- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310199
Pharmacist-Led Transition of Care Program in the Emergency Department (Pharm TOC-ED): A Pilot Trial (PharmTOC-ED)
Pharmacist-Led Transition of Care Program in the Emergency Department (Pharm TOC-ED): A Pilot Randomized, Parallel-Group, Open-Label Trial With Embedded Process Evaluation
When patients leave the emergency department, mistakes with their medications are common and can lead to complications or hospital readmissions. Pharmacists are trained to help prevent these problems, but pharmacist-led transition of care services are not routinely provided in emergency departments.
This study is a small pilot randomized controlled trial designed to see whether a pharmacist-led transition of care program can be carried out successfully in the emergency department at Al-Wakra Hospital. The study will help determine if a larger trial is feasible in the future.
Patients who are being discharged home from the emergency department and meet the study criteria will be invited to participate. Those who agree will be randomly assigned to one of two groups:
Usual care, or Usual care plus the pharmacist-led transition of care program The pharmacist-led program includes reviewing the discharge prescription, checking and updating the medication list, providing medication education, arranging follow-up with a pharmacist-run clinic, communicating with outpatient pharmacists, and following up with the patient after discharge.
The pilot trial will help determine how many patients are eligible, how many agree to participate, how well the intervention can be delivered in the emergency department, and whether patients and staff find it acceptable. The results will be used to plan a larger study that will test whether this program can reduce healthcare use after discharge.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Abdul Hadi, PhD
- Phone Number: 0097433114549
- Email: mabdulhadi@qu.edu.qa
Study Contact Backup
- Name: Eman Alhmoud, MSc
- Phone Number: 0097455572121
- Email: ea2201377@qu.edu.qa
Study Locations
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-
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Al Wakrah, Qatar
- Recruiting
- Al- Wakra Hospital- Hamad Medical Corporation
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Contact:
- Dr. Sameer Pathan, PhD
- Phone Number: 0097466857650
- Email: SPATHAN@hamad.qa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (aged 18 years or more) discharged from the ED with at least one of the following:
- Polypharmacy: Five or more scheduled prescription medications for chronic illnesses (i.e., chronic maintenance medications, even if such medications were not refilled during the index ED visit)
- Discharged with a new prescription of high-risk medication, including:
- Drugs with the potential of withdrawal symptoms upon abrupt discontinuation such as antipsychotics, antiepileptics, antidepressants, and tapering glucocorticoids.
- Insulin (initiation or intensification of therapy)
- Oral hypoglycemic agents
- Visiting ED for an exacerbation of chronic illness (e.g., exacerbation of asthma, COPD, CHF, uncontrolled diabetes mellitus, hypertension urgency, uncontrolled epilepsy)
Exclusion Criteria:
- The following patients will be excluded:
- Presenting with acute minor illnesses
- Lack of decision-making capacity (including documented moderate or severe dementia, altered mental status, unstable psychiatric illness, altered consciousness level, lack of orientation to person/place/time as reported in EHR, delirium, patients seen in the ED for a psychiatric evaluation)
- Language barrier, i.e., inability to communicate in either English or Arabic as the intervention will be provided by English/Arabic speaking clinical pharmacists
- Expected length of stay in Qatar of <30 days post discharge (including transit passengers)
- Substance use disorders (e.g., alcoholism, opioid dependency) or drug-seeking behavior, as reported in EHR
- Prisoners who are serving an active sentence
- Patients presenting for non-medical, socially driven reasons (e.g., seeking shelter, support, or resources) with no identifiable acute medical condition, and known to the ED team as recurrent visitors.
- Discharge to a location other than home (e.g., patients transferred to another hospital, long-term or skilled nursing facility)
- Study pharmacists unavailable to deliver the intervention if the patients were randomized to the intervention arm
- Pregnant women
- Patients seen for trauma or planned surgery
- Terminally ill patients
- Patients discharged from ED with watchful waiting (e.g., expected to be readmitted for an intervention such as surgical intervention if conservative management failed)
- Patients who are admitted to the hospital after enrollment (i.e., following consent but prior to ED discharge)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control arm (Usual Care)
Patients in this group will receive standard care in accordance with Hamad Medical Corporation's (HMC) policies and practices.
Currently, case review by clinical pharmacists for all ED patients at the study site is not part of routine care.
Medication review, reconciliation, discharge education, and follow-up are typically managed by ED-physicians and nurses.
Clinical pharmacists may be consulted, depending on availability, for complex or selected cases only.
Control group patients will not be denied pharmacist-led TOC services when deemed necessary as part of routine clinical judgment.
These instances will be recorded, including the reason, nature, and timing of the care provided by the pharmacist.
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|
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Active Comparator: Multi-faceted pharmacist-led transition of care (ToC) program (Intervention)
Participants receive usual care plus a pharmacist-led transition of care (ToC) program, which includes medication review, reconciliation, discharge counseling, coordination of follow-up, and post-discharge pharmacist visits.
|
The pharmacist-led transition of care (ToC) intervention begins once a patient is deemed ready for ED discharge.
ED pharmacists conduct a comprehensive discharge medication review, identify and resolve medication therapy problems, and document recommendations in the electronic health record (EHR).
They perform discharge medication reconciliation, generate the best possible medication list, and correct any discrepancies.
Pharmacists provide structured medication counseling using teach-back and address adherence barriers.
Discharge planning includes scheduling post-discharge follow-up in a pharmacist-led medication therapy management clinic and delivering a standardized handover to ambulatory pharmacists.
Patients receive two post-discharge follow-up visits within 7 and 14 days, during which pharmacists reassess medications, resolve new or ongoing issues, provide education, and coordinate additional care when needed.
All activities follow standardized documentation procedures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eligibility rate among screened patients
Time Frame: At baseline (Day 1)
|
Proportion of screened emergency department (ED) patients who meet all inclusion criteria and none of the exclusion criteria for the pilot trial.
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At baseline (Day 1)
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Recruitment rate among eligible patients
Time Frame: At baseline (Day 1)
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Proportion of eligible patients who agree to participate, provide informed consent, and are randomized into the trial.
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At baseline (Day 1)
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Retention rate at post-discharge follow-up
Time Frame: Intervention arm: Day 7, Day 14, and Day 30 after ED discharge, Control arm: Day 30 after ED discharge
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Proportion of enrolled patients who: (a) in the intervention group, attend pharmacist-led follow-up visits at 7 and 14 days after ED discharge; and (b) in both groups, complete the 30-day follow-up phone call.
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Intervention arm: Day 7, Day 14, and Day 30 after ED discharge, Control arm: Day 30 after ED discharge
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Intervention fidelity: receipt of all ToC program components
Time Frame: Through day 30 after ED discharge
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Proportion of participants in the intervention arm who receive all prespecified components of the pharmacist-led transition of care intervention (discharge medication review, discharge medication reconciliation, patient counseling, discharge planning, and post-discharge follow-up).
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Through day 30 after ED discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with ≥1 unintentional medication discrepancy
Time Frame: Through day 30 after ED discharge
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Proportion of patients with at least one unintentional medication discrepancy identified by the clinical pharmacist at ED discharge and during post-discharge follow-up visits.
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Through day 30 after ED discharge
|
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Number and types of unintentional medication discrepancies
Time Frame: Through Day 30 after ED discharge
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Total number, mean number per patient, and types of unintentional medication discrepancies identified by the clinical pharmacist at ED discharge and during post-discharge follow-up visits.
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Through Day 30 after ED discharge
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Proportion of patients with ≥1 medication therapy problem (MTP)
Time Frame: Through Day 30 after ED discharge
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Proportion of patients with at least one medication therapy problem identified by the clinical pharmacist at ED discharge and during post-discharge follow-up visits.
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Through Day 30 after ED discharge
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Number and types of medication therapy problems
Time Frame: Through Day 30 after ED discharge
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Total number, mean number per patient, and types of medication therapy problems identified by the clinical pharmacist at ED discharge and during post-discharge follow-up visits.
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Through Day 30 after ED discharge
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Resolution of medication discrepancies and medication therapy problems
Time Frame: Through Day 30 after ED discharge
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Proportion of identified medication discrepancies and medication therapy problems that are resolved before ED discharge, resolved during post-discharge follow-up, or remain unresolved at the end of follow-up.
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Through Day 30 after ED discharge
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Unplanned healthcare utilization within 30 days
Time Frame: Through Day 30 after ED discharge
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Proportion of patients with a composite outcome of unplanned ED revisit and/or unplanned hospital admission for any acute health problem within 30 days of discharge from the index ED visit.
Elective admissions and scheduled outpatient visits are excluded.
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Through Day 30 after ED discharge
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ED revisit or hospital admission related to index ED presentation
Time Frame: Through Day 30 after ED discharge
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Proportion of patients with an ED revisit and/or hospital admission determined to be related to the index ED presentation within 30 days of discharge.
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Through Day 30 after ED discharge
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Medication-related ED visits or hospital admissions
Time Frame: Through Day 30 after ED discharge
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Proportion of patients with medication-related ED revisits and/or hospital admissions within 30 days of discharge, identified using AT-HARM10 screening followed by adjudication by a clinical pharmacist and physician.
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Through Day 30 after ED discharge
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Patient satisfaction with pharmacist-led ToC intervention
Time Frame: Day 30 after discharge
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Patient satisfaction with pharmacist-led transition of care interventions assessed using the Medication Management Patient Satisfaction Survey (MMPSS).
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Day 30 after discharge
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2394800-1
- CG 838 (Other Grant/Funding Number: Qatar University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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