient’s address, but are able to schedule at either location. Established
patient appointments are allocated a 15-minute visit with the provider. Each provider typically
sees between 30 and 40 patients daily. As the practice has grown, time with patients has become
more limited creating a need to be more efficient while providing quality care.
Planning the Intervention
QI projects involve using a systematic improvement process, such as the PDSA cycle,
that focuses on feasible organizational changes to achieve measurable improvements (Minnesota
Department of Health, 2014). Prior to implementation, a plan for the implementation of the QI
project must be developed. The plan consists of providing details on what the organization is
trying to accomplish and how the organization will manage, deploy, and review quality. The plan
needs to inform staff and stakeholders on details for the QI including the direction, timeline,
activities and importance of quality and QI.
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The first component of planning an intervention is defining the vision, scope, and goals
of quality for the organization (Minnesota Department of Health, 2014). The Machuca Family
Medicine Clinic’s vision for quality is to provide the right care to the right patient at the right
time, every time. The clinic’s goals for quality are to continually improve safety, effectiveness,
patient-centered, timely, efficient, and equitable care. Providers at the Machuca Family Medicine
Clinic identified a need for QI within the organization, as goals for care in patients with T2DM
were not being met. Specifically, performance rates of A1C testing, LDL testing, and
performance of comprehensive foot examinations, as recommend by ADA guidelines (2015),
were below the goal of 90% (Table 1).
The structure for the QI project was defined including resources, roles, and
responsibilities. The DNP student led the QI project as a pilot at Machuca Family Medicine
Clinic. The PDSA cycle provided the conceptual framework for QI. Details on each step of the
PDSA cycle are described in the following sections. The owner of the practice, the primary
physician, oversaw and provided approval for all decisions prior to implementation. The owner
of the practice also provided the DNP student with access to the data specialist for collection of
de-identified data. The DNP student recruited support staff for the development of the QI team as
described in detailed below.
The next component of planning an intervention was defining the goals, objectives and
measures for the QI project (Minnesota Department of Health, 2014). The overall goal for the QI
was to improve quality of care in patients with T2DM at the Machuca Family Medicine Clinic.
Quality indicators include performance rates of A1C testing, LDL testing, and comprehensive
foot examinations for patients with T2DM. The objective was to increase current performance
27
rates of A1C testing, LDL testing, and comprehensive foot examinations by at least 10% within
four weeks of implementing the project.
Recruitment
During the first week of the QI project, the DNP student met with the Machuca Family
Medicine Clinic staff to develop the QI team. The DNP student presented the office manager,
MA, and receptionist a power point presentation with background information on T2DM disease
process, ADA standards of care in clinical management of T2DM, analysis on current clinical
performance rates for A1C testing, LDL testing, and comprehensive foot exams at Machuca
Family Medicine Clinic, and an overview of the PDSA cycle for QI. The DNP student explained
that current performance rates at Machuca Family Medicine Clinic were below the goal of 90%
(Table 1). The primary physician, a major stakeholder, attended this meeting to highlight the
need to improve performance rates of A1C testing, LDL testing, and comprehensive foot exams
to maintain contracts with health insurance providers. The DNP student and primary physician
answered all questions from the staff. The DNP student offered the staff the opportunity to
voluntarily join the QI team at Machuca Family Medicine for the development and
implementation of the QI project. All staff members agreed to join the QI team.
Plan-Do-Study-Act (PDSA) Cycle
The Plan-Do-Study-Act (PDSA) cycle (Figure 1) is a four-step systematic QI model used
for improving processes and carrying out change (Minnesota Department of Health (MDH),
2014). Research findings highlight the need for interventions in healthcare to adapt to the local
context and respond to complex systems (Taylor et al., 2014). In this QI project the DNP student
led the QI team through the PDSA cycle to implement a change process for improving
28
implementation rates of A1C testing, LDL testing, and performance of comprehensive foot
examinations for adult patients diagnosed with T2DM at Machuca Family Medicine Clinic. The
QI team used the PDSA cycle, as it is an effective QI tool that facilitates rapid assessment during
change and provides continuous learning from feedback for adaptation (Taylor et al., 2014; The
W. Edwards Deming Institute, 2014). Each step of the PDSA cycle was explained in detail
below.
FIGURE 1. Plan-Do-Study-Act (PDSA) Cycle (MDH, 2014).
Plan
The first step in the PDSA cycle is the Plan stage. The plan stage consists of identifying
and planning the change to be implemented. To effectively address clinical problems, the nature
of the problem needs to be identified prior to seeking a solution (Hewitt-Taylor, 2012). Root
cause analysis involves exploring what appears to have happened, different people's perception
of what happened and why people perceive there to be a problem. Causes and effects are
differentiated during this process and various elements and possible causes of a problem are
29
identified. Utilizing a root cause analysis tool to conduct a systematic problem analysis can help
challenge assumptions and provide prompts to investigate causes to the problem. Furthermore,
changes are more likely to be successful when those required to change understand why the
changes are needed and are involved in the problem analysis process.
The DNP student facilitated a discussion with the stakeholders about the absence of a
T2DM decision support tool (Table 2) as a potential barrier and contributing factor to the
problem of low implementation rate of standards in A1C testing, LDL testing, and
comprehensive foot examinations in patients with T2DM at Machuca Family Medicine Clinic.
The tool lists quality indicators needing improvement within the practice including A1C tests,
LDL tests, and comprehensive foot exams. It provides the last date tests were performed, the lab
value, and whether tests were ordered or performed during the office visit. The T2DM decision
support tool is intended to provide point-of-care information about patients with T2DM and
provide reminders for timely implementation of T2DM ADA (2015) standards.
TABLE 2. T2DM Decision Support Tool.
T2DM Decision Support Tool (ADA Standards, 2015)
A1C Last lab date: Value: Ordered today � *Recommended every 3 months if A1C >7% and every 6 months if A1C <7%
LDL Last lab date: Value: Ordered today � *Recommended at least once a year
Comprehensive Foot Exam Last exam date: Performed during visit � *Recommended at least once a year
The QI project took place over a six-week period, the duration of one PDSA cycle.
During week 1, the DNP student facilitated recruitment of the staff, provided background
information on the identified problems to emphasize the need for change, applied the Fishbone
Diagram for conducting a root cause analysis, selected priority measures for change, and
30
collaborated with the QI team to develop an intervention to achieve the perfect project aim.
Implementation occurred in weeks 2-5 and data regarding implementation of the selected T2DM
quality indicators concurrently be collected during this time. The QI team met each week to
discuss and review observations specific to implementation of the select quality indicators.
During week 6, the DNP student reviewed data and analyzed results. The DNP student reviewed
T2DM de-identified data with the QI team and compared the desired outcomes with the actual
outcomes. This completed one PDSA cycle and this project.
Do
Once planning was complete, implementation began in the Do step. The plan was carried
out on a small scale as initial plans do not always produce desired outcomes (Institute for
Healthcare Improvement, 2014). The QI project was implemented at the Machuca Family Clinic
staffed by an APRN, an office manager, a medical assistant, and a receptionist. The QI team
implemented the proposed solutions derived from the Fishbone Diagram during this stage.
The implementation of the proposed process changes began on week 2 and continued
through week 5. The QI team met once a week for 30 minutes on Fridays to discuss, review, and
document observations. The Do step also includes documenting any problems and unexpected
observations. The QI team discussed pertinent issues and made suggestions for improvement.
Each week the team reviewed observations from the implemented changes.
Data collection and analysis began during the Do step (Institute for Healthcare
Improvement, 2014; The W. Edwards Deming Institute, 2014). The QI team utilized run charts
to plot data from the data specialist each week. The team visually compared weekly performance
rates against pre-intervention rates.
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Planning the Study of the Intervention
Study
Descriptive statistics will be used during the Study phase of the PDSA cycle to determine
if the change being implemented resulted in an improvement. This step consists of reviewing the
results and completing data analysis (Institute for Healthcare Improvement, 2014). The QI team
will use run charts to evaluate the expected outcome. A run chart (Figure 2) is a graph that
displays data over time and may be used to assess the effectiveness of change (Institute for
Healthcare Improvement, 2014). Data are plotted over an X and Y axis. Time is plotted on the X
axis and the variables being measured are plotted on the Y axis. The median is added as a
reference point and to help determine non-random patterns (Perla, Provost, & Murray, 2011). A
goal or target line is added to the chart to visually display expected outcome. While run charts
work best with more than 10 data points, a smaller amount of data may still provide an early
indication of central tendency and trend.
FIGURE 2. Run Chart Example (Institute for Healthcare Improvement, 2014).
For this project, data was collected by the data specialist once a week over a four week
period after the intervention. Data was obtained from four weeks prior to the intervention for
32
comparison, analysis of change. The variables that were measured included performance percent
rates of A1C testing, LDL testing, and comprehensive foot examinations. The DNP student will
obtained weekly de-identified EHR queries from the data specialist at Machuca Family Medicine
Clinic that included raw data on the performance of A1C testing, LDL testing and
comprehensive foot examinations on patients meeting criteria for inclusion in the program
evaluation. The DNP student will calculated the percent, performance rate, for each A1C testing,
LDL testing and performance of comprehensive foot examinations and plotted them on separate
run charts. The QI team visually determined how well or poorly the change performed. The
intended outcome was to increase implementation rates of A1C testing, LDL testing, and
comprehensive foot examinations for patients with T2DM by at least 10%. The actual outcomes
of change will be compared to the intended results. This was done by comparing the pre-
intervention median rates to the post-intervention median rates. Lessons learned were be
summarized for reflection and will be used in developing the next cycle of change.
Analysis
An essential aspect of QI projects is the ability to demonstrate that the intervention brings
about a measurable difference in the process measures. The DNP student will utilize run charts
(Figure 2) as a tool for analysis of the QI. Run charts help QI teams determine if a process
demonstrates non-random patterns over time and if changes tested resulted in improvement
(Perla, Provost, & Murray, 2011).
Three probability rules are used when analyzing run charts to demonstrate evidence of
non-random patterns in the data based on a level of significance of p<0.05 (Perla, Provost, &
Murray, 2011). These rules include: shift- six or more consecutive points all above or all below
33
the median; trend- five or more consecutive points all going up or all going down; and runs-too
few or too many crossings of the median line based on set critical values. These rules require
more than 10 points to be applicable, however, run charts with fewer data points may still be
useful. A smaller amount of data points can help determine an early indication of a trend. In
these instances, pre-intervention medians and post-intervention medians are used for comparison.
For this QI, pre-intervention and post-intervention medians will be compared.
Act
The following element in the PDSA cycle is the Act step. During the Act step,
modifications are made to the intervention based on the lessons learned during the previous steps
(Minnesota Department of Health, 2014). This is the final stage for this QI project. Based on
outcomes the team may: adapt- modify the changes and repeat PDSA cycle; adopt- consider
expanding the changes to the additional clinic; or abandon- change the approach and repeat the
PDSA cycle (Centers for Medicare and Medicaid Services, n.d.).
Summary
This chapter presented the methods for the QI project. An overview of ethical
considerations was provided. The project setting and recruitment of staff were described. The
PDSA cycle used to guide the implementation of the proposed QI intervention was explained.
Lastly, an overview of data collection and analysis to evaluate the QI intervention and practice
change were discussed.
RESULTS
The aim of the QI project was to increase performance rates of A1C testing, LDL testing,
and performance of comprehensive foot examinations by 10% within four weeks of
34
implementing the QI. The expected primary outcome was a 10% increase in the pre-intervention
median for each of the quality indicators. Performance rates improved within the four weeks of
the QI implementation. While the clinic goal is to have 90% performance rates for each of the
measures, a 10% increase from the pre-intervention median would provide an early indication of
improvement. Figures 8, 9, and 10 demonstrate the run charts for each quality indicator with pre-
intervention and post-intervention medians for comparison. While these run charts demonstrate
improvement in performance rates, longer-term analyses are needed to determine sustainability.
Nature of Setting and Improvement Intervention
The QI project was conducted at the Machuca Family Medicine Clinic, a privately owned
family care practice servicing the Las Vegas, Nevada area. The practice has two locations and
this QI project was conducted at the smaller location as a pilot. The clinic serves an array of
patients including those with Medicare, Medicaid, private insurance, and cash paying patients.
Elements of the setting including physical resources, organizational culture, and history of
change efforts as well as structures and patterns of care including staffing and leadership
influenced the context for this intervention (Institute for Healthcare Improvement, 2014).
The owner of the Machuca Family Medicine Clinic, the primary physician, focuses on
providing quality care to all patients. The primary physician advocates a culture of continuous
change and improvement to provide affordable quality care to all patients. Since the opening of
the practice four years ago, the primary physician, along with the healthcare team, have been
making process changes to improve the quality of care for patients; however, a structured QI had
never been conducted. One of the primary insurance providers for the practice provides report
cards on quality care measures for patients with T2DM. Deficits in A1C testing, LDL testing,
35
and comprehensive foot examinations prompted the healthcare providers to focus on quality of
care for patients with T2DM.
The primary physician oversaw all aspects of the QI project and assigned the DNP
student as a QI champion. In ongoing efforts for improving care, a data specialist was hired to
help identify and monitor the quality of care for the practice. The data specialist was available to
the DNP student throughout the QI project and provided weekly de–identified data. All staff
members at the pilot clinic voluntarily joined the QI team.
PDSA Cycle
The QI team worked through one PDSA cycle in the implementation of the proposed
changes for improvement of A1C testing, LDL testing, and performance of comprehensive foot
examinations at the Machuca Family Medicine Clinic.
Plan. The QI team used the Fishbone (Ishikawa) Diagram (Figure 3) as a root cause
analysis tool to identify barriers and contributing factors to the problem - low implementation
rate of standards in A1C testing, LDL testing, and comprehensive foot examinations in patients
with T2DM at Machuca Family Medicine Clinic (Institute for Healthcare Improvement, 2014).
The Fishbone Diagram is a visual tool that aids QI teams in identifying possible causes of an
identified effect, or problem. The Fishbone Diagram helps team members recognize the
relationship between categories of potential causes, system and outside forces, and their
influence on the effect or outcome. These categories may include materials, methods and
process, environment, equipment, people, and measurement. The DNP student guided the QI
team in determining specific causes at Machuca Family Medicine Clinic that lead to low
36
implementation rates of A1C testing, LDL testing, and performance of comprehensive foot
examinations.
FIGURE 3. Fishbone Diagram Template (Institute for Healthcare Improvement, 2014).
The DNP student led the QI team in the development of a Fishbone Diagram (Figure 4)
to identify possible causes to the problem - low implementation rates of A1C testing, LDL
testing, and performance of comprehensive foot examinations. The DNP student introduced the
team to the Fishbone Diagram tool by showing an example. A white board was utilized to
complete the diagram. The DNP student drew a horizontal line in the middle of the white board
ending with an arrow pointing to a box. The problem statement was written inside the box. Four
diagonal lines or “fishbones” were drawn stemming from the horizontal line. Each line was
labeled for a category of potential causes to the problem including equipment/supplies,
environment, methods/measurements, and staff/people. The team brainstormed on possible
barriers that could potentially result in low implementation rates of A1C testing, LDL testing,
37
and performance of comprehensive foot examinations. The team reflected on the clinical care
process for patients with T2DM under each category. The DNP student probed the team by
stating the problem and asking “why does this happen?” Each response or cause was placed
under the appropriate category. For example, “lack of supplies in exam rooms” was placed under
the equipment/supplies category. With each response the DNP student continued to ask “why
does this happen?” to help create specific enough responses that would prove useful when
creating change. For example, a sub-cause of “lack of supplies in exam rooms” would be
“supplies are kept in a central location outside the exam rooms.” Probing of the QI team
continued until responses were exhausted and considered variations of previous responses were
considered. The DNP student led the team in a discussion about the relationships between each
category and how they affect each other. For example, having an electronic health record that is
difficult to navigate adds to the providers’ workload and adds pressure to the time allotted with
patients.
The team discussed and agreed upon four causes that the team felt could be changed for
improvement including the lack of reminders or notices to guide providers on standards, patients
not identified as having T2DM with no additional measures at time of rooming, and lack of
communication between support staff and providers for needs in ordering labs and performance
of foot exams. The four selected causes were highlighted on the Fishbone diagram (Figure 4).
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FIGURE 4. Fishbone Diagram.
Proposed changes. For each cause chosen from the Fishbone Diagram, the team
developed a potential solution to create change for improvement:
1. Cause: Support staff is not educated on standards of care for T2DM patients.
Proposed Solution: The DNP student will provide staff with a handout listing the ADA
(2015) standards specifically related to A1C testing, LDL testing, and performance of
comprehensive foot exams.
Equipment/ Supplies Environment
Methods/ Measurement
Staff/ People
Low implementation rates of A1C testing, LDL testing, and performance of comprehensive foot exams.
Fishbone Diagram
Electronic health record limitations
Lack of supplies in room
Workload
Scheduling
Rooming
Staff knowledge
Communication
Lack of support tool
Time with patients is limited to about 15min.
Lack of reminders or notices to guide providers on standards and due dates for labs and foot exams
Difficult to navigates between windows to obtain lab results
Supplies for foot exams and lab orders are in central location, outside rooms
Patients are not identified as having T2DM at time of scheduling
Patients are not identified as having T2DM with no additional measures at time of rooming
Support staff is not educated on standards of care for T2DM patients
Lack of communication between support staff and providers for needs in ordering labs and performance for foot exams
Administrative support
Lack of policies and feedback for T2DM level of care
39
2. Cause: Supplies for foot examinations and lab order forms are in a central location
outside the exam rooms. This adds to the provider and MA workload in having to look
for supplies and interrupt time spent with the patient.
Proposed Solution: Each examination room will be stocked with lab orders, chux pads,
and monofilaments. The MA will routinely stock examination rooms on a daily and as
needed basis.
3. Cause: Lack of reminders or notices to guide providers on ADA (2015) standards and due
dates for labs and foot examinations.
Proposed Solution: The T2DM decision support tool (Table 2) will be implemented into
EHR. The T2DM decision support tool will provide point-of-care information about
patients for the provider and support staff. The T2DM decision support tool will be
applied to the EHR for all adult patients 18 years and older with a diagnosis of T2DM at
Machuca Family Medicine Clinic. This will include patients with and without co-
morbidities. It will serve as a reminder for ordering A1C tests, LDL tests, and performing
comprehensive foot examinations for patients with T2DM utilizing ADA (2015)
standards.
4. Cause: Patients are not identified as having T2DM with no additional measures at time of
rooming.
Proposed Solution: During patient intake, the MA will review patient diagnosis for
identification of patients with T2DM. If patient is identified as having T2DM, the MA
will review the T2DM Decision Support Tool, update any labs and identify the need for a
comprehensive foot examination. If needed, the MA will give the patient a chux pad,
40
have patient remove shoes and socks in exam room, and ensure room is stocked with
monofilaments. The MA will prepare a lab order for the provider to sign if deemed
appropriate.
Changes in Process of Care and Patient Outcomes Associated with the Intervention
Do
With planning complete, the QI team continued with the next step Do, implementing the
proposed changes. The DNP student met with the data specialist and EHR technical support team
to add the T2DM Decision Support Tool to the EHR. The tool was successfully added to the
EHR. The tool remained “closed” to allow for training of the staff to use the tool. The tool was
functional in the test EHR environment for the duration of the training and PDSA.
Next, the DNP student met individually with each staff member of the Machuca Family
Medicine Clinic for training on the use of the T2DM decision support tool and proposed process
changes. One hour was allocated daily during the first week for each member to meet with the
DNP student for training. The DNP student provided each member with a simple outline of ADA
(2015) standards specifically related to A1C testing, LDL testing, and performance of
comprehensive foot exams (Appendix C) and a training sheet (Appendix D).
Implementation of the proposed changes began on week 2 of the PDSA cycle. Prior to
rooming patients on day 1, the QI team met briefly to review the proposed changes. Addressing
the first change, the DNP student distributed a simple outline of ADA (2015) standards
specifically related to A1C testing, LDL testing, and performance of comprehensive foot exams
(Appendix C). The outline was made available to each staff member and they kept it in their
workspace for reference throughout the duration of the QI project. For the second proposed
41
change, the MA stocked each of the exam rooms with foot examination supplies, including chux
pads and monofilaments, and lab orders. The MA was responsible for keeping each of the rooms
stocked throughout the duration of the QI project. For changes three and four, the DNP student
reviewed the training material (Appendix D) from the previous week with the staff regarding
utilization of the T2DM decision support tool. The MA was able to follow the steps for
completing the T2DM decision Support Tool for the provider to review during the patient visit.
The steps included identifying patients with a diagnosis of T2DM, reviewing the T2DM decision
support tool, updating laboratory results and identifying the need for a comprehensive foot
examination. The MA prepped the rooms for the provider as needed.
At the end of the week, the QI team met to discuss process changes and identify any issues with
the changes. The DNP student received the de-identified data on performance rates of the quality
indicators - A1C testing, LDL testing, and performance of comprehensive foot examinations.
The results were plotted on run charts for review (Figures 5, 6, & 7). The team stated that the
T2DM decision support tool was “easy to follow and straightforward.” The QI team voiced
concerns over increased time needed to room patients with T2DM due to extra steps the MA was
responsible for at patient intake. The team brainstormed on possible solutions and agreed that the
MA would review the schedule daily and begin filling out the T2DM decision support tool prior
to patient arrival when possible. The changes were continued weeks 3-5 and the QI team met
weekly for ongoing feedback on the implementation of changes. The QI team was able to
maintain focus on the aim of the project by meeting each week and reviewing progress. Each
week the DNP student received de-identified data that were added to the run charts (Figures 5, 6,
& 7). The QI team reported being able to follow the process changes the majority of the time.
42
69% 73% 71% 71%
87% 85%
100% 93%
0%
25%
50%
75%
100%
125%
5/8/15 5/15/15 5/22/15 5/29/15 6/5/15 6/12/15 6/19/15 6/26/15
A1C Testing
A1C Test Median = 80.83% Goal = 90%
FIGURE 5. A1C Testing Run Chart.
FIGURE 6. LDL Testing Run Chart.
43
FIGURE 7. Foot Exams Run Chart.
Study
The Machuca Family Medicine Clinic data specialist provided data on the quality
indicators. The DNP student received weekly de-identified raw data from EHR queries for four
weeks post-intervention. Raw data from four weeks pre-intervention were also provided for
comparison. This included the total number of patients with T2DM seen each week and the
number of A1C tests, LDL tests, and comprehensive foot examinations performed. The DNP
student calculated the performance rate by dividing the number of patients who received the
service by the total number of eligible patients.
The effectiveness of the QI project was evaluated by comparing pre-intervention and
post-intervention performance rates of A1C testing, LDL testing, and performance of
comprehensive foot examinations (see Figures 8, 9, & 10).
44
FIGURE 8. A1C Testing Median Comparison.
FIGURE 9. LDL Testing Median Comparison.
45
FIGURE 10. Foot Exams Median Comparison.
The expected outcome of this QI project was to increase performance rates of A1C
testing, LDL testing, and comprehensive foot examinations by at least 10% within four weeks of
implementing the project. Results demonstrate a trend of improvement in performance rates of
A1C testing, LDL testing and performance of comprehensive foot examinations; however, the
duration of the intervention was insufficient to apply probability based rules for significance.
There was an increase in performance rates for A1C testing, LDL testing, and performance of
comprehensive foot examinations (Figures 8, 9, & 10). A1C testing improved from a pre-
intervention median of 70.97% to a post-intervention median of 91.38%, an increase of 20.41%.
LDL testing improved from a pre-intervention median of 74.19% to a post-intervention median
of 91.38%, an increase of 17.19%. Comprehensive foot examinations improved from a pre-
intervention median of 58.06% to a post intervention median of 84.48%, an increase of 26.42%.
46
For A1C testing and LDL testing, the post-intervention median met the clinical goal for
performance rates of 90%.
Act
The QI team met on week 6 of the intervention to review the outcomes of the PDSA
cycle. The DNP student led a discussion for feedback on the observations from the
implementation of the project. Overall, the QI team felt satisfied with implementation of the
changes and the positive outcomes. The QI team suggested extending the changes longer-term as
a potential next step to determine if positive outcomes would be sustainable. This is consistent
with the underpinnings of the PDSA cycle that it may be repeating by either modifying the
intervention or developing a new plan (Institute for Healthcare Improvement, 2014; Minnesota
Department of Health, 2014). The team also suggested reviewing A1C levels and LDL levels for
patients with T2DM in three months and six months to determine if the changes will affect these
levels. The PDSA cycle is ongoing with continuous modifications to change based on outcomes
and need for improvement (Taylor et al., 2014).
Summary
This chapter presented the results, the actual QI project outcomes compared to the
expected outcomes. Each step of the PDSA cycle was presented as performed by the QI team.
The nature of the setting and the improvement intervention were discussed. Changes in process
of care and patient outcomes associated with the intervention.
DISCUSSION
The QI team successfully completed one cycle of the PDSA cycle. The aim of the QI
project was met as performance rates of A1C testing, LDL testing, and comprehensive foot
47
examinations for patients with T2DM increased by more than 10% over four weeks of
implementation of the intervention. Pre-intervention medians were compared with post-
intervention medians to analyze results. A1C testing rates improved by 20.41%, LDL testing
rates improved by 17.19%, and comprehensive foot examination rates improved by 26.42%. A
major strength of this QI project was the QI team’s willingness to participate in the PDSA
process and ability to implement the changes in the short amount of time.
Relation to Other Evidence
Previous studies have shown improvement in DM care in the primary care setting when
multi-component quality improvement interventions are utilized (Guzek, J., Guzek, S., Murphy,
Gallacher, & Lesneski, 2009; Lasky, Homa, & Splaine, 2010; Peterson et al., 2008). Components
of these interventions included changes to visit structure, protocol driven electronic reminders
for staff, clinical decisions support, and audit and feedback. In these studies, providers as well as
staff members were involved throughout the development and implementation processes of the
interventional changes.
Lasky, Homa, and Splaine (2010) evaluated an improvement team’s ability to produce
change in the delivery of care for patients with DM. In this study, an improvement team was
created that included providers and staff members in a general medicine clinic. The team worked
through root cause analysis in the development of interventions aimed at improving routine DM
care. The interventions focused on visit-based care and providing increased transparency of
patient data at practice and team levels. Staff members were involved in modifying workflow
and tools, identifying barriers, and documenting items in the electronic medical record. Another
aspect of the intervention consisted of identifying patients before their appointments,
48
determining whether they needed a test done, and documenting these needs on a flow sheet, a
patient visit-based tool. Nursing staff utilized the patient visit-based tool to document current and
new data on quality indicators. Using the visit-based tool helped the providers quickly identify
tests that needed to be completed. To analyze changes, the team identified annual eye and foot
examinations, annual urine microalbumin measurement, and pneumococcal vaccinations as
quality measures. During a two year period, all quality measures had statistically significant
(p<0.01) improvement. Performance of annual foot examinations had the highest improvement,
from 21% to 59%. It should be noted that a nurse practitioner led the training for licensed
nursing assistance staff on interventional changes related to performance of foot exams.
The effect of a multi-tiered quality improvement intervention on DM care was evaluated
over a 12 month period (Guzek, J., Guzek, S., Murphy, Gallacher, & Lesneski, 2009). A quality
committee comprised of providers, clinical staff, representatives from information-technology,
and administration sought to develop a DM care process change based on best practice and
consensus. The committee determined an urgent need to address unacceptable baseline levels of
care. The intervention consisted of protocol-based electronic tools to guide nursing staff and
clinicians including prompts, electronic clinical decision support, tailored handouts to encourage
patient self-management, and a simplified referral process for DM education. The electronic
protocol based tool loaded automatically to at the beginning of each visit. Prompts, including
pop-up dialog boxes, within the electronic medical record directed nursing staff and clinicians on
protocols. The committee examined a number of study indicators including measurement of
A1C, blood pressure, cholesterol, urine microalbumin, and performance of eye exams and foot
exams. A1C levels, blood pressure levels and cholesterol levels are also evaluated. The DM
49
summary index, the average percentage of the 12 study indicator outcomes was created as a
summary measure. Results demonstrated a robust improvement in quality measures (p<0.001).
Over the 12-month intervention, the DM summary index increased from 61.2% to 70.1%, an
increase of 8.87%. The greatest change was found in performance of foot examinations and urine
microalbumin, an increase of 34.6% and 21.2% respectively. This study highlights the potential
for rapid improvement in quality indicators when team members have a common goal, quality is
built into the encounter, and regular feedback is provided.
A systematic review and meta-analysis conducted by Tricco et al. (2012) examined the
effectiveness of QI strategies on the management of DM (Tricco et al., 2012). Studies included
in the review were those that assessed 11 predefined QI strategies or financial incentives to
improve patient management of adult outpatients with DM. There were 48 cluster-randomized
trials and 94 patient-randomized trials that met the criteria. A number of outcome quality
indicators were reviewed including A1C, LDL, and monitoring for DM complications. The
authors found that QI strategies significantly improved A1C, LDL, aspirin use, antihypertensive
drug use, retinopathy screening, renal screening, and foot screening. QI strategies noted to have
the most improvement on A1C control were those that targeted health systems and patients.
Studies that enrolled patients with higher baseline A1C levels, greater than 8%, found team
changes, case management, patient education, and promotion of self-management to be the most
effective strategies for improvement.
A qualitative evaluation conducted by Wan, Makeham, Zwar and Petche (2012)
examined the uptake and use of an electronic DM support tool by general practitioners and
practical nurses. Perspectives on the impact of the tool were also described. The electronic
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decision support tool used by providers was designed to support primary care practitioners in the
care and management of patients with T2DM. Features of the tool included a toolbar showing the
patient’s latest measurements, highlighting whether they were at the recommended level of due
for a check-up. The tool brought together critical information to an easy-to-review format. The
tool was compatible with the clinical record system and allowed for proactive monitoring of
patient health status and progress to clinical goals. A total of 22 general practitioner and two
practical nurses participated. Data was collected utilizing telephone interviews. Results found
that the electronic DM support tool had a positive impact on the quality of care of T2DM and
facilitated practitioners’ ability to more effectively manage patients with T2DM. The main
reason practitioners reported using the tool was that the tool provided a quick summary of patient
care, provided reminders of risk factor information and care that was outstanding. The tool
helped reinforce application of the guidelines for DM management. The providers also used the
tool as a visual aide for patient education by sharing the screen with the patients and not having
to navigate through various fields for results and recommendations. Barriers identified included
slow loading speed, missing pathology results, lengthening of consultation time, poor knowledge
of tool functions, time pressure, and lack of incentives. Overall, practitioners did find the tool to
be useful and was considered feasible and practical for use in the clinical setting.
Similar to this QI project, studies (Guzek, J., Guzek, S., Murphy, Gallacher, & Lesneski,
2009; Lasky, Homa, & Splaine, 2010; Peterson et al., 2008) have demonstrated an improvement
in T2DM care in the primary care setting when utilizing multi-component interventions,
including the implementation of an electronic diabetes support tool. Guzek, J., Guzek, S.,
Murphy, Gallacher, and Lesneski (2009), and Lasky, Homa, and Splaine (2010) reported
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statistically significant improvement in quality indicators, including A1C testing, LDL testing,
and performance of comprehensive foot examinations. This QI project demonstrated a trend
towards improvement in all quality indicators; however, results are not statistically significant
due to the short duration of the implementation at the Machuca Family Medicine Clinic. Results
from Guzek, J., Guzek, S., Murphy, Gallacher, and Lesneski (2009), and Lasky, Homa, and
Splaine (2010) indicate a potential for sustainability of statistically significant improvement in
quality indicators at the one and two year mark. Staff involvement from the planning phase
through implementation was a crucial component in the development of the interventions. In this
QI project, the QI team worked through each phase of the PDSA cycle. Involvement through the
change process provided staff with a sense of ownership and responsibility in the implementation
of change. Wan, Makeham, Zwar and Petche (2012) reported positive perspectives from general
practitioners that utilized an electronic diabetes support tool to improve the care of patients with
T2DM. While this QI project did not focus on staff perspectives of the T2DM Diabetes Support
tool, the QI team found the T2DM Decision Support Tool was “easy to follow and
straightforward.”
Limitations
Factors such as confounding and imprecision in the design, methods, and measurements
may limit the internal validity of the project. This QI project examined the overall contribution of
the intervention to the observed outcomes, improvement of quality indicators. The contribution
of each intervention component was not evaluated as data were not collected on individual
interventions of the QI project. The observed outcome was a result of the combination of
changes that were implemented. For this reason, the strength of association between each
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component and the observed changes cannot be determined. Another limitation is intervention
fidelity, the lack of measurement of the consistency of implementation of the changes. The DNP
student relied on feedback from the QI team on how consistently the changes were implemented.
The limited timeframe of the implementation of the changes is another limitation of the
QI project. The PDSA cycle is designed for rapid change and assessment; however, it is difficult
to determine sustainability (Taylor et al., 2014; The W. Edwards Deming Institute, 2014).
Additional measurement of the quality indicators would be required at six months, one year, and
later to determine if the improvements have sustained. The short-term duration of the project also
limited the ability to measure patient outcome measures such as A1C levels, LDL levels, and
foot ulceration rates.
Strengths
A strength of this QI project was the QI team’s ability to engage in a collaborate effort to
address the Machuca Family Medicine Clinic’s deficits in goals for quality care in patients with
T2DM. The QI team worked through a PDSA cycle to create rapid change by planning and
implementing proposed changes. Through the implementation of changes, Machuca Family
Medicine Clinic’s goals for quality specific to implementation rates of A1C testing, LDL testing,
and performance of comprehensive foot examinations were met.
Interpretation
The findings of this QI project demonstrated an improvement in quality indicators, A1C
testing, LDL testing, and performance of comprehensive foot examinations. The post-
intervention performance rate medians were higher than the pre-intervention performance rate
medians for the quality indicators. While the intervention signaled an improvement, the duration
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of the intervention was inadequate to demonstrate statistically significant changes. This
limitation could be addressed in a future longer-term QI study with measurements at three-month
increments to determine statistical significance and sustainability.
Implementation of the QI project produced a positive impact on the clinic staff and
systems. Formulating a QI team helped nurture a sense of teamwork within staff. The QI team
developed a sense of responsibility and ownership for the changes to be implemented. Staff’s
willingness to participate played a major role in the success of the implementation of the
proposed changes. While one team member felt the project increased their work, the team was
able to adjust based on feedback.
Improvements in A1C testing, LDL testing, and performance of comprehensive foot
examinations could produce financial benefits for the Machuca Family Medicine Clinic and
patients with T2DM. The resources needed for the implementation of the intervention were
available at the clinic and additional costs were not incurred. One of the clinic’s largest health
insurance providers renews contracts with clinics based on performance. Clinics with
consistently below goal quality indicators are at risk of losing contracts with the health insurance
provider. Having quality indicators at goal is essential to maintain contracts with the clinic’s
health insurance providers. Patients with T2DM may also benefit from improved quality
indicators as risk of complications from T2DM such as heart attacks, strokes, and foot
amputations are decreased (ADA, 2015). Direct medical costs from DM are approximately $176
billion a year and $69 billion due to indirect costs such as disability (ADA, 2013a). Decreasing
such complications would decrease the burden to patients with T2DM and to the healthcare
system.
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Conclusion
The findings of this QI project showed a trend of improvement in quality indicators after
the implementation of a multicomponent intervention that included the utilization of a T2DM
decision-support tool. The QI team worked through one PDSA cycle in the development and
implementation of changes. While the results showed improvement, extending the duration of
the intervention may have produced statistically significant results and insight to the
sustainability of the changes. The QI project served a first systematic change process for the
Machuca Family Medicine clinic and a model for future change processes at the clinic.
This QI project is considered pilot study as it compares pre-intervention medians and
post-intervention medians and serves as a stepping-stone for future hypothesis testing projects.
Further studies are needed to determine the sustainability of outcomes observed in this QI project
and to determine the effects on patient outcome measures such as levels of glucose control and
LDL control and rates of foot complications.
Significance to Nursing
This project highlights the DNP’s role in utilizing evidence-based research and applying
a systematic change model for quality improvement in the primary care practice setting.
According to the American Association of Nurse Practitioners (2015), only 6% of NPs were
involved in research from 2013-2014. NPs have a responsibility to provide quality care in
chronic disease management. One way DNPs can improve the level of care in chronic disease
management within the primary care practice setting is through quality improvements that
produce rapid change and are able to be analyzed quickly. This QI project adds to the body of
55
literature contributing to improving quality care for patients with T2DM in the primary care
practice setting.
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APPENDIX A:
LETTER OF APPROVAL FROM MACHUCA FAMILY MEDICINE
57
58
APPENDIX B:
IRB REVIEW NOT REQUIRED LETTER
59
1618 E. Helen St.P.O.Box 245137Tucson, AZ 85724-5137Tel: (520) 626-6721http://orcr.arizona.edu/hspp
Human SubjectsProtection Program
Date: May 27, 2015Principal Investigator: Maria Magdalena ChavezProtocol Number: 1505870587Protocol Title: Improving Diabetes Care in Family Care Practice: A Quality
Improvement Project
Determination: Human Subjects Review not Required
The project listed above does not require oversight by the University of Arizona becausethe project does not meet the definition of 'research' and/or 'human subject'.
• Not Research as defined by 45 CFR 46.102(d): As presented, the activities described above do not meet the definition of research as cited in the regulations issued by the U.S. Department of Health and Human Services which state that "research means a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge".
• Not Human Subjects Research as defined by 45 CFR 46.102(f): As presented, the activities described above do not meet the definition of research involving human subjects as cited in the regulations issued by the U.S. Department of Health and Human Services which state that "human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information".
Note: Modifications to projects not requiring human subjects review that change the natureof the project should be submitted to the Human Subjects Protection Program (HSPP) for a newdetermination (e.g. addition of research with children, specimen collection, participantobservation, prospective collection of data when the study was previously retrospective innature, and broadening the scope or nature of the research question). Please contact theHSPP to consult on whether the proposed changes need further review.
The University of Arizona maintains a Federalwide Assurance with the Office for HumanResearch Protections (FWA #00004218).
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APPENDIX C:
ADA (2015) STANDARDS IN DIABETES FOR QI PROJECT
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ADA (2015) Standards in Diabetes for QI Project Quality Indicators Being Monitored I. A1C testing
A. Helps determine glucose control in patients with T2DM B. Recommended every 3 months if A1C >7% and every 6 months if A1C
<7% II. LDL testing
A. Helps determine risk for cardiovascular disease and complications in patients with T2DM
B. Recommended at least once a year III. Comprehensive foot examinations
A. May help, prevent or delay ulcerations and lower extremity amputations B. Recommended at least once a year
*A full copy of the Standards of Medical Care in Diabetes– 2015 is available upon request from the office manager and the DNP student. American Diabetes Association. (2015). Standards of medical care in diabetes – 2015. Diabetes Care, 38(1), S1-S94. www.diabetes.org/diabetescare
Created May 2015 for Machuca Family Medicine Clinic
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APPENDIX D:
IMPLEMENTATION OF T2DM DECISION SUPPORT TOOL TRAINING SHEET
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