NCT06802393

Brief Summary

The study is a quasi-experimental pilot study conducted at Buffalo General Medical Center (BGMC). It aims to evaluate the feasibility, acceptability, and effectiveness of a pharmacist-led intervention addressing health-related social needs (HRSN) during transitions of care in the emergency department. The intervention involves: 1) pharmacist led medication review, 2) screening patients using the Accountable Health Communities (AHC) HRSN tool, connecting them to local community-based organizations, and 3) conducting follow-up to assess outcomes. The study will recruit 150 patients (50 intervention and 100 control) and assess healthcare utilization metrics, including hospital readmissions and emergency department visits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 24, 2026

Completed
Last Updated

September 24, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

January 23, 2025

Results QC Date

June 23, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

health related social needspharmacistshospitalemergency departmentmedication reconciliation

Outcome Measures

Primary Outcomes (1)

  • Intervention Fidelity

    Recruitment Rates: The proportion of eligible patients who are approached and consented for the intervention.

    30 days

Secondary Outcomes (3)

  • Healthcare Utilization

    30 days post discharge

  • Intervention Acceptability

    30-days post-discharge

  • Rates of Unplanned Hospital Readmissions and Emergency Department Visits

    Up to 90 days post-discharge

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention

Other: Intervention

Interventions

The intervention incorporates a multifaceted pharmacist-led approach to addressing health-related social needs (HRSN) during transitions of care in the emergency department (ED) at Buffalo General Medical Center (BGMC). The intervention includes: 1) pharmacist-led medication reconciliation, and 2) HRSN screening using the Accountable Health Communities (AHC) HRSN tool. Based on the results, patients receive tailored referrals to community-based organizations using the 211 WNY database, which provides localized resources aligned with their social needs. Each patient is given a printed handout detailing the referral information. Within one month, a follow-up phone call is conducted to follow up with patients and assess additional needs as well as collect feedback through a patient satisfaction survey.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: Patients must be at least 18 years old.
  • Status: Patients being seen at Buffalo General Medical Center (BGMC).

You may not qualify if:

  • Cognitive Impairment: Patients who are cognitively impaired and unable to consent will be excluded.
  • Non-English Speakers: Non-English speaking individuals are excluded due to the nature of the intervention requiring direct communication between the clinical pharmacist and participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Emergencies

Interventions

Methods

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

This study has several limitations. The use of convenience sampling may limit generalizability as patient flow and staffing patterns vary across ED pods. The study included only English-speaking patients, which may underestimate needs among individuals with limited English proficiency. Our modified screening tool did not include the interpersonal domain, which may have led to lower estimates of unmet needs in this area. This study also focused on operational and patient-reported outcomes and did

Results Point of Contact

Title
David Jacobs, Associate Professor
Organization
University at Buffalo

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The intervention study employs a quasi-experimental pre-post design with a non-equivalent control group to evaluate the impact of a pharmacist-led health-related social needs (HRSN) screening and referral intervention in an acute care setting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 31, 2025

Study Start

October 1, 2024

Primary Completion

July 15, 2025

Study Completion

September 15, 2025

Last Updated

September 24, 2026

Results First Posted

September 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations