running head: early implementation of...

Running head: EARLY IMPLEMENTATION OF CAPSULE ENDOSCOPY Chambers 1

Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia:

A Cost-Benefit Analysis

Winde R. Chambers

Texas Woman's University

Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 2

Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia:

A Cost-Benefit Analysis

Contact information: Winde R. Chambers, APRN, FNP

156 Kingston Road

Benton, Louisiana 71006

318-426-0774

Capsule endoscopy has revolutionized the diagnosis and management of iron deficiency

anemia and obscure gastrointestinal bleeding over the past decade. It allows visualization of

areas of the small bowel that are not reached with conventional endoscopic procedures. In 2005,

the International Conference on Capsule Endoscopy published a consensus statement that

delineates the use capsule endoscopy as part of the initial evaluation for patients with obscure

gastrointestinal bleeding (Pennazio, Eisen & Goldfarb, 2005). Regardless of this consensus,

initial evaluation with capsule endoscopy in patients without gross gastrointestinal bleeding is

debatable (Rockey, 2005). Standard management is often to treat with iron supplementation,

followed by observation and/or repeat endoscopy (Rockey, 2010). The purpose of this study is

to evaluate the efficacy of early intervention with capsule endoscopy compared to standard

management, using cost effectiveness and time to diagnosis as quality outcome measures for care

of patients with iron deficiency anemia related to obscure gastrointestinal bleeding.

Context

Iron deficiency anemia is most frequently caused by chronic occult gastrointestinal

bleeding in men and postmenopausal women therefore the standard of care is

investigation of the gastrointestinal tract (Rockey, 2010).


Obscure bleeding is characterized by bleeding that persists or recurs without

identification of a source on initial evaluation with esophagogastroduodenoscopy (EGD)

or colonoscopy (American Gastroenterological Association [AGA], 2007b).

Obscure occult bleeding is distinguished by patients with iron deficiency anemia and

documented evidence of positive fecal occult blood test and obscure overt bleeding is

differentiated by recurrent melena, hematemesis or hematochezia (Rockey, 2010).

OGIB represents approximately 5% of all gastrointestinal bleeding with small bowel

sources identified in 75% of these cases (AGA, 2007a).

Capsule endoscopy has a positive impact on health outcomes, although evidence is

lacking regarding outcomes of interventions following capsule endoscopy (AGA, 2007b).

It has been estimated that the average cost associated with diagnosing obscure

gastrointestinal bleeding is $33,630 (Goldfarb, Phillips, Conn, Lewis & Nash, 2002),

however more recent literature asserts that these figures are significantly underestimated

(AGA, 2007b). Diagnosing the cause of obscure gastrointestinal bleeding may take a

significant amount of time which contributes to substantial medical cost (AGA, 2007b).

It takes from one month to eight years to diagnose patients with obscure gastrointestinal

bleeding with a median of two years (AGA, 2007b).

Medicare and private insurers require documentation of normal EGD and colonoscopy

within six months to one year prior to capsule endoscopy approval (AGA, 2007b).

Project Description

Goal/Objectives

The goal of this clinical inquiry is to investigate the efficacy of early capsule endoscopy

compared to conventional diagnostic evaluation based on cost effectiveness for patients with iron


deficiency anemia. Objectives include (a) developing a timely and cost effective practice

protocol for the management of patients with iron deficiency anemia; (b) and increasing

available evidence to support the development of a clinical practice guideline.

Research Question

The research question guiding this project is: What is the efficacy of early

implementation capsule endoscopy compared to conventional diagnostic evaluation for cost

effective care management in patients diagnosed with iron deficiency anemia? The intervention

is conceptually defined as the diagnostic approach for identifying the source of obscure

gastrointestinal bleeding and operationally defined as early implementation of capsule endoscopy

(immediate use following initial non-definitive scopes) compared to conventional diagnostic

evaluation (trial of iron therapy, repeated endoscopy). The conceptual definition for the outcome

variable is cost effective care management operationally defined as incurred procedural cost and

time between initial and problem resolution.

Methodology

A retrospective chart review of patients diagnosed with iron deficiency anemia will be

conducted in order to answer the proposed research question. Patients evaluated for iron

deficiency anemia from April 2007 to April 2008 will be identified data collected in the practice

electronic medical record (EMR). Inclusion criteria include men and postmenopausal women

ages 50 to 70 diagnosed with iron deficiency and obscure gastrointestinal bleeding. Patients

with history of gastric bypass, cases involving obscure overt gastrointestinal bleeding and those

with contraindications for capsule endoscopy will be excluded. Premenopausal women with

documentation of abnormal menstrual bleeding will be eliminated from the study. The

intervention group will be defined as patients diagnosed with iron deficiency anemia who


underwent capsule endoscopy within 6 months of initial EGD and colonoscopy. The

conventional group will be defined as patients diagnosed with iron deficiency anemia that did not

have capsule endoscopy following normal EGD and colonoscopy (Appendix C).

Data collection tools (Appendix E) developed by the researcher will be used to collect

anonymous data from the patients' medical records. Demographics and pre-procedure

hemoglobin, mean corpuscular volume, serum iron, total iron binding capacity will be recorded

for both groups. Results of fecal occult blood testing and prior blood transfusions will be

documented if available. Information regarding use of non- steroidal anti-inflammatory drugs,

antiplatelets and anticoagulants will be obtained for both groups. For the intervention group,

capsule endoscopy date, findings and recommendations will be recorded. Follow-up laboratory

data and clinical outcomes will be recorded. A positive outcome will be defined as identification

of the source of bleeding and/or resolution of anemia. A negative outcome will be defined as

retained capsule, persistent anemia and/or no definite source of bleeding identified on capsule

endoscopy. For the conventional group, the length of time from negative EGD and colonoscopy

to date of symptoms resolution or capsule endoscopy will be recorded. The number of

endoscopic procedures, radiological images, follow-up visits, laboratory test (including CBC,

iron studies) and blood transfusions between these dates will be collected.

Timeline and Duration

The study is projected to last approximately six months. An exempt application will be

submitted to the Texas Woman's University (TWU) Institutional Review Board in September

2010. The written document will be submitted to the capstone committee by March 2011.

Specific dates and activities are illustrated in Table 1.


Table 1

Projected Timeline

Date Activity

September 1-31, 2010 TWU IRB approval

October 1-7, 2010 Educate data collectors

October 8- November 31, 2010 Data collection

December 1-31, 2010 Statistical analysis

January 1- March 15, 2011 Complete project/paper

Sites, Support and Personnel Required for Project

The study will be conducted a private gastroenterology practice in the Southern United

States. No financial support will be needed from the practice. The researcher will require

assistance from the health information manager at the practice to obtain the sample from the

EMR. The researcher will be responsible for data collectors and statistician.

Deliverables to Institution

The results of the study will be discussed with the health care providers and personnel at

the gastroenterology practice. These findings will aid in the development of a timely and cost

effective practice protocol for the management of patients with iron deficiency anemia. A copy

of the written documented will be provided by the researcher.

Benefits/Anticipated outcomes

Findings from this study will increase available evidence to support the development of

clinical practice guidelines. The placement of capsule endoscopy immediately after

conventional endoscopic evaluation in diagnostic algorithms for iron deficiency anemia will be

beneficial for all stakeholders. Patients will reduce losses in productivity and quality of life as


evident by decreasing time off from work for unwarranted testing and preparation for

endoscopic procedures. Providers will improve diagnostic precision and enhance patient

satisfaction in care provided.


References

American Gastroenterological Association Institute. (2007a). American Gastroenterological

Association Institute medical position statement on obscure gastrointestinal bleeding.

Gastroenterology, 133, 1694-1696. doi:10.1053/j.gastro.2007.06.008

American Gastroenterological Association Institute. (2007b). American Gastroenterological

Association Institute technical review on obscure gastrointestinal bleeding.

Goldfarb, N., Philips, A., Conn, M., Lewis, B., & Nash, D. (2002). Economic and health

outcomes of capsule endoscopy: Opportunities for improved management of the

diagnostic process for obscure gastrointestinal bleeding. Disease Management, 5(3), 123-

135.

Pennazio, M., Eisen., & Goldfarb, N. (2005). ICCE consensus for obscure gastrointestinal

bleeding. Endoscopy, 37, 1046-1050.

Rockey, D. (2005). Occult gastrointestinal bleeding. Gastroenterology Clinics of North America,

31, 699-718. doi: 10.1016/j.gtc.2005.08.010

Rockey, D. (2010). Occult and obscure gastrointestinal bleeding: causes and clinical managment.

Natures Reviews: Gastroenterology and Hepatology, 7(5), 265-279. doi:

10.1038/nrgastro.2010.42


Appendix A

August 7, 2010

156 Kingston Road

Benton, Louisiana 71006

GastroIntestinal Specialist, AMC

3217 Mabel Street

Shreveport, Louisiana 71103

Attn: Linda Ray, Administrator

Dear Mrs. Ray:

As you know, I am currently pursuing my Doctor of Nursing Practice degree at Texas Woman's

University and will be starting my professional capstone project in September. I am seeking

approval to conduct a retrospective chart review in order to determine the efficacy of early

capsule endoscopy in patients with iron deficiency anemia. The practice has performed

thousands of capsule endoscopies since the development of this innovative diagnostic tool.

Findings from this study will contribute to the delivery of high quality gastroenterology

endoscopic services in an professional and cost effective manner.

I have attached my concept paper that describes elements of the proposed research.

If any other information is needed you can contact me by phone at (318) 426-0774 or email at

[email protected]

Sincerely,

Winde R. Chambers, APRN, FNP-BC


Appendix B

Research Project Overview

Research Questions and Hypothesis

Research Question: What is the efficacy of early implementation capsule endoscopy

compared to conventional diagnostic evaluation for cost effective care management in

patients diagnosed with iron deficiency anemia?

PICO Question: In patients with iron deficiency anemia, is early implementation of capsule

endoscopy more cost effective than conventional diagnostic evaluation?

Null Hypothesis: There is no difference in cost of early implementation of capsule endoscopy

compared to conventional diagnostic evaluation in patients diagnosed with iron deficiency

anemia.

Proposed Statistical Analysis of Project

Simple frequencies will be obtained on demographics such as age, gender, ethnicity as

well as capsule endoscopy findings and recommendations.

Chi-square test for independence or the Fisher's Exact Probability Test will be used in

order to explore the relationship between categorical variables. For example, the

relationship between interventions based on capsule endoscopy findings and clinical

outcomes will be examined.

Cost-Analysis


Appendix C

Sample

IDA Exclude Patients with:

Overt GI bleeding

History gastric bypass

Capsule endoscopy contraindicated

Pre-menopausal women

EGD/Colon

(Negative

findings)

Exclude:

EGD/Colon

positive findings

Intervention

Group:

Capsule endoscopy

within 6 months

Conventional

Group:

Second look

iron trial


Appendix D

SPSS Code Book

FULL VARIABLE NAME SPSS VARIABLE NAME CODING INSTRUCTIONS

Identification number

ID Number assigned to each subject. Last four numbers of subjects’ medical record number.

Group Group 1= Intervention group 2=Conventional group

Age Age Age in years Gender Gender 1= Male 2= Female Ethnicity Ethnicity 1=White/Caucasian

2= Black/African American 3= Asian 4=Hispanic 5= American Indian 6= Not indicated

Hemoglobin HgB Total in grams/dl Mean corpuscular volume MCV Total in femtoliters/cell Serum iron Iron Total in nanograms/ml Total iron binding capacity TIBC Total in ng/ml Ferritin Ferritin Total in ng/ml Fecal occult blood test FOBT 1= Negative

2= Positive 3= Not available

Blood transfusion Blood 1= No 2= Yes

Medications Medications 1= No risk medications 2= NSAIDS 3= Plavix 4= Coumadin

Capsule endoscopy findings CE findings 1= Normal 2= AVM/Angiodysplasia 3=Tumor 4= Stricture 5= Ulcer 6= Erosion

Complications Complication 1= No complications 2= Capsule failure 3= Retained capsule

Recommendations Recs 1= Monitor laboratory data/CBC 2= Medication 3= Endoscopy 4= Surgery


Source identified on capsule endoscopy

SourceID 1= Yes 2=No

Anemia resolved after capsule endoscopy

AnemiaResolved 1=Yes 2=No

Capsule retained during capsule endoscopy

CapsuleRetained 1=Yes 2=No 3= Not Performed/conventional group

Clinical Outcome following capsule endoscopy

Outcome 1=Positive 2=Negative

ER visits ERVisits Number of ER visits for conventional group

Established Outpatient Follow-up Visits

99211/99212/99213/99214/99215 Number of specific follow-up visits

Complete blood count CBC Number of CBC's performed Iron Profile IronProfile Number of Iron Profiles

Performed EGD Number of EGD's performed Colonoscopy Colon Number of colonoscopies

performed Blood Transfusions PRBC Number of blood transfusions Iron Transfusion IronTrans Number of iron transfusions Capsule Endoscopy performed CapsuleEndo 1= Yes

2=No


Appendix E

Data Collection Tools

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