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

NCT01774799 | Completed Results DMC

• 2 other identifiers: 12-013R01AG043440
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Dementia

Keywords

advanced dementia; advance care planning; nursing home

Outcome Measures

Primary Outcomes (1)

• Documented Decisions to Forgo Hospitalization

  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)

  by six months

Secondary Outcomes (2)

• Acquisition of Decisions Not to Hospitalize

  by 12 months

• Acquisition of Preference for Level of Care

  6 months

Other Outcomes (2)

• Acquisition of Other Documented Advance Care Planning

  by 6 months

• Burdensome Treatments

  by 12 months

Study Arms (2)

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.

Behavioral: Advance care planning intervention

Usual care

ACTIVE COMPARATOR

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

Other: Control group

Interventions

Advance care planning intervention BEHAVIORAL

Advance care planning intervention

Control group OTHER

Usual care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hebrew SeniorLife: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Hebrew Rehabilitation Center

Boston, Massachusetts, 02131, United States

Location

Related Publications (1)

• 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.

  PMID: 29868778 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Susan Mitchell
• Organization: Hebrew SeniorLife

smitchell@hsl.harvard.edu

617-971-5326

Study Officials

• Susan L Mitchell, MD, MPH

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

• Angelo Volandes, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Now, indefinetly
• Access Criteria: open

Locations

US (1)