Open Access Study protocol

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

Darren A DeWalt1, Kimberly A Broucksou1*, Victoria Hawk1, David W Baker3, Dean Schillinger4, Bernice Ruo3, Kirsten Bibbins-Domingo4, Mark Holmes1, Morris Weinberger2, Aurelia Macabasco-O'Connell5 and Michael Pignone1

Author Affiliations

1 Cecil G Sheps Center for Health Services Research, Division of General Internal Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

2 Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

3 Feinberg School of Medicine, Northwestern University, Chicago, Ill, USA

4 Center for Vulnerable Populations, Department of Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA

5 Olive View – UCLA Medical Center, UCLA School of Nursing, University of California Los Angeles, Los Angeles, CA, USA

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BMC Health Services Research 2009, 9:99  doi:10.1186/1472-6963-9-99

Published: 11 June 2009

Abstract

Background

Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level.

Methods/Design

In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months

Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success.

The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects.

Discussion

Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011.

Trial Registration

ClinicalTrials.gov http://www.clinicaltrials.gov/ webcite NCT00378950