Frailty in elderly patients is associated with an increased risk of poor health outcomes, including falls, delirium, malnutrition, hospitalisation, and mortality. Because polypharmacy is recognised as a possible major contributor to the pathogenesis of geriatric frailty, reducing inappropriate medication exposure is supposed to be a promising approach to improve health-related quality of life and prevent adverse outcomes. A major challenge for the process of deprescribing of inappropriate polypharmacy is to improve the communication between general practitioner (GPs), patient and family carer. This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home. This is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70 years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing guideline and providing information on how to conduct a family conference focussing on prioritisation of treatment goals concerning drug therapy. During the 1-year intervention, GPs are expected to perform a total of three family conferences, each including a structured medication review with patients and their family carers. GPs of the control group will receive no training and will deliver care as usual. Geriatric assessment of all patients will be performed by study nurses during home visits at baseline and after 6 and 12 months. The primary outcome is the hospitalisation rate during the observation period of 12 months. Secondary outcomes are number and appropriateness of medications, mobility, weakness, cognition, depressive disorder, health-related quality of life, activities of daily living, weight, and costs of health care use. This study will provide evidence for a pragmatic co-operative and patient-centred educational intervention using family conferences to improve patient safety in frail elderly patients with polypharmacy. German Clinical Trials Register, DRKS00015055 (WHO International Clinical Trials Registry Platform [ICTRP]). Registered on 6 February 2019.

中文翻译：

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家庭会议和优先事项，以提高体弱老年人的安全性（COFRAIL）：一项在初级保健中进行的随机分组干预试验研究方案

老年患者虚弱会增加不良健康后果的风险，包括跌倒，del妄，营养不良，住院和死亡率。由于人们认为多药治疗可能是导致衰老的主要原因，因此减少不适当的药物暴露被认为是改善健康相关生活质量并预防不良后果的一种有前途的方法。弃用不合适的多药店过程的主要挑战是改善全科医生（GPs），患者和家庭护理人员之间的沟通。这项研究调查了复杂干预措施对在家中生活虚弱的老年多药患者的影响。这是一项包括136名GP和676名患者的整群随机对照试验。临床上对身体虚弱的筛查呈阳性的患者，如果年龄大于或等于70岁，在家中接受家庭或专业护理，并且每天服用五种或以上药物，则符合资格。排除标准为痴呆等级较高，预期寿命不超过6个月。干预小组的全科医生将接受教育培训，以推广既定的指导方针，并提供有关如何召开家庭会议的信息，重点是对与药物治疗有关的治疗目标进行优先排序。在为期1年的干预期间，预计全科医生将举行总共三场家庭会议，每次会议都包括与患者及其家庭护理人员进行的结构性药物审查。对照组的全科医生将不接受任何培训，并将照常提供护理。研究护士将在基线时的家访期间以及6和12个月后对所有患者进行老年病评估。主要结果是观察期12个月的住院率。次要结果是药物的数量和适当性，流动性，虚弱，认知，抑郁症，与健康相关的生活质量，日常生活活动，体重和医疗费用。这项研究将提供证据，证明使用家庭会议进行务实的合作和以患者为中心的教育干预措施，可以改善弱多药的老年老年患者的安全性。德国临床试验注册簿DRKS00015055（世卫组织国际临床试验注册平台[ICTRP]）。于2019年2月6日注册。主要结局是观察期12个月的住院率。次要结果是药物的数量和适当性，流动性，虚弱，认知，抑郁症，与健康相关的生活质量，日常生活活动，体重和医疗费用。这项研究将提供证据，证明使用家庭会议进行务实的合作和以患者为中心的教育干预措施，可以改善弱多药的老年老年患者的安全性。德国临床试验注册簿DRKS00015055（世卫组织国际临床试验注册平台[ICTRP]）。于2019年2月6日注册。主要结局是观察期12个月的住院率。次要结果是药物的数量和适当性，流动性，虚弱，认知，抑郁症，与健康相关的生活质量，日常生活活动，体重和医疗费用。这项研究将提供证据，证明使用家庭会议进行务实的合作和以患者为中心的教育干预措施，可以改善弱多药的老年老年患者的安全性。德国临床试验注册簿DRKS00015055（世卫组织国际临床试验注册平台[ICTRP]）。于2019年2月6日注册。与健康有关的生活质量，日常生活活动，体重和保健费用。这项研究将提供证据，证明使用家庭会议进行务实的合作和以患者为中心的教育干预措施，可以改善弱多药的老年老年患者的安全性。德国临床试验注册簿DRKS00015055（世卫组织国际临床试验注册平台[ICTRP]）。于2019年2月6日注册。与健康有关的生活质量，日常生活活动，体重和保健费用。这项研究将提供证据，证明使用家庭会议进行务实的合作和以患者为中心的教育干预措施，以提高脆弱的老年多药患者的安全性。德国临床试验注册簿DRKS00015055（世卫组织国际临床试验注册平台[ICTRP]）。于2019年2月6日注册。