Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches

NCT04176510 | Unknown DMC

• 2 other identifiers: IHS-2017C3-89238923
• Study Type: interventional
• Target: 1,920
• Locations: 1 country
• Sites: 4

Brief Summary

This pragmatic cluster randomized clinical trial (cRCT) aims to evaluate the comparative effectiveness (CER) of two approaches to preventing destabilization ("tipping points") that lead to unplanned hospitalization and increased disability. The cRCT compares the outcomes of patients randomized in clusters by site within four Federally Qualified Health Center (FQHC) networks in New York City (NYC) and Chicago to either: 1) the Patient Centered Medical Home (PCMH); or 2) the Patient Centered Home plus 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 (experimental). 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.

Conditions

Comorbidity; Self-Management

Keywords

Comorbidity; Self-Management; Charlson Comorbidity Index; Health Coach

Outcome Measures

Primary Outcomes (2)

• Number of Unplanned Hospitalizations

  Unplanned hospitalizations are hospitalizations for any reason other than elective procedures. This specifically excludes admissions for a planned procedure (i.e. elective surgery, chemotherapy, childbirth, etc.). Admissions not accompanied by an acute diagnosis are not counted. Circumstances surrounding hospitalization will be recorded through a vignette, classified by two independent blinded reviewers.

  24 months

• World Health Organization Disability Assessment Scale (WHODAS) Scale

  The WHODAS 2.0 (36 items) assesses individual level of function in six major life domains: cognition (understanding and communication) mobility (move and get around), self-care (attend to personal hygiene, dress, eat and live alone), getting along (interact with other people); life activities (carry out responsibility of home, work, school), and participation in society (engage in community, civil and recreational activities).Chronbach's α was \>0.79 for each of the domains. The test-retest reliability ranged from 0.93 to 0.96 at the domain level. WHODAS 2.0 generates one global score and six domain-specific scores, validated against the Short Form 36 (SF-36) Health Survey and other scales and is responsive to change.

  24 months

Secondary Outcomes (3)

• Number of Emergency Department Visits

  24 months

• Health Education Impact Questionnaire

  24 months

• Patient Activation Measure

  24 months

Study Arms (2)

Patient Centered Medical Home (PCMH) plus Health Coach

EXPERIMENTAL

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).

Behavioral: Health Coach Intervention

Patient Centered Medical Home (PCMH)

NO INTERVENTION

Usual care provided for patients with multiple chronic diseases by the Patient-Centered Medical Home (PCMH).

Interventions

Health Coach Intervention BEHAVIORAL

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) plus Health Coach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established patients of the participating Federally Qualified Health Centers (FHQCs)
• Charlson comorbidity index ≥4

You may not qualify if:

• Metastatic cancer,
• End stage renal disease on dialysis
• Post-transplant
• Severe mental illness
• Drug/alcohol abuse
• Cannot communicate in English or Spanish.

Sponsors & Collaborators

• Clinical Directors Network: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Friend Health, Inc.

Chicago, Illinois, 60615, United States

RECRUITING

Erie Family Health Centers

Chicago, Illinois, 60622, United States

RECRUITING

Family Health Centers at NYU Langone

Brooklyn, New York, 11220, United States

RECRUITING

Community Healthcare Network

New York, New York, 10010, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40024364 DERIVED

Study Officials

• Jonathan N Tobin, PhD

  Clinical Directors Network

  PRINCIPAL INVESTIGATOR

• Mary Charlson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Andrea Cassells, MPH

  Clinical Directors Network

  STUDY DIRECTOR

• Anisa Mian, MPH

  Clinical Directors Network

  STUDY DIRECTOR

Central Study Contacts

Anisa Mian, MPH

CONTACT

2123820699; tp@cdnetwork.org

TJ Lin, MPH

CONTACT

2123820699; tlin@cdnetwork.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: November 25, 2019
• Study Start: November 20, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (4)