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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Eligibility rate among screened patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Eligibility rate among screened patients
时间窗: 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.
Intervention fidelity: receipt of all ToC program components
时间窗: Through day 30 after ED discharge
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).
Recruitment rate among eligible patients
时间窗: At baseline (Day 1)
Proportion of eligible patients who agree to participate, provide informed consent, and are randomized into the trial.
Retention rate at post-discharge follow-up
时间窗: Intervention arm: Day 7, Day 14, and Day 30 after ED discharge, Control arm: Day 30 after ED discharge
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.
次要结局
- Number and types of medication therapy problems(Through Day 30 after ED discharge)
- Medication-related ED visits or hospital admissions(Through Day 30 after ED discharge)
- Proportion of patients with ≥1 unintentional medication discrepancy(Through day 30 after ED discharge)
- Number and types of unintentional medication discrepancies(Through Day 30 after ED discharge)
- Proportion of patients with ≥1 medication therapy problem (MTP)(Through Day 30 after ED discharge)
- Resolution of medication discrepancies and medication therapy problems(Through Day 30 after ED discharge)
- Unplanned healthcare utilization within 30 days(Through Day 30 after ED discharge)
- ED revisit or hospital admission related to index ED presentation(Through Day 30 after ED discharge)
- Patient satisfaction with pharmacist-led ToC intervention(Day 30 after discharge)
研究者
Dr. Muhammad Abdul Hadi
Associate Professor of Clinical Pharmacy and Practice
Qatar University