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

Self-Management Clinical Trial

— Tipping Points  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04176510
• Other study ID #: IHS-2017C3-8923
• Secondary ID: 8923
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2023
• Source: Clinical Directors Network
• Contact: Anisa Mian, MPH
• Phone: 2123820699
• Email: tp[@]cdnetwork.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1920
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comorbidity
• Self-Management

Intervention

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.

Locations

Country	Name	City	State
United States	Family Health Centers at NYU Langone	Brooklyn	New York
United States	Erie Family Health Centers	Chicago	Illinois
United States	Friend Health, Inc.	Chicago	Illinois
United States	Community Healthcare Network	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Directors Network	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 a 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	Number of Emergency Department Visits	This includes visits to emergency departments as captured by Encounter Type, Provider and Facility Location in Electronic Health Records.	24 months
Secondary	Health Education Impact Questionnaire	The Health Education Impact Questionnaire evaluates eight domains: positive and active engagement in life, health directed behavior, skill and technique acquisition, constructive attitudes and approaches, self-monitoring and insight, health services navigation, social integration and support, and emotional wellbeing. Each domain is scored separately and domain scores range between 1 and 4. For the domain of emotional wellbeing, lower score represents better outcome. For all other domains, higher scores represent better outcomes.	24 months
Secondary	Patient Activation Measure	The Patient Activation Measure (PAM-13) assesses skill and confidence for self-management of chronic conditions. It is a 13 item scale with a 5-point Likert response scale (disagree strongly, disagree, agree, agree strongly, or N/A). Raw scores are transformed to a scale of 0-100 with 100 being the highest activation and 0 the lowest activation in self-management.	24 months