Preventing "tipping points" in high comorbidity patients: A lifeline from health coaches - rationale, design and methods

Mary E. Charlson, Department of Medicine, Weill Cornell Medical College, 1300 York Ave, New York, NY 10021, USA.
Ilana Mittleman, Clinical Directors Network (CDN), 5 West 37(th) Street, 10(th) Floor, New York, NY 10018, USA.
Rosio Ramos, Department of Medicine, Weill Cornell Medical College, 1300 York Ave, New York, NY 10021, USA.
Andrea Cassells, Clinical Directors Network (CDN), 5 West 37(th) Street, 10(th) Floor, New York, NY 10018, USA.
T J. Lin, Clinical Directors Network (CDN), 5 West 37(th) Street, 10(th) Floor, New York, NY 10018, USA.
Alice Eggleston, AllianceChicago, 225 W Illinois Street, Suite 500, Chicago, IL 60654, USA.
Martin T. Wells, Cornell University Department of Statistics and Data Science, Comstock Hall, 1198, 129 Garden Ave, Ithaca, NY 14853, USA.
James Hollenberg, Department of Medicine, Weill Cornell Medical College, 1300 York Ave, New York, NY 10021, USA.
Paul Pirraglia, Department of Medicine, Weill Cornell Medical College, 1300 York Ave, New York, NY 10021, USA; UMass Chan - Baystate Regional Campus, Baystate Health Regional Campus, 759 Chestnut Street, Springfield, MA 01199, USA.
Ginger Winston, George Washington University- School of Medicine and Health Sciences, 2300 Street NW, Washington, DC 20052, USA.
Jonathan N. Tobin, Clinical Directors Network (CDN), 5 West 37(th) Street, 10(th) Floor, New York, NY 10018, USA; The Rockefeller University Center for Clinical and Translational Science, 1230 York Avenue, New York, NY 10065, USA. Electronic address: JNTobin@CDNetwork.org.

Document Type

Journal Article

Publication Date

5-1-2025

Journal

Contemporary clinical trials

Volume

152

DOI

10.1016/j.cct.2025.107865

Keywords

Chronic conditions; Cluster randomized controlled trial; Federally qualified health centers; Health coaches; Practice-based Research Networks (PBRNs)

Abstract

BACKGROUND: This paper describes an innovative cluster randomized controlled trial design to evaluate the comparative effectiveness of two approaches to preventing significant destabilization, leading to unplanned hospitalization and increased disability for patients with high comorbidity, that is, multiple chronic diseases defined by an enhanced Charlson Comorbidity Index ≥4. METHODS: A total of 1974 patients were randomized in four waves at each of the sixteen Federally Qualified Health Centers (FQHCs) in four health systems -two in New York and two in Chicago. The two interventions compared 1) Patient-Centered Medical Home (PCMH) as implemented by the FQHCs (usual care control); or 2) PCMH plus a coaching intervention delivered by Health Coaches (experimental) helping patients identify life goals to encourage self-management enhanced by a positive affect/self-affirmation strategy. The two primary patient-centered clinical outcomes are 1) Unplanned hospitalizations; and 2) Within-patient changes in quality of life and disability, as measured by the World Health Organization Disability Assessment Scale 2 (WHODAS 2.0). The hypotheses are: 1) intervention patients will have a 5 % relative reduction in unplanned hospitalizations as compared to control patients; and 2) reduced disability measured by WHODAS2.0; 3) destabilization or 'tipping points' leading to hospitalization will be more often triggered by psychosocial issues than by medical Issues. CONCLUSION: This cluster RCT has the potential to transform the care for patients with high comorbidity by helping motivate patients to engage in self-management and to successfully navigate the barriers, challenges, and stresses leading to destabilization, hospitalization, and increased disability. CLINICALTRIALS: gov registration number: NCT04176510.

Department

Medicine

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