HeLP: Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program
Study Details
Study Description
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 200 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Cardiac Rehabilitation Attendance [Within 4 months of the intake assessment]
Number of cardiac rehabilitation sessions completed out of a possible 36
- Cardiac Rehabilitation Completion [Within 4 months of the intake assessment]
Proportion of patients who complete 30+ sessions of cardiac rehabilitation
Secondary Outcome Measures
- Change in fitness [Within 4 months of the intake assessment]
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).
- 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).
- 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).
- 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).
- 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).
- Changes in Executive Function (DD) [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).
- 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).
- 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).
- 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).
- 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.
Other Outcome Measures
- Maintenance of fitness following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
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).
- Maintenance of waist circumference following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of smoking status following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of quality of life (cardiac-specific) following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in QoL(MacNew) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of quality of life (noncardiac-specific) following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in QoL (EuroQol) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of mental health following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in mental health (Adult Self-Report) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of depressive symptoms following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in depressive symptoms (BDI) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Executive Function (DD) following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Executive Function (DS) following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Executive Function (BRIEF) following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Executive Function (SST) following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Executive Function (Trail) following intervention. [From completion of intervention (4 months) to follow-up (one-year).]
Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Cost-effectiveness [One year period starting at intake assessment.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A recent myocardial infarction, coronary revascularization, diagnosis of congestive heart failure (CHF) or heart valve replacement or repair
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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.
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Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden county) for the next 12 mos.
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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)
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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:
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Dementia (MMSE<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
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Advanced cancer, advanced frailty, or other longevity-limiting systemic disease that would preclude CR participation
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Rest angina or very low threshold angina (<2 METS) until adequate therapy is instituted
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Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
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Class 4 chronic heart failure (symptoms at rest)
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Exercise-limiting non-cardiac disease such as severe arthritis, past stroke, severe lung disease
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Previous successful attendance at cardiac rehabilitation (defined as completing 6+ sessions in the past 10 years)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Vermont Medical Center | Burlington | Vermont | United States | 05405 |
Sponsors and Collaborators
- University of Vermont
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- R61HL143305