Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.
Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.
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DOI：
10.1016/j.conctc.2020.100675
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发表时间：
2020-12
影响因子：
1.5
通讯作者：
Lee YC
中科院分区：
文献类型：
--
作者：
Baker FA;Stretton-Smith PA;Sousa TV;Clark I;Cotton A;Gold C;Lee YC
在住宅老年护理设施（RACF）中进行临床试验所涉及的资源非常重要，试验的成功取决于充分的规划，包括研究每个组成部分的适当时间表和所需预算。本文介绍了招募过程中的过程和资源评估，收集结果的措施和干预措施的交付，并提出了学习和考虑进行试验的RACF与痴呆症患者。在一项为期18个月的随机对照试验中，在12个RACF的24个集群中收集了数据，该试验旨在测试音乐干预对痴呆症患者的有效性。收集了关于征聘和评估基线数据所需资源的数据，以及参与者不参加干预措施的原因。从联系亲属到获得正式同意的时间往往超过45天。直接和间接研究活动之间的时间比例约为1：2。参与者干预措施的依从性因计划外的RACF封锁而面临风险，不出席的原因包括与参与者直接相关的原因以及与工作人员资源、日程安排或其他实际考虑因素直接相关的原因。研究计划应侧重于与RACF工作人员和居民家庭建立关系，在研究时间轴中考虑充足的招募时间，并考虑在数据收集阶段为RACF工作人员的回填编制预算，以加快该过程并确保遵守研究方案时间表。一
The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia. Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions. Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. A
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影响因子：
1.5
作者：
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通讯作者：
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