Social Needs Program for Addressing Social Determinants of Health

(SDoH Trial)

Recruiting at 4 trial locations

Overseen By Christopher Daly

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Under 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pharmacies can address social challenges affecting health by screening individuals and guiding them to community resources. Community pharmacies in Western New York serve as health navigators, especially in under-resourced areas. Participants will either receive social needs screenings and referrals or join a control group. Ideal candidates are English-speaking adults who visit participating pharmacies in Erie County. As an unphased trial, this study allows participants to contribute to innovative solutions for improving community health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on social needs and pharmacy services, so it's unlikely that medication changes are required.

What prior data suggests that this program is safe for participants?

Research has shown that using community pharmacies to address social needs is generally safe. These programs connect people with local resources for essentials like food or housing. Studies have not reported negative effects from these pharmacy-based programs.

Community pharmacies are part of many people's daily routines, and adding services like checking for social needs and making referrals is generally well-received. The focus remains on assisting with needs rather than providing new medications, keeping risks low. Overall, current evidence considers participation in such programs safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using community pharmacies as navigators for social determinants of health because it brings healthcare support directly into communities where people live. Unlike traditional healthcare models that often address health issues only after they arise, this approach proactively screens for social needs, like housing or food insecurity, that can impact overall health. By involving pharmacists as navigators, patients get personalized referrals to community resources, potentially preventing health problems before they start. This could lead to a more holistic approach to healthcare, reducing the need for more intensive medical interventions down the line.

What evidence suggests that using community pharmacies as social determinant of health navigators is effective for addressing social needs?

Research has shown that local pharmacies can assist with essential needs such as food, housing, and healthcare. In this trial, one group of participants will receive social needs screenings and referrals from community pharmacies acting as Social Determinant of Health Navigators. These pharmacies identify the support people need and connect them with local community groups. Studies have found that this approach can lead to improved health outcomes. For instance, individuals who receive help with these needs often adhere to their medications and manage their health conditions more effectively. By guiding people through the healthcare system, pharmacies simplify access to necessary support. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals in Western New York who frequent community pharmacies and may have unmet social needs. The study aims to understand if having Community Health Workers (CHWs) at these pharmacies can help address those needs.

Inclusion Criteria

English speaking

I am 18 years old or older.

Presenting to one of the participating pharmacies enrolled within the Community Pharmacy Enhanced Services Network - NY (CPESN-NY) or associated with Tops Pharmacies, with the ability to collaborate with Healthelink and referring partners, 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

I am 18 years old or younger.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Social Needs Screening and Navigation

Participants receive a comprehensive social needs screening and are referred to community-based organizations by pharmacist navigators

12 months

Follow-up

Participants are monitored for effectiveness outcomes in healthcare utilization, including hospital admissions and ED visits

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Pharmacies as Social Determinant of Health Navigators

Trial Overview

The intervention being tested involves CHWs conducting social needs screenings and providing referrals at community pharmacies. The effectiveness of this approach will be measured using a difference-in-difference (DID) study design.

How Is the Trial Designed?

Group I: Social needs screenings and referrals participants Experimental Treatment 1 Intervention

Patients who have been identified to have needs via the screening survey who are referred to a community based organization by the pharmacist navigator.

Group II: Social needs screenings control group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

CPESN-NY Pharmacies

Collaborator

Tops Pharmacies

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07278401

Community Pharmacies as Social Determinant of Health ...

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

2.

trial.medpath.com

trial.medpath.com/clinical-trial/69c355f704eb0bfb/nct07278401-community-pharmacies-health-navigators

Community Pharmacies as Social Determinant of Health ...

Type 1 hybrid effectiveness-implementation study using a quasi-experimental, difference-in-difference (DID) design to deliver a comprehensive social needs ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35256284/

Implementation and evaluation of social determinants of ...

Our primary objective was to describe 2 social determinant of health (SDOH) practice models implemented within community pharmacies.

4.

jmcp.org

jmcp.org/doi/10.18553/jmcp.2024.30.11.1217

Potential benefits of incorporating social determinants ...

This study is the first to our knowledge to examine the potential impact of SDoH on the clinical effectiveness of comprehensive medication management.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1544319121001825

Addressing social determinants of health in community ...

In this article, we explore novel community pharmacy practice models that address SDoH, provide real-world examples of these models, and discuss pathways for ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11522447/

Potential benefits of incorporating social determinants ...

This study is the first to our knowledge to examine the potential impact of SDoH on the clinical effectiveness of comprehensive medication management.

7.

communitypharmacyfoundation.org

communitypharmacyfoundation.org/resources/grant_docs/CPFGrantDoc_99859.pdf

Implementing a Social Determinants of Health Program

Community pharmacists are accessible and local and are well-positioned to address these SDoH. In this section you will find evidence of improvements in outcomes ...