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临床试验/NCT01774799
NCT01774799已完成不适用

Educational Video to Improve Nursing Home Care in End-stage Dementia

Hebrew SeniorLife2 个研究点 分布在 1 个国家目标入组 804 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
804
试验地点
2
主要终点
Documented Decisions to Forgo Hospitalization

研究概览

简要总结

This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly (up to 12-months) regarding goals of care preferences, advance care planning, and treatments received. The primary outcome is decisions not to be hospitalized at 6 months.

详细描述

The over-riding goal of the EVINCE study is to conduct a cluster RCT of a video Advance Care Planning intervention in nursing home residents with advanced dementia. A total of 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control) will be recruited. These residents' proxies with also be recruited for a total sample size of 720 residents and proxies (resident/proxy dyads). Outcomes will be compared between residents in the intervention vs, control nursing homes at baseline and every 3 months up to 12 months. At baseline proxies of residents in the intervention nursing homes will view a 12-minutes video describing three level of care options in advanced dementia (intensive, basic and comfort) and their choice will be communicated to the resident's primary care providers. Residents in the control nursing homes will receive the usual advance care planning practiced in those facilities.

UPDATE SEPT 19, 2014: During the first 18 months of the study, recruitment of resident/proxy dyads was lower per facility than anticipated at the time of study design. Therefore, the number of matched pairs of NH recruited was increased. As of September 19, 2014, 19 NH pairs (38 NHs) were recruited and randomized with a plans to continue to up to 30 pairs as needed.

NHs were originally randomized using a paired approach matched for for-profit status and whether or not the NH had a special care dementia unit (SCU). In March 2014, the state of Massachusetts changed legislation defining an SCU. Many of the changes focused on specifics of staff training. As a result, SCUs in several participating facilities did not meet the new criteria and lost this official designation, although the actual clinical structure of the existing units did not change. Nonetheless, we opted to maintain the initial matching criteria of the first 19 NHs which included SCU based on the definition before the Massachusetts legislation change, but dropped this matching criterion after the legislation change. Thus, beginning with matched pair 20, NHs were matched solely on for-profit status.

UPDATE MARCH 2016 To reach subject recruitment numbers, additional facilities were recruited. As of this date, 60 NHs (30/arm) have been recruited, randomized and have had subject enrolled.

To achieve additional for power for Outcome 2, (aquisition of new decisions to forego hospitalizations) the target sample size was increased to 400.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 65
  • A diagnosis of dementia (any type)
  • Global Deterioration Scale (GDS) score of 7
  • Nursing home length of stay > 30 days
  • Proxy is available who can speak in English
  • Proxy must either live within a 60 mile radius of Boston or be available to come to the residents nursing home within 2 weeks of recruitment in order to conduct the in-person baseline interview.

排除标准

  • Residents with cognitive impairment due to causes other than dementia (e.g. head trauma) and in short-term, sub-acute SNFs will be excluded

研究组 & 干预措施

Usual care

Active Comparator

Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home.

干预措施: Control group (Other)

Advance care planning intervention

Experimental

At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form.

干预措施: Advance care planning intervention (Behavioral)

结局指标

主要结局

Documented Decisions to Forgo Hospitalization

时间窗: by six months

The proportion of residents with this outcome will be considered cumulatively at 6 months, including those who died; i.e., a composite of the percent of residents alive at six months who had a decision not to hospitalize and those who died before six months with this outcome prior to death. This cumulative outcome will only be based on time points following baseline as the baseline chart review data is conducted before the baseline proxy interview (i.e., before the proxy has seen the video in the intervention arm or heard options verbally in the control arm). (Decisions to forehospitalizations will be examined in a similar fashion at 3, 9, and 12 months, however the six month time frame is the primary trial outcome)

次要结局

  • Acquisition of Decisions Not to Hospitalize(by 12 months)
  • Acquisition of Preference for Level of Care(6 months)

研究者

发起方
Hebrew SeniorLife
申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Mitchell, MD

Senior Scientist

Hebrew SeniorLife

研究点 (2)

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