OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly Hospitalized Patients: Application of a Definitive Intervention by Physicians or Clinical Pharmacists
试验速览
- 阶段
- 不适用
- 入组人数
- 642
- 试验地点
- 3
- 主要终点
- Emergency Department attendance.
研究概览
简要总结
This study is being done to find out if a multi-faceted intervention designed to optimize medication in hospitalized older people with multiple chronic medical conditions exposed to multiple medications can reduce unplanned hospital readmission and emergency department attendance compared to current usual medication management. The study intervention aims to minimize potentially inappropriate medications in a structured way and involves follow up with patients and GPs. Patients will be allocated equally to (i) standard medication management (control arm) or (ii) trained physician-delivered intervention or (iii) clinical pharmacist-delivered intervention.
详细描述
Background:
Recurrent hospitalization and unplanned emergency department (ED) attendance resulting from potentially inappropriate medication is an increasingly common phenomenon in older people with multi-morbidity and associated polypharmacy. With a growing older population with multi-morbidity/polypharmacy, there is a pressing need to address the increasing challenge of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) and associated problems that accentuate adverse drug reactions/events and avoidable excess morbidity. There is also an imperative to curb excess healthcare expenditure related to preventable medication-related problems.
Objective:
To test the clinical and economic impact of a multi-faceted medication optimization definitive intervention on avoidable rehospitalization and unscheduled ED attendance in multi-morbid patients aged ≥ 70 years hospitalized with acute illness.To test the clinical and economic impact of a multi-faceted medication optimization definitive intervention (DI) on avoidable rehospitalization and unscheduled ED attendance in multi-morbid patients aged ≥ 70 years hospitalized with acute illness.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
To mimic the intervention for blinding purposes of the participants, both control and intervention arm patients will receive a sham intervention.While the intervention will be known to clinical staff, the trial statistician will remain blinded until the results are finalized.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70years
- •3 or more chronic conditions.
- •≥ 5 daily medications pre-admission, all medications taken for at least 4 weeks continuously.
- •Can speak and understand English (in the two Irish medical centres), and Dutch or French in Ghent University Hospital (Ghent is predominantly Dutch-speaking).
- •Can give informed consent or give witnessed verbal consent or have a suitable proxy who can give informed assent on the patient's behalf.
- •Agrees to follow-up contact post-discharge up to 180 days post-randomization.
- •Agrees to primary researcher contacting the GP and community pharmacist post-discharge.
排除标准
- •Terminal illness.
- •Severe dementia and clearly unable to understand the purpose of the trial or give consent to participation.
- •Severe communication disorder, making informed consent impossible.
- •Likely to be discharged from hospital within 48 hours of arrival.
- •Intensive Care Unit (ICU) admission.
- •Primary psychiatric presenting illness.
- •Unavailable for post-discharge follow-up for any reason.
- •Non-accidental poisoning.
- •Previous participation in medication optimization trials.
- •Active participation in another clinical trial
- •Infectious illness requiring strict isolation (including COVID-19 infection) blocking access of the primary researcher to the patient for enrolment.
- •End-stage renal, liver or lung disease requiring organ replacement therapy.
- •Admitted under the care of specialists in Clinical Pharmacology, Palliative Medicine, Clinical Oncology or Haematology.
- •Admitted under the care of specialists in Geriatric Medicine in Ghent University Hospital.
- •Trial participation refusal.
研究组 & 干预措施
Control: standard pharmaceutical care
Patients in the control arm (standard pharmaceutical care) will receive a sham intervention in the form of the modified Medication Adherence Rating Scale (MARS) questionnaire
干预措施: Sham Intervention (Other)
trained physician-implemented intervention
The definitive multi-faceted intervention delivered by a trained physician.
干预措施: Definitive multi-faceted intervention consisting of several components (Other)
clinical pharmacist-implemented intervention
The definitive multi-faceted intervention delivered by a trained pharmacist.
干预措施: Definitive multi-faceted intervention consisting of several components (Other)
结局指标
主要结局
Emergency Department attendance.
时间窗: At between days 90 and 180 post-discharge.
Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance at 180 days since discharge from the index hospital admission.
Unscheduled readmission to hospital.
时间窗: At between days 90 and 180 post-discharge.
Unscheduled readmission at 180 days post-discharge in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled readmission at 180 days since discharge from the index hospital admission.
Composite endpoint 1
时间窗: At day 30 post-discharge.
Composite endpoint of readmission to hospital or emergency department attendance within 30 days of discharge from the index admission.
Composite endpoint 2
时间窗: At between days 90 and 180 post-discharge.
Composite endpoint of readmission to hospital or emergency department attendance within 180 days of discharge from the index admission.
Unscheduled readmission to hospital.
时间窗: At day 30 post-discharge.
All-cause re-hospitalization in multi-morbid older people exposed to polypharmacy. Computerized hospital admission records will be inspected. If hospital readmission has occurred dates of admission and discharge will be recorded in the electronic case report form.
Emergency Department attendance.
时间窗: At day 30 post-discharge.
Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance since the first follow-up post discharge.
次要结局
- Occurrence of first admission to residential care facility for long-term nursing care(At between days 90 and 180 post-discharge.)
- All-cause mortality(At between days 90 and 180 post-discharge.)
- Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument(At between days 90 and 180 post-discharge.)
- Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument (incorporating pain control)(At day 30 post-discharge.)
- All-cause mortality(At day 30 post-discharge.)
- Occurrence of first admission to residential care facility for long-term nursing care(At day 30 post-discharge.)
研究者
Denis O'Mahony
Professor
University College Cork