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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Eligibility rate among screened patients [Time frame: At baseline (Day 1)]
• Recruitment rate among eligible patients [Time frame: At baseline (Day 1)]
• 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]
• Intervention fidelity: receipt of all ToC program components [Time frame: Through day 30 after ED discharge]

Secondary outcome measures (9)

• Proportion of patients with ≥1 unintentional medication discrepancy [Time frame: Through day 30 after ED discharge]
• Number and types of unintentional medication discrepancies [Time frame: Through Day 30 after ED discharge]
• Proportion of patients with ≥1 medication therapy problem (MTP) [Time frame: Through Day 30 after ED discharge]
• Number and types of medication therapy problems [Time frame: Through Day 30 after ED discharge]
• Resolution of medication discrepancies and medication therapy problems [Time frame: Through Day 30 after ED discharge]
• Unplanned healthcare utilization within 30 days [Time frame: Through Day 30 after ED discharge]
• ED revisit or hospital admission related to index ED presentation [Time frame: Through Day 30 after ED discharge]
• Medication-related ED visits or hospital admissions [Time frame: Through Day 30 after ED discharge]
• Patient satisfaction with pharmacist-led ToC intervention [Time frame: Day 30 after discharge]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Qatar · 1 center

• Al- Wakra Hospital- Hamad Medical Corporation — Al Wakrah

Identifiers

NCT: NCT07310199 · 2394800-1 · CG 838

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗