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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03759873

Acronym

HeLP

Enrollment

209

Registered

2018-11-30

Start date

2018-12-03

Completion date

2024-02-28

Last updated

2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Rehabilitation

Keywords

Incentives, Case management, Socioeconomic status

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.

Interventions

BEHAVIORALIncentives

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

BEHAVIORALCase 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.

Other

Measure	Time frame	Description
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 perceived quality of life (MacNew) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.
Maintenance of Quality of Life (Noncardiac-specific) Following Intervention.	From completion of intervention (4 months) to follow-up (one-year).	Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.
Maintenance of Mental Health Following Intervention.	From completion of intervention (4 months) to follow-up (one-year).	Changes in mental health (Adult Self-Report) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion) 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.
Maintenance of Depressive Symptoms Following Intervention.	From completion of intervention (4 months) to follow-up (one-year).	Changes in reported depressive symptoms The Beck Depression Inventory (BDI) will be measured from intervention completion until follow-up (8 months after intervention completion). 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.
Maintenance of Executive Function (Delay Discounting) 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). A 5-trial adjusting delay discounting task will be 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.
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). 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.
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). 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.
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). 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.
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.
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 Fitness Following Intervention (Peak Oxygen Uptake)	From completion of intervention (4 months) to follow-up (one-year).	Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).
Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task)	From completion of intervention (4 months) to follow-up (one-year).	Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Incentives Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	53
Case Management Patient is assigned a case manager while in hospital. 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.	51
Incentives and Case Management Patient receives both the Incentives and Case Management interventions. 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.	52
Usual Care This control condition does not receive either intervention.	36
Total	192

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Moved outside eligible area	0	2	0	0
Overall Study	Not appropriate for cardiac rehab	4	4	4	2
Overall Study	Withdrawal by Subject	0	0	1	0

Baseline characteristics

Characteristic	Case Management	Incentives and Case Management	Total	Incentives	Usual Care
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	12 Participants	10 Participants	45 Participants	14 Participants	9 Participants
Age, Categorical Between 18 and 65 years	39 Participants	42 Participants	147 Participants	39 Participants	27 Participants
Age, Continuous	57.9 years STANDARD_DEVIATION 12.7	57.9 years STANDARD_DEVIATION 10.9	57.7 years STANDARD_DEVIATION 11.3	57.6 years STANDARD_DEVIATION 11.2	57.1 years STANDARD_DEVIATION 10.5
Beck Depression Inventory	14.6 units on a scale STANDARD_DEVIATION 10.4	11.1 units on a scale STANDARD_DEVIATION 8.2	12.6 units on a scale STANDARD_DEVIATION 10	9.3 units on a scale STANDARD_DEVIATION 7.5	17.5 units on a scale STANDARD_DEVIATION 13.7
Currently Smoking	21 Participants	23 Participants	85 Participants	23 Participants	18 Participants
Education College/Advanced Degree	10 Participants	16 Participants	49 Participants	13 Participants	10 Participants
Education Data Missing	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Education High School/Some College	22 Participants	28 Participants	93 Participants	28 Participants	15 Participants
Education Less Than High School/GED	19 Participants	8 Participants	49 Participants	11 Participants	11 Participants
Enrolled in Medicaid	48 Participants	50 Participants	185 Participants	52 Participants	35 Participants
Estimated Metabolic Equivalent of Task (METs)	5.5 kilocalories per kilogram per hour STANDARD_DEVIATION 2.3	6.2 kilocalories per kilogram per hour STANDARD_DEVIATION 2.2	5.9 kilocalories per kilogram per hour STANDARD_DEVIATION 2.5	5.8 kilocalories per kilogram per hour STANDARD_DEVIATION 2.7	6.4 kilocalories per kilogram per hour STANDARD_DEVIATION 3
EuroQol Visual Analogue Scale	55.2 units on a scale STANDARD_DEVIATION 22.4	60.1 units on a scale STANDARD_DEVIATION 19.3	60.2 units on a scale STANDARD_DEVIATION 19.9	64.1 units on a scale STANDARD_DEVIATION 16.4	62.4 units on a scale STANDARD_DEVIATION 20.9
MacNew Heart Disease Health-related Quality of Life Questionnaire	4.9 units on a scale STANDARD_DEVIATION 1.1	5.1 units on a scale STANDARD_DEVIATION 1	4.9 units on a scale STANDARD_DEVIATION 1.1	5.0 units on a scale STANDARD_DEVIATION 1	4.7 units on a scale STANDARD_DEVIATION 1.3
Patient Health Questionnaire-2 Data Missing	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Patient Health Questionnaire-2 Screen Negative (0-2)	41 Participants	40 Participants	145 Participants	39 Participants	25 Participants
Patient Health Questionnaire-2 Screen Positive (0-2)	10 Participants	11 Participants	45 Participants	13 Participants	11 Participants
Peak Oxygen Uptake (Peak VO2)	16.8 milliliters per kilogram per minute STANDARD_DEVIATION 5.5	18.8 milliliters per kilogram per minute STANDARD_DEVIATION 5.5	17.9 milliliters per kilogram per minute STANDARD_DEVIATION 5.9	17.9 milliliters per kilogram per minute STANDARD_DEVIATION 6.3	17.7 milliliters per kilogram per minute STANDARD_DEVIATION 6.7
Primary Diagnosis Chronic Systolic Heart Failure	6 Participants	4 Participants	21 Participants	6 Participants	5 Participants
Primary Diagnosis Coronary Artery Bypass Graft	7 Participants	6 Participants	29 Participants	12 Participants	4 Participants
Primary Diagnosis Myocardial Infarction	1 Participants	5 Participants	9 Participants	1 Participants	2 Participants
Primary Diagnosis Percutaneous Intervention	27 Participants	31 Participants	108 Participants	27 Participants	23 Participants
Primary Diagnosis Stable Angina	2 Participants	1 Participants	3 Participants	0 Participants	0 Participants
Primary Diagnosis Valve Replacement/Repair	8 Participants	5 Participants	22 Participants	7 Participants	2 Participants
Race/Ethnicity, Customized American Indian	1 participants	1 participants	5 participants	2 participants	1 participants
Race/Ethnicity, Customized Asian	0 participants	0 participants	3 participants	1 participants	2 participants
Race/Ethnicity, Customized Black or African American	4 participants	1 participants	9 participants	3 participants	1 participants
Race/Ethnicity, Customized Hispanic Other/Multiracial	0 participants	0 participants	1 participants	1 participants	0 participants
Race/Ethnicity, Customized Hispanic White	3 participants	0 participants	3 participants	0 participants	0 participants
Race/Ethnicity, Customized Non-Hispanic White	41 participants	48 participants	162 participants	44 participants	29 participants
Race/Ethnicity, Customized Other/Multiracial	2 participants	2 participants	9 participants	2 participants	3 participants
Region Rural	14 Participants	15 Participants	48 Participants	16 Participants	3 Participants
Region Urban	37 Participants	37 Participants	144 Participants	37 Participants	33 Participants
Region of Enrollment United States	51 participants	52 participants	192 participants	53 participants	36 participants
Sex: Female, Male Female	21 Participants	20 Participants	67 Participants	12 Participants	14 Participants
Sex: Female, Male Male	30 Participants	32 Participants	125 Participants	41 Participants	22 Participants
Waist Circumference	44.6 inches STANDARD_DEVIATION 8.7	43.0 inches STANDARD_DEVIATION 6.8	42.8 inches STANDARD_DEVIATION 7.2	41.3 inches STANDARD_DEVIATION 6.4	42.2 inches STANDARD_DEVIATION 6.3

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	3 / 53	5 / 51	3 / 52	0 / 36
other Total, other adverse events	39 / 53	42 / 51	42 / 52	27 / 36
serious Total, serious adverse events	15 / 53	25 / 51	20 / 52	16 / 36