COHERE - COntextualized Care in cHcs' Electronic Health REcords (COHERE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: CDS Tool Access

Detailed Description

The investigators will use a randomized quasi-experimental design to assess impact of the CDS tools designed to support social risk-informed care. After conducting a 12-month pilot study with 3 CHCs to test and further refine the CDS tools, 6 CHCs will be recruited to participate in the main trial. All OCHIN clinics with >200 SDH screenings (excluding the pilot clinics) will be identified and randomized to a potential intervention group or a control group. Clinics from the potential intervention group will be recruited in a random order until 6 agree to participate. This recruitment method ensures randomization between intervention and control clinics, without recruiting CHCs to a study in which they might not receive an intervention. Intervention sites will be trained in how to use the tools shortly before the tools are activated and will be followed for 12 months to assess tool adoption and impact on the CQMs of interest. Use of the CDS tools will occur as part of the regular care patients receive and will not require special clinic visits. Patients will interact with providers as they normally would, augmented by the intervention when clinicians choose to utilize the CDS tools. For all study clinics, quantitative data will be collected (via EHR data extraction) on social risk data collection and action by care team members. Limited clinical data will be collected on patients who are seen at a study CHC during the study period. Qualitative data will also be collected which includes semi-structured interviews with clinic staff from all study CHCs enrolled in the main trial.

NOTE: Individual patients will not be assigned to an intervention. Instead, randomization and intervention will occur at the clinic level. While CHCs will be recruited that have previously screened patients for social risks, it is unlikely that these CHCs will have screened all patients in their clinics. Thus, the CDS tools will not apply to all patients in participating clinics, and it cannot be guaranteed that individual patients will receive an intervention.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research
    • Portland, Oregon, United States, 97228
      • OCHIN, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Control clinics will not receive an intervention.
Experimental: Intervention Arm; Intervention clinics will have the CDS tools turned on in their EHR.	Other: CDS Tool Access; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
completion of social risk screening	binary outcome of patient whose last social risk screening is >12 months old at the time of an encounter (0=no, 1=yes)	12 months
SDH z-codes added to problem list and/or visit list	binary outcome of patient with a positive screening for social risks and without an associated SDH z-code having the z-code added to the problem/visit list (0=no, 1=yes)	12 months
completion of medication adherence documentation	binary outcome of patient with prescribed medications has up-to-date medication adherence data documented in the EHR (0=no, 1=yes)	12 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: University of California, San Francisco; OCHIN, Inc.
• Investigators: Principal Investigator: Rachel Gold, PhD, MPH, Kaiser Permanente Center for Health Research; OCHIN; Principal Investigator: Laura Gottlieb, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Community Health Centers; Social Determinants of Health; Decision Support Systems, Clinical; Electronic Health Records; Health Status Disparities
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 5R01MD014886 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All EHR data are proprietary to the OCHIN clinics and thus will not be made directly available beyond the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No