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

Phase 2

Completed

• Conditions: Cardiac Rehabilitation
• Interventions: Behavioral: Incentives; Behavioral: Case Management

• Registration Number: NCT03759873
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2018-12-03
• Primary Completion: 2023-05-01
• Study Completion: 2024-02-28
• Results First Submitted: 2024-08-06
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Results First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incentives	Incentives	Patient earns incentives for completing cardiac rehabilitation sessions.
Incentives and Case Management	Incentives	Patient receives both the Incentives and Case Management interventions.
Incentives and Case Management	Case Management	Patient receives both the Incentives and Case Management interventions.
Case Management	Case Management	Patient is assigned a case manager while in hospital.

Primary Outcome Measures

Name	Time	Method
Cardiac Rehabilitation Completion	Within 4 months of the intake assessment	Proportion of patients who complete 30+ sessions of cardiac rehabilitation
Cardiac Rehabilitation Attendance	Within 4 months of the intake assessment	Number of cardiac rehabilitation sessions completed out of a possible 36

Secondary Outcome Measures

Name	Time	Method
Change in Fitness (Peak Oxygen Uptake)	Within 4 months of the intake assessment	Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).
Change in Fitness (Estimated Metabolic Equivalent of Task)	Within 4 months of the intake assessment	Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).
Change in Body Composition	Within 4 months of the intake assessment	Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).
Changes in Smoking Status	Within 4 months of the intake assessment	Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).
Changes in Quality of Life - Cardiac Specific	Within 4 months of the intake assessment	Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.
Changes in Quality of Life - Non-specific	Within 4 months of the intake assessment	Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.
Changes in Mental Health	Within 4 months of the intake assessment	Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range.
Changes in Depressive Symptoms	Within 4 months of the intake assessment	Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes.
Changes in Executive Function (Delay Discounting)	Within 4 months of the intake assessment	Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake). A 5-trial adjusting delay discounting task was used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting.
Changes in Executive Function (DS)	Within 4 months of the intake assessment	Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.
Changes in Executive Function (Trail)	Within 4 months of the intake assessment	Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.
Changes in Executive Function (BRIEF)	Within 4 months of the intake assessment	Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.
Changes in Executive Function (SST)	Within 4 months of the intake assessment	Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).
Health Care Contacts	One year period starting at intake assessment.	Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.
Health Care Costs	One year period starting at intake assessment.	Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States