1920 Participants Needed

Health Coaching for Patients with Comorbidities

(Tipping Points Trial)

Recruiting at 3 trial locations
AM
TL
Overseen ByTJ Lin, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Clinical Directors Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JN

Jonathan N Tobin, PhD

Principal Investigator

Clinical Directors Network

MC

Mary Charlson, MD

Principal Investigator

Weill Medical College of Cornell University

AC

Andrea Cassells, MPH

Principal Investigator

Clinical Directors Network

AM

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

You have multiple serious health conditions with a score of 4 or higher on the Charlson Comorbidity Index.
Established patients of the participating Federally Qualified Health Centers (FHQCs)

Exclusion Criteria

You have a history of drug or alcohol abuse.
My cancer has spread to other parts of my body.
I am on dialysis for end-stage kidney disease.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Patient Centered Medical Home (PCMH) care or PCMH plus a health coaching intervention

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

  • Health Coach Intervention
Trial Overview The study tests if adding a health coaching intervention to the standard Patient Centered Medical Home care can prevent serious health declines leading to hospital stays and disability in high-risk patients. Participants will be grouped by their healthcare center location and randomly assigned one of the two approaches.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient Centered Medical Home (PCMH) plus Health CoachExperimental Treatment1 Intervention
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).
Group II: Patient Centered Medical Home (PCMH)Active Control1 Intervention
Usual care provided for patients with multiple chronic diseases by the Patient-Centered Medical Home (PCMH).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Clinical Directors Network

Lead Sponsor

Trials
13
Recruited
14,200+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Findings from Research

This systematic review aims to evaluate the effectiveness of health coaching (HC) interventions for adults with chronic conditions, synthesizing studies published in the last four years to assess patient improvement and coaching characteristics.
If health coaching is found to be effective, it could lead to broader public health applications and integration into current management strategies for chronic diseases, potentially improving patient outcomes.
Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials.Yang, J., Bauer, BA., Lindeen, SA., et al.[2023]
In a study of Kaiser Permanente Northern California patients, 70% of those who completed two or more telephonic health coaching sessions reported satisfaction with the program, indicating a positive patient experience.
73% of participants who engaged in multiple sessions felt that the coaching helped them achieve their weight-related goals, highlighting the efficacy of telephonic coaching in promoting healthy lifestyle changes.
Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011.Adams, SR., Goler, NC., Sanna, RS., et al.[2021]
This systematic review and meta-analysis aims to evaluate the effectiveness of health coaching in improving health outcomes for individuals with chronic conditions, focusing on clinically important and disease-specific outcomes.
The study will analyze how different components of health coaching, such as the type of coach (health professional vs. trained peer), frequency, and setting, influence its effectiveness, providing valuable insights for optimizing health coaching interventions.
Health coaching interventions for persons with chronic conditions: a systematic review and meta-analysis protocol.Boehmer, KR., Barakat, S., Ahn, S., et al.[2019]

References

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. [2023]
Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011. [2021]
Health coaching interventions for persons with chronic conditions: a systematic review and meta-analysis protocol. [2019]
[Coaching and diabetes]. [2011]
Can life coaching improve health outcomes?--A systematic review of intervention studies. [2022]
Compendium of the Health and Wellness Coaching Literature. [2020]
[Health counseling in primary care doctors' offices: a new wind! The Health Coaching Program of the Swiss College of Primary Care Medicine]. [2015]
Clinical Effectiveness of Lifestyle Health Coaching: Case Study of an Evidence-Based Program. [2020]
The impact of Telephonic Health Coaching on Health Outcomes in a High-risk Population. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
How effective is health coaching in reducing health services expenditures? [2022]
My Health, My Life, My Way-An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Delivery of Health Coaching by Medical Assistants in Primary Care. [2022]
Is telephone health coaching a useful population health strategy for supporting older people with multimorbidity? An evaluation of reach, effectiveness and cost-effectiveness using a 'trial within a cohort'. [2022]
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