Social Determinants of HealthDEDICATENCT06489002
DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters
A study testing Implementation Support in people with Social Determinants of Health and Primary Care, run by OCHIN, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health, Primary Care, Diabetes Mellitus, Type 2
- What is being tested?
- Implementation Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- Health center participated in pilot
- Health center is a school-based health center
- Health center provides care to prison population
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Social Determinants of Health, Primary Care, Diabetes Mellitus, Type 2, Hypertension, Non-medical Health-related Needs, Contextual Drivers of Health
- Being tested
- Implementation Support
- Keywords
- Social Determinants of Health, Implementation support, Primary Care, Electronic health records
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intervention health centers will receive implementation support when they crossover from Control to Intervention. Receives: Other: Implementation Support |
| Control Arm | No intervention | Control health centers will not receive an intervention prior to crossover to Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Baseline, through study completion, an average of 7.5 months.
Secondary outcomes (4)
Referrals with a documented outcome (all non-medical health-related needs)
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).
Measured: Baseline, through study completion, an average of 7.5 months.
Referrals with an outcome documented as received (all non-medical health-related needs)
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).
Measured: Baseline, through study completion, an average of 7.5 months.
Controlled hypertension
Binary outcome of blood pressure control (defined as <140/90) at the most recent visit among patients with hypertension
Measured: Baseline, through study completion, an average of 7.5 months.
Controlled type 2 diabetes mellitus
Binary outcome in HbA1c control (defined as <9%) at the most recent visit among patients with diabetes mellitus
Measured: Baseline, through study completion, an average of 7.5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OCHIN, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Cook, OCHIN, Inc.
- Investigators
- Rachel Gold, PhD, Principal investigator, OCHIN, Inc.Nicole Cook, PhD, Principal investigator, OCHIN, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489002
- Sponsor's protocol ID
- 00074727
- Acronym
- DEDICATE
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All EHR data are proprietary to the OCHIN health centers and thus will not be made directly available beyond the study team.
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.
PubMed 41198205Cook 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.
PubMed 40747910Cook 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.
PubMed 39483896
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters
- ClinicalTrials.gov ID
- NCT06489002
- Acronym / sponsor ID
- DEDICATE / 00074727
- Conditions
- Social Determinants of Health, Primary Care, Diabetes Mellitus, Type 2, Hypertension, Non-medical Health-related Needs, Contextual Drivers of Health
- Keywords
- Social Determinants of Health, Implementation support, Primary Care, Electronic health records
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- OCHIN, Inc.University, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Implementation SupportIntervention health centers will receive implementation support when they crossover from Control to Intervention. |
| Control Arm | No intervention | –Control health centers will not receive an intervention prior to crossover to Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • 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.
Key exclusion criteria (3 listed)
- Health center participated in pilot
- Health center is a school-based health center
- Health center provides care to prison population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation SupportHealth 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. | Other | Intervention Arm |
Primary outcome
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).
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)
4 secondary outcomes
Referrals with a documented outcome (all non-medical health-related needs)
Time frame: 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.
Controlled hypertension
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 41198205Cook 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.
- Derived from this study: PubMed 40747910Cook 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.
- Derived from this study: PubMed 39483896Cook 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.
- Individual participant dataSharing planned: No. All EHR data are proprietary to the OCHIN health centers and thus will not be made directly available beyond the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Gold, PhD principal investigator
OCHIN, Inc.
Nicole Cook, PhD principal investigator
OCHIN, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Support in people with Social Determinants of Health and Primary Care, run by OCHIN, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening for non-medical health-related needs (time frame: From six months prior to the intervention, assessed up to 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06489002, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.