Educational Video to Improve Nursing Home Care in End-stage Dementia (EVINCE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Advanced Dementia |
Behavioral: Advance care planning intervention Other: Control group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) |
| Official Title: | Educational Video to Improve Nursing Home Care in End-stage Dementia |
- Documented decisions to forgo hospitalization [ Time Frame: by six months ] [ Designated as safety issue: No ]Comparison of documents proxy decisions to forgo hospitalization of the resident in the intervention vs. control nursing homes.
- Preference for level of care [ Time Frame: baseline and quarterly for 12 months from baseline ] [ Designated as safety issue: No ]Comparison of proxies decisions about preferred level of care for residents in the intervention vs. control nursing homes at baseline, 3,6,9,and 12 month. Outcome will be categorized as comfort vs. other (basic or intensive treatment),
- Decisions to forego other burdensome treatments [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]Documented decisions by the residents proxy to forego tube-feeding and/or parenteral
- Receipt of burdensome treatments [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]Burdensome treatments include: i. Hospitals transfers (hospitalizations or emergency room visits) and ii. tube feeding or parenteral threapy.
| Estimated Enrollment: | 720 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Advance care planning intervention
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.
|
Behavioral: Advance care planning intervention |
|
Active Comparator: Usual care
Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home.
|
Other: Control group |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 65
- A diagnosis of dementia (any type)
- Global Deteriorazation 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.
Exclusion Criteria:
- Residents with cognitive impairment due to causes other than dementia (e.g. head trauma) and in short-term, sub-acute SNFs will be exluded
Contacts and Locations| Contact: Ruth Carroll, RN | 617-971-5314 | rcarroll@hsl.harvard.edu |
| Contact: Elaine Bergman, MGS | 617-971-5335 | elainebergman@hsl.harvard.edu |
| United States, Massachusetts | |
| Hebrew Rehabilitation Center | Recruiting |
| Boston, Massachusetts, United States, 02131 | |
| Contact: Susan L Mitchell, MD, MPH 617-971-5326 smitchell@hsl.harvard.edi | |
| Principal Investigator: | Susan L Mitchell, MD, MPH | Hebrew Rehabilitation Center, Boston |
| Principal Investigator: | Angelo Volandes, MD, MPH | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Susan Mitchell, MD, Senior Scientist, Hebrew Rehabilitation Center, Boston |
| ClinicalTrials.gov Identifier: | NCT01774799 History of Changes |
| Other Study ID Numbers: | 12-013, R01AG043440 |
| Study First Received: | January 21, 2013 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Hebrew Rehabilitation Center, Boston:
|
advanced dementia advance care planning nursing home |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013