NCT06489002

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 non-medical health-related 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 screenings and referrals to community organization to address unmet non-medical health-related needs needs through a cluster-randomized trial. This study's results will have implications for patients with non-medical health-related needs receiving care management in primary care settings.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Oct 2025Jun 2028

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

June 27, 2024

Last Update Submit

April 29, 2026

Conditions

Keywords

Social Determinants of HealthImplementation supportPrimary CareElectronic health records

Outcome Measures

Primary Outcomes (2)

  • Screening for non-medical health-related needs

    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

    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 Outcomes (4)

  • Referrals with a documented outcome (all non-medical health-related needs)

    Baseline, through study completion, an average of 7.5 months.

  • Referrals with an outcome documented as received (all non-medical health-related needs)

    Baseline, through study completion, an average of 7.5 months.

  • Controlled hypertension

    Baseline, through study completion, an average of 7.5 months.

  • Controlled type 2 diabetes mellitus

    Baseline, through study completion, an average of 7.5 months.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Other: Implementation Support

Control Arm

NO INTERVENTION

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

Interventions

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.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OCHIN

Portland, Oregon, 97228, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rachel Gold, PhD

    OCHIN, Inc.

    PRINCIPAL INVESTIGATOR
  • Nicole Cook, PhD

    OCHIN, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: A stepped-wedge cluster randomization design will be used to assess the impact of implementation support strategies to support non-medical health-related screening and referrals for patients in care management.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

October 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

All EHR data are proprietary to the OCHIN health centers and thus will not be made directly available beyond the study team.

Locations