Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program

NCT03759873 | Completed Phase 2 Results DMC

• 1 other identifier: R61HL143305
• Study Type: interventional
• Target: 209
• 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. Lower socioeconomic status (SES) is a robust predictor of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are almost no evidence-based interventions available for doing so. The present study will examine the efficacy of using early case management and financial incentives for increasing CR participation among lower-SES patients. Case management has been effective at promoting attendance at a variety of health-related programs (e.g. treatment for diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial incentives are also highly effective in altering health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss) including CR participation in a prior trial. For this study 209 CR-eligible lower-SES patients will be randomized to: a treatment condition where patients are assigned a case manager while in hospital who will facilitate CR attendance and coordinate cardiac care, a treatment condition where patients receive financial incentives contingent on initiation of and continued attendance at CR sessions, a combination of these two interventions, or to a "usual-care" condition. Participants in all conditions will complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, executive function, and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of delivering the interventions and the usual care condition, taking into account increases in CR participation. Furthermore, the value of the interventions will be modeled based on increases in participation rates, intervention costs, long-term medical costs, and health outcomes after a coronary event. This systematic examination of promising interventions will allow testing of the efficacy and cost-effectiveness of approaches that have the potential to substantially increase CR participation and significantly improve health outcomes among lower-SES cardiac patients.

Conditions

Cardiac Rehabilitation

Keywords

Incentives; Case management; Socioeconomic status

Outcome Measures

Primary Outcomes (2)

• Cardiac Rehabilitation Attendance

  Number of cardiac rehabilitation sessions completed out of a possible 36

  Within 4 months of the intake assessment

• Cardiac Rehabilitation Completion

  Proportion of patients who complete 30+ sessions of cardiac rehabilitation

  Within 4 months of the intake assessment

Secondary Outcomes (15)

• Change in Fitness (Peak Oxygen Uptake)

  Within 4 months of the intake assessment

• Change in Fitness (Estimated Metabolic Equivalent of Task)

  Within 4 months of the intake assessment

• Change in Body Composition

  Within 4 months of the intake assessment

• Changes in Smoking Status

  Within 4 months of the intake assessment

• Changes in Quality of Life - Cardiac Specific

  Within 4 months of the intake assessment

Other Outcomes (14)

• Maintenance of Fitness Following Intervention (Peak Oxygen Uptake)

  From completion of intervention (4 months) to follow-up (one-year).

• Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task)

  From completion of intervention (4 months) to follow-up (one-year).

• Maintenance of Waist Circumference Following Intervention.

  From completion of intervention (4 months) to follow-up (one-year).

Study Arms (4)

Incentives

EXPERIMENTAL

Patient earns incentives for completing cardiac rehabilitation sessions.

Behavioral: Incentives

Case Management

EXPERIMENTAL

Patient is assigned a case manager while in hospital.

Behavioral: Case Management

Incentives and Case Management

EXPERIMENTAL

Patient receives both the Incentives and Case Management interventions.

Behavioral: Incentives; Behavioral: Case Management

Usual care

NO INTERVENTION

This control condition does not receive either intervention.

Interventions

Incentives BEHAVIORAL

Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.

Incentives; Incentives and Case Management

Case Management BEHAVIORAL

A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.

Case Management; Incentives and Case Management

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, coronary revascularization, diagnosis of congestive heart failure (CHF) or heart valve replacement or repair
• Enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need (housing subsidy, food stamps, etc.), or with a less than high school education.
• Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden county) for the next 12 mos.
• Copley Hospital (Morrisville, VT) transfer patient (enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need)
• Northwestern Medical Center (St Albans, VT) transfer patient (enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need)

You may not qualify if:

• Dementia (MMSE\<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
• 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
• Previous successful attendance at cardiac rehabilitation (defined as completing 6+ sessions in the past 10 years)

Sponsors & Collaborators

• University of Vermont: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

• Gaalema DE, Khadanga S, Savage PD, Yant B, Katz BR, DeSarno M, Ades PA. Improving Cardiac Rehabilitation Adherence in Patients With Lower Socioeconomic Status: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1095-1104. doi: 10.1001/jamainternmed.2024.3338.

  PMID: 39037811 DERIVED

MeSH Terms

Interventions

Fertility; Case Management

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Study was powered for attendance rather than clinical outcomes; Study was conducted exclusively within Vermont, which may limit generalizability; Some assessment data are limited due to COVID-19 restrictions

Results Point of Contact

• Title: Dr. Diann Gaalema
• Organization: University of Texas Medical Branch, Division of Cardiovascular Medicine

digaalem@utmb.edu

409-772-1533

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 30, 2018
• Study Start: December 3, 2018
• Primary Completion: May 1, 2023
• Study Completion: February 28, 2024
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)