NCT04176510

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,920 (estimated)
• Sponsor: Clinical Directors Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2019-11-20
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-11-25
• Last updated: 2023-02-08

Locations

4 sites across 1 country: United States