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

Primary Purpose

Hypertension, Diabetes Mellitus, Type 2

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CDS Tool Access
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Social Determinants of Health, Decision Support Systems, Clinical, Electronic Health Records, Community Health Centers, Health Status Disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco
  • Kaiser Permanente Center for Health Research
  • OCHIN, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Intervention Arm

Arm Description

Control clinics will not receive an intervention.

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

Outcomes

Primary Outcome Measures

hypertension control
binary outcome of patient having a blood pressure of <140/90 at the time of the clinic visit (0=no, 1=yes)
diabetes control
binary outcome of patient with diabetes having an HbA1c of <9% at the time of the clinic visit (0=no, 1=yes)

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
August 18, 2021
Last Updated
July 7, 2023
Sponsor
Kaiser Permanente
Collaborators
OCHIN, Inc., University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05022316
Brief Title
COHERE - COntextualized Care in cHcs' Electronic Health REcords
Acronym
COHERE
Official Title
COHERE - COntextualized Care in cHcs' Electronic Health REcords
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
OCHIN, Inc., University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Type 2
Keywords
Social Determinants of Health, Decision Support Systems, Clinical, Electronic Health Records, Community Health Centers, Health Status Disparities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Control clinics will not receive an intervention.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Intervention clinics will have the CDS tools turned on in their EHR.
Intervention Type
Other
Intervention Name(s)
CDS Tool Access
Intervention Description
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 Measure Information:
Title
hypertension control
Description
binary outcome of patient having a blood pressure of <140/90 at the time of the clinic visit (0=no, 1=yes)
Time Frame
12 months
Title
diabetes control
Description
binary outcome of patient with diabetes having an HbA1c of <9% at the time of the clinic visit (0=no, 1=yes)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
completion of social risk screening
Description
binary outcome of patient whose last social risk screening is >12 months old at the time of an encounter (0=no, 1=yes)
Time Frame
12 months
Title
SDH z-codes added to problem list and/or visit list
Description
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)
Time Frame
12 months
Title
completion of medication adherence documentation
Description
binary outcome of patient with prescribed medications has up-to-date medication adherence data documented in the EHR (0=no, 1=yes)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Gold, PhD, MPH
Organizational Affiliation
Kaiser Permanente Center for Health Research; OCHIN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Gottlieb, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
OCHIN, Inc
City
Portland
State/Province
Oregon
ZIP/Postal Code
97228
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All EHR data are proprietary to the OCHIN clinics and thus will not be made directly available beyond the study team.

Learn more about this trial

COHERE - COntextualized Care in cHcs' Electronic Health REcords

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