Pharmacist-Led Transition of Care Program in the Emergency Department (Pharm TOC-ED): A Pilot Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Muhammad Abdul Hadi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-faceted pharmacist-led transition of care (ToC) program

    Behavioral

    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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Control arm (Usual Care)No intervention 0 interventions
Group B: Multi-faceted pharmacist-led transition of care (ToC) program (Intervention)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Eligibility rate among screened patients

Proportion of screened emergency department (ED) patients who meet all inclusion criteria and none of the exclusion criteria for the pilot trial.

Time frame
At baseline (Day 1)
2

Recruitment rate among eligible patients

Proportion of eligible patients who agree to participate, provide informed consent, and are randomized into the trial.

Time frame
At baseline (Day 1)
3

Retention rate at post-discharge follow-up

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.

Time frame
Intervention arm: Day 7, Day 14, and Day 30 after ED discharge, Control arm: Day 30 after ED discharge
4

Intervention fidelity: receipt of all ToC program components

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).

Time frame
Through day 30 after ED discharge

Secondary outcomes

1

Proportion of patients with ≥1 unintentional medication discrepancy

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.

Time frame
Through day 30 after ED discharge
2

Number and types of unintentional medication discrepancies

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.

Time frame
Through Day 30 after ED discharge
3

Proportion of patients with ≥1 medication therapy problem (MTP)

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.

Time frame
Through Day 30 after ED discharge
4

Number and types of medication therapy problems

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.

Time frame
Through Day 30 after ED discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Muhammad Abdul Hadi

Lead sponsor

Qatar University

Sponsor institution

Hamad Medical Corporation

Collaborator