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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hebrew Rehabilitation Center, Boston
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Susan Mitchell, MD, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier:
NCT01774799
First received: January 21, 2013
Last updated: September 19, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Hebrew Rehabilitation Center, Boston:

Primary Outcome Measures:
  • Documented decisions to forgo hospitalization [ Time Frame: by six months ] [ Designated as safety issue: No ]
    Comparison of documented proxy decisions to forgo hospitalization of the resident in the intervention vs. control nursing homes.The proportion of all 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 decision not to hospitalize or those who died before six months with a decision not to hospitalize prior to death.


Secondary Outcome Measures:
  • 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),


Other Outcome Measures:
  • 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 therapy.

  • Acquisition of decisions not to hospitalize [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This is a sub primary outcome. The analysis will be conducted in subgroup of residents who begin the study without a documented decision to forego hospitalization, and the outcome will be acquisition of a documented decision to forego hospitalization at 6 months months. The analysis will utilize Cox proportional hazards regression. Results will be summarized using a hazard ratio and associated 95% confidence interval as well as plots of the cumulative incidence by group.


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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774799

Contacts
Contact: Ruth Carroll, RN 617-971-5314 rcarroll@hsl.harvard.edu
Contact: Elaine Bergman, MGS 617-971-5335 elainebergman@hsl.harvard.edu

Locations
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   
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Investigators
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: September 19, 2014
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014