Community Pharmacies as Social Determinant of Health Navigators (SDoH)

December 1, 2025 updated by: David Matthew Jacobs, State University of New York at Buffalo
Type 1 hybrid effectiveness-implementation study using a quasi-experimental, difference-in-difference (DID) design to deliver a comprehensive social needs screening and navigation program by integrating Community Health Workers (CHWs) into community pharmacies across under-resourced areas in Western New York (WNY).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14207
        • Recruiting
        • Black Rock Pharmacy
      • Buffalo, New York, United States, 14213
        • Recruiting
        • Vital Pharmacy
      • Buffalo, New York, United States, 14226
        • Recruiting
        • Riverview Professional Pharmacy
      • Middleport, New York, United States, 14105
        • Recruiting
        • Middleport Family Health Center
      • Niagara Falls, New York, United States, 14304
        • Recruiting
        • Niagara Apothecary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult subjects ≥ 18 years
  • English speaking
  • Presenting to one of the participating pharmacies. For the pharmacies to be included, they must be enrolled within the Community Pharmacy Enhanced Services Network - NY (CPESN-NY) or associated with Tops Pharmacies. The pharmacies must have the ability to collaborate with Healthelink and referring partners (e.g., Wellconnected) and the staffing capacity to have a SDoH screening program with Community Health Worker Training. The pharmacies' physical address must be located within Erie County

Exclusion Criteria:

  • Subjects ≤ 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Social needs screenings control group
Individuals within the same healthcare system that are matched based on similar characteristics.
Other: Social needs screenings and referrals participants
Patients who have been identified to have needs via the screening survey who are referred to a community based organization by the pharmacist navigator.
Other: Social needs screenings and referrals
Community pharmacies will distribute social needs screening surveys to patients and refer them to local community based organizations based off of identified needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness Outcomes
Time Frame: 12 months
Primary effectiveness outcomes in composite healthcare utilization including hospital admissions and ED visits at 12 months, and we hypothesize that utilization will be reduced in subjects who receive a pharmacy social needs intervention.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost Analysis
Time Frame: 12 months
We will calculate interventions costs combined with cost savings from reduced utilization to calculate the net costs from a health system perspective.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

National Center for Advancing Translational Sciences (NCATS)
CPESN-NY Pharmacies
Tops Pharmacies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8733
  • UM1TR005296 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Sharing IPD will be based on specific agreements between the institution, community partners, and the local health information exchange.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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