Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Financial incentives

• Registration Number: NCT02172820
• Lead Sponsor: University of Vermont

Brief Summary

Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Medicaid coverage and similar state-supported insurance are robust predictors of CR non-participation. There is growing recognition of the need to increase CR among patients with this form of insurance and other economically disadvantaged patients, but there are no evidence-based interventions available for doing so. In the present study we are examining the efficacy of using financial incentives for increasing CR participation among Medicaid patients. Financial incentives have been highly effective in altering other health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study are randomizing 130 CR-eligible Medicaid enrollees to a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at CR sessions or to a "usual-care" condition where they will not receive these incentives. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, decision making and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of the incentive intervention and usual care conditions with their effects on increasing CR initiation and adherence. Should this intervention be efficacious and cost-effective, it has the potential to substantially increase CR participation and significantly improve health outcomes among low-income cardiac patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Primary Completion: 2017-07
• Study Completion: 2018-02
• Results First Submitted: 2019-02-26
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-21
• Last Update Submitted: 2019-05-21
• Results First Posted: 2019-06-11
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• A recent myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, heart valve replacement or repair, or stable heart failure.
• Enrolled in a state-supported insurance plan for low income individuals
• Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden County) for the next 12 mos.

Exclusion criteria:

• Dementia (MMSE<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
• Non-English speaking
• Prior participation in cardiac rehabilitation
• Advanced cancer, advanced frailty, or other longevity-limiting systemic disease that would preclude CR participation
• Rest angina or very low threshold angina (<2 METS) until adequate therapy is instituted
• Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
• Class 4 chronic heart failure (symptoms at rest)
• Exercise-limiting non-cardiac disease such as severe arthritis, past stroke, severe lung disease

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Financial incentives	Financial incentives	Participants receive financial incentives for completing exercise sessions.

Primary Outcome Measures

Name	Time	Method
Attendance at Cardiac Rehabilitation Exercise Sessions	Within 4 months of initial stress test	The number of patients who completed cardiac rehabilitation (CR) as defined as greater than or equal to 30 sessions. Must have been completed within 4 months of the entry stress test.

Secondary Outcome Measures

Name	Time	Method
Change in Physical Health	Intake, 4 months	Secondary outcomes included changes between baseline and 4-month assessment in fitness (peak oxygen uptake directly measured by expired gas analysis or estimated by metabolic equivalents), body composition (body mass index, waist circumference), and quality of life (MacNew).The MacNew was designed to evaluate how daily activities and physical,emotional and social functioning are affected by heart disease and its treatment. It consists of 27 questions grouped into 3 domains: physical, mental and social functioning. Both subscales and summary score are interpreted as scores between 1 and 7; higher scores are better, and a change of at least 0.5 is a useful indicator of the minimal important difference.Changes over time were assessed using paired differences in scores from intake to four months. Due to non-normal distributions, Wilcoxon Signed Rank Test was used. Contributions of other variables to changes in secondary outcomes were examined using analyses of covariance.
Changes in Mental Health/Cognition	Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)	The Achenbach System of Empirically Based Assessment (ASEABA) is an integrated system of multi-informant assessments, including self-reports, to measure adaptive functioning and problems. The problem items have been factor-analytically reduced to 8 syndrome scales that are consistent across age, informant and culture. Higher scores represent higher symptoms (e.g. emotional/behavioral problems). The Stop Signal Reaction Time (SSRT) task measures the ability to inhibit incorrect responses. Lower scores represent a better ability to inhibit reactions. The BRIEF-A is a rating scale developed to look at everyday behaviors associated with specific domains of executive functions in adults ages 18-90.T-scores (standardized scores) are used to interpret the individual's level of executive functioning (EF). Higher scores represent more self-reported problems. A score of 50 represents the mean.A difference of 10 from the mean indicates a difference of one standard deviation (SD).

Trial Locations

Locations (1)

University of Vermont; 🇺🇸 Burlington, Vermont, United States