Me & My Wishes: An Efficacy Trial Using Videos

June 21, 2024 updated by: Gail Towsley, University of Utah

Me & My Wishes: An Efficacy Trial of Long Term Care Residents With Alzheimer's Using Videos to Communicate Care Preferences With Caregivers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Canby, Oregon, United States, 97209
        • Marquis Hope Village Assisted Living
      • Forest Grove, Oregon, United States, 97116
        • Marquis Forest Grove Assisted Living
      • Forest Grove, Oregon, United States, 97116
        • Marquis Forest Grove Post Acute Rehab
      • Gresham, Oregon, United States, 97080
        • Regency Gresham Nursing and Rehabilitation Center
      • Wilsonville, Oregon, United States, 97070
        • Marquis Wilsonville Assisted Living
      • Wilsonville, Oregon, United States, 97070
        • Marquis Wilsonville Post Acute Rehab
      • Woodburn, Oregon, United States, 97071
        • French Prairie Nursing and Rehab
    • Washington
      • Woodland, Washington, United States, 98674
        • Woodland Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Documented Discussion of Goals of Care
Time Frame: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video

At each specified time point, a chart review was conducted to obtain whether goals of care discussions occurred (change in documentation in medical record, e.g. social work note), yes/no. Reported values indicated residents who had a documented GOC in chart (yes) at any time point.

Goal of Care Conversations encompass two parts. A) some sharing of disease status / prognosis + B) discussion of a choice of goals/treatment decisions.

Examples of Part A include disease understanding, disease state, disease progression, prognosis/life expectancy, documentation that the clinician tried to discuss prognosis but the patient/family refused
Baseline, time of sharing (3 months from baseline), and 90 days post sharing video

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy for Communicating Preferences
Time Frame: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
Confidence in expressing or communicating about resident preferences. Self-efficacy items, range 1-5, higher is more confident.
Baseline, time of sharing (3 months from baseline), and 90 days post sharing video

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of Psychosocial Preferences Between Video and Staff
Time Frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched.
Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Concordance of End of Life Preferences, Video and Staff
Time Frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched.
Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Concordance of Psychosocial Preferences, Video and Family
Time Frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched.
Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
Concordance of End of Life Preferences, Video and Family
Time Frame: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video
EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched.
Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Brown University
National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2019

Primary Completion (Actual)

January 29, 2020

Study Completion (Actual)

January 29, 2021

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB_00111417
  • 1R21AG058094 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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