COHERE - COntextualized Care in cHcs' Electronic Health REcords

Hypertension Clinical Trial

— COHERE  

Official title:

COHERE - COntextualized Care in cHcs' Electronic Health REcords

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05022316
• Other study ID #: 5R01MD014886
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension

Intervention

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).

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	OCHIN, Inc	Portland	Oregon
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	OCHIN, Inc., University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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