Successful clinical trial research in nursing homes: the Improving Decision-Making Study
Successful clinical trial research in nursing homes: the Improving Decision-Making Study
复制标题
DOI：
10.1177/1740774510380241
复制
发表时间：
2010-12-01
期刊：
影响因子：
2.7
通讯作者：
Lee, Tae Joon
中科院分区：
文献类型：
--
作者：
Hanson, Laura C.;Gilliam, Robin;Lee, Tae Joon
//ctj.sagepubBackground四分之一的美国人，70%的痴呆症患者，将在疗养院度过他们的最后几天。由于研究方法和伦理方面的独特挑战，临床研究，特别是临床试验，很少包括这一人群。晚期痴呆症患者的家庭选择管饲和其他喂养方式，但信息或沟通渠道有限。整群随机试验，改善决策有关喂养选项痴呆症患者，测试决策辅助干预，以提高决策的质量，这choice.Purpose我们的目标是（1）描述在本试验中使用的方法;（2）描述有效的护理之家和护理之家居民招聘和保留的挑战和战略;和（3）描述研究伦理方法，以尽量减少伤害和最大限度地提高效益，为这个population.Methods的研究是一个集群随机试验的决策援助，以告知和支持之间的选择管喂养和辅助口服喂养在晚期痴呆症。研究对象是配对的代理决策者和居民与先进的痴呆症和喂养问题，从疗养院在北卡罗来纳州招募。结果这项试验招募了256对代理决策者和居民在24个疗养院网站，99%完成参与通过3个月的研究期间。研究团队在此背景下具有先前的临床和调查经验，并使用多种策略来招募和保留养老院网站，提供者，代理人以及他们所代表的居民。知情同意和人类受试者的保护旨在解决这个population.Limitations的脆弱性集群随机化是必要的，以避免控制和干预科目之间的污染，但可能会引入由网站和集群内的相关性effects在analysis.Conclusions策略，促进疗养院招聘，未来的研究人员可以使用参与者招募和保护弱势人群的人类受试者来扩大疗养院和痴呆症护理的研究证据基础。临床试验2010; 7：735-743。http://ctj.sagepub.com
//ctj.sagepubBackground One in four Americans, and 70% of people who have dementia, will spend their final days in nursing home care. Clinical research, particularly clinical trials, rarely includes this population due to unique challenges in research methods and ethics. Families of advanced dementia patients make choices about tube feeding and other feeding options with limited access to information or communication. The cluster randomized trial, Improving Decision Making about Feeding Options for Dementia Patients, tests a decision aid intervention to improve the quality of decision making for this choice.Purpose Our objectives are (1) to describe the methods used in this trial; (2) to describe challenges and strategies for effective nursing home and nursing home resident recruitment and retention; and (3) to describe research ethics approaches to minimize harms and maximize benefits for this population.Methods The study is a cluster randomized trial of a decision aid to inform and support the choice between tube feeding and assisted oral feeding in advanced dementia. Study subjects are paired surrogate decision makers and residents with advanced dementia and feeding problems, enrolled from nursing homes in North Carolina.Results This trial enrolled 256 paired surrogate decision makers and residents in 24 nursing home sites, and 99% completed participation through the 3-month study period. The research team had prior clinical and investigative experience in this setting, and used multiple strategies to recruit and retain nursing home sites, providers, surrogates, and the residents for whom they spoke. Informed consent and human subjects' protections were designed to address the vulnerability of this population.Limitations Cluster randomization was necessary to avoid contamination between control and intervention subjects, but may introduce confounding by site and intracluster correlation effects in analyses.Conclusions Strategies that facilitate nursing home recruitment, participant recruitment and protection of human subjects for a vulnerable population may be used by future investigators to expand the research evidence base for nursing home and dementia care. Clinical Trials 2010; 7: 735-743. http://ctj.sagepub.com