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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Rehabilitation

Intervention / Treatment
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* Behavioral: Incentives
* Behavioral: Case Management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incentives, Case management, Socioeconomic status