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Trial record 1 of 1 for:    NCT03861429
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Me & My Wishes: An Efficacy Trial Using Videos

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ClinicalTrials.gov Identifier: NCT03861429
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Brown University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Gail Towsley, University of Utah

Tracking Information
First Submitted Date  ICMJE February 19, 2019
First Posted Date  ICMJE March 4, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE April 9, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • Communication of preferences [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Goals of care discussions (change in documentation in medical record, e.g. social work note)
  • Communication of preferences [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Self-reported conversations (change in self report: resident, family, staff surveys)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
Confidence of communicating preferences [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
Confidence in expressing or communicating about resident preferences; 1) change in resident, Family, Staff Survey (self-efficacy items, range 1-5, higher is more confident); 2) New or changed care planning documents (e.g. POLST)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2019)
  • Congruence of preferences observed in video [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Presence/absence of preferences in video 1) Describe presence/absence of preferences in video
  • Congruence of preferences observed in medical record [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Presence/absence of preferences in video 1) Describe presence/absence of preferences in medical record via medical record review
  • Congruence of preferences observed in video, medical record, and surveys [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Presence/absence of preferences in video 1) Describe presence/absence of preferences in surveys via self-report surveys
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Me & My Wishes: An Efficacy Trial Using Videos
Official Title  ICMJE Me & My Wishes: An Efficacy Trial of Long Term Care Residents With Alzheimer's Using Videos to Communicate Care Preferences With Caregivers
Brief Summary The aim of this study is to determine whether the Me & My Wishes intervention positively impacts communication of preferences among nursing home residents with dementia and their family caregivers and care team.
Detailed Description Me & My Wishes are videos of nursing home residents talking about their preferences for care, including four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Knowing what residents want is essential to staff's ability to provide quality care and can inform family caregivers decision making especially in later stages of life as the resident's cognition declines-a time when family caregivers often feel unprepared. Persons with mild to moderate dementia can accurately express their everyday and EOL preferences, however, stereotypes persist about the decision making abilities of people with dementia that often prevent their involvement in conversations about care. The investigators propose to conduct a Stage II efficacy trial of Me & My Wishes-a novel approach for communicating resident care preferences-by creating videos with 48-54 nursing home residents with mild to moderate dementia and sharing their personalized video with informal (family) and formal (staff) caregivers. The investigators will employ a randomized wait-list control design in which residents in control nursing homes will delay sharing their video. Videos may be viewed two ways: 1) in resident quarterly care conferences; and 2) via a web-based link with resident-identified family members or friends.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
The investigators propose Stage II efficacy testing of Me & My Wishes using a randomized wait-list control design that allows the investigators to compare the effects between an early intervention group (Group 1) and a wait-list "control" group (Group 2).Six NHs matched on number of beds and payor mix will be randomly assigned to one of two groups.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Health Communication
Intervention  ICMJE Behavioral: Me & My Wishes
Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
Study Arms  ICMJE
  • Experimental: Me & My Wishes Intervention/Group 1
    In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
    Intervention: Behavioral: Me & My Wishes
  • Me & My Wishes Wait-list control/Group 2
    In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
    Intervention: Behavioral: Me & My Wishes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2019)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Resident Inclusion Criteria:

  • Identified as having Alzheimer's or related dementia
  • Mild to moderate cognitive impairment (BIMS = 8-15, (MDS C0500) (nursing home residents only)
  • Makes Self Understood = <1 (MDS B0700)/present in medical record
  • Understood By Others = <1 (MDS B0800)/present in medical record
  • Reside at the facility at least 2 weeks identified as a long-term resident
  • Age >65 years
  • Speaks English

Family Inclusion Criteria:

  • Speaks English
  • Willing and able to watch the videos
  • Willing to complete short surveys. Being unable to attend care conference to view the video (e.g. due to distance) will not exclude family from participating.

Staff Inclusion Criteria:

  • Speaks English
  • Willing to watch the videos
  • Willing to complete short surveys

Resident Exclusion Criteria:

  • Limited communication capacity (e.g. aphasia)
  • Comatose
  • Cognitively intact
  • Severe cognitive impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gail L Towsley, PhD 801-585-9085 gail.towsley@nurs.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03861429
Other Study ID Numbers  ICMJE IRB_00111417
1R21AG058094 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gail Towsley, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE
  • Brown University
  • National Institute on Aging (NIA)
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP