Key Points
Question
What is the added benefit of mobile integrated health compared with a transitions of care coordinator alone for patients discharged after heart failure?
Findings
This randomized clinical trial analyzing 2003 patients found that health status and 30-day readmissions were similar between groups whether a transitions of care coordinator was supplemented by mobile integrated health or not. However, exploratory analyses suggested that mobile integrated health was associated with better health status in patients younger than 70 years and a possible effect modification by sex on readmissions.
Meaning
These results indicate that adding mobile integrated health to transitions of care coordinator did not reduce readmissions at 30 days or improve health status; however, specific groups of patients did experience greater improved health status at 30 days and fewer readmissions—findings that warrant further research.
Abstract
Importance
The comparative effectiveness of 2 transitions of care programs for improving health status and reducing readmissions among patients hospitalized with heart failure is unknown.
Objective
To compare the effectiveness adding mobile integrated health (MIH) to a transitions of care coordinator for improving health status and reducing 30-day all-cause readmissions among patients discharged after heart failure.
Design, Settings, and Participants
The Mighty-Heart randomized clinical trial included Medicare- or Medicaid-enrolled adult (≥18 years) patients hospitalized with heart failure in 11 New York City (New York) hospitals between January 2021 and September 2024. Participants were randomized 1:1 to MIH or TOCC. TOCC provided a follow-up call by a nurse 48 to 72 hours after discharge. MIH included the same TOCC postdischarge call, and added ongoing nurse care coordination, community paramedic home visits, and facilitated synchronous telehealth with emergency medicine physicians. Data analysis occurred between September 2024 and June 2025.
Interventions
Receiving MIH plus TOCC or TOCC alone during the first 30 days after hospital discharge.
Main Outcomes and Measures
Coprimary outcomes were health status at 30 days measured with the Kansas City Cardiomyopathy Questionnaire Overall Summary score, and 30-day all-cause hospital readmission, with heart failure-specific readmissions as a secondary outcome.
Results
Among 2003 participants (median [IQR] age, 67 [58-78] years; 1040 female [52%]), no adjusted differences were observed in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 30 days between MIH and TOCC groups (mean difference, 1.83; 95% CI, −0.75 to 4.40; P = .16). Exploratory analysis showed a significant age-by-treatment interaction effect, with younger participants who received MIH having larger improvement in health status (β: 4.40; 95% CI, 1.01 to 7.79). There were no significant differences in overall 30-day readmissions between study groups (20.3% vs 20.4%; odds ratio, 0.99; 95% CI, 0.83 to 1.19; P = .95).
Conclusions and Relevance
This randomized clinical trial found that MIH conferred no additional benefit on health status or 30-day readmissions for postacute patients with heart failure compared to TOCC alone. Preliminary subgroup analyses suggest potential variations in MIH effects by age and sex; therefore, further research is warranted.
Trial Registration
ClinicalTrials.gov Identifier: NCT04662541
This randomized clinical trial assesses the effectiveness of mobile integrated health compared with a transitions of care coordinator alone for improved health status and reduced readmissions among patients discharged after heart failure.
Introduction
Heart failure is the leading cause of hospitalization among older adults in the US and has the highest 30-day all-cause readmission rates (20% to 25%) among Medicare beneficiaries.1 These readmissions create substantial financial and psychosocial burdens, especially for those facing adverse social determinants of health.1 Despite medical advances, many patients continue to experience poor health status and persistent symptoms.2,3
Multiple interventions have been tested to improve care transitions and postdischarge outcomes for patients hospitalized for heart failure,4 yet few comparative effectiveness trials have evaluated alternative strategies. Two possible interventions—mobile integrated health (MIH) and a transitions of care coordinator (TOCC)—have shown effectiveness in smaller trials or observational studies on postacute health care utilization5,6,7,8 and health status4,9,10; however, they have not previously been directly compared in a randomized clinical trial. In the Mighty-Heart (Mobile Integrated Health and Telehealth to support transitions of care among patients with Heart failure) multicenter randomized clinical trial, we aimed to compare the effects of these 2 interventions on 30-day health status and all-cause readmission rates.11
Methods
The design and recruitment protocols for the Mighty-Heart trial have been described previously,11 and the full protocol and statistical analysis plan are available in Supplement 1 and eAppendix 1 in Supplement 2. The protocol was approved by the Biomedical Research Alliance of New York centralized institutional review board (protocol #20-08-329-380) with reliance agreements from participating sites. All participants provided written informed consent (Supplement 1). The Mighty-Heart trial adhered to the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline for randomized trials.
Trial Design
The Mighty-Heart trial was conducted across 11 academic and community hospitals affiliated with 2 health care systems, New York Presbyterian and Mount Sinai Health in New York, New York (eAppendix 2 and eFigure 1 in Supplement 2). The trial was intentionally designed to align with clinical practice in the community setting, as evidenced by a mean score of 4.6 of 5.0 across the Pragmatic Explanatory Continuum Indicator Summary domains (eFigure 2 in Supplement 2). The MIH and TOCC programs were operating within each health system before study initiation, with existing community paramedics and nurse care coordinators available to deliver the interventions. Operational changes, treatment protocols, and clinical decisions were made at the discretion of local medical directors in accordance with regional and New York state regulations.
A patient stakeholder and advisory board was established at the beginning of the study to incorporate patient and stakeholder perspectives throughout all trial phases (eAppendix 3 in Supplement 2). Study enrollment began January 4, 2021, and concluded September 27, 2024, with the final 30-day follow-up completed on October 28, 2024. Weill Cornell Medicine was the study data coordinating center (eFigure 3 in Supplement 2).
Trial Participants
Eligible patients were hospitalized with heart failure at a participating New York Presbyterian or Mount Sinai hospital, resided in New York City, were adults (≥18 years old), enrolled in Medicare or Medicaid, expected to be discharged home, and able to provide informed consent in English, French, Mandarin, Russian, or Spanish (eTable 1 in Supplement 2). Exclusion criteria included a diagnosis of dementia or unstable psychiatric illness. Because some patients with advanced heart failure had access to the MIH program as part of their routine care, patients with advanced heart failure were also excluded. Recruitment was conducted across the 2 health systems using a consistent strategy adapted to each site’s clinical workflow (eAppendix 4 in Supplement 2), including a custom screening dashboard (eTable 2 in Supplement 2) and a daily electronic health record (EHR)−generated patient list using heart failure based on International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes (eTable 3 in Supplement 2).
Once enrolled, participants completed a baseline survey capturing self-reported sociodemographic information and baseline health status using the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) (additional details are available in eTable 4 in Supplement 2).12,13 After survey completion, participants were randomized 1:1 to MIH or TOCC, stratified by health system (Figure 1). All research staff and investigators were blinded to treatment assignment, except for the statisticians and health care professionals administering the interventions. A study crossover was defined as a participant who was randomly assigned to the TOCC group and then referred to MIH by their cardiologist or heart team within 30 days of hospital discharge.
Figure 1. Mighty-Heart CONSORT Flow Diagram.
Data Sources
Data for this study originated from patient-reported sociodemographic and outcomes surveys, and from multiple EHR data sources (eFigure 3 in Supplement 2). These included the Patient-Centered Outcomes Research Institute (PCORI) INSIGHT Clinical Research Network—a research-focused information exchange that aggregates and standardizes patient data across health care systems within a specific network in a common data format14—and each institution’s clinical data warehouse.
Study Interventions
Transition of Care Coordinator
The TOCC intervention was implemented at the 2 health systems independent of the research study, for all patients discharged after a heart failure exacerbation. TOCC consists of a single follow-up telephone call 48 to 72 hours after discharge by a registered nurse employed by each health system. Calls were conducted to assess clinical status, including new or worsening symptoms, review discharge instructions, identify unmet clinical and social needs, and reinforce patient education on medication adherence and lifestyle modifications. TOCC nurses could provide advice and education, encourage the patient to contact their primary or specialty care practitioner, or refer the patient to the emergency department.15,16 Due to the pragmatic nature of this study, each health system implemented and modified their TOCC interventions independently, so structured assessments were not implemented consistently between the hospital sites. One system used nurses from the inpatient units from which patients had been discharged to complete TOCC calls, and automated text messages to perform postdischarge follow-up; whereas the other system used nurses who were employed at a centralized call center.
Mobile Integrated Health
Patients randomized to MIH received a follow-up call from a nurse care coordinator within 48 to 72 hours of discharge, as described previously for TOCC, plus ongoing nurse care coordination, home visits by community paramedics, and telehealth visits with emergency medicine physicians, as needed. Based on clinical acuity, clinical judgment, and patient preference, a small team of trained nurse care coordinators made the outreach calls and could dispatch community paramedics equipped with Wi-Fi−connected tablets and laptop computers to facilitate telehealth evaluations.
Community paramedics—experienced emergency medical technicians and paramedics with advanced heart failure training—completed standardized home assessments using REDCap checklists (eAppendix 5 in Supplement 2), conducted physical examinations, reviewed discharge instructions, confirmed follow-up appointments, and performed medication reconciliation. Community paramedics administered treatments per emergency medical services protocols and arranged emergency department transport when necessary. As part of the MIH program, community paramedics participated in mandatory joint education sessions, including didactic lectures and simulated cases developed collaboratively by emergency medicine physicians and heart failure cardiologists at both hospital systems.
During telehealth visits, emergency medicine physicians could access clinical notes, discharge summaries, and medication lists from the patient’s EHR. They could consult the heart team in real time to adjust medications, arrange follow-up care, request diagnostics (eg, electrocardiograms), and suggest treatments, such as intravenous diuretics. Encounter summaries were sent to the patient’s heart care team.
Nurse care coordinators also addressed home-based needs, including nursing services, physical therapy, assistive devices, laboratory testing, transportation, and appointments. MIH services continued for up to 3 months, with further outreach or visits at the discretion of the nurse care coordinator.
Study Outcomes
Baseline measures (eg, education, financial resources, and social isolation)13 were collected during hospitalization. Follow-up assessments were conducted electronically or by telephone by trained research personnel blinded to group assignment (eFigure 4 in Supplement 2). The coprimary outcomes, both measured at 30 days, were health status and all-cause readmission.
Health status was assessed using the 23-item Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score, ranging from 0 to 100 (higher scores indicate better health); a 5-point change is considered clinically meaningful.17
All-cause 30-day readmission was defined as any rehospitalization within 30 days of the index hospitalization discharge date and categorized as a binary variable. Thirty-day heart failure specific readmissions were defined as any rehospitalization using ICD-10 codes for the admitting or discharge diagnosis (eAppendix 6 in Supplement 2). Readmission outcomes were assessed using electronic health record data from INSIGHT and each institution’s clinical data warehouse (eAppendix 1 in Supplement 2).
Sample Size Calculation
Power calculations were based on simulations using historical data from the INSIGHT Clinical Research Network in collaboration with the sponsor (PCORI). An α of .04 was allocated for 30-day all-cause readmissions and .01 for 30-day health status. Assuming a binary outcome for readmissions, a sample size of 2000 (1000 per group) provided 84% or greater power to detect a 5% absolute reduction in readmissions at a P = .04 significance level using a minimum loss-based estimation. The sample size also provided 84% or greater power to detect a 0.13 SD difference in health status using a 2-group t test at the 0.01 level (eAppendix 1 in Supplement 2).
Statistical Analysis
The primary analyses were conducted using a complete-case approach. Baseline characteristics were compared using Wilcoxon rank sum tests for continuous variables and χ2 tests for categorical variables. The initial protocol included time-to-event analysis via targeted maximum likelihood estimation as the primary analytic approach; however, due to high administrative censoring at the 30-day time point (with only 20% of participants experiencing the event), a weighted logistic regression model was used. This approach aligns with clinical decision-making at these fixed intervals and provides straightforward interpretation of treatment effects on event probability18,19,20 (eAppendix 1 in Supplement 2).
Health status was assessed with multivariable linear regression. For 30-day all-cause readmissions and heart failure specific readmissions, a weighted logistic regression model was used to examine the differences in proportions of readmissions between study groups, accounting for class imbalance in readmission status.18,19,20 Models were run with and without adjustment for prespecified covariates (eAppendix 1 in Supplement 2).
To assess heterogeneity of treatment effect prespecified interactions by age, sex, and site were assessed. Stratum-specific odds ratios or differences in marginal means were reported. Two-sided tests for main treatment effects used an overall α of .05 (.04 for readmissions and .01 for health status). In exploratory subgroup analyses, we used a permutation test that randomly shuffled the subgroup labels to assess heterogeneity of treatment effects between subgroups. For each permutation we re-estimated subgroup-specific treatment effects, and calculated treatment differences between subgroups. A 2-sided P value was obtained by calculating the proportion of permutations where the absolute treatment difference between subgroups was equal to or greater than the observed absolute difference from 10 000 permutations. We also include weighted logistic regression and time to event analyses for both 60- and 90-day readmission data (eAppendix 1 in Supplement 2). Analyses were conducted in R version, 4.2.2 (R Foundation for Statistical Computing) from September 2024 to June 2025.
To address missing data for the coprimary outcome of health status at 30 days, several sensitivity analyses were conducted. First, multivariate imputation by chained equations was used to manage missing KCCQ data. The covariates used in the imputation model, including the interaction terms, were the same as those of the primary analytic model. Fifty imputed datasets were generated and combined using Rubin rules.21 Second, inverse probability weighting (IPW) was used, based on the inverse of predicted probability from a logistic regression model estimating likelihood of missing 30-day KCCQ data, to more heavily weight the observations of those with complete data who were most like those missing 30-day KCCQ-OS score (eAppendix 1 in Supplement 2).
Results
The analysis included 2003 of the 2012 patients randomized between January 4, 2021, and September 27, 2024 (1005 patients to MIH and 998 to TOCC). Median (range) age was 67 (19-98) years, with 1040 (52%) female and 963 were male (48%) participants, of whom 937 (47%) self-identified as Black, 537 (27%) as Hispanic, and 570 (28%) as White. Participants had notable adverse social determinants of health, with 803 (40%) reporting not having enough money to “make ends meet,” and 369 (18%) not having graduated from high school. The recruitment was relatively balanced across health systems, with 1142 participants (57%) recruited from health system 1, and 862 (43%) from health system 2. Baseline characteristics were similar between the MIH and TOCC groups (Table), except for modest differences by marital status and race and ethnicity.
Table. Baseline Characteristics of the Trial Participants by Study Group.
| Characteristic | No. (%)a | |
|---|---|---|
| Mobile integrated health | Transition of care coordinator | |
| Participants, No. | 1005 | 998 |
| Age, median (IQR), y | 67 (58-78) | 68 (58-78) |
| Age category | ||
| <70 y | 435 (43) | 465 (47) |
| ≥70 y | 570 (47) | 533 (53) |
| Sex | ||
| Female | 529 (53) | 511 (51) |
| Male | 476 (47) | 487 (49) |
| Raceb | ||
| American Indian or Alaska Native | 1 (<0.1) | 8 (0.8) |
| Asian | 27 (3) | 28 (3) |
| Black or African American | 504 (50) | 433 (43) |
| Hawaiian or other Pacific Islander | 23 (2) | 17 (2) |
| White | 255 (25) | 315 (32) |
| Multiracial | 41 (4) | 42 (4) |
| Otherb | 153 (15) | 154 (15) |
| Missing data | 1 | 1 |
| Ethnicityb | ||
| Hispanicc | 274 (27) | 263 (27) |
| Not Hispanicc | 725 (73) | 727 (73) |
| Missing data | 6 | 8 |
| Marital status | ||
| Married/living with a partner | 283 (28) | 279 (28) |
| Divorced/separated/widowed | 263 (26) | 318 (32) |
| Single | 459 (46) | 400 (40) |
| Missing data | 0 | 1 |
| Financial resources | ||
| Not enough to make ends meet | 401 (40) | 402 (40) |
| Enough to make ends meet | 541 (54) | 526 (53) |
| More than enough to make ends meet | 62 (6.2) | 69 (6.9) |
| Missing data | 1 | 1 |
| Education | ||
| Less than high school | 182 (18) | 187 (19) |
| Completed high school | 539 (54) | 537 (54) |
| College and/or graduate school | 281 (28) | 272 (27) |
| Missing data | 3 | 2 |
| Hypertensionc | 764 (76) | 710 (71) |
| Diabetesc | 463 (46) | 444 (45) |
| COPDc | 372 (37) | 363 (36) |
| Chronic kidney diseasec | 457 (46) | 445 (45) |
| Chronic atrial fibrillation/flutterc | 330 (33) | 326 (33) |
| Stroke or transient ischemic attackc | 124 (12) | 113 (11) |
| Metastatic cancerc | 29 (2.9) | 24 (2.4) |
| Previous hospital admissions within 2 y of index hospitalizationc | ||
| None | 327 (33) | 348 (35) |
| 1-2 | 376 (37) | 370 (37) |
| ≥3 | 301 (30) | 279 (28) |
| Elixhauser Indexc | 15 (6, 23) | 15 (5, 23) |
| Charlson Comorbidity Indexc | 4 (2, 5) | 3 (1, 5) |
| KCCQ12 Overall Summary score, mean (SD) | 46 (25) | 46 (26) |
| Missing data | 0 | 1 |
| Recruitment, total | ||
| Health system 1 | 571 (57) | 571 (57) |
| Health system 2 | 435 (43) | 427 (43) |
| UCLA Loneliness Scale score13 | ||
| Lonely | 308 (32) | 301 (32) |
| Not lonely | 659 (68) | 641 (68) |
| Missing data | 38 | 56 |
Abbreviations: COPD, chronic obstructive pulmonary disease; KCCQ, Kansas City Cardiomyopathy Questionnaire Overall Summary; UCLA, University of California Los Angeles.
Percentages may not total 100 because of rounding and missing data.
Race and ethnicity group were self-reported by the participants from a list of options. Other was an available option for race.
This characteristic had missing data from 2 participants, so percentages are of those with data.
Among participants randomized to MIH (n = 1005), postdischarge follow-up calls were initiated, and 414 (41%) received a community paramedic home visit within 30 days of discharge. Eight participants assigned to TOCC were later referred to MIH and received MIH visits within 30 days of discharge. There were no adverse events associated with the interventions (eAppendix 7 in Supplement 2). Regarding deaths, 17 participants died after randomization and before discharge, while 37 were discharged and died before 30 days. There were no differences between study groups (23 deaths in the MIH and 14 in TOCC group).
Health Status
Overall, 1070 participants (53%) completed the 30-day KCCQ OS score. A comparison of the characteristics of patients who did and did not complete the 30-day KCCQ-OS score is available in eTable 5 in Supplement 2. The observed mean (SD) baseline KCCQ-OS score were 46 (25) in the MIH group and 46 (26) in the TOCC group (Table), with 30-day unadjusted mean KCCQ-OS scores of 55.6 ( 26) in the MIH group and 53.2 (25) in the TOCC group. There were no significant differences in 30-day KCCQ-OS scores between the 2 groups in our overall model (MIH, 9.82 vs TOCC, 7.99; adjusted mean difference: 1.83; 95% CI, −0.75 to 4.40; P = .16). Age-specific subgroup analyses showed MIH was associated with better health status among younger patients (β = 4.40; 95% CI, 1.01 to 7.79), but not among older patients (β = −1.87; 95% CI, −5.91 to 2.17); age-by-treatment interaction was statistically significant (P = .02). Age-by-treatment effects were consistent across multiple sensitivity analyses (eFigure 5 in Supplement 2). There were no significant site- or sex-by-treatment effects (Figure 2).
Figure 2. Heterogeneity of Treatment Effects for 30-Day Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores Across Prespecified Subgroups.
MIH indicates mobile integrated health; TOCC, transitions of care coordinator.
aAdjusted β estimates show effect of MIH vs TOCC on 30-day KCCQ scores.
bP values derived from permutation-based tests.
30-Day All-Cause Readmissions
Overall, 408 participants (20.4%; 204 [20.3%] with MIH and 204 [20.4%] with TOCC) were readmitted within 30 days of discharge. There were no significant main treatment effects on 30-day all-cause readmissions in unadjusted (odds ratio [OR], 0.99; 95% CI, 0.83-1.19; P = .95), or adjusted analyses (OR, 0.97; 95% CI, 0.80-1.16; P = .72). Sex-specific subgroup analyses showed MIH was associated with higher odds of 30-day readmission in males (OR, 1.19; 95% CI, 0.91-1.56) and lower odds in females (OR, 0.78; 95% CI, 0.60-1.01); however, the sex-by-treatment interaction was not statistically significant (95% CI, 0.49-0.99; P = .07), and there were no significant sex-specific treatment differences. There were no significant site- or age-by-treatment effects (Figure 3).
Figure 3. Heterogeneity of Treatment Effects for 30-Day All-Cause Readmissions Across Prespecified Subgroups.
MIH indicates mobile integrated health; OR, odds ratio; TOCC, transitions of care coordinator.
aAdjusted ORs examine odds of 30-day all-cause readmissions among MIH patients compared with TOCC patients.
bP values derived from permutation-based tests.
30-Day Heart Failure Readmissions
A total of 259 participants (12.9%) experienced a heart failure-specific readmission within 30 days. There were no significant main treatment effects on 30-day heart failure specific readmissions in unadjusted (OR, 0.90; 95% CI, 0.74- 1.09; P = .27) or adjusted (OR, 0.90; 95% CI, 0.74-1.10; P = .32) analyses. Similarly, MIH was associated with higher odds of heart failure specific readmissions in males (OR, 1.16; 95% CI, 0.87-1.54) and lower odds in females (OR, 0.70; 95% CI, 0.52-0.92); however, this interaction effect was not statistically significant (P = .08), and there were no significant sex-specific treatment differences. There were no significant site- or age-by-treatment effects (Figure 4).
Figure 4. Heterogeneity of Treatment Effects for 30-day Heart Failure (HF) Readmissions Across Prespecified Subgroups.
MIH indicates mobile integrated health; TOCC, transitions of care coordinator.
aAdjusted ORs examine odds of 30-day HF-specific readmissions among MIH patients compared with TOCC patients.
bP values derived from permutation-based tests.
60- and 90-Day All-Cause Readmissions
There were no significant main treatment effects on 60- and 90-day all-cause readmissions in both the unadjusted (60 days: 95% CI, 0.85-1.21; P = .90; 90 days: 95% CI, 0.83-1.18; P > .90) and adjusted analyses (60 days: 95% CI, 0.83-1.14; P > .90; 90 days: 95% CI, 0.79-1.14; P = .60) (eAppendix 1 in Supplement 2). There was also no further interaction with treatment at 60 days: sex-by-treatment (95% CI, 0.72-1.49; P = .85); age-by-treatment (95% CI, 0.68-1.42; P = .92); site-by-treatment (95% CI, 0.59-1.22; P = .37) or 90 days: sex-by-treatment (95% CI, 0.72-1.50; P = .84); age-by-treatment (95% CI, 0.84-1.75; P = .30); site-by-treatment (95% CI, 0.52-1.09; P = .13) (eAppendix 1 in Supplement 2).
Discussion
More than 1 in 5 patients hospitalized for decompensated heart failure are readmitted within 30 days, highlighting the need for more effective postacute care strategies. In this large randomized clinical trial involving a racially and socioeconomically diverse cohort, no significant differences were observed in 30-day readmission rates or patient-reported health status between 2 effective postdischarge interventions: MIH and TOCC. Exploratory analyses suggest significant interaction effects between age and treatment, with younger participants having better 30-day health status with MIH than with TOCC. Collectively these findings do not support universal adoption of either strategy. However, future research may help refine the MIH program by identifying which components are most effective for optimizing the transitions of care for patients living with heart failure after hospitalization.
While there was no overall difference in health status scores between patients randomized to MIH compared to TOCC, the finding that health status outcomes with TOCC were significantly worse in younger participants is consistent with prior studies22 and may be explained by younger patients having a higher burden of adverse social determinants of health. The added at-home support and ongoing care coordination provided by MIH may have contributed to the observed increase in health status in this subgroup. Similarly, there were no overall differences in hospital readmissions. However, among women, a lower proportion of patients randomized to the MIH group had 30-day all-cause (OR, 0.78; 95% CI, 0.60-1.01), or heart failure−specific hospital readmissions (OR, 0.70; 95% CI, 0.52-0.92), warranting further study.
Limitations
These findings should be interpreted in the context of several potential limitations. Mighty-Heart was a pragmatic trial of existing transitions of care programs, and both TOCC and MIH were operationalized differently across the 2 health systems. The interventions were delivered by health system−employed professionals (nurse care coordinators, physicians, community paramedics) independent of the research team, enhancing clinical relevance and generalizability to medically underserved populations, but potentially diluting the fidelity of the interventions. It is noteworthy that MIH continues to be used in these health systems and that some heart failure cardiologists deferred randomizing patients in Mighty-Heart because they felt that their patients needed MIH. The trial’s first year also coincided with the peak of the COVID-19 pandemic in New York, New York, which may have limited study enrollment and reduced acceptance of in-home paramedic visits (eAppendix 8 in Supplement 2).
Of note, fewer than half of the patients randomized to MIH received a home visit, likely reflecting a combination of clinical need, difficulties contacting patients after discharge, and patient preference. Those not receiving the full suite of MIH services ended up receiving a similar intervention as TOCC, likely diluting the potential benefit of MIH, but also reflecting clinical practice in the community setting. Patients who did not receive an MIH visit did receive nurse care coordinator calls. During this call, the need for a MIH home visit was assessed by the care managers along with patients’ willingness to accept a home visit. While reasons for not receiving a MIH visit were not documented during the trial, exploratory analyses of patients who did and did not receive a visit suggest participants were similar with respect to key demographic characteristics.
Follow-up was limited by several factors common in pragmatic trials: unreachable with the provided contact information, competing demands following hospital discharge in a medically and socially complex population, and patient preference not to engage with further data collection. These factors help to explain the low response rate for the 30-day KCCQ outcome despite extensive outreach effort that included multiple telephone, text, and email attempts by trained study coordinators (eFigure 4 in Supplement 2). Importantly, participants were not excluded from the trial based on their availability for follow-up survey completion, which enhances the generalizability of the findings. We used multivariate imputation by chained equations and IPW sensitivity analyses to evaluate the potential impact of response bias due to missing KCCQ scores at 30 days. These analyses yielded similar results as the primary analysis (eFigure 5 in Supplement 2).
Conclusions
The Mighty-Heart randomized clinical trial observed similar overall outcomes for health status and 30-day readmission in the MIH and TOCC alone groups, suggesting no added benefit of MIH to support transitions of care for patients discharged after heart failure. However, the exploratory findings that MIH may have supported better health status in younger patients underscores the importance of further research to better define optimal transition of care strategies for patients hospitalized with heart failure.
Trial Protocol
eAppendix 1. Additional statistical analyses
eAppendix 2. Study Sites and PIs
eAppendix 3. MIGHTy-Heart Stakeholder Advisory Board
eAppendix 4. Screening, Enrollment and Randomization Procedures
eAppendix 5. Mobile Integrated Health visit checklist
eAppendix 6. Criteria for Heart Failure-Related Readmissions
eAppendix 7. Adverse Events
eAppendix 8. Impact of the COVID-19 Pandemic on Study Conduct and Results
eTable 1. Inclusion and Exclusion Criteria
eTable 2. Data Points for the Screening Dashboard
eTable 3. List of ICD Codes to identify eligible patients with heart failure
eTable 4. Baseline survey measures
eTable 5. Baseline characteristics of participants with completed vs missing 30-day KCCQ OS scores
eFigure 1. Map of MIGHTy-Heart Study Sites
eFigure 2. Pragmatic Elements of the MIGHTy-Heart trial using PRECIS-2
eFigure 3. Data Sources across the MIGHTy-Heart Trial
eFigure 4. MIGHTy-Heart multi-pronged approach to support follow-up at 30 days
eFigure 5. Sensitivity analyses of the interaction between age group and treatment on health status across three analytic approaches
eReferences
Data Sharing Statement
References
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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
eAppendix 1. Additional statistical analyses
eAppendix 2. Study Sites and PIs
eAppendix 3. MIGHTy-Heart Stakeholder Advisory Board
eAppendix 4. Screening, Enrollment and Randomization Procedures
eAppendix 5. Mobile Integrated Health visit checklist
eAppendix 6. Criteria for Heart Failure-Related Readmissions
eAppendix 7. Adverse Events
eAppendix 8. Impact of the COVID-19 Pandemic on Study Conduct and Results
eTable 1. Inclusion and Exclusion Criteria
eTable 2. Data Points for the Screening Dashboard
eTable 3. List of ICD Codes to identify eligible patients with heart failure
eTable 4. Baseline survey measures
eTable 5. Baseline characteristics of participants with completed vs missing 30-day KCCQ OS scores
eFigure 1. Map of MIGHTy-Heart Study Sites
eFigure 2. Pragmatic Elements of the MIGHTy-Heart trial using PRECIS-2
eFigure 3. Data Sources across the MIGHTy-Heart Trial
eFigure 4. MIGHTy-Heart multi-pronged approach to support follow-up at 30 days
eFigure 5. Sensitivity analyses of the interaction between age group and treatment on health status across three analytic approaches
eReferences
Data Sharing Statement
