- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06489002
DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters (DEDICATE)
Study Overview
Status
Conditions
Intervention / Treatment
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 screening and referrals to community organizations for non-medical health-related needs. 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 non-medical health-related needs for more than 10 enrolled patients from April-June 2025. Once 20 health centers have been enrolled, health centers will be randomized to one of four wedges for staggered receipt of the intervention. This method will allow us to provide tailored support to five 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 unmet non-medical health-related needs. After receiving the intervention, participating health centers will be followed until Y4Q4 to assess primary and secondary outcomes.
The intervention includes implementation strategies to support adoption of EHR-based functionalities for non-medical health-related needs activities by care management teams in health centers. 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 non-medical health-related needs screening and coordination provided by care teams. Limited clinical data will be collected on patients seen at included health centers during the study period. Qualitative data will also be collected, including semi-structured interviews with clinic staff from all enrolled study sites.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97228
- OCHIN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
• • Health centers that use an EHR-based care management tool for at least one care management or population health program that addresses non-medical health-related needs for more than 10 enrolled patients from April-June 2025.
Exclusion Criteria
- Health center participated in pilot
- Health center is a school-based health center
- Health center provides care to prison population
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
Intervention health centers will receive implementation support when they crossover from Control to Intervention.
|
Health centers receiving the intervention will have access to implementation support strategies designed to support adoption of screenings and referrals to community organizations for patients with unmet non-medical health-related needs receiving care management.
Implementation support will be provided by an OCHIN trainer, practice facilitators, workflow engineer, and analysts.
|
|
No Intervention: Control Arm
Control health centers will not receive an intervention prior to crossover to Intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screening for non-medical health-related needs
Time Frame: From six months prior to the intervention, assessed up to 12 months.
|
Whether a patient enrolled in a care management program was screened for unmet non-medical health-related needs (binary, patient-level).
|
From six months prior to the intervention, assessed up to 12 months.
|
|
Referral for non-medical health-related need
Time Frame: Baseline, through study completion, an average of 7.5 months.
|
Among patients with one or more identified non-medical health-related need, whether a referral was made for each identified need (binary, patient-level)
|
Baseline, through study completion, an average of 7.5 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Referrals with a documented outcome (all non-medical health-related needs)
Time Frame: Baseline, through study completion, an average of 7.5 months.
|
Among referrals made for any identified financial-related need, whether outcome has been recorded in the EHR.
Documented outcome statuses (also referred to as dispositions), may include successful connection to services, referral closure without service delivery, service unavailability, patient ineligibility, or other outcomes as defined by the care management team (binary, financial-related need-level).
|
Baseline, through study completion, an average of 7.5 months.
|
|
Referrals with an outcome documented as received (all non-medical health-related needs)
Time Frame: Baseline, through study completion, an average of 7.5 months.
|
Among referrals made for any identified financial-related need, whether documented outcome status indicates "successful connection to services" (binary, non-medical health-related need-level).
|
Baseline, through study completion, an average of 7.5 months.
|
|
Controlled hypertension
Time Frame: Baseline, through study completion, an average of 7.5 months.
|
Binary outcome of blood pressure control (defined as <140/90) at the most recent visit among patients with hypertension
|
Baseline, through study completion, an average of 7.5 months.
|
|
Controlled type 2 diabetes mellitus
Time Frame: Baseline, through study completion, an average of 7.5 months.
|
Binary outcome in HbA1c control (defined as <9%) at the most recent visit among patients with diabetes mellitus
|
Baseline, through study completion, an average of 7.5 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rachel Gold, PhD, OCHIN, Inc.
- Principal Investigator: Nicole Cook, PhD, OCHIN, Inc.
Publications and helpful links
General Publications
- 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 screening and linkages for non-medical drivers of health in care management using enabling technologies: study protocol for a cluster randomised trial. BMJ Open. 2025 Nov 5;15(11):e100340. doi: 10.1136/bmjopen-2025-100340.
- 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. 2026 Apr;82(4):3779-3787. doi: 10.1111/jan.70109. Epub 2025 Aug 1.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00074727
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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