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

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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
Last Updated

September 17, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 23, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

health related social needspharmacistshospitalemergency departmentmedication reconciliation

Outcome Measures

Primary Outcomes (1)

  • Healthcare Utilization

    The primary outcome measure of the study is the composite rate of unplanned, all-cause hospital readmissions or emergency department (ED) visits within 30 days of hospital discharge.

    30 days post discharge

Secondary Outcomes (3)

  • Intervention feasibility and fidelity metrics

    Through study completion and up to 30 day post discharge

  • Intervention Acceptability

    Through study completion and up to 30 days post-discharge

  • Rates of unplanned hospital readmissions and emergency department visits

    Up to 90 days post-discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention

Other: Intervention

Control

OTHER

Control

Other: Control

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
ControlOTHER

The control arm of the study consists of a historical cohort of patients who were admitted to or discharged from the emergency department (ED) at Buffalo General Medical Center (BGMC) during the same timeframe as the intervention arm but did not receive the pharmacist-led health-related social needs (HRSN) screening or referral intervention. These patients are identified through the electronic health record (EHR) based on the same inclusion criteria as the intervention group, such as age, geographic location, and discharge disposition. Control participants are matched 1:1 with intervention participants using demographic and clinical characteristics, including age (within 5 years), zip code, insurance type, discharge status, and race. Data for the control arm include healthcare utilization metrics such as 30- and 90-day unplanned hospital readmissions and emergency department visits. The control arm serves as a comparator to evaluate the effectiveness of the intervention

Control

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

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 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations