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

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ClinicalTrials.gov Identifier: NCT05022316
Recruitment Status : Not yet recruiting
First Posted : August 26, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborators:
OCHIN, Inc.
University of California, San Francisco
Information provided by (Responsible Party):
Kaiser Permanente

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 focus is on hypertension and diabetes control, but the results will have implications for a wide range of morbidities.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitus, Type 2 Other: CDS Tool Access Not Applicable

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 18 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 and a provider survey (card study) for the clinics 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: COHERE - COntextualized Care in cHcs' Electronic Health REcords
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. blood pressure [ Time Frame: 12 months; in secondary analyses, we will do repeated cross-sectional analysis using 6-, 12-, and 18-month data ]
    change in blood pressure control

  2. HbA1c [ Time Frame: 12 months; in secondary analyses, we will do repeated cross-sectional analysis using 6-, 12-, and 18-month data ]
    change in HbA1c control


Secondary Outcome Measures :
  1. BMI [ Time Frame: 12 months; in secondary analyses, we will do repeated cross-sectional analysis using 6-, 12-, and 18-month data ]
    change in BMI control

  2. LDL [ Time Frame: 12 months; in secondary analyses, we will do repeated cross-sectional analysis using 6-, 12-, and 18-month data ]
    change in LDL control

  3. anti-lipid therapy [ Time Frame: 12 months; in secondary analyses, we will do repeated cross-sectional analysis using 6-, 12-, and 18-month data ]
    anti-lipid medication prescription



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinic has conducted >200 social risk screenings in the last 12 months at the time of recruitment
  • Clinic provides primary care

Exclusion Criteria:

  • Clinic participated in pilot
  • Clinic provides care to prison population

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05022316


Contacts
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Contact: Christina Sheppler, PhD 971-232-9394 christina.r.sheppler@kpchr.org
Contact: Nadia Yosuf, MPH nadia.m.yosuf@kpchr.org

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Oregon
OCHIN, Inc
Portland, Oregon, United States, 97201
Contact: Rose Gunn, MA       gunnr@ochin.org   
Principal Investigator: Erika Cottrell, PhD, MPP         
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
OCHIN, Inc.
University of California, San Francisco
Investigators
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Principal Investigator: Rachel Gold, PhD, MPH Kaiser Permanente Center for Health Research; OCHIN
Principal Investigator: Laura Gottlieb, MD, MPH University of California, San Francisco
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT05022316    
Other Study ID Numbers: 5R01MD014886 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All EHR data are proprietary to the OCHIN clinics and thus will not be made directly available beyond the study team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
Social Determinants of Health
Decision Support Systems, Clinical
Electronic Health Records
Community Health Centers
Health Status Disparities
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases