Cooperation Across Healthcare Service Levels for Medication Reviews in Older People with Polypharmacy Admitted to a Municipal In-patient Acute Care Unit (The COOP II Study): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Health-related quality of life (HRQoL)
研究概览
简要总结
The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal in-patient acute care (MipAC) unit in Oslo, Norway. The intervention involves a clinical drug review conducted by a MipAC physician under the guidance of a geriatrician, followed by a telephone consultation between the MipAC physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.
详细描述
The aim of this study is to evaluate the effect of collaborative drug reviews by MipAC physicians, supervised by geriatricians, and FPs on clinically relevant outcome measures in the MipAC patient population aged 70+. The investigators will also assess the environmental impact of the study intervention and compare it to usual care.
The study is a randomized, single-blind, controlled trial with 16 weeks follow-up. In addition, we plan to acquire registry data on MipAC readmissions, hospital admissions, and mortality after one year.
The investigators will recruit 1-4 MipAC physicians to take part in the study. The project physicians will be responsible for the patient's general medical treatment, but will also perform a structured, clinical drug review that goes beyond what is considered usual care. The project physicians will provide necessary information on the patient's medical history and drug use from the medical records, carry out a medical history from the patient, and a physical examination. Relevant blood analyses and other supplementary tests will be ordered if not already available. The clinical drug review will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The investigators will develop a structured framework for the drug reviews, and the MipAC physicians will receive clinical supervision from a consultant in geriatric medicine.
After performing the clinical drug review, the MipAC physician will offer the patient's FP a telephone based or digital meeting with the purpose of combining the assessments of the MipAC physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Admitted to the MipAC unit
- •Use of at least six different systemic medications taken regularly
- •Informed consent by the patient
排除标准
- •Previously included in the study
- •Not speaking or understanding Norwegian
- •Residing outside of the municipality of Oslo
- •Planned discharge within 24 hours
- •Isolated for infection control reasons
- •Considered too ill to approach or life expectancy judged to be less than six months
- •Personnel at the MipAC unit discourage participation (in case of important reasons not covered by the other exclusion criteria)
结局指标
主要结局
Health-related quality of life (HRQoL)
时间窗: 16 weeks
HRQoL assessed with the 15-dimensional instrument 15D. 15D is a generic, 15-dimensional instrument concerning different aspects of HRQoL. The dimensions are mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is rated on an ordinal scale with five levels, and the respondent chooses the level best describing his/her present health status. Single index scores are calculated by population-based utility weights, and range from 0 to 1, with higher scores indicating better HRQoL.
次要结局
- Digit span backwards(16 weeks)
- Unstimulated whole saliva flow(16 weeks)
- Falls(16 weeks)
- Digit span forward(16 weeks)
- Handgrip strength(16 weeks)
- The Shortened Xerostomia Inventory (SXI)(16 weeks)
- The eight-item Visual Analog Scale xerostomia questionnaire(16 weeks)
- Orthostatic blood pressure(16 weeks)
- Oral pain/discomfort(16 weeks)
- Admissions to health institutions(16 weeks and 1 year)
- Mortality(16 weeks and 1 year)
研究者
Rita Romskaug
MD, PhD
Oslo University Hospital