Health Related Social Needs (HRSN)NCT06802393
Pharmacist-Led SDoH Screening Intervention During Transitions of Care in an Acute Care Setting
A study testing Intervention in people with Health Related Social Needs (HRSN) and Pharmacy, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Related Social Needs (HRSN), Pharmacy, Medication Reconciliation
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo General Medical Center
Buffalo, New York, 14203
About this study
Official title: Implementation of a Pharmacist-Led Social Determinants of Health Screening Intervention During Transitions of Care in an Acute Care Setting
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.
Read the 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.
- Being tested
- Intervention
- Keywords
- health related social needs, pharmacists, hospital, emergency department, medication reconciliation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Fidelity
Recruitment Rates: The proportion of eligible patients who are approached and consented for the intervention.
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 30 days post discharge
Intervention Acceptability
Patient satisfaction with the HRSN screening and referral process, assessed through post-intervention surveys.
Measured: 30-days post-discharge
Rates of Unplanned Hospital Readmissions and Emergency Department Visits
Rate of Unplanned, All-Cause Hospital Readmissions and ED visits at 30 and 90 Days: This evaluates the frequency of unplanned hospital readmissions and ED visits within 30 and 90 days post-discharge in both the intervention and control groups.
Measured: Up to 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Oct 2024
- Primary completion15 Jul 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health Related Social Needs (HRSN)Studies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Matthew Jacobs, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802393
- Sponsor's protocol ID
- STUDY00007867
- Other IDs
- K23HL153582
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2025
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Pharmacist-Led Social Determinants of Health Screening Intervention During Transitions of Care in an Acute Care Setting
- ClinicalTrials.gov ID
- NCT06802393
- Acronym / sponsor ID
- STUDY00007867
- Keywords
- health related social needs, pharmacists, hospital, emergency department, medication reconciliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionIntervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Other | Intervention |
Primary outcome
Intervention Fidelity
Time frame: 30 days
Recruitment Rates: The proportion of eligible patients who are approached and consented for the intervention.
3 secondary outcomes
Healthcare Utilization
Time frame: 30 days post discharge
Intervention Acceptability
Time frame: 30-days post-discharge
Rates of Unplanned Hospital Readmissions and Emergency Department Visits
Time frame: Up to 90 days post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Health Related Social Needs (HRSN) and Pharmacy, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Fidelity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.