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
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Diabetes Mellitus, Type 2||Other: CDS Tool Access||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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).
- 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
- 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
- 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
- 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
- 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
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
|Contact: Christina Sheppler, PhDfirstname.lastname@example.org|
|Contact: Nadia Yosuf, MPHemail@example.com|
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Oregon|
|Portland, Oregon, United States, 97201|
|Contact: Rose Gunn, MA firstname.lastname@example.org|
|Principal Investigator: Erika Cottrell, PhD, MPP|
|Kaiser Permanente Center for Health Research|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Rachel Gold, PhD, MPH||Kaiser Permanente Center for Health Research; OCHIN|
|Principal Investigator:||Laura Gottlieb, MD, MPH||University of California, San Francisco|