Advanced Dementia Clinical Trial
Official title:
Educational Video to Improve Nursing Home Care in End-stage Dementia
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03382223 -
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|
||
| Completed |
NCT03548142 -
Advanced Dementia and End-of-life
|
N/A | |
| Completed |
NCT04779684 -
Promoting Self-determination for Institutionalized Older People Without Decision-making Capacity: Advance Care Planning by Proxy
|
N/A |