COHERE - COntextualized Care in cHcs' Electronic Health REcords

Study Overview
=================
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.

Official Title
-----------------
COHERE - COntextualized Care in cHcs' Electronic Health REcords

Conditions
-----------------
Hypertension, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: CDS Tool Access


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Determinants of Health, Decision Support Systems, Clinical, Electronic Health Records, Community Health Centers, Health Status Disparities