Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches
NCT ID: NCT04176510
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1920 participants
INTERVENTIONAL
2019-11-20
2025-12-01
Brief Summary
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This RCT embeds novel effective interventions within large FQHC networks, namely, Community Healthcare Network and the Family Health Centers of New York University (NYU) Langone in NYC and Erie Family Health Centers and Friend Family Health Center in Chicago, serving patients with multiple chronic diseases or high comorbidity. This CER study compares two PCMH-based strategies and will provide a manualized training system that can be disseminated and implemented across the national FQHC networks, with over 9,000 delivery sites that serve nearly 25 million low-income and minority patients, and can be implemented in a wider range of practice settings, organization types and population characteristics.
Among 1920 adult patients with a Charlson Comorbidity Index ≥4 who are established primary care patients of 16 Federally Qualified Health Centers (FQHCs) in NYC (8 FQHCs) and Chicago (8 FQHCs) this pragmatic cRCT aims to evaluate the effectiveness of two approaches to preventing destabilization that leads to unplanned hospitalization and increased disability.
This Patient-Centered Outcomes Research Institute (PCORI) study builds on the National Patient-Centered Clinical Research Network (PCORnet) Clinical Data Research Networks (CDRNs) in NYC and Chicago. Patients will be identified via electronic health records (EHRs) and their outcomes assessed through comprehensive, longitudinal, electronic health records that are aggregated by these PCORnet CDRNs.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Patient Centered Medical Home (PCMH) plus Health Coach
A health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals, in addition to the usual care provided for patients with multiple chronic diseases by the The Patient-Centered Medical Home (PCMH).
Health Coach Intervention
A structured, manualized coaching intervention by a lay Health Coach that employs a standardized positive affect/self-affirmation intervention, not tied to specific chronic diseases, to help motivate patients to learn to implement self-management by setting life goals.
Patient Centered Medical Home (PCMH)
Usual care provided for patients with multiple chronic diseases by the Patient-Centered Medical Home (PCMH).
No interventions assigned to this group
Interventions
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Health Coach Intervention
A structured, manualized coaching intervention by a lay Health Coach that employs a standardized positive affect/self-affirmation intervention, not tied to specific chronic diseases, to help motivate patients to learn to implement self-management by setting life goals.
Eligibility Criteria
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Inclusion Criteria
* Charlson comorbidity index ≥4
Exclusion Criteria
* End stage renal disease on dialysis
* Post-transplant
* Severe mental illness
* Drug/alcohol abuse
* Cannot communicate in English or Spanish.
18 Years
ALL
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Clinical Directors Network
NETWORK
Responsible Party
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Principal Investigators
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Jonathan N Tobin, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Directors Network
Mary Charlson, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Andrea Cassells, MPH
Role: STUDY_DIRECTOR
Clinical Directors Network
Anisa Mian, MPH
Role: STUDY_DIRECTOR
Clinical Directors Network
Locations
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Friend Health, Inc.
Chicago, Illinois, United States
Erie Family Health Centers
Chicago, Illinois, United States
Family Health Centers at NYU Langone
Brooklyn, New York, United States
Community Healthcare Network
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Charlson ME, Mittleman I, Ramos R, Cassells A, Lin TJ, Eggleston A, Wells MT, Hollenberg J, Pirraglia P, Winston G, Tobin JN. Preventing "tipping points" in high comorbidity patients: A lifeline from health coaches - rationale, design and methods. Contemp Clin Trials. 2025 May;152:107865. doi: 10.1016/j.cct.2025.107865. Epub 2025 Feb 28.
Other Identifiers
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8923
Identifier Type: OTHER
Identifier Source: secondary_id
IHS-2017C3-8923
Identifier Type: -
Identifier Source: org_study_id
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