COHERE - COntextualized Care in cHcs' Electronic Health REcords

NCT05022316 | Completed

• 1 other identifier: 5R01MD014886
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's primary outcomes are hypertension and diabetes control, but the results will have implications for a wide range of morbidities.

Conditions

Hypertension; Diabetes Mellitus, Type 2

Keywords

Social Determinants of Health; Decision Support Systems, Clinical; Electronic Health Records; Community Health Centers; Health Status Disparities

Outcome Measures

Primary Outcomes (2)

• hypertension control

  binary outcome of patient having a blood pressure of \<140/90 at the time of the clinic visit (0=no, 1=yes)

  12 months

• diabetes control

  binary outcome of patient with diabetes having an HbA1c of \<9% at the time of the clinic visit (0=no, 1=yes)

  12 months

Secondary Outcomes (3)

• completion of social risk screening

  12 months

• SDH z-codes added to problem list and/or visit list

  12 months

• completion of medication adherence documentation

  12 months

Study Arms (2)

Control Arm

NO INTERVENTION

Control clinics will not receive an intervention.

Intervention Arm

EXPERIMENTAL

Intervention clinics will have the CDS tools turned on in their EHR.

Other: CDS Tool Access

Interventions

CDS Tool Access OTHER

Clinics receiving the intervention will have access to EHR-based CDS tools designed to support social risk-informed care. Prior to tool activation in participating community health centers (CHCs), clinic staff members will be oriented to the CDS tools by an EHR trainer (either on-site or remotely).

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinic has conducted \>200 social risk screenings in the last 12 months at the time of randomization.
• Clinic provides primary care
• Joined OCHIN by 07/01/2021

You may not qualify if:

• Clinic participated in pilot
• Clinic is a school-based health center
• Clinic provides care to prison population

Sponsors & Collaborators

• Kaiser Permanente: lead
• OCHIN, Inc.: collaborator
• University of California, San Francisco: collaborator

Study Sites (3)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

OCHIN, Inc

Portland, Oregon, 97228, United States

Location

Related Publications (1)

• Gunn R, Pisciotta M, Gold R, Bunce A, Dambrun K, Cottrell EK, Hessler D, Middendorf M, Alvarez M, Giles L, Gottlieb LM. Partner-developed electronic health record tools to facilitate social risk-informed care planning. J Am Med Inform Assoc. 2023 Apr 19;30(5):869-877. doi: 10.1093/jamia/ocad010.

  PMID: 36779911 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rachel Gold, PhD, MPH

  Kaiser Permanente Center for Health Research; OCHIN

  PRINCIPAL INVESTIGATOR

• Laura Gottlieb, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized quasi-experimental design will be used to assess the impact of the newly developed CDS tools designed to support social-risk informed care.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 26, 2021
• Study Start: September 12, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)