COHERE - COntextualized Care in cHcs' Electronic Health REcords

NCT ID: NCT05022316

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2024-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Arm

Control clinics will not receive an intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

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

Group Type EXPERIMENTAL

CDS Tool Access

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OCHIN, Inc.

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Gold, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Center for Health Research; OCHIN

Laura Gottlieb, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Site Status

OCHIN, Inc

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36779911 (View on PubMed)

Other Identifiers

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5R01MD014886

Identifier Type: NIH

Identifier Source: org_study_id

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