Clinical trial NCT06802393: Pharmacist-Led SDoH Screening Intervention During Transitions of Care in an Acute Care Setting
Official title: Implementation of a Pharmacist-Led Social Determinants of Health Screening Intervention During Transitions of Care in an Acute Care Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Related Social Needs (HRSN)
Pharmacy
Medication Reconciliation
Keywords: health related social needs
pharmacists
hospital
emergency department
medication reconciliation
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-01-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healthcare Utilization
timeFrame: 30 days post discharge
Secondary outcomes:
measure: Intervention feasibility and fidelity metrics
timeFrame: Through study completion and up to 30 day post discharge
measure: Intervention Acceptability
timeFrame: Through study completion and up to 30 days post-discharge
measure: Rates of unplanned hospital readmissions and emergency department visits
timeFrame: Up to 90 days post-discharge
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
Study officials:
References: