Key Points
Question
What is the efficacy of early case management and/or financial incentives for increasing cardiac rehabilitation attendance among patients with lower socioeconomic status?
Findings
In this randomized clinical trial, 192 patients with lower socioeconomic status eligible for cardiac rehabilitation were randomized to 1 of 4 conditions: usual care control, a case manager starting in-hospital, financial incentives for completing cardiac rehabilitation sessions, or both interventions. The combined interventions of case management and financial incentives had the highest efficacy for improving completion of cardiac rehabilitation.
Meaning
This intervention strategy may be an effective method to improve health outcomes among a vulnerable, underserved population.
Abstract
Importance
Participation in cardiac rehabilitation is associated with significant decreases in morbidity and mortality. Despite the proven benefits, cardiac rehabilitation is severely underutilized in certain populations, specifically those with lower socioeconomic status (SES).
Objective
To assess the efficacy of early case management and/or financial incentives for increasing cardiac rehabilitation adherence among patients with lower SES.
Design, Setting, and Participants
This randomized clinical trial enrolled patients from December 2018 to December 2022. Participants were followed up for 1 year with assessors and cardiac rehabilitation staff blinded to study condition. Patients with lower SES with a cardiac rehabilitation–qualifying diagnosis (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention, heart valve replacement/repair, or stable systolic heart failure) were recruited. Then patients attended one of 3 cardiac rehabilitation programs at 1 university or 2 community-based hospitals. A consecutively recruited sample was randomized and stratified by age (<57 vs ≥57 years) and smoking status (current smoker vs nonsmoker or former smoker).
Intervention
Participants were randomized 2:3:3:3 to either a usual care control, case management starting in-hospital, financial incentives for completing cardiac rehabilitation sessions, or both interventions (case management plus financial incentives). Interventions were in place for 4 months following informed consent.
Main Outcomes and Measures
The main outcome was cardiac rehabilitation adherence (proportion of patients completing ≥30 sessions). The a priori hypothesis was that interventions would improve adherence, with the combined intervention performing best.
Results
Of 314 individuals approached, 11 were ineligible, and 94 declined participation. Of the 209 individuals who were randomized, 17 were withdrawn. A total of 192 individuals (67 [35%] female; mean [SD] age, 58 [11] years) were included in the analysis. Interventions significantly improved cardiac rehabilitation adherence with 4 of 36 (11%), 13 of 51 (25%), 22 of 53 (42%), and 32 of 52 (62%) participants completing at least 30 sessions in the usual care, case management, financial incentives, and case management plus financial incentives conditions, respectively. The financial incentives and case management plus financial incentives conditions significantly improved cardiac rehabilitation adherence vs usual care (adjusted odds ratio [AOR], 5.1 [95% CI, 1.5-16.7]; P = .01; AOR, 13.2 [95% CI, 4.0-43.5]; P < .001, respectively), and the case management plus financial incentives condition was superior to both case management or financial incentives alone (AOR, 5.0 [95% CI, 2.1-11.9]; P < .001; AOR, 2.6 [95% CI, 1.2-5.9]; P = .02, respectively). Interventions were received well by participants: 86 of 105 (82%) in the financial incentives conditions earned at least some incentives, and 96 of 103 participants (93%) assigned to a case manager completed the initial needs assessment.
Conclusion and Relevance
In this randomized clinical trial, financial incentives improved cardiac rehabilitation adherence in a population with higher risk and lower SES with additional benefit from adding case management.
Trial Registration
ClinicalTrials.gov Identifier: NCT03759873
This randomized clinical trial assesses the efficacy of early case management, financial incentives, and their combination for increasing cardiac rehabilitation adherence among patients with lower socioeconomic status.
Introduction
Cardiovascular disease (CVD) is not spread equally across the population. Individuals of lower socioeconomic status (SES), which is measured in many ways including earnings and educational attainment, carry a higher proportion of morbidity and mortality from CVD.1 However, disparities by SES are largely due to modifiable behaviors.2 Patients with lower SES have higher-risk cardiac profiles (smoking, obesity, diabetes, and lower cardiorespiratory fitness [CRF]), which result in increased rates of cardiac events.3,4,5 Thus, the increased morbidity and mortality following a cardiac event in individuals with lower SES may be modifiable by engaging in cardiac rehabilitation.6
Cardiac rehabilitation is a structured program of supervised exercise and risk-factor control that is standard of care (class 1 American Heart Association/American College of Cardiology recommendation) following a myocardial infarction (MI) or coronary revascularization.7,8,9 Results from meta-analyses show that cardiac rehabilitation attendance is associated with a 26% reduction in cardiovascular mortality, a 23% to 31% reduction in 1-year hospital readmission rate, and improved quality of life.10,11 Benefits of cardiac rehabilitation appear to accrue in a dose-dependent manner.12,13,14
Individuals with lower SES have remarkably low rates of cardiac rehabilitation participation.6,15 A comprehensive examination of the US population with Medicare (aged ≥65 years) showed that dual-eligible individuals (ie, also Medicaid-enrolled and thus generally having lower income) had a cardiac rehabilitation participation rate of 6.9%, compared to 26.7% in those not dually enrolled.16 Contemporary studies confirm these disparities by SES.17,18,19 Thus, despite potentially significant health gains, patients with lower SES are less likely to access cardiac rehabilitation.
Several interventions show promise for addressing this issue. Case management assigns a trained individual to a patient with the goal of improving health outcomes through assessment, planning, coordination of care, patient monitoring, and evaluation. Case management has been shown to reduce the risk of developing CVD and rehospitalizations after MI.20,21 Case management during transitions from inpatient to outpatient has been shown to increase cardiac rehabilitation participation.22 However, case management has not been specifically tested in individuals with lower SES.
One use of financial incentives was initially developed to encourage abstinence in individuals with cocaine dependence in outpatient care.23 This approach was subsequently found to be effective for many health-related behaviors, including smoking cessation in those who are pregnant,24 medication adherence in individuals with HIV,25 and weight loss in disadvantaged populations.26 Financial incentives have also been tested for improving cardiac rehabilitation attendance in individuals with lower SES.27,28 In an initial study, individuals enrolled in Medicaid randomized to the financial incentives condition completed more cardiac rehabilitation sessions (22.4 vs 14.7 sessions) and were almost twice as likely to complete cardiac rehabilitation (55% vs 29%) as individuals in the control group.28
Both financial incentives and case management may help overcome specific barriers for patients with lower SES. Obviously, financial incentives can ameliorate monetary barriers. However, they can also help overcome delay discounting, where short-term consequences (eg, costs and initial discomfort of attending cardiac rehabilitation) are given too much weight, and long-term outcomes (eg, improved health) are weighed more lightly.29,30 Similarly, patients with lower SES may have challenges with executive function,31 which can limit their ability to plan, organize, and navigate the medical system, challenges that can be overcome with case management.
Both the case management and financial incentives interventions have the potential to improve cardiac rehabilitation attendance and may also have additive effects.32 Accordingly, in the current study, we strove to compare the effects of case management, financial incentives, or their combination on increasing the number of participants completing at least 30 cardiac rehabilitation sessions in patients with lower SES who were eligible for cardiac rehabilitation. We hypothesized that case management and financial incentives would similarly increase cardiac rehabilitation adherence but that their combination would be superior to either intervention alone.33
Methods
This was a randomized clinical trial conducted at the University of Vermont Medical Center (UVMMC) that enrolled participants from December 2018 to December 2022. The University of Vermont institutional review board approved all procedures and written informed consent was obtained from all participants prior to study participation. A detailed protocol is available in Supplement 1. Major protocol changes during the trial included the addition of an eligible diagnosis (heart failure), expanding recruitment sites (2 community programs, Copley Hospital and Northwest Medical Center), and changes required during COVID-19. An external Data Safety and Monitoring Board met semiannually and had unblinded access to all safety data during the trial. The Consolidated Standards of Reporting Trials (CONSORT) reporting guideline was followed.
Study Population
Eligibility criteria included cardiac rehabilitation–eligible diagnosis (coronary artery bypass graft, MI, percutaneous coronary intervention, heart valve replacement/repair, or stable systolic heart failure), having lower SES (defined as having Medicaid insurance or attaining less than a high school education), and living in the catchment area of either UVMMC, Copley Hospital, or Northwest Medical Center with no plans of moving within the next year. Exclusion criteria included conditions that would make a patient inappropriate for cardiac rehabilitation such as dementia, current untreated substance use disorder, advanced cancer, advanced frailty, or other longevity-limiting systemic disease, as determined by medical record review. Patients who did not speak English were also excluded due to cognitive assessments given as part of this protocol, which were only normed for English-speaking populations. This was not a major exclusion factor as 95% of people residing in Vermont speak English as a primary language.
Recruitment and Randomization
Potential participants were screened through daily review of the cardiology inpatient records and outpatient cardiology clinic schedules. Eligible patients were approached either while inpatient or as outpatients in conjunction with visits to cardiac clinics. Following informed consent, participants were randomized to experimental conditions stratified by age (<57 years vs ≥57 years) and self-reported cigarette smoking status (current smoker vs nonsmoker or former smoker), the strongest predictors of cardiac rehabilitation attendance in this population.28,34 The biostatistician created randomization codes, placed them in sealed envelopes and labeled them by strata (block size 11). Following informed consent, participants were randomized by opening the appropriate envelope.
Participants were randomized 2:3:3:3 to either usual care control, case management starting in-hospital, financial incentives for completing cardiac rehabilitation sessions, or both interventions (case management plus financial incentives) (Figure 1). The prespecified 209 individuals were initially enrolled and randomized, 17 participants were withdrawn, generally for having a change in status that made them no longer eligible for cardiac rehabilitation (eTable 1 in Supplement 2). The proportion of patients withdrawn did not differ across conditions, and the final sample included 192 participants.
Figure 1. CONSORT Diagram.
This flow diagram shows the participants who moved through the study from eligibility assessment to randomization, the number excluded from final analysis, and those included in the final data analysis. CR indicates cardiac rehabilitation.
Study Setting
All study assessments were completed at UVMMC by personnel blinded to study conditions. Participants completed cardiac rehabilitation sessions at the program of their choice. All cardiac rehabilitation programs were nationally accredited and offered for participants to complete up to 36 sessions. Sessions were conducted by clinical staff as part of usual clinical care. Study interventions were delivered by research staff and clinical staff were blinded to condition assignment.
Experimental Conditions
Intervention details are included in Supplement 1 and protocol article.33 Briefly, for the usual care condition, research staff ensured the participant had an appropriately placed referral for cardiac rehabilitation, but participants did not receive any further intervention. Participants were expected to complete 2 study assessments (intake and exit) and were compensated for completing these visits. Usual care participants were also contacted weekly for adverse event (AE) checks.
In the case management intervention, participants were assigned to a case manager immediately following informed consent. Individuals in the case management condition completed an initial brief check-in (generally within 24 hours of consent), an in-depth needs assessment (within the first week of consent), and weekly calls with the case manager for 16 weeks where they reviewed behavioral goals and helped troubleshoot barriers. Case managers were also available ad hoc by phone during normal working hours and Saturday mornings.
In the financial incentives condition, participants earned incentives for completing an initial cardiac rehabilitation orientation session and for each of the 36 cardiac rehabilitation sessions. Completion of cardiac rehabilitation sessions was reinforced on an escalating scale starting at $10 and increasing by $2 for each consecutive session attended (maximum of $40 per session). The reinforcement schedule included a reset, where an unexcused absence caused loss of progress on the escalation. However, attending 2 consecutive sessions after a reset restored progress.35 Participants could earn a maximum of $1220 ($20 for orientation and $1200 total for the 36 sessions). Incentives could be accumulated, or paid out as they were earned, and were distributed as gift cards or checks written to local businesses. Those in the combined condition (case management plus financial incentives) received both previously described interventions. Detailed manuals for these interventions are included in eAppendices 3 and 4 in Supplement 2.
Outcomes and Assessments
Clinical and demographic characteristics (age, sex, educational attainment, self-reported race [Asian/Pacific Islander, Black, Native American/American Indian, White] and ethnicity [Hispanic or non-Hispanic], smoking status, cardiac rehabilitation–qualifying diagnosis) and depressive symptoms (Patient Health Questionnaire [PHQ-2])36 were collected following consent. The primary outcome was the proportion of participants completing at least 30 sessions (categorical outcome with 2 levels). Data on completed sessions were recorded, confirmed against the electronic health record, and collected on all participants. Requirements for session completion differed during COVID-19 shutdowns but only impacted 1.1% of sessions completed (eAppendix 1 in Supplement 2).
Secondary outcomes data were collected at assessments conducted at 2 time points, intake (after consent but prior to cardiac rehabilitation participation) and exit (4 months following intake). Assessments include clinical and sociocognitive measures. Clinical measures included: cardiorespiratory fitness (CRF), peak VO2 (oxygen uptake in mL × kg−1 × min−1) directly measured by expired gas analysis or estimated by metabolic equivalents of task (METs),37 body composition (body mass index and waist circumference), and quality of life (cardiac specific: MacNew Cardiac Health Status Questionnaire [26 items scored from 1 to 7 and averaged across items with higher scores indicating higher cardiac-related quality of life] and general: EuroQol [visual analog scale component; scores ranged from 0 to 100 with higher scores indicating more highly rated general quality of life]).38,39 Sociocognitive measures included psychological complaints (Beck Depression Inventory, Achenbach System of Empirically Based Assessment),40,41 and measures of executive function (Behavior Rating Inventory of Executive Function, Stop Signal Task, Delis-Kaplan Executive Function System [Trail Making subtest], Digit Span Test, and Delay Discounting).42,43,44,45,46 Data on AEs, obtained for 1 year from informed consent, were collected weekly from participants and electronic health record notifications of emergency department (ED) visits and hospitalizations.
Statistical Analysis
Analyses were done as intent to treat, including all participants randomized (minus those who withdrew). Descriptive statistics for the primary outcome (percentage of participants who completed ≥30 sessions) by condition and for the number of completed sessions were calculated (No. [%] and mean [SD], respectively). This study was powered to detect a significant difference in cardiac rehabilitation adherence (completing ≥30 sessions).30 For the primary end point analysis, the percentage of participants completing at least 30 sessions was compared between conditions using multivariable logistic regression with sex, age, smoking status, and cardiac rehabilitation–qualifying diagnoses (surgical vs nonsurgical) included in the model as covariates. Covariates were included based on past demonstrated associations with cardiac rehabilitation outcomes (Supplement 2). The primary results of interest from this analysis were preplanned pairwise comparisons between each pair of conditions. In addition, the mean number of sessions completed was compared across conditions and between each pair of conditions using analysis of covariance including the same covariates listed previously.
Secondary outcomes were analyzed over time using mixed-model repeated measures analyses of covariance with random effects of participants and repeated factor of time point. Primary predictors for these models were time point (entry vs exit), condition (usual care, case management, financial incentives, or financial incentives plus case management), and completion status (completed ≥30 sessions, yes/no). Models including all 2-way and 3-way interactions of these variables were also evaluated. In addition to the previously mentioned covariates of sex, age, smoking status, and diagnosis, intake value for each measure was also included in these models. For all mixed effect models, missing data were handled by using SAS mixed procedure, which provides estimates using the maximum likelihood method to enable the use of data for all participants in the analyses. All comparisons were preplanned, and statistical significance level was set a priori at P < .05 using 2-sided testing. Corrections for multiple comparisons were done using the Tukey-Kramer method. All statistical analyses were conducted using SAS, version 9.4 (SAS Institute, Inc).
Results
Participants
Of 314 individuals approached, 11 were ineligible, and 94 declined participation. Of the 209 individuals who were randomized, 17 were withdrawn. Of 192 participants, the study population included 67 female participants (35%) and had a mean (SD) age of 58 (11) years; 85 participants (44%) were smoking at the time of hospitalization/consent. Baseline characteristics are listed in Table 1. There were no clinically meaningful differences between conditions. Participants had remarkably low CRF (peak VO2, 18.08 mL × kg−1 × min−1; estimated METs, 6.12; Table 2).
Table 1. Baseline Characteristics Overall and by Condition.
| Characteristic | No. (%) | ||||
|---|---|---|---|---|---|
| Total (N = 192) | Usual care (n = 36) | Financial incentives (n = 53) | Case management (n = 51) | Financial incentives plus case management (n = 52) | |
| Age, mean (SD), y | 57.7 (11.3) | 57.1 (10.5) | 57.6 (11.2) | 57.9 (12.7) | 57.9 (10.9) |
| Sex | |||||
| Female | 67 (34.9) | 14 (38.9) | 12 (22.6) | 21 (41.2) | 20 (38.5) |
| Male | 125 (65.1) | 22 (61.1) | 41 (77.4) | 30 (58.8) | 32 (61.5) |
| Primary diagnosis | |||||
| Percutaneous intervention | 108 (56.3) | 23 (63.9) | 27 (50.9) | 27 (52.9) | 31 (59.6) |
| Coronary artery bypass graft | 29 (15.1) | 4 (11.1) | 12 (22.6) | 7 (13.7) | 6 (11.5) |
| Valve replacement/repair | 22 (11.5) | 2 (5.6) | 7 (13.2) | 8 (15.7) | 5 (9.6) |
| Chronic systolic heart failure | 21 (10.9) | 5 (13.9) | 6 (11.3) | 6 (11.8) | 4 (7.7) |
| Myocardial infarction | 9 (4.7) | 2 (5.6) | 1 (1.9) | 1 (2.0) | 5 (9.6) |
| Stable angina | 3 (1.6) | 0 | 0 | 2 (3.9) | 1 (1.9) |
| Currently smokinga | 85 (44.3) | 18 (50.0) | 23 (43.4) | 21 (41.2) | 23 (44.2) |
| Depressive symptoms measured by PHQ-2 scoreb | |||||
| Negative on screening (0-2) | 145 (76.3) | 25 (69.4) | 39 (75.0) | 41 (80.4) | 40 (78.4) |
| Positive on screening (3-6 points) | 45 (23.7) | 11 (30.6) | 13 (25.0) | 10 (19.6) | 11 (21.6) |
| Enrolled in Medicaid | 185 (96.4) | 35 (97.2) | 52 (98.1) | 48 (94.1) | 50 (96.2) |
| Education | |||||
| Less than high school/GED | 49 (25.7) | 11 (30.6) | 11 (21.2) | 19 (37.3) | 8 (15.4) |
| High school/some college | 93 (48.7) | 15 (41.7) | 28 (53.9) | 22 (43.1) | 28 (53.9) |
| College/advanced degree | 49 (25.7) | 10 (27.8) | 13 (25.0) | 10 (19.6) | 16 (30.8) |
| Race and ethnicityc | |||||
| Hispanic | |||||
| White | 3 (1.6) | 0 | 0 | 3 (5.9) | 0 |
| Other/multiracial | 1 (0.5) | 0 | 1 (1.9) | 0 | 0 |
| Non-Hispanic | |||||
| American Indian | 5 (2.6) | 1 (2.8) | 2 (3.8) | 1 (2.0) | 1 (1.9) |
| Asian | 3 (1.6) | 2 (5.6) | 1 (1.9) | 0 | 0 |
| Black | 9 (4.7) | 1 (2.8) | 3 (5.7) | 4 (7.8) | 1 (1.9) |
| Other/multiracial | 9 (4.7) | 3 (8.3) | 2 (3.8) | 2 (3.9) | 2 (3.9) |
| White | 162 (84.4) | 29 (80.6) | 44 (83.0) | 41 (80.4) | 48 (92.3) |
| Region | |||||
| Rural | 48 (25.0) | 3 (8.3) | 16 (30.2) | 14 (27.5) | 15 (28.9) |
| Urban | 144 (75.0) | 33 (91.7) | 37 (69.8) | 37 (72.5) | 37 (71.2) |
Abbreviations: GED, general educational development; PHQ-2, Patient Health Questionnaire. There were no significant differences by condition for any variable listed in Table 1.
At time of hospitalization.
Data missing for 2 individuals.
Data missing for 1 individual. Self-reported race and ethnicity were surveyed with 2 separate questions: (1) What race do you consider yourself? (Asian/Pacific Islander, Black, Native American/American Indian, White [with ability to select multiple options]); and (2) Do you consider yourself Hispanic or non-Hispanic?
Table 2. Outcomes by Time, Condition, and Cardiac Rehabilitation Completion.
| Variable | Least squares mean (95% CI)a | P valueb | |
|---|---|---|---|
| Intake | Exit | ||
| Peak VO2, mL × kg−1 × min−1 | |||
| Usual care | 18.0 (16.9-19.0) | 21.2 (19.8-22.6) | .01 |
| Financial incentives only | 18.1 (17.3-18.8) | 20.9 (20.0-21.9) | <.001 |
| Case management only | 18.0 (17.1-18.8) | 18.3 (17.3-19.3) | .99 |
| Case management plus financial incentives | 18.1 (17.3-18.9) | 18.6 (17.7-19.5) | .98 |
| <30 Sessions | 18.1 (17.5-18.7) | 19.0 (18.2-19.8) | .24 |
| ≥30 Sessions | 18.0 (17.2-18.6) | 20.5 (19.8-21.3) | <.001 |
| Estimated METs | |||
| Usual care | 6.1 (5.4-6.9) | 6.7 (5.7-7.8) | .97 |
| Financial incentives only | 6.1 (5.5-6.7) | 7.4 (6.8-8.1) | .049 |
| Case management only | 6.1 (5.5-6.7) | 6.5 (5.8-7.2) | .99 |
| Case management plus financial incentives | 6.2 (5.6-6.8) | 7.0 (6.3-7.7) | .56 |
| <30 Sessions | 6.2 (5.7-6.6) | 6.3 (5.7-6.9) | .98 |
| ≥30 Sessions | 6.1 (5.6-6.5) | 7.6 (7.1-8.1) | <.001 |
| Waist circumference, in | |||
| Usual care | 42.7 (42.1-43.3) | 42.0 (41.3-42.7) | .77 |
| Financial incentives only | 42.8 (42.4-43.2) | 42.1 (41.6-42.6) | .32 |
| Case management only | 42.7 (42.3-43.2) | 42.7 (42.1-43.2) | .99 |
| Case management plus financial incentive | 42.7 (42.3-43.1) | 42.1 (41.7-42.6) | .54 |
| <30 Sessions | 42.7 (42.4-43.0) | 42.0 (41.6-42.4) | .03 |
| ≥30 Sessions | 42.8 (42.4-43.1) | 42.4 (42.0-42.8) | .58 |
| Beck Depression Inventory c | |||
| Usual care | 11.0 (8.7-13.4) | 6.6 (4.7-8.8) | .12 |
| Financial incentives only | 10.2 (8.6-12.0) | 9.0 (7.3-10.8) | .97 |
| Case management only | 10.4 (8.8-12.1) | 6.6 (5.1-8.3) | .04 |
| Case management plus financial incentive | 10.3 (8.8-12.0) | 9.1 (7.5-10.9) | .97 |
| <30 Sessions | 10.6 (9.4-11.8) | 9.9 (8.5-11.4) | .89 |
| ≥30 Sessions | 10.1 (8.7-11.5) | 6.2 (5.1-7.4) | <.001 |
| MacNew | |||
| Usual care | 5.0 (4.8-5.2) | 5.4 (5.2-5.7) | .04 |
| Financial incentives only | 5.0 (4.8-5.1) | 5.4 (5.3-5.6) | .002 |
| Case management only | 5.0 (4.8-5.1) | 5.4 (5.2-5.6) | .01 |
| Case management plus financial incentive | 5.0 (4.9-5.1) | 5.2 (5.1-5.4) | .28 |
| <30 Sessions | 5.0 (4.9-5.1) | 5.3 (5.2-5.4) | .003 |
| ≥30 Sessions | 5.0 (4.9-5.1) | 5.5 (5.4-5.6) | <.001 |
| EuroQol VAS | |||
| Usual care | 64.5 (58.4-70.5) | 64.0 (57.7-70.4) | .99 |
| Financial incentives only | 61.8 (58.0-65.6) | 66.0 (61.9-70.2) | .85 |
| Case management only | 61.0 (57.2-64.8) | 66.2 (61.5-70.9) | .73 |
| Case management plus financial incentive | 62.2 (58.5-65.8) | 70.3 (66.2-74.3) | .09 |
| <30 Sessions | 61.6 (58.9-64.3) | 63.5 (60.3-66.7) | .83 |
| ≥30 Sessions | 63.1 (59.4-66.8) | 69.8 (65.9-73.6) | .04 |
Abbreviations: METs, metabolic equivalents of task; VAS, visual analog scale; VO2, oxygen uptake.
Adjusted least squares mean values from analyses.
P values corrected for multiple comparisons using the Tukey-Kramer method where applicable.
Beck Depression Inventory results back transformed due to data being square root transformed.
This sample had high rates of sociocognitive challenges. At the time of consent, 45 participants (24%) had scores on the PHQ-2 indicative of requiring screening for depression (score of 3 or more). At intake, many participants had cognitive scores suggestive of impairment (52 [34%] for working memory, 29 [21%] for cognitive flexibility, 36 [25%] for self-reported psychological issues, and 28 [19%] for executive functioning; eTable 2 in Supplement 2).
Primary Outcome
No data were missing for the primary outcome. Overall, 71 (37%) of participants completed at least 30 sessions, with participants completing 17 sessions on average. The percentage of participants completing at least 30 sessions differed significantly by condition (Figure 2). In the usual care, case management, financial incentives, and case management plus financial incentives conditions, 4 of 36 (11%), 13 of 51 (25%), 22 of 53 (42%), and 32 of 52 (62%) participants, respectively, completed at least 30 sessions. Post hoc pairwise comparisons demonstrated financial incentives and case management plus financial incentives significantly improved cardiac rehabilitation adherence over usual care (adjusted odds ratio [AOR], 5.1 [95% CI, 1.5-16.7]; P = .01; AOR, 13.2 [95% CI, 4.0-43.5]; P < .001, respectively), and that case management plus financial incentives was superior to both case management and financial incentives (AOR, 5.0 [95% CI, 2.1-11.9]; P < .001; AOR, 2.6 [95% CI, 1.2-5.9]; P = .02, respectively). There were no significant differences in cardiac rehabilitation adherence between case management and usual care (AOR, 2.6 [95% CI, 0.8-9.0]; P = .12) or between financial incentives and case management (AOR, 1.9 [95% CI, 0.8-4.6]; P = .13). Initial pairwise comparisons were done without correction for multiple comparisons because these were preplanned. After Tukey correction, all results remained significant, with the exception of case management plus financial incentives vs financial incentives.
Figure 2. Cardiac Rehabilitation Attendance by Condition.
This graph illustrates the proportion of participants who attended sessions and the number of sessions they attended. The conditions included financial incentives plus case management, financial incentives alone, case management alone, and usual care.
Uptake of Clinical Interventions
Both interventions had high rates of uptake and were well-received by participants (Figure 3). Within case management, 96 of 103 participants (93%) completed the initial needs assessment and an average of 10.7 of 15 weekly calls (71%) were completed. When asked how useful they found the intervention, 33 of 64 (52%) rated case management as extremely helpful on a Likert scale from 1 to 4 (not helpful to extremely helpful). Within the financial incentives conditions, 86 of 105 participants (82%) earned at least some financial incentives, with mean (SD) earnings of $670 ($526), and 33 of 68 participants (49%) rated financial incentives as extremely helpful.
Figure 3. Uptake of Clinical Interventions by Condition.
This graph shows the proportion of individuals for each condition that completed or earned the specified outcomes, including (1) a need assessment, (2) weekly check-ins, and (3) incentives earned.
Secondary Outcomes
Mean number of sessions completed also differed significantly by condition, with the least sessions completed in usual care (least squares mean [LSM], 10.9 [95% CI, 5.8-15.9]), intermediate amounts in case management (LSM, 12.0 [95% CI, 7.7-16.1]) and financial incentives (LSM, 16.9 [95% CI, 12.7-21.1]), and the highest completed in case management plus financial incentives (LSM, 24.1 [95% CI, 19.9-28.4]) (P < .001). Post hoc pairwise comparisons (with Tukey correction) showed that case management plus financial incentives significantly increased the mean number of sessions completed over usual care and case management (adjusted mean differences, 13.3 [95% CI, 5.1-21.4]; P < .001; 12.2 [95% CI, 4.8-19.7]; P < .001, respectively). There were no significant differences between financial incentives or case management and usual care (adjusted mean differences, 6.0 [95% CI, −2.3 to 14.3]; P = .24; 1.0 [95% CI, −7.2 to 9.3]; P = .99, respectively).
Additional results of secondary outcomes analyses can be seen in Table 2. Overall, participants improved significantly in CRF, body composition, depression scores, and quality of life (general and cardiac-specific) between intake and exit assessments. However, improvements were generally restricted to those who completed at least 30 sessions. Missingness of data for secondary outcomes is outlined in eAppendix 2 in Supplement 2.
Safety Outcomes
AE and serious AE data occurring in the year participants were enrolled can be seen in eTables 3, 4, and 5 in Supplement 2. In total, 646 AEs and 136 serious AEs were reported, with 10 deaths. There were 315 ED visits and 126 hospitalizations. The proportion of participants having an AE and/or serious AE did not differ by condition. All were determined not related to this study.
Discussion
This randomized clinical trial demonstrated that intensive interventions can significantly improve cardiac rehabilitation adherence in a population with lower SES. The number of sessions completed increased from 11 of 36 in the usual care condition to 25 of 36 in the case management plus financial incentives condition. The percentage of participants completing at least 30 sessions was only 11% in usual care vs 62% in the case management plus financial incentives condition. Indeed, both conditions that included a financial incentives component (financial incentives alone or case management plus financial incentives) significantly improved adherence. Case management alone did not significantly affect adherence.
The success of financial incentives in this population aligns with existing literature. Financial incentives have been used successfully to improve multiple health-related behaviors and perform particularly well when the behavior is related to attendance.23,47,48 These results also replicated a previous trial in patients with lower SES where financial incentives almost doubled cardiac rehabilitation adherence (55% vs 29%).28 In comparable conditions in the current trial, financial incentives more than tripled cardiac rehabilitation adherence compared with usual care (42% vs 11%).
The success of financial incentives for health-related behaviors can be seen in the integration of the intervention outside of research contexts. For example, following 2 decades of research on the successful use of financial incentives to treat substance use, the Veterans Administration began nationwide implementation of a financial incentive–based treatment.49 As of 2015, more than 70 Veterans Administration clinics had implemented the treatment strategy. Similarly, financial incentive–based interventions have been used in private industry for primary prevention and are being tested by other systems, such as the California Department of Health Care Services.50,51
Notably, case management alone did not significantly impact attendance in this study. However, this should not be interpreted to mean that case management should not be used. Instead, it is likely that case management cannot fully overcome barriers to attendance without tangible resources such as gasoline cards for travel or the ability to offset copays. Additionally, case management may have been perceived as enough support, such as helping set healthy behavior goals and answering questions about symptoms, that participants felt that attending cardiac rehabilitation was unnecessary. However, case management added to financial incentives improved outcomes beyond financial incentives alone. This cumulative effect is in line with existing literature, which showed that the combination of case management and financial incentives approach maximized outcomes.32 In this prior trial, the addition of case management improved attendance while also decreasing depressive symptoms and hospitalizations. Given that patients with cardiac health visits and lower SES have high rates of sociocognitive issues, case management support could potentially impact multiple outcomes outside of attendance.
While this study was not powered to examine clinical outcomes, the entire sample did improve on most clinical measures over time. CRF, body composition, and depressive symptoms all improved. In line with past research,12,13,14 improvements were closely aligned with the number of sessions attended.
This sample was a population at higher risk for complications, as generally seen in patients with lower SES.5 More than 40% were smoking at the time of diagnosis (a subgroup for which attendance is particularly difficult),52,53 CRF levels were exceptionally low, and many had concerning scores on depression or cognitive functioning. Additionally, during the trial, 315 ED visits, 126 hospitalizations, and 10 deaths also occurred. This population needs support and additional inquiry.
Limitations
Several limitations of this study need to be mentioned. Foremost, this study was powered for attendance, not for clinical outcomes. Second, this study was conducted at 3 sites (1 university and 2 community-based hospitals) within Vermont, which could limit generalizability. Third, given study blinding, case managers could not directly interface with cardiac rehabilitation staff. Fourth, an attention control was not provided for the usual care condition. Additionally, given various challenges (eg, COVID-19–related restrictions) some assessment data are limited.
Conclusions
The results of this randomized clinical trial suggest that attendance at cardiac rehabilitation in populations with lower SES can be improved with intensive interventions. Financial incentives alone, and in combination with case management, were successful at improving adherence to cardiac rehabilitation in this population.
Trial Protocol
eTable 1. Withdrawals by Condition
eAppendix 1. Effects of COVID
eTable 2. Executive Function Measures at Intake
eAppendix 2. Additional Analyses
eTable 3. Total Number of Adverse Events by Condition
eTable 4. Number/Percent of Participants Having an Adverse Event
eTable 5. Serious Adverse Events by Condition
eAppendix 3. Case Management Manual
eAppendix 4. Financial Incentives Manual
Data Sharing Statement
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Trial Protocol
eTable 1. Withdrawals by Condition
eAppendix 1. Effects of COVID
eTable 2. Executive Function Measures at Intake
eAppendix 2. Additional Analyses
eTable 3. Total Number of Adverse Events by Condition
eTable 4. Number/Percent of Participants Having an Adverse Event
eTable 5. Serious Adverse Events by Condition
eAppendix 3. Case Management Manual
eAppendix 4. Financial Incentives Manual
Data Sharing Statement