Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Financial incentives

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Financial incentives; Participants receive financial incentives for completing exercise sessions.	Behavioral: Financial incentives; Patients in the experimental group will receive financial incentives for completing exercise sessions.
No Intervention: Control; Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance at Cardiac Rehabilitation Exercise Sessions	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.	Within 4 months of initial stress test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Health	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.	Intake, 4 months
Changes in Mental Health/Cognition	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).	Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Physical Health Gains Following Intervention.	Changes in measures of physical health and fitness (peak oxygen uptake, metabolic equivalents, waist circumference, BMI, treadmill time, smoking status, perceived quality of life) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).	4 months and 1 year.
Maintenance of Mental Health/Cognition Scores Following Intervention.	Changes in measures of mental health (Beck Depression Inventory, Adult Self-Report) as well as changes in measures of executive function (Trail Making and Tower tasks, Delay Discounting, Time Perspective Questionnaire, Stop Signal Task, Behavior Rating Inventory of Executive Function) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).	4 months and 1 year.
Health Care Costs	Health care costs (cost of delivering care at the cardiac rehabilitation clinic as well as hospital costs) will be calculated from study entry to one year follow-up.	From intake to one year follow-up
Costs of Attending Care	Costs to the patient of attending care (transportation, child/elder care, missed wages) will be calculated from study entry to one year follow-up.	Intake to 1 year follow-up

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Publications and helpful links

General Publications

• Gaalema DE, Elliott RJ, Savage PD, Rengo JL, Cutler AY, Pericot-Valverde I, Priest JS, Shepard DS, Higgins ST, Ades PA. Financial Incentives to Increase Cardiac Rehabilitation Participation Among Low-Socioeconomic Status Patients: A Randomized Clinical Trial. JACC Heart Fail. 2019 Jul;7(7):537-546. doi: 10.1016/j.jchf.2018.12.008. Epub 2019 May 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: cardiac rehabilitation; contingency management
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CRINCN9874; P20GM103644 (U.S. NIH Grant/Contract)