Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

NCT02172820 | Completed Results

• 2 other identifiers: CRINCN9874P20GM103644
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

cardiac rehabilitation; contingency management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Physical Health

  Intake, 4 months

• Changes in Mental Health/Cognition

  Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)

Other Outcomes (4)

• Maintenance of Physical Health Gains Following Intervention.

  4 months and 1 year.

• Maintenance of Mental Health/Cognition Scores Following Intervention.

  4 months and 1 year.

• Health Care Costs

  From intake to one year follow-up

Study Arms (2)

Financial incentives

EXPERIMENTAL

Participants receive financial incentives for completing exercise sessions.

Behavioral: Financial incentives

Control

NO INTERVENTION

Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.

Interventions

Financial incentives BEHAVIORAL

Patients in the experimental group will receive financial incentives for completing exercise sessions.

Financial incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• 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.

  PMID: 31078475 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

Racially homogenous patient population; Baseline assessments were conducted on site; Clinical staff could not be fully blinded; Hospitalizations outside University of Vermont Medical Center may have been missed; Small sample size.

Results Point of Contact

• Title: Diann Gaalema, Ph.D., PI
• Organization: The University of Vermont

Diann.Gaalema@med.uvm.edu

802-656-9874

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2018
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-05

Locations

US (1)