- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06802393
Pharmacist-Led SDoH Screening Intervention During Transitions of Care in an Acute Care Setting
Implementation of a Pharmacist-Led Social Determinants of Health Screening Intervention During Transitions of Care in an Acute Care Setting
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14203
- Buffalo General Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age: Patients must be at least 18 years old.
Status: Patients being seen at Buffalo General Medical Center (BGMC).
Discharge Plan: It is anticipated that the patient will be discharged home. Control Group: Patients in the control group will meet the same inclusion criteria as those in the intervention group, except they will not receive the health-related social needs (HRSN) screening.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
|
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
|
|
Experimental: Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare Utilization
Time Frame: 30 days post discharge
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention feasibility and fidelity metrics
Time Frame: Through study completion and up to 30 day post discharge
|
Recruitment Rates: The proportion of eligible patients who are approached and consented for the intervention. Completion Rates: The number of patients who complete all aspects of the intervention, including follow-up and patient satisfaction surveys. Follow-Up Rates: The proportion of participants who successfully engage with referred community-based organizations (CBOs). |
Through study completion and up to 30 day post discharge
|
|
Intervention Acceptability
Time Frame: Through study completion and up to 30 days post-discharge
|
Patient satisfaction with the HRSN screening and referral process, assessed through post-intervention surveys. Participant attitudes toward pharmacist-led social care interventions in an acute care setting. |
Through study completion and up to 30 days post-discharge
|
|
Rates of unplanned hospital readmissions and emergency department visits
Time Frame: Up to 90 days post-discharge
|
Rate of Unplanned, All-Cause Hospital Readmissions at 30 and 90 Days: This evaluates the frequency of unplanned hospital readmissions within 30 and 90 days post-discharge in both the intervention and control groups. Rate of Unplanned, All-Cause Emergency Department (ED) Visits at 30 and 90 Days: This measures the number of unplanned ED visits within 30 and 90 days post-discharge for both groups, providing additional insights into healthcare utilization. |
Up to 90 days post-discharge
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007867
- K23HL153582 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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