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Recruiting NCT07278401

Community Pharmacies as Social Determinant of Health Navigators

No phase Interventional Social Needs Status

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Social needs screenings and referrals.
Who it may be relevant to
Registry conditions: Social Needs Status. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Effectiveness Outcomes [Time frame: 12 months]
Secondary outcome measures (1)
  • Cost Analysis [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 5 centers
  • Black Rock Pharmacy — Buffalo
  • Vital Pharmacy — Buffalo
  • Riverview Professional Pharmacy — Buffalo
  • Middleport Family Health Center — Middleport
  • Niagara Apothecary — Niagara Falls

Publications

  • Morse JM. Determining sample size. Qual Health Res. 2000;10(1):3-5. doi: Doi 10.1177/104973200129118183. PubMed PMID: WOS:000084385600001.
  • Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Method. 2006;18(1):59-82. doi: 10.1177/1525822x05279903. PubMed PMID: WOS:000242853100004.
  • Daly CJ, Costello J, Mak A, Quinn B, Lindenau R, Jacobs DM. Pharmacists' perceptions on patient care services and social determinants of health within independent community pharmacies in an enhanced services network. J Am Coll Clin Pharm. 2021;4(3):288-95. doi: 10.1002/jac5.1398. PubMed PMID: WOS:000710530900005.
  • LaForge K, Gold R, Cottrell E, Bunce AE, Proser M, Hollombe C, Dambrun K, Cohen DJ, Clark KD. How 6 Organizations Developed Tools and Processes for Social Determinants of Health Screening in Primary Care: An Overview. J Ambul Care Manage. 2018 Jan/Mar;41(1):2-14. doi: 10.1097/JAC.0000000000000221. PMID 28990990
  • Committee on the Recommended Social and Behavioral Domains and Measures for Electronic Health Records; Board on Population Health and Public Health Practice; Institute of Medicine. Capturing Social and Behavioral Domains in Electronic Health Records: Phase 1. Washington (DC): National Academies Press (US); 2014 Jun 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK195994/ PMID 24757748
  • Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6. PMID 18468362
  • Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426
  • Buitron de la Vega P, Ashe EM, Xuan Z, Gast V, Saint-Phard T, Brody-Fialkin J, Okonkwo F, Power J, Wang N, Lyons C, Silverstein M, Lasser KE. A Pharmacy Liaison-Patient Navigation Intervention to Reduce Inpatient and Emergency Department Utilization Among Primary Care Patients in a Medicaid Accountable Care Organization: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250004. d PMID 36622674

Identifiers

NCT: NCT07278401 · 8733 · UM1TR005296

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗