Clinical trial NCT03759873: Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program
Official title: Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Rehabilitation
Keywords: Incentives
Case management
Socioeconomic status
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-11-30
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac Rehabilitation Attendance
timeFrame: Within 4 months of the intake assessment
measure: Cardiac Rehabilitation Completion
timeFrame: Within 4 months of the intake assessment
Secondary outcomes:
measure: Change in Fitness (Peak Oxygen Uptake)
timeFrame: Within 4 months of the intake assessment
measure: Change in Fitness (Estimated Metabolic Equivalent of Task)
timeFrame: Within 4 months of the intake assessment
measure: Change in Body Composition
timeFrame: Within 4 months of the intake assessment
measure: Changes in Smoking Status
timeFrame: Within 4 months of the intake assessment
measure: Changes in Quality of Life - Cardiac Specific
timeFrame: Within 4 months of the intake assessment
measure: Changes in Quality of Life - Non-specific
timeFrame: Within 4 months of the intake assessment
measure: Changes in Mental Health
timeFrame: Within 4 months of the intake assessment
measure: Changes in Depressive Symptoms
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (Delay Discounting)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (DS)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (Trail)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (BRIEF)
timeFrame: Within 4 months of the intake assessment
measure: Changes in Executive Function (SST)
timeFrame: Within 4 months of the intake assessment
measure: Health Care Contacts
timeFrame: One year period starting at intake assessment.
measure: Health Care Costs
timeFrame: One year period starting at intake assessment.
Other outcomes:
measure: Maintenance of Fitness Following Intervention (Peak Oxygen Uptake)
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task)
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Waist Circumference Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Smoking Status Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Quality of Life (Cardiac-specific) Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Quality of Life (Noncardiac-specific) Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Mental Health Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Depressive Symptoms Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Executive Function (Delay Discounting) Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Executive Function (DS) Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Executive Function (BRIEF) Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Executive Function (SST) Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Maintenance of Executive Function (Trail) Following Intervention.
timeFrame: From completion of intervention (4 months) to follow-up (one-year).
measure: Cost-effectiveness
timeFrame: One year period starting at intake assessment.
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References: