Clinical trial NCT04176510: Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches
Official title: Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Comorbidity
Self-Management
Keywords: Comorbidity
Self-Management
Charlson Comorbidity Index
Health Coach
Lead sponsor: Clinical Directors Network
Sponsor class: NETWORK
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-11-25
Enrollment: 1920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Unplanned Hospitalizations
timeFrame: 24 months
measure: World Health Organization Disability Assessment Scale (WHODAS) Scale
timeFrame: 24 months
Secondary outcomes:
measure: Number of Emergency Department Visits
timeFrame: 24 months
measure: Health Education Impact Questionnaire
timeFrame: 24 months
measure: Patient Activation Measure
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Friend Health, Inc.
state: Illinois
city: Chicago
country: United States
facility: Erie Family Health Centers
state: Illinois
city: Brooklyn
country: United States
facility: Family Health Centers at NYU Langone
state: New York
city: New York
country: United States
facility: Community Healthcare Network
state: New York
Study officials:
affiliation: Clinical Directors Network
name: Jonathan N Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mary Charlson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network
name: Andrea Cassells, MPH
role: STUDY_DIRECTOR
affiliation: Clinical Directors Network
name: Anisa Mian, MPH
role: STUDY_DIRECTOR
References: