Mobile Integrated Health in Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to compare how two different types of care after a hospitalization reduce hospital readmissions and symptom burden. The two types of care are a Transitions of Care Coordinator and Mobile Integrated Health. In the Transitions of Care Coordinator group, participants will receive a phone call from a care coordinator right after they go home following a hospitalization to check in. In the Mobile Integrated Health group, participants will be offered access to a community paramedic in case they need medical care while they are recovering at home after a hospitalization. The community paramedic will come to their home to perform an evaluation and set up a visit with an emergency physician via video conference. They may receive treatment at home or be transported to the emergency department. The investigators will be compare how well a Transitions of Care Coordinator and Mobile Integrated Health reduce readmissions to the hospital within 30 days of discharge and improve patient-reported health-related quality of life. The investigators hypothesize that participants in the Mobile Integrated Health group will have fewer readmissions to the hospital within 30 days of discharge and better health-related quality of life compared to participants in the Transitions of Care Coordinator group.

Detailed Description
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High 30-day readmission rates among heart failure (HF) patients (25% nationally) inflict substantial burden on both health systems and patients. The majority of hospital readmissions occur in the first seven days following a hospitalization for HF and are driven by lack of improvement in persistent symptoms. While early, proactive follow-up after hospital discharge can improve health outcomes and patient-reported quality of life, barriers within health systems (lack of appointment availability, transportation, limited ability to deliver medical therapies in the home) have hampered efforts to provide comprehensive follow-up. Evidence suggests that Mobile Integrated Health (MIH), involving community paramedicine coupled with telemedicine, may be an effective intervention to reduce readmissions. The long-term goal of this research is to provide rigorous evidence of MIH with a diverse, representative sample. In this pragmatic randomized clinical trial the investigators will compare MIH to a Transitions of Care Coordinator (TOCC) intervention. Specifically, the investigators aim to compare the effectiveness of MIH versus TOCC on healthcare utilization (aim 1), patient-reported outcomes (PROs; aim 2), and healthcare quality (aim 3). The investigators will also evaluate the factors that support the adoption, implementation, and maintenance from the perspective of multiple key stakeholders (aim 4). Participants in this RCT will be randomized 1:1 to either MIH (intervention) or TOCC (comparator). All participants will be enrolled and randomized during a hospitalization for HF. Participants in MIH will receive a follow-up phone call and access to community paramedics who provide a comprehensive assessment in the home, and specific medical therapies while consulting with an emergency room physician in real-time via telemedicine. Participants in TOCC will receive a follow-up phone call within 48-72 hours of discharge and connection to appropriate services (social work, care coordination, home care) as needed. Participants in both groups will complete PROs using a rigorously developed, visually enhanced mobile PRO reporting system. The study population will include patients at NewYork-Presbyterian (NYP) and Mount Sinai health systems, which are part of the New York City-based INSIGHT PCORI-funded clinical research network. The targeted sample size across the two sites is 2,100 patients (1,050 per arm). This record is for the parent PCORI-funded trial evaluating MIH among HF patients. There is a separate sub-study being conducted locally at NYP which is described in another record.

Official Title
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Using Mobile Integrated Health and Telehealth to Support Transitions of Care Among Heart Failure Patients - Parent Study

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Mobile Integrated Health (MIH)
* Other: Transitions of care coordinator (TOCC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medicare or Medicaid recipient Current diagnosis of HF Receiving inpatient care at NewYork Presbyterian or Mount Sinai Health Systems Live in NYC, specifically Manhattan, Brooklyn, Queens or the Bronx Exclusion Criteria: Non-English, Spanish, Mandarin, or French speaking Diagnosis of dementia or psychosis Anticipated discharge to, or current residence in, skilled nursing facility or rehab center Anticipated discharge to, or currently receiving, hospice including home hospice Current candidate for and awaiting heart transplant Current left ventricular assist device (LVAD)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Integrated Health (MIH)<br>Patients with urgent medical needs are seen and treated in the home by trained community paramedics. The community paramedics perform a standardized assessment, including a physical examination, vital signs, home safety evaluation, and medication reconciliation. During the MIH encounter, the emergency medicine physician at each site is contacted via telemedicine. Physicians can access clinical notes, discharge summaries, and medication lists via the institutional EHR. Adjustments to outpatient medications can be e-prescribed and follow-up appointments can be scheduled with primary care clinicians. | Other: Mobile Integrated Health (MIH)<br>* MIH leverages paramedics in the community and telemedicine (technology-enabled communication for health purposes) to provide medical care to heart failure patients in the home.<br>|
| Active Comparator: Transitions of care coordinator (TOCC)<br>Patients receive a follow-up phone calls for a nurse coordinator within 48-72 hours of hospital discharge. Phone calls include clinical/social needs assessment with escalation to primary care team, emergency care, or social work as needed; patient education; and reminder about follow-up appointments. | Other: Transitions of care coordinator (TOCC)<br>* The TOCC group will receive a follow-up phone call shortly after discharge in which the patient is assessed and connected to clinical and social services as needed and patient education is reinforced.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all-cause hospital readmissions | Number of readmissions to the hospital for any reason following a hospitalization | 30 days | 
| Patient-reported health-related quality of life score assessed using the KCCQ | Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of preventable emergency department visits | Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm | 30 days | 
| Number of preventable emergency department visits | Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm | 60 days | 
| Number of preventable emergency department visits | Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm | 90 days | 
| Number of preventable emergency department visits | Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm | 6 months | 
| Number of unplanned hospital readmissions | Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm | 30 days | 
| Number of unplanned hospital readmissions | Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm | 60 days | 
| Number of unplanned hospital readmissions | Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm | 90 days | 
| Number of unplanned hospital readmissions | Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm | 6 months | 
| Number of days at home | Number of days at home (alive and not in a hospital or other medical facility) following a hospitalization | 30 days | 
| Number of days at home | Number of days at home (alive and not in a hospital or other medical facility) following a hospitalization | 60 days | 
| Number of days at home | Number of days at home (alive and not in a hospital or other medical facility) following a hospitalization | 90 days | 
| Number of days at home | Number of days at home (alive and not in a hospital or other medical facility) following a hospitalization | 6 months | 
| Patient-reported symptoms and functioning score assessed using PROMIS-29 | Patient-reported symptoms and functioning score, measured using the Patient-Reported Outcomes Measurement Information System 29-item survey (PROMIS-29). PROMIS-29 domains are scored separately: physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, and pain interference. Each domain is scored using a standardized T-score ranging from approximately 20 to 80, with lower scores indicating less of the symptom (i.e., less fatigue), and higher scores indicating more of the symptom (i.e., more fatigue). | 30 days | 
| Patient-reported symptoms and functioning score assessed using PROMIS-29 | Patient-reported symptoms and functioning score, measured using the Patient-Reported Outcomes Measurement Information System 29-item survey (PROMIS-29). PROMIS-29 domains are scored separately: physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, and pain interference. Each domain is scored using a standardized T-score ranging from approximately 20 to 80, with lower scores indicating less of the symptom (i.e., less fatigue), and higher scores indicating more of the symptom (i.e., more fatigue). | 60 days | 
| Patient-reported symptoms and functioning score assessed using PROMIS-29 | Patient-reported symptoms and functioning score, measured using the Patient-Reported Outcomes Measurement Information System 29-item survey (PROMIS-29). PROMIS-29 domains are scored separately: physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, and pain interference. Each domain is scored using a standardized T-score ranging from approximately 20 to 80, with lower scores indicating less of the symptom (i.e., less fatigue), and higher scores indicating more of the symptom (i.e., more fatigue). | 90 days | 
| Patient self-care score assessed using the SCHFI | Patient self-care score assessed using the Self-Care of Heart Failure Index (SCHFI). SCHFI standardized scores are reported separately for each domain: self-care maintenance, self-care monitoring, and self-care management. Scores range from 0 to 100, with lower scores (closer to 0) representing worse self-care and higher scores (closer to 100) representing better self-care. | 30 days | 
| Patient self-care score assessed using the SCHFI | Patient self-care score assessed using the Self-Care of Heart Failure Index (SCHFI). SCHFI standardized scores are reported separately for each domain: self-care maintenance, self-care monitoring, and self-care management. Scores range from 0 to 100, with lower scores (closer to 0) representing worse self-care and higher scores (closer to 100) representing better self-care. | 60 days | 
| Patient self-care score assessed using the SCHFI | Patient self-care score assessed using the Self-Care of Heart Failure Index (SCHFI). SCHFI standardized scores are reported separately for each domain: self-care maintenance, self-care monitoring, and self-care management. Scores range from 0 to 100, with lower scores (closer to 0) representing worse self-care and higher scores (closer to 100) representing better self-care. | 90 days | 
| Patient-reported health-related quality of life score assessed using the KCCQ | Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning. | 60 days | 
| Patient-reported health-related quality of life score assessed using the KCCQ | Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning. | 90 days | 
| Number of all-cause hospital readmissions | Number of readmissions to the hospital for any reason following a hospitalization | 60 days | 
| Number of all-cause hospital readmissions | Number of readmissions to the hospital for any reason following a hospitalization | 90 days | 
| Number of all-cause hospital readmissions | Number of readmissions to the hospital for any reason following a hospitalization | 6 months | 
| National Quality Forum metric: Follow-up appointment attendance | Binary indicator of whether the patient attended a follow-up appointment after discharge among those with a scheduled follow-up appointment at discharge. | 30 days | 
| National Quality Forum metric: Follow-up appointment attendance | Binary indicator of whether the patient attended a follow-up appointment after discharge among those with a scheduled follow-up appointment at discharge. | 60 days | 
| National Quality Forum metric: Follow-up appointment attendance | Binary indicator of whether the patient attended a follow-up appointment after discharge among those with a scheduled follow-up appointment at discharge. | 90 days | 
| National Quality Forum metric: Follow-up appointment attendance | Binary indicator of whether the patient attended a follow-up appointment after discharge among those with a scheduled follow-up appointment at discharge. | 6 months | 
| National Quality Forum metric: Prescription medications | Binary indicator of whether the patient was prescribed either an Angiotensin-Converting Enzyme Inhibitor or an Angiotensin Receptor Blocker therapy plus a Beta-Blocker Therapy as clinically indicated on discharge. | 30 days | 
| National Quality Forum metric: Prescription medications | Binary indicator of whether the patient was prescribed either an Angiotensin-Converting Enzyme Inhibitor or an Angiotensin Receptor Blocker therapy plus a Beta-Blocker Therapy as clinically indicated on discharge. | 60 days | 
| National Quality Forum metric: Prescription medications | Binary indicator of whether the patient was prescribed either an Angiotensin-Converting Enzyme Inhibitor or an Angiotensin Receptor Blocker therapy plus a Beta-Blocker Therapy as clinically indicated on discharge. | 90 days | 
| National Quality Forum metric: Prescription medications | Binary indicator of whether the patient was prescribed either an Angiotensin-Converting Enzyme Inhibitor or an Angiotensin Receptor Blocker therapy plus a Beta-Blocker Therapy as clinically indicated on discharge. | 6 months | 
| National Quality Forum metric: Functional status assessment | Binary indicator of whether the patient had a functional status assessment completed in their chart after hospital discharge. | 30 days | 
| National Quality Forum metric: Functional status assessment | Binary indicator of whether the patient had a functional status assessment completed in their chart after hospital discharge. | 60 days | 
| National Quality Forum metric: Functional status assessment | Binary indicator of whether the patient had a functional status assessment completed in their chart after hospital discharge. | 90 days | 
| National Quality Forum metric: Functional status assessment | Binary indicator of whether the patient had a functional status assessment completed in their chart after hospital discharge. | 6 months |