NCT02816086已完成不适用
A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 2
- 主要终点
- Emergency medical visits
研究概览
简要总结
Suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. By using a randomized controlled trial (RCT) design the investigators aim to explore a new inter-professional working structure. The working structure is based on the scientifically and clinically acknowledged integrated medicines management (IMM) model. The overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital 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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥70 years
- •Admitted to the geriatric internal medicine ward in the University Hospital of North Norway (UNN) Tromsø or the general internal medicine ward in UNN Harstad.
- •Willing to provide written informed consent during hospital stay (patient or next of kin)
排除标准
- •Unable to communicate in Norwegian (patient or next of kind)
- •Terminally ill, e.g cancer in end-life stage
- •Control group patients where the physician request an assessment from a pharmacist
- •Time from admittance to the ward to inclusion is more than 72 hours
- •Occupying a bed in the study wards but under the care of physicians from a non-study ward.
- •Planned discharged on the inclusion day
结局指标
主要结局
Emergency medical visits
时间窗: 12 months after hospital discharge
Rate of emergency Medical visits at 12 months. Emergency Medical visits is a composite endpoint including emergency department visits and unscheduled hospitalization
次要结局
- Potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)(Baseline at randomization)
- Change in potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)(From baseline to date of discharge from hospital, assessed up to 12 months)
- Change in Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)(From baseline to date of discharge from hospital, assessed up to 12 months)
- Time to first rehospitalization(First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.)
- Total score of the Medication appropriateness index (MAI)(Baseline at randomization)
- Mortality rate(12 months after randomization)
- Potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)(Baseline at randomization)
- Changes in medication, identified through screening of drug lists at their primary care physician.(3 months after discharge from index hospital stay)
- Rehospitalizations where the reason for hospitalization is possibly, probably or certainly drug-related.(First rehospitalization after discharge from index hospital stay, up to 12 months after inclusion in study)
- Self-reported quality of life(12 months after hospital discharge)
- length in days of index hospital stay(Days from hospitalization to discharge of index hospital stay, assessed up to 12 months)
- Change in total score of the Medication appropriateness index (MAI)(From baseline to date of discharge from hospital, assessed up to 12 months)
- Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)(Baseline at randomization)
- Visits to primary care physician(12 months after discharge for index hospital stay)
- Change in inappropriate medications identified through the Norwegian general practice criteria (NORGEP)(From baseline to 3 months after discharge from index hospital stay, assessed up to 12 months)
- Hip fracture(12 months after discharge from index hospital stay)
- Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)(From baseline to 12 months after discharge from hospital)
- Stroke(12 months after discharge from index hospital stay)
- The proportion of patients readmitted acutely within 30 days(30 days after discharge from index hospital stay)
研究者
研究点 (2)
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