Clinical trial NCT06489002: DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters
Official title: DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Determinants of Health
Primary Care
Diabetes Mellitus, Type 2
Hypertension
Keywords: Social Determinants of Health
Implementation support
Primary Care
Electronic health records
Lead sponsor: OCHIN, Inc.
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A stepped-wedge cluster randomization design will be used to assess the impact of implementation support strategies to support social needs screening and referrals for patients in care management.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: DEDICATE will refine and test the effectiveness of evidence-based implementation support strategies designed to support care management teams' sustained use of electronic health record (EHR)-based functionalities to address unmet social needs through improved clinical-community linkages. This study will test the hypothesis that providing implementation support to health center care management teams will lead to increased adoption of EHR functionalities and increased social needs screenings and referrals to community organization to address unmet social needs through a cluster-randomized trial. This study's results will have implications for patients with social needs receiving care management in primary care settings.

Detailed description: The investigators will use a hybrid effectiveness-implementation mixed methods design to assess the impact of evidence-based implementation support strategies designed to support the care management teams' adoption of EHR functionalities that enable social needs screening and referrals to community organizations. After conducting a three-month pilot study with three health centers to test and refine the implementation support strategies, 20 community-based health centers will be recruited to participate in a stepped-wedge, cluster-randomized trial. Eligible OCHIN health centers include those that provide primary care, use an EHR-based care management tool for at least one care management or population health program that addresses social needs for a monthly average of \> 15 enrolled patients. Once 20 health centers have been enrolled, health centers will be randomized to one of five wedges for staggered receipt of the intervention. This method will allow us to provide tailored support to four health centers at a time and enables all health centers to eventually receive the intervention. Participating sites will be provided implementation support strategies for using EHR-based functionalities to conduct screening and referrals for patients with social needs. Participating sites will be followed after receiving the intervention until Y4Q4 to assess primary and secondary outcomes.

Implementation strategies to support adoption of EHR-based functionalities for social needs activities by care management teams in health centers comprises the intervention. The intervention will be delivered to health center care management staff outside of patient care. Patients will not directly receive the intervention and will continue to receive regular care from the health center. For all study health centers, quantitative data will be collected (via EHR data extraction) on care team use of EHR functionalities and social risk screening and coordination provided by care teams. Limited clinical data will be collected on patients seen at a study health centers during the study period. Qualitative data will also be collected, including semi-structured interviews with clinic staff from all enrolled study sites.

NOTE: Individual patients will not be assigned to an intervention. Instead, randomization and intervention will occur at the health center level.

Eligibility criteria: Inclusion Criteria

• Health centers that use an EHR-based care management tool for at least one care management or population health program that addresses social needs for a monthly average of \> 15 enrolled patients

Exclusion Criteria

* Health center participated in pilot
* Health center is a school-based health center
* Health center provides care to prison population

Primary outcomes:
measure: Social needs screening
timeFrame: From six months prior to the intervention, assessed up to 12 months.
measure: Social needs referral
timeFrame: From six months prior to the intervention, assessed up to 12 months.
Secondary outcomes:
measure: Community-based services receipt for referred social needs
timeFrame: From six months prior to the intervention, assessed up to 12 months.
measure: Controlled hypertension
timeFrame: From six months prior to the intervention, assessed up to 12 months.
measure: Controlled type 2 diabetes mellitus
timeFrame: From six months prior to the intervention, assessed up to 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: OCHIN, Inc.
name: Rachel Gold, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: OCHIN, Inc.
name: Nicole Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: