Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT06802393
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2025-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacist-Led SDoH Screening Intervention During Transitions of Care in an Acute Care Setting
Sponsor:
State University of New York at Buffalo
Organization:
Study Overview
Official Title:
Implementation of a Pharmacist-Led Social Determinants of Health Screening Intervention During Transitions of Care in an Acute Care Setting
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
The study is a quasi-experimental pilot project conducted at Buffalo General Medical Center (BGMC). Using a pre-post design with a non-equivalent control group, the study aims to evaluate the feasibility, acceptability, and effectiveness of a pharmacist-led intervention addressing health-related social needs (HRSN) during care transitions in the emergency department (ED). Eligible patients, including English-speaking adults aged 18 or older will be identified daily through the ED worklist by trained research assistants. Participants will undergo screening using the Accountable Health Communities (AHC) HRSN tool to identify unmet needs such as housing instability, food insecurity, and transportation challenges.
The intervention includes: 1) pharmacist led medication reconciliation, 2) providing patients with tailored referrals to community-based organizations identified through the 211 WNY resource database, based on their specific social needs and geographic location and 3) follow-up phone calls within one month will assess whether participants contacted the referred organizations and whether these services were helpful. A patient satisfaction survey will also be conducted during these follow-up calls to gauge attitudes toward the intervention.
The historical control group will include patients admitted or discharged from the ED during the same timeframe as the intervention group but without HRSN screening. Control group data, including healthcare utilization outcomes, will be extracted from the electronic health record (EHR). Outcomes of interest include feasibility measures such as recruitment rates and data completeness, acceptability metrics like patient satisfaction, and secondary outcomes such as unplanned hospital readmissions and ED visits at 30 days and 3 months post-discharge.
Data analysis will involve statistical comparisons of demographic and clinical characteristics between the intervention and control groups using Chi-square tests for categorical variables and Wilcoxon Rank-sum or t-tests for continuous variables. Multivariable logistic regression will assess the impact of the intervention on healthcare utilization outcomes.
The study expects to recruit 50 patients in the intervention group and 100 in the control group over eight months, with a total study duration of 12 months, including follow-up and data analysis. By integrating pharmacists into HRSN screening and referral processes, the study aims to address critical social determinants of health, improve care transitions, and reduce healthcare utilization in underserved populations.
The intervention includes: 1) pharmacist led medication reconciliation, 2) providing patients with tailored referrals to community-based organizations identified through the 211 WNY resource database, based on their specific social needs and geographic location and 3) follow-up phone calls within one month will assess whether participants contacted the referred organizations and whether these services were helpful. A patient satisfaction survey will also be conducted during these follow-up calls to gauge attitudes toward the intervention.
The historical control group will include patients admitted or discharged from the ED during the same timeframe as the intervention group but without HRSN screening. Control group data, including healthcare utilization outcomes, will be extracted from the electronic health record (EHR). Outcomes of interest include feasibility measures such as recruitment rates and data completeness, acceptability metrics like patient satisfaction, and secondary outcomes such as unplanned hospital readmissions and ED visits at 30 days and 3 months post-discharge.
Data analysis will involve statistical comparisons of demographic and clinical characteristics between the intervention and control groups using Chi-square tests for categorical variables and Wilcoxon Rank-sum or t-tests for continuous variables. Multivariable logistic regression will assess the impact of the intervention on healthcare utilization outcomes.
The study expects to recruit 50 patients in the intervention group and 100 in the control group over eight months, with a total study duration of 12 months, including follow-up and data analysis. By integrating pharmacists into HRSN screening and referral processes, the study aims to address critical social determinants of health, improve care transitions, and reduce healthcare utilization in underserved populations.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23HL153582 | NIH | None | https://reporter.nih.gov/quic… | View |