Clinical trial NCT02172820: Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
Official title: Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: cardiac rehabilitation
contingency management
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2014-06-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Attendance at Cardiac Rehabilitation Exercise Sessions
timeFrame: Within 4 months of initial stress test
Secondary outcomes:
measure: Change in Physical Health
timeFrame: Intake, 4 months
measure: Changes in Mental Health/Cognition
timeFrame: Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)
Other outcomes:
measure: Maintenance of Physical Health Gains Following Intervention.
timeFrame: 4 months and 1 year.
measure: Maintenance of Mental Health/Cognition Scores Following Intervention.
timeFrame: 4 months and 1 year.
measure: Health Care Costs
timeFrame: From intake to one year follow-up
measure: Costs of Attending Care
timeFrame: Intake to 1 year follow-up
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
citation: 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.