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

Cardiac Rehabilitation Clinical Trial

— HeLP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759873
• Other study ID #: R61HL143305
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2018
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: February 28, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

Behavioral:
• Incentives
Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
• 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.

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maintenance of fitness following intervention.	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).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of waist circumference following intervention.	Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of smoking status following intervention.	Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of quality of life (cardiac-specific) following intervention.	Changes in QoL(MacNew) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of quality of life (noncardiac-specific) following intervention.	Changes in QoL (EuroQol) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of mental health following intervention.	Changes in mental health (Adult Self-Report) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of depressive symptoms following intervention.	Changes in depressive symptoms (BDI) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of Executive Function (DD) following intervention.	Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of Executive Function (DS) following intervention.	Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of Executive Function (BRIEF) following intervention.	Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of Executive Function (SST) following intervention.	Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Maintenance of Executive Function (Trail) following intervention.	Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion).	From completion of intervention (4 months) to follow-up (one-year).
Other	Cost-effectiveness	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.	One year period starting at intake assessment.
Primary	Cardiac Rehabilitation Attendance	Number of cardiac rehabilitation sessions completed out of a possible 36	Within 4 months of the intake assessment
Primary	Cardiac Rehabilitation Completion	Proportion of patients who complete 30+ sessions of cardiac rehabilitation	Within 4 months of the intake assessment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health care contacts	Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.	One year period starting at intake assessment.
Secondary	Health care costs	Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.	One year period starting at intake assessment.