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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
209
Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
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.
University of Vermont Medical Center
Burlington, Vermont, United States
Cardiac Rehabilitation Attendance
Number of cardiac rehabilitation sessions completed out of a possible 36
Time frame: Within 4 months of the intake assessment
Cardiac Rehabilitation Completion
Proportion of patients who complete 30+ sessions of cardiac rehabilitation
Time frame: Within 4 months of the intake assessment
Change in Fitness (Peak Oxygen Uptake)
Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).
Time frame: Within 4 months of the intake assessment
Change in Fitness (Estimated Metabolic Equivalent of Task)
Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).
Time frame: 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).
Time frame: 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).
Time frame: 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). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.
Time frame: 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). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.
Time frame: 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) 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.
Time frame: 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). 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.
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (Delay Discounting)
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.
Time frame: 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). 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.
Time frame: 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). 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.
Time frame: 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). 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.
Time frame: 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).
Time frame: Within 4 months of the intake assessment
Health Care Contacts
Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.
Time frame: One year period starting at intake assessment.
Health Care Costs
Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.
Time frame: One year period starting at intake assessment.
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