Perinatal Population HealthCARENCT07869212
Enhancing Perinatal Population Health Through Community Care Hubs
A study testing Integrated Data Systems, Learning Collaborative and Resiliency Skill Building in people with Perinatal Population Health, run by Ohio State University.
Trial summary
Enhancing Perinatal Population Health through Community Care Hubs (CARE) is designed to test system level, organizational level, and workforce level strategies that may activate individual, community health worker (CHW), CHW supervisor, and system level mechanisms to improve care coordination, timely connection to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perinatal Population Health
- What is being tested?
- Integrated Data Systems, Learning Collaborative and Resiliency Skill Building
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2027to 30 Apr 2031
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
The trial includes 8 Pathways Community Hubs located throughout Ohio. Hubs are randomly assigned to study conditions rather than individual participants.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Enhancing Perinatal Population Health through Community Care Hubs (CARE) is designed to test system level, organizational level, and workforce level strategies that may activate individual, community health worker (CHW), CHW supervisor, and system level mechanisms to improve care coordination, timely connection to prenatal and postpartum services, and downstream clinical outcomes related to maternal morbidity and mortality.
Read the detailed description
Enhancing Perinatal Population Health through Community Care Hubs (CARE) is designed to test system level, organizational level, and workforce level strategies that may activate individual, community health worker (CHW), CHW supervisor, and system level mechanisms to improve care coordination, timely connection to prenatal and postpartum services, and downstream clinical outcomes related to maternal morbidity and mortality. The purpose of this study is to evaluate whether multi-level enhancements to Pathways Community Hub infrastructure improve evidence based prenatal and postpartum service delivery and maternal health outcomes among pregnant and postpartum women experiencing social needs.
- Conditions
- Perinatal Population Health
- Being tested
- Integrated Data Systems, Learning Collaborative, Resiliency Skill Building
- Keywords
- Community Care Hubs, Community Health Worker, Prenatal Care, Postpartum Care, Integrated Data Systems, Resiliency Skill Building, Learning Collaboratives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Data SystemsOther
Integrated Data Systems support intervention includes standardized social needs screening, improved data sharing and care coordination and health information exchange integration.
Learning CollaborativeOther
Learning Collaborative intervention includes specialized perinatal training for CHWs, peer learning and expert-led education, and trauma-informed and evidence-based care practices.
Resiliency Skill BuildingOther
Resiliency Skill Building intervention includes Community Resiliency Model training, burnout prevention and workforce well-being support and ongoing coaching for CHWs and supervisors.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Integrated Data Systems | Other | Community Care Hub infrastructure enhanced with Integrated Data Systems support. Receives: Other: Integrated Data Systems |
| Arm 2: Integrated Data Systems + Learning Collaborative | Other | Community Care Hub infrastructure enhanced with Integrated Data Systems and Learning Collaborative support. Receives: Other: Integrated Data Systems; Other: Learning Collaborative |
| Arm 3: Integrated Data Systems + Resiliency Skill Building | Other | Community Care Hub infrastructure enhanced with Integrated Data Systems and Resiliency Skill Building support. Receives: Other: Integrated Data Systems; Other: Resiliency Skill Building |
| Arm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building | Other | Community Care Hub infrastructure enhanced with Integrated Data Systems, Learning Collaborative and Resiliency Skill Building support. Receives: Other: Integrated Data Systems; Other: Learning Collaborative; Other: Resiliency Skill Building |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timely prenatal and postpartum care connection
Prenatal care initiation and postpartum care attendance
Measured: Prenatal care visit within first trimester AND postpartum care visit within 7-84 days after delivery
Secondary outcomes (9)
Screening completion rates
The percentage of participants who are screened for social needs by CHWs
Measured: First trimester of pregnancy
Brief Resiliency Scale
Measure of resiliency for CHWs
Measured: Annually during the trial
Self-efficacy for CHWs
self-efficacy to support perinatal care for CHWs
Measured: Annually during the trial
turnover intention
Interest in leaving the CHW workforce
Measured: Annually during the trial
Patient engagement
Patient Activation Measure
Measured: Postpartum (7-84 days after delivery)
Preterm Birth
<37 weeks gestational age
Measured: At delivery
Depression
PHQ-9
Measured: Postpartum (7-84 days after delivery)
Social Service Connections
Completed referrals through the Hub pathways
Measured: From client enrollment to 6 months postpartum
Turnover
The number of CHWs that leave a Hub
Measured: Annually during the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Apr 2027 (estimated)
- Primary completion31 Mar 2030 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Population HealthStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- This study is an experimental, cluster-randomized trial using a 2×2 factorial design. The research evaluates hub-level system-level and workforce-level interventions implemented within Pathways Community Hubs that serve pregnant and postpartum individuals.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Daniel Walker, Ohio State University
- Investigators
- Daniel Walker, PhD, MPH, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869212
- Sponsor's protocol ID
- STUDY20261022
- Other IDs
- 1R01NR022265-01
- Acronym
- CARE
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Perinatal Population Health Through Community Care Hubs
- ClinicalTrials.gov ID
- NCT07869212
- Acronym / sponsor ID
- CARE / STUDY20261022
- Conditions
- Perinatal Population Health
- Keywords
- Community Care Hubs, Community Health Worker, Prenatal Care, Postpartum Care, Integrated Data Systems, Resiliency Skill Building, Learning Collaboratives
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 9 Oct 2026 (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.
Enhancing Perinatal Population Health through Community Care Hubs (CARE) is designed to test system level, organizational level, and workforce level strategies that may activate individual, community health worker (CHW), CHW supervisor, and system level mechanisms to improve care coordination, timely connection to prenatal and postpartum services, and downstream clinical outcomes related to maternal morbidity and mortality.
Detailed description
Enhancing Perinatal Population Health through Community Care Hubs (CARE) is designed to test system level, organizational level, and workforce level strategies that may activate individual, community health worker (CHW), CHW supervisor, and system level mechanisms to improve care coordination, timely connection to prenatal and postpartum services, and downstream clinical outcomes related to maternal morbidity and mortality. The purpose of this study is to evaluate whether multi-level enhancements to Pathways Community Hub infrastructure improve evidence based prenatal and postpartum service delivery and maternal health outcomes among pregnant and postpartum women experiencing social needs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is an experimental, cluster-randomized trial using a 2×2 factorial design. The research evaluates hub-level system-level and workforce-level interventions implemented within Pathways Community Hubs that serve pregnant and postpartum individuals.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Integrated Data Systems | Other | Other: Integrated Data SystemsCommunity Care Hub infrastructure enhanced with Integrated Data Systems support. |
| Arm 2: Integrated Data Systems + Learning Collaborative | Other | Other: Integrated Data Systems, Other: Learning CollaborativeCommunity Care Hub infrastructure enhanced with Integrated Data Systems and Learning Collaborative support. |
| Arm 3: Integrated Data Systems + Resiliency Skill Building | Other | Other: Integrated Data Systems, Other: Resiliency Skill BuildingCommunity Care Hub infrastructure enhanced with Integrated Data Systems and Resiliency Skill Building support. |
| Arm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building | Other | Other: Integrated Data Systems, Other: Learning Collaborative, Other: Resiliency Skill BuildingCommunity Care Hub infrastructure enhanced with Integrated Data Systems, Learning Collaborative and Resiliency Skill Building support. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Integrated Data SystemsIntegrated Data Systems support intervention includes standardized social needs screening, improved data sharing and care coordination and health information exchange integration. | Other | Arm 1: Integrated Data Systems, Arm 2: Integrated Data Systems + Learning Collaborative, Arm 3: Integrated Data Systems + Resiliency Skill Building, Arm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building |
| Learning CollaborativeLearning Collaborative intervention includes specialized perinatal training for CHWs, peer learning and expert-led education, and trauma-informed and evidence-based care practices. | Other | Arm 2: Integrated Data Systems + Learning Collaborative, Arm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building |
| Resiliency Skill BuildingResiliency Skill Building intervention includes Community Resiliency Model training, burnout prevention and workforce well-being support and ongoing coaching for CHWs and supervisors. | Other | Arm 3: Integrated Data Systems + Resiliency Skill Building, Arm 4: Integrated Data Systems + Learning Collaborative + Resiliency Skill Building |
Primary outcome
Timely prenatal and postpartum care connection
Time frame: Prenatal care visit within first trimester AND postpartum care visit within 7-84 days after delivery
Prenatal care initiation and postpartum care attendance
9 secondary outcomes
Screening completion rates
Time frame: First trimester of pregnancy
Brief Resiliency Scale
Time frame: Annually during the trial
Self-efficacy for CHWs
Time frame: Annually during the trial
turnover intention
Time frame: Annually during the trial
Patient engagement
Time frame: Postpartum (7-84 days after delivery)
Preterm Birth
Time frame: At delivery
Depression
Time frame: Postpartum (7-84 days after delivery)
Social Service Connections
Time frame: From client enrollment to 6 months postpartum
Turnover
Time frame: Annually during the trial
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Walker, PhD, MPH principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Data Systems, Learning Collaborative and Resiliency Skill Building in people with Perinatal Population Health, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Laura Binkley, PhD, MSc, MPH (614-685-1510, laura.binkley@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timely prenatal and postpartum care connection (time frame: Prenatal care visit within first trimester AND postpartum care visit within 7-84 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.