Recruiting

Health Coaches

Sponsor:

Clinical Directors Network

Code:

NCT04176510

Conditions

Comorbidity

Self-Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Health Coach Intervention

Study Details

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

Study ID

NCT04176510

Start date

Nov 20, 2019

Status verified date

Feb, 2023

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

1920 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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).

no intervention: Patient Centered Medical Home (PCMH)

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

Interventions

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.

Primary outcome measure

  • Number of Unplanned Hospitalizations [ Time Frame: 24 months ]
  • World Health Organization Disability Assessment Scale (WHODAS) Scale [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

Friend Health, Inc.

Recruiting

Chicago, Illinois, United States, 60615

Contacts

Erie Family Health Centers

Recruiting

Chicago, Illinois, United States, 60622

Contacts

Family Health Centers at NYU Langone

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Community Healthcare Network

Recruiting

New York, New York, United States, 10010

Contacts

Christine Rutkoski

CRutkoski@chnnyc.org

More Information

Sponsor

Clinical Directors Network

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Clinical Directors Network on 2023-02-08.