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

Clinical Directors Network

Status: Enrolling

Conditions: Self-Management; Comorbidity

Treatments: Behavioral: Health Coach Intervention

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04176510

IHS-2017C3-8923

8923

Details and patient eligibility

About

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.

Enrollment: 1,920 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,920 participants in 2 patient groups

Patient Centered Medical Home (PCMH) plus Health Coach

Experimental group

Description:

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).

Treatment:

Behavioral: Health Coach Intervention

Patient Centered Medical Home (PCMH)

No Intervention group

Description:

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