Community Pharmacies as Social Determinant of Health Navigators

NCT07278401 | Recruiting

• 2 other identifiers: 8733UM1TR005296
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Social Needs Status

Keywords

Social Determinants of Health; Community Pharmacies

Outcome Measures

Primary Outcomes (1)

• Effectiveness Outcomes

  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 Outcomes (1)

• Cost Analysis

  12 months

Study Arms (2)

Social needs screenings control group

NO INTERVENTION

Individuals within the same healthcare system that are matched based on similar characteristics.

Social needs screenings and referrals participants

OTHER

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

Interventions

Social needs screenings and referrals OTHER

Community pharmacies will distribute social needs screening surveys to patients and refer them to local community based organizations based off of identified needs.

Social needs screenings and referrals participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects ≤ 18 years

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• CPESN-NY Pharmacies: collaborator
• Tops Pharmacies: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (5)

Black Rock Pharmacy

Buffalo, New York, 14207, United States

RECRUITING

Vital Pharmacy

Buffalo, New York, 14213, United States

RECRUITING

Riverview Professional Pharmacy

Buffalo, New York, 14226, United States

RECRUITING

Middleport Family Health Center

Middleport, New York, 14105, United States

RECRUITING

Niagara Apothecary

Niagara Falls, New York, 14304, United States

RECRUITING

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Related Links

• The Health Leads Screening Toolkit
• The Pharmacists' Patient Care Process. Joint Commission of Pharmacy Practitioners

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Central Study Contacts

David Jacobs

CONTACT

716-829-2134; dmjacobs@buffalo.edu

Christopher Daly

CONTACT

716-645-2828; cjdaly@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single intervention group with a matched control group with a local health information exchange.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

US (5)