Clinical trial NCT05022316: COHERE - COntextualized Care in cHcs' Electronic Health REcords
Official title: COHERE - COntextualized Care in cHcs' Electronic Health REcords
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus, Type 2
Keywords: Social Determinants of Health
Decision Support Systems, Clinical
Electronic Health Records
Community Health Centers
Health Status Disparities
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: University of California, San Francisco
First posted: 2021-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: hypertension control
timeFrame: 12 months
measure: diabetes control
timeFrame: 12 months
Secondary outcomes:
measure: completion of social risk screening
timeFrame: 12 months
measure: SDH z-codes added to problem list and/or visit list
timeFrame: 12 months
measure: completion of medication adherence documentation
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Portland
country: United States
facility: OCHIN, Inc
state: Oregon
Study officials:
affiliation: Kaiser Permanente Center for Health Research; OCHIN
name: Rachel Gold, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Laura Gottlieb, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: