Clinical trial NCT04662541: Mobile Integrated Health in Heart Failure
Official title: Using Mobile Integrated Health and Telehealth to Support Transitions of Care Among Heart Failure Patients - Parent Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Mobile Health
Mobile Integrated Health (MIH)
Heart Failure (HF)
mHealth
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-12-10
Enrollment: 2005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Medicare or Medicaid recipient
* Current diagnosis of HF
* Receiving inpatient care at NewYork Presbyterian or Mount Sinai Health Systems
* Live in NYC

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)

Primary outcomes:
measure: Number of all-cause hospital readmissions
timeFrame: 30 days
measure: Patient-reported health-related quality of life score assessed using the KCCQ
timeFrame: 30 days
Secondary outcomes:
measure: Number of preventable emergency department visits
timeFrame: 30 days
measure: Number of preventable emergency department visits
timeFrame: 60 days
measure: Number of preventable emergency department visits
timeFrame: 90 days
measure: Number of preventable emergency department visits
timeFrame: 6 months
measure: Number of unplanned hospital readmissions
timeFrame: 30 days
measure: Number of unplanned hospital readmissions
timeFrame: 60 days
measure: Number of unplanned hospital readmissions
timeFrame: 90 days
measure: Number of unplanned hospital readmissions
timeFrame: 6 months
measure: Number of days at home
timeFrame: 30 days
measure: Patient-reported symptoms and functioning score assessed using PROMIS-29
timeFrame: 30 days
measure: Patient-reported symptoms and functioning score assessed using PROMIS-29
timeFrame: 60 days
measure: Patient-reported symptoms and functioning score assessed using PROMIS-29
timeFrame: 90 days
measure: Patient self-care score assessed using the SCHFI
timeFrame: 30 days
measure: Patient self-care score assessed using the SCHFI
timeFrame: 60 days
measure: Patient self-care score assessed using the SCHFI
timeFrame: 90 days
measure: Patient-reported health-related quality of life score assessed using the KCCQ
timeFrame: 60 days
measure: Patient-reported health-related quality of life score assessed using the KCCQ
timeFrame: 90 days
measure: Number of all-cause hospital readmissions
timeFrame: 60 days
measure: Number of all-cause hospital readmissions
timeFrame: 90 days
measure: Number of all-cause hospital readmissions
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian/Weill Cornell Medicine
state: New York
Study officials:
affiliation: Columbia University
name: Ruth M. Masterson Creber, PhD, MSc, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Leah Shafran Topaz, BPT, MSc
role: STUDY_DIRECTOR
References:
citation: Masterson Creber RM, Daniels B, Munjal K, Reading Turchioe M, Shafran Topaz L, Goytia C, Diaz I, Goyal P, Weiner M, Yu J, Khullar D, Slotwiner D, Ramasubbu K, Kaushal R. Using Mobile Integrated Health and telehealth to support transitions of care among patients with heart failure (MIGHTy-Heart): protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Mar 10;12(3):e054956. doi: 10.1136/bmjopen-2021-054956.