Social Needs StatusSDoHNCT07278401
Community Pharmacies as Social Determinant of Health Navigators
A study testing Social needs screenings and referrals in people with Social Needs Status, run by State University of New York at Buffalo at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Needs Status
- What is being tested?
- Social needs screenings and referrals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2025to May 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects ≤ 18 years
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Black Rock Pharmacy
Buffalo, New York, 14207
- Recruiting
Vital Pharmacy
Buffalo, New York, 14213
- Recruiting
Riverview Professional Pharmacy
Buffalo, New York, 14226
- Recruiting
Middleport Family Health Center
Middleport, New York, 14105
- Recruiting
Niagara Apothecary
Niagara Falls, New York, 14304
About this study
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
- Being tested
- Social needs screenings and referrals
- Keywords
- Social Determinants of Health, Community Pharmacies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social needs screenings and referralsOther
Community pharmacies will distribute social needs screening surveys to patients and refer them to local community based organizations based off of identified needs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Social needs screenings and referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Cost Analysis
We will calculate interventions costs combined with cost savings from reduced utilization to calculate the net costs from a health system perspective.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Social Needs StatusStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a single intervention group with a matched control group with a local health information exchange.
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- CPESN-NY Pharmacies, Tops Pharmacies, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, David Matthew Jacobs, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278401
- Sponsor's protocol ID
- 8733
- Other IDs
- UM1TR005296
- Acronym
- SDoH
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing IPD will be based on specific agreements between the institution, community partners, and the local health information exchange.
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.
PubMed 28990990Committee 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/
PubMed 24757748Feldstein 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.
PubMed 18468362Proctor 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.
PubMed 20957426Buitron 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. doi: 10.1001/jamanetworkopen.2022.50004.
PubMed 36622674Handley MA, Lyles CR, McCulloch C, Cattamanchi A. Selecting and Improving Quasi-Experimental Designs in Effectiveness and Implementation Research. Annu Rev Public Health. 2018 Apr 1;39:5-25. doi: 10.1146/annurev-publhealth-040617-014128. Epub 2018 Jan 12.
PubMed 29328873Daly CJ, Quinn B, Mak A, Jacobs DM. Community Pharmacists' Perceptions of Patient Care Services within an Enhanced Service Network. Pharmacy (Basel). 2020 Sep 16;8(3):172. doi: 10.3390/pharmacy8030172.
PubMed 32947887Martinez LS, Russell B, Rubin CL, Leslie LK, Brugge D. Clinical and translational research and community engagement: implications for researcher capacity building. Clin Transl Sci. 2012 Aug;5(4):329-32. doi: 10.1111/j.1752-8062.2012.00433.x. Epub 2012 Jun 28.
PubMed 22883610Wheat L, Roane TE, Connelly A, Zeigler M, Wallace J, Kim JH, Segal R. Using a pharmacist-community health worker collaboration to address medication adherence barriers. J Am Pharm Assoc (2003). 2020 Nov-Dec;60(6):1009-1014. doi: 10.1016/j.japh.2020.08.021. Epub 2020 Sep 14.
PubMed 32943338Ruiz Escobar E, Pathak S, Blanchard CM. Screening and Referral Care Delivery Services and Unmet Health-Related Social Needs: A Systematic Review. Prev Chronic Dis. 2021 Aug 12;18:E78. doi: 10.5888/pcd18.200569.
PubMed 34387188Gundersen C, Ziliak JP. Food Insecurity And Health Outcomes. Health Aff (Millwood). 2015 Nov;34(11):1830-9. doi: 10.1377/hlthaff.2015.0645.
PubMed 26526240Berkowitz SA, Hulberg AC, Hong C, Stowell BJ, Tirozzi KJ, Traore CY, Atlas SJ. Addressing basic resource needs to improve primary care quality: a community collaboration programme. BMJ Qual Saf. 2016 Mar;25(3):164-72. doi: 10.1136/bmjqs-2015-004521. Epub 2015 Nov 30.
PubMed 26621916
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Pharmacies as Social Determinant of Health Navigators
- ClinicalTrials.gov ID
- NCT07278401
- Acronym / sponsor ID
- SDoH / 8733
- Conditions
- Social Needs Status
- Keywords
- Social Determinants of Health, Community Pharmacies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- CPESN-NY Pharmacies, Tops Pharmacies, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Dec 2025 (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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single intervention group with a matched control group with a local health information exchange.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Social needs screenings and referralsPatients who have been identified to have needs via the screening survey who are referred to a community based organization by the pharmacist navigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects ≤ 18 years
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 |
|---|---|---|
| Social needs screenings and referralsCommunity pharmacies will distribute social needs screening surveys to patients and refer them to local community based organizations based off of identified needs. | Other | Social needs screenings and referrals participants |
Primary outcome
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.
1 secondary outcome
Cost Analysis
Time frame: 12 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 28 Oct 2026.
- BackgroundMorse JM. Determining sample size. Qual Health Res. 2000;10(1):3-5. doi: Doi 10.1177/104973200129118183. PubMed PMID: WOS:000084385600001.
- BackgroundGuest 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.
- BackgroundDaly 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.
- Background: PubMed 28990990LaForge 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.
- Background: PubMed 24757748Committee 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/
- Background: PubMed 18468362Feldstein 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.
- Background: PubMed 20957426Proctor 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.
- Background: PubMed 36622674Buitron 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. doi: 10.1001/jamanetworkopen.2022.50004.
- Background: PubMed 29328873Handley MA, Lyles CR, McCulloch C, Cattamanchi A. Selecting and Improving Quasi-Experimental Designs in Effectiveness and Implementation Research. Annu Rev Public Health. 2018 Apr 1;39:5-25. doi: 10.1146/annurev-publhealth-040617-014128. Epub 2018 Jan 12.
- Background: PubMed 32947887Daly CJ, Quinn B, Mak A, Jacobs DM. Community Pharmacists' Perceptions of Patient Care Services within an Enhanced Service Network. Pharmacy (Basel). 2020 Sep 16;8(3):172. doi: 10.3390/pharmacy8030172.
- Background: PubMed 22883610Martinez LS, Russell B, Rubin CL, Leslie LK, Brugge D. Clinical and translational research and community engagement: implications for researcher capacity building. Clin Transl Sci. 2012 Aug;5(4):329-32. doi: 10.1111/j.1752-8062.2012.00433.x. Epub 2012 Jun 28.
- Background: PubMed 32943338Wheat L, Roane TE, Connelly A, Zeigler M, Wallace J, Kim JH, Segal R. Using a pharmacist-community health worker collaboration to address medication adherence barriers. J Am Pharm Assoc (2003). 2020 Nov-Dec;60(6):1009-1014. doi: 10.1016/j.japh.2020.08.021. Epub 2020 Sep 14.
- The Health Leads Screening ToolkitLink provided by the sponsor.
- The Pharmacists' Patient Care Process. Joint Commission of Pharmacy PractitionersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Sharing IPD will be based on specific agreements between the institution, community partners, and the local health information exchange.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social needs screenings and referrals in people with Social Needs Status, run by State University of New York at Buffalo at 5 sites 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact David Jacobs (716-829-2134, dmjacobs@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Outcomes (time frame: 12 months). 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 NCT07278401, which also lists 26 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 28 Oct 2026.