DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters

NCT ID: NCT06489002

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2028-06-30

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.

Conditions

Social Determinants of Health; Primary Care; Diabetes Mellitus, Type 2; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Intervention health centers will receive implementation support when they crossover from Control to Intervention.

Group Type: EXPERIMENTAL

Implementation Support

Intervention Type: OTHER

Health centers receiving the intervention will have access to implementation support strategies designed to support adoption of social needs screenings and referrals to community organizations for patients with unmet social needs receiving care management. Implementation support will be provided by an OCHIN trainer, practice facilitators, workflow engineer, and analysts.

Control Arm

Control health centers will not receive an intervention prior to crossover to Intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implementation Support

Health centers receiving the intervention will have access to implementation support strategies designed to support adoption of social needs screenings and referrals to community organizations for patients with unmet social needs receiving care management. Implementation support will be provided by an OCHIN trainer, practice facilitators, workflow engineer, and analysts.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OCHIN, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Nicole Cook

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Gold, PhD

Role: PRINCIPAL_INVESTIGATOR

OCHIN, Inc.

Nicole Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

OCHIN, Inc.

Central Contacts

Maura Pisciotta, MS

Role: CONTACT

pisciottam@ochin.org

5035462161

Nicole Cook, PhD

Role: CONTACT

cookn@ochin.org

1 458-292-2142

References

Cook N, Pisciotta M, Larson Z, Fein HL, Donovan J, McGrath BM, Gunn R, Owens-Jasey C, Templeton A, Volk-Britton M, Nishiike Y, Stowe S, Gold R. Using a Modified Delphi Process to Develop an Intervention to Support Care Coordination of Patient Social Needs in Primary Care. J Adv Nurs. 2025 Aug 1. doi: 10.1111/jan.70109. Online ahead of print.

Reference Type: DERIVED

PMID: 40747910 (View on PubMed)

Cook N, Gunn R, McGrath BM, Donovan J, Pisciotta M, Owens-Jasey C, Fein HL, Templeton A, Larson Z, Gold R. Implementation strategies to improve adoption of unmet social needs screening and referrals in care management using enabling technologies: study protocol for a cluster randomized trial. Res Sq [Preprint]. 2024 Oct 17:rs.3.rs-4985627. doi: 10.21203/rs.3.rs-4985627/v1.

Reference Type: DERIVED

PMID: 39483896 (View on PubMed)

Other Identifiers

00074727

Identifier Type: -

Identifier Source: org_study_id