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

Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Behavioral: Incentives; Behavioral: Case Management

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Incentives; Patient earns incentives for completing cardiac rehabilitation sessions.	Behavioral: Incentives; Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
Experimental: Case Management; Patient is assigned a case manager while in hospital.	Behavioral: Case Management; 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.
Experimental: Incentives and Case Management; Patient receives both the Incentives and Case Management interventions.	Behavioral: Incentives; Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.; Behavioral: Case Management; 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.
No Intervention: Usual care; This control condition does not receive either intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fitness	Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Change in body composition	Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in smoking status	Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in quality of life - cardiac specific	Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in quality of life - non-specific	Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in mental health	Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in depressive symptoms	Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in Executive Function (DD)	Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in Executive Function (DS)	Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in Executive Function (Trail)	Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in Executive Function (BRIEF)	Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Changes in Executive Function (SST)	Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).	Within 4 months of the intake assessment
Health care contacts	Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.	One year period starting at intake assessment.
Health care costs	Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.	One year period starting at intake assessment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of fitness following intervention.	Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of waist circumference following intervention.	Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of smoking status following intervention.	Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of quality of life (cardiac-specific) following intervention.	Changes in QoL(MacNew) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of quality of life (noncardiac-specific) following intervention.	Changes in QoL (EuroQol) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of mental health following intervention.	Changes in mental health (Adult Self-Report) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of depressive symptoms following intervention.	Changes in depressive symptoms (BDI) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (DD) following intervention.	Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (DS) following intervention.	Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (BRIEF) following intervention.	Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (SST) following intervention.	Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (Trail) following intervention.	Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Cost-effectiveness	Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization.	One year period starting at intake assessment.

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Incentives; Socioeconomic status; Case management
• Other Study ID Numbers: R61HL143305 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No