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NCT Number: NCT06489002

DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Social Determinants of Health Cardiovascular Diseases Contextual Drivers of Health Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Non-medical Health-related Needs Nutritional and Metabolic Diseases Primary Care Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OCHIN

Portland, Oregon, 97228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation Support

Other

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.

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. 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).

  2. 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).

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

OCHIN, Inc.

Other

Registry information

Acronym: DEDICATE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 5, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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