Health Coaching for Patients with Comorbidities
(Tipping Points Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Health Coach Intervention, Health Coaching, Lifestyle Coaching, Wellness Coaching for patients with comorbidities?
Research shows that health coaching can help people with chronic conditions improve their lifestyle habits, which can lead to better health outcomes and quality of life. Studies have found that coaching can support effective lifestyle changes and improve patient satisfaction and perceived success in managing conditions like diabetes.12345
Is health coaching safe for humans?
Health coaching, which includes health and wellness coaching, has been used in various settings like hospitals and primary care, and is generally considered safe. It has been tested successfully with high acceptance and feasibility among both patients and physicians, with no specific safety concerns reported in the available literature.678910
How is the Health Coach Intervention treatment different from other treatments for patients with comorbidities?
Health Coach Intervention is unique because it involves a personalized partnership between a coach and the patient, focusing on discovering the patient's strengths and challenges to promote healthy behaviors. Unlike traditional treatments, it often includes regular phone calls for support and encouragement, making it a flexible and accessible option for managing multiple health conditions.13111213
Research Team
Jonathan N Tobin, PhD
Principal Investigator
Clinical Directors Network
Mary Charlson, MD
Principal Investigator
Weill Medical College of Cornell University
Andrea Cassells, MPH
Principal Investigator
Clinical Directors Network
Anisa Mian, MPH
Principal Investigator
Clinical Directors Network
Eligibility Criteria
This trial is for adult patients with multiple chronic diseases (comorbidity index ≥4) who are already receiving care at certain health centers in NYC and Chicago. It's not open to those with metastatic cancer, end-stage renal disease on dialysis, severe mental illness, language barriers (non-English/Spanish speakers), post-transplant status, or drug/alcohol abuse issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Patient Centered Medical Home (PCMH) care or PCMH plus a health coaching intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Health Coach Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clinical Directors Network
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator