randomized controlled trial to evaluate a focused communication intervention to reduce length of...

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Randomized controlled trial to evaluate a focused communication intervention to reduce length of stay for critically ill children in a pediatric intensive care unit Karen LeGrow Lawrence Bloomberg Faculty of Nursing, University of Toronto Supported by: CIHR Allied Health Fellowship Award & Sick Kids Foundation Nursing Scholarship Award

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Randomized controlled trial to evaluate a focused communication

intervention to reduce length of stay for critically ill children in a

pediatric intensive care unitKaren LeGrow

Lawrence Bloomberg Faculty of Nursing, University of Toronto

Supported by: CIHR Allied Health Fellowship Award & Sick Kids Foundation Nursing Scholarship Award

Background – Critical Care

Children are admitted with severe complex conditions that require critical care management of surgical, medical, & cardiac illnesses.

Majority of children stay for a short period of time However, the profile of the critically ill child has

undergone dramatic changes with recent advances in medical technology

increasing numbers of children require frequent and prolonged periods of hospitalization in critical care units.

Background – ‘PICU Space’

ICU’s consume a disproportionate amount of health care resources

Fast paced & highly acuity The ICU space is designed for the quick turn

around of patients’ to facilitate optimum utilization of beds and resources.

The prolonged stay of patients is viewed as disruptive to patient flow and therefore not effective use of critical care beds and resources.

Background - Length of Stay (LOS) noticeable trend: an increase in the number

of children whose PICU LOS extends beyond the norm (Mean=6.27 days, SD=12.06).

Sick Kids (2005): 151 children whose LOS was at least 14 days (8.8% of total patient admissions & 32% of total patient days)

Background-Parent/Physician Conflict ICU environment is conducive to conflict. ICU clinicians must perform highly technical

tasks and provide constant prognostic updates.

families must make complex decisions regarding their child’s care when high levels of stress, grief, and fatigue threaten optimum decision making .

Literature Review

An organizational pattern of institutional, medical, social, and psychological factors have been identified as influencing LOS in the ICU.

Social factors such as communication problems and conflict between families and physicians can delay both treatment and decision making, resulting in unnecessarily prolonged intensive care stays.

Karens -los figure copy.pdf

Karens -los figure copy.pdf

Communication

Conflict

Theoretical Considerations Family Systems Nursing (limitations)

Family Centered Care (Rhetoric)

Parent-Physician Relationships (Rhetoric)

Communication theory

Complexity Theory

Change Theory

Conflict Mediation

Purpose of the Study

To evaluate a structured formal approach aimed at the social factors which influence length of stay for critically ill children in a pediatric intensive care unit.

Research Design & Methods

randomized controlled trial design

to evaluate a focused communication intervention to reduce length of stay for critically ill children in a paediatric intensive care unit.

Research Questions

Primary:What is the effect of a focused communication intervention on

length of stay for critically ill children in a pediatric intensive care unit?

Secondary:What is the effect of a focused communication intervention on

parent-physician conflict for critically ill children in a pediatric intensive care unit?

Study Criteria

Inclusion criteria include:

(1) Acute, unplanned admission to the PCCU,

(2) Predictive length of stay ≥10 days,

(3) A parent must be able to speak English, and

(4) Parent(s) must be a legal guardian of the child.

Exclusion criteria:

(1) Child is undergoing surgery on the day of recruitment, and

(2) Child is receiving active palliative and/or bereavement care.

Research Design & Methods

Trial maneuver Eligibility – assessed daily using standardized checklist Consent process – review study, inform about uncertainty

of intervention, expectations of trial participants, answering their questions, signing a consent form (copy given to family)

Randomization – using a computerized telephone randomization service upon confirmation of eligibility criteria, signed consent form, and that collection of all baseline data is completed

Control group – usual care Experimental group – usual care plus study intervention

Study Intervention

A focused communication intervention will be led by an advance practice nurse (APN) with expertise in pediatric critical care nursing.

Environmental fit: technology and activity Short & standardized: feasible The intervention will be conducted at the bedside of

the hospitalized child within the critical care unit at the Hospital for Sick Children. A private meeting room maybe used for the meetings if the parents prefer this option.

Focused Communication InterventionImportant elements: timing of intervention key components of communication participants use of language documentation of communication

Admission to PICU

Assess Eligibility

Obtain Consent & Baseline Data

Control GroupExperimental

Group

Collect Outcome Measure Data – 5 Days

Post Discharge

Collect Outcome Measure Data – 5 Days

Post Discharge

Randomization

Study Intervention

Outcome Measures

primary outcome: data regarding length of stay will be collected on date of discharge or transfer from the PICU using the PICU data base that collects length of stay for all children admitted to the PICU.

secondary outcome: data regarding family-team conflict will be measured 5 days post discharge from the PICU using a semi-structured interview process and a measurement tool.

Sample Size

With an alpha of 0.05 (two tailed) and 80% power, to reduce by 25% the number of children whose PICU stay exceeds 10 days, we require a sample size of 74.

The sample will be recruited within 12 months based upon LOS statistics from the patient census data of the PICU.

Data Analysis Plan

An intention to treat approach will be used in which all families randomized are included in the data analysis.

A significance level of 0.05 (two-tailed) will be used for the primary question, length of PICU stay > 10 days.

A significance level of 0.025 will be used for the secondary research question, family-team conflict.

Expected Outcomes

The results are expected to have relevance for clinicians, researchers, administrators, and policy makers who are interested in the social aspects of care that effect length of stay for critically ill children in a fast paced and highly technical paediatric intensive care environment.