Empirical assessment of a research advance directive for persons with dementia and their proxies

Empirical assessment of a research advance directive for persons with dementia and their proxies
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DOI:
10.1111/j.1532-5415.2007.01318.x
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发表时间:
2007-10-01
影响因子:
6.3
通讯作者:
Sachs, Greg A.
Sachs, Greg A.
中科院分区:
医学1区
文献类型:
--
作者:
Stocking, Carol B.;Hougham, Gavin W.;Sachs, Greg A.

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目的:评估针对已确诊为痴呆症的患者及其家庭照顾者或代理人的研究预先指示。设计:前瞻性随机对照试验。地点:三个诊所,俄亥俄州、肯塔基州和伊利诺伊州各一个。参与者:在五种假设研究项目的入组选择的单独访谈结束时,149 名已确诊为痴呆症的患者及其家庭代理人被随机分配,共同完成提前计划一起 (PAT) 文件、研究预先指示 (n=69) 或留在对照组 (n=80)。 干预:在两个点评估该指示:在样本成员自然收到参与其他研究的邀请后立即评估,并在初始入组后 2 年后再次评估。测量:在实验组和对照组之间比较个人入组率、报告的患者和代理人的入组决策难易度以及代理人舒适度。 结果:对 41 人进行了重新访谈在其他试验的同意讨论后立即进行。 47 名患者和 106 名代理人在 2 年随访中接受了采访。在试验登记机会之后或在后续访谈中没有证据表明研究预先指示(PAT)对患者或代理人有帮助。 PAT 组和对照组的入组率、决策难易程度以及代理人的舒适度和确定性相似。结论:患者和代理人在访谈中做出假设性决定的经历可能会影响 PAT 组和对照组的入组决策。尽管招募尝试次数较少和老年人口的自然流失限制了从这个独特的数据集中得出的关于有效性的结论,但研究预先指示的可行性已得到明确证明。
OBJECTIVES: To evaluate a research advance directive for persons with established dementia diagnoses and their family caregivers or proxies.DESIGN: Prospective randomized, controlled trial.SETTING: Three clinics, one each in Ohio, Kentucky, and Illinois.PARTICIPANTS: At the end of separate interviews about enrollment choices in five types of hypothetical research projects, 149 persons with established dementia diagnoses and their family proxies were randomized to jointly complete the Planning Ahead Together (PAT) document, a research advance directive (n=69) or to remain in the control group (n=80).INTERVENTION: The directive was assessed at two points: immediately after sample members received naturally occurring invitations to participate in other studies and again 2 years after initial enrollment.MEASUREMENTS: Personal enrollment rates, reported ease of enrollment decision for patients and proxies, and proxy comfort were compared between the experimental and control groups.RESULTS: Forty-one dyads were reinterviewed immediately after consent discussions for other trials. Forty-seven patients and 106 proxies were interviewed at 2-year follow-up. There was no evidence immediately after a trial enrollment opportunity or in the follow-up interview that the research advance directive (PAT) assisted patients or proxies. Enrollment rates, decision ease, and proxy comfort and certainty were similar in the PAT and control groups.CONCLUSION: Patient and proxy experience making hypothetical decisions in the interview may have affected enrollment decisions by the PAT and control groups. Although the low number of recruitment attempts and the natural attrition of the geriatric population limit conclusions about effectiveness that may be drawn from this unique data set, the feasibility of a research advance directive is clearly demonstrated.