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

NCT ID: NCT01774799

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 804 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-08-31

Brief Summary

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.

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.

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.

Conditions

Advanced Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Advance care planning intervention

Intervention Type: BEHAVIORAL

Usual care

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

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Interventions

Advance care planning intervention

Intervention Type: BEHAVIORAL

Control group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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 excluded

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Hebrew SeniorLife

OTHER

Sponsor Role: lead

Responsible Party

Susan Mitchell, MD

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan L Mitchell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Angelo Volandes, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Hebrew Rehabilitation Center

Boston, Massachusetts, United States

Countries

United States

References

Mitchell SL, Shaffer ML, Cohen S, Hanson LC, Habtemariam D, Volandes AE. An Advance Care Planning Video Decision Support Tool for Nursing Home Residents With Advanced Dementia: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):961-969. doi: 10.1001/jamainternmed.2018.1506.

Reference Type: DERIVED

PMID: 29868778 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01AG043440

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-013

Identifier Type: -

Identifier Source: org_study_id