A Prospective, Multinational, Randomized, Open Label Parallel Arm Trial With Blinded Outcome Adjudication Quantifying the Efficacy of SENATOR in Reducing Adverse Drug Reactions in Older Hospitalized Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,537
- 试验地点
- 1
- 主要终点
- Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR.
研究概览
简要总结
Primary Objective: To quantify the benefits of the SENATOR decision support software on the reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the effect of SENATOR with regard to use of appropriate non-pharmacological therapies in subjects with one core geriatric syndrome.
Tertiary Objectives: to examine the association of SENATOR use with subject survival, morbidity and health related quality of life.
Health Economic Objective: To examine the potential health economic consequences of using SENATOR.
There are two study phases:
Phase I: Prospective multinational, multicentre observational study to estimate the baseline adjudicated medical and surgical ADR rates by clinical subspeciality in 6 international sites.
Phase II: Prospective multinational, multicentre, block randomized, two parallel arm, open label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR software in reducing ADRs in older hospitalized subjects.
详细描述
Phase I is designed to test the electronic case report form (eCRF) and the ADR ascertainment method in the six clinical sites in advance of Phase II (randomization phase).
In Phase I, we recruited 644 older multi-morbid patients from the 6 clinical sites. After obtaining written informed consent, patients' demographic, clinical and medication details were entered to the eCRF. In the event of one a 12 item Trigger List of adverse clinical events occurring, the eCRF automatically generated a Trigger List assessment proforma. The 12 items in the Trigger List included:
- New onset falls
- New onset unsteady gait
- Acute kidney injury
- Symptomatic orthostatic hypotension
- Serum electrolyte disturbance
- Symptomatic bradycardia
- New onset major constipation
- Acute bleeding
- Acute dyspepsia/nausea/vomiting
- Acute diarrhea
- Delirium
- Symptomatic hypoglycemia
In addition, we have included 'Unspecified adverse event' in order to capture the wide range of well recognized ADRs associated with various medications. For example, the rapid onset of a generalized maculopapular rash in a patient with penicillin hypersensitivity would be identified as an ADR under the 'Unspecified adverse event' category.
ADR adjudication in Phase I was blinded and no ADR adjudications were undertaken by the site principal investigator (PI). ADRs were defined as 'definite', probable', 'possible', 'unlikely' or 'indeterminate' according to WHO-UMC ADR causality critria. ADR severity was defined according to a modified Hartwig ADR severity scale ranging from Level 1 (trivial) to Level 7 (fatal).
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 (Outcomes Assessor)
盲法说明
For outcome data, details were extracted from patients' case records to determine if trigger list adverse clinical events had occurred following randomization. These trigger list events represented the great majority of adverse drug reactions (ADRs) and were independently adjudicated by a blinded end-point committee comprised of the co-PI's, such that no co-PI adjudicated potential ADRs at his own site.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent by the patient or legal guardian/next-of-kin
- •Age ≥ 65 years
- •Arrival to hospital within previous 72 hours
- •Admitted as a general medical or surgical on call patient
- •Anticipated in-hospital stay of > 48 hours,
- •≥ 3 active (requiring current medication) chronic medical disorders
排除标准
- •Admitted under:
- •Geriatric Medicine
- •Clinical Pharmacology
- •Palliative Medicine
- •Clinical Oncology
- •Hematology
- •Intention of primary team at the time of subject admission to seek a Geriatric Medicine, Clinical Pharmacology or Palliative Medicine in-patient consultation
- •Life expectancy in the opinion of the admitting clinician of < 3 months
- •Admission directly to an intensive care unit,
- •Admission with primary acute psychiatric illness (excluding delirium)
- •Admission with non-accidental overdose/self-harm
- •Anticipated immediate transfer to alternative non-participating clinical service/hospital
- •Clinical diagnosis of acute Liver failure
- •estimated Glomerular Filtration Rate <10 ml/min per 1.73 m2
- •Solid organ transplant recipients
- •Patients with malignancy receiving systemic chemotherapy
- •Hospitalized for elective procedure
- •Patient was more than 24 hours in the Emergency Department under the care of a different team to that which finally is in charge of them
- •Patients who are actively participating in another clinical trial
研究组 & 干预措施
SENATOR
Physicians attending multi-morbid older patients i.e. with 3 or more chronic medical conditions receive a SENATOR software-generated report with advice details on potentially inappropriate pharmacotherapy and/or potentially inappropriate prescribing omissions.
干预措施: SENATOR software generated pharmacotherapy advice report. (Other)
Control
Standard pharmaceutical care as per local practice.
结局指标
主要结局
Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR.
时间窗: Day 14 of hospital stay or discharge, which ever comes first
Subjects adjudicated by the Potential Endpoint Committee as having experienced one or more probable or certain adverse drug reactions (ADRs).
次要结局
未报告次要终点
研究者
Denis O'Mahony
Professor, Department of Medicine
University College Cork