NCT03861429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

June 26, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

February 19, 2019

Results QC Date

July 11, 2023

Last Update Submit

June 21, 2024

Conditions

Health Communication

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Documented Discussion of Goals of Care

    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 Outcomes (1)

  • Self-efficacy for Communicating Preferences

    Baseline, time of sharing (3 months from baseline), and 90 days post sharing video

Other Outcomes (4)

  • Concordance of Psychosocial Preferences Between Video and Staff

    Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video

  • Concordance of End of Life Preferences, Video and Staff

    Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video

  • Concordance of Psychosocial Preferences, Video and Family

    Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing video

  • +1 more other outcomes

Study Arms (2)

Me & My Wishes Intervention/Group 1

EXPERIMENTAL

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 Wait-list control/Group 2

OTHER

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

Interventions

Me & My WishesBEHAVIORAL

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.

Me & My Wishes Intervention/Group 1Me & My Wishes Wait-list control/Group 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Limited communication capacity (e.g. aphasia)
  • Comatose
  • Cognitively intact
  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Marquis Hope Village Assisted Living

Canby, Oregon, 97209, United States

Location

Marquis Forest Grove Assisted Living

Forest Grove, Oregon, 97116, United States

Location

Marquis Forest Grove Post Acute Rehab

Forest Grove, Oregon, 97116, United States

Location

Regency Gresham Nursing and Rehabilitation Center

Gresham, Oregon, 97080, United States

Location

Marquis Wilsonville Assisted Living

Wilsonville, Oregon, 97070, United States

Location

Marquis Wilsonville Post Acute Rehab

Wilsonville, Oregon, 97070, United States

Location

French Prairie Nursing and Rehab

Woodburn, Oregon, 97071, United States

Location

Woodland Care Center

Woodland, Washington, 98674, United States

Location

Related Publications (1)

  • Towsley GL, Neller S, Baier RR, Wong B. Me & My Wishes: Concordance of End-of-Life Preferences between Residents with Dementia, Family, and Staff. J Palliat Med. 2022 Jun;25(6):880-887. doi: 10.1089/jpm.2021.0111. Epub 2021 Dec 28.

    PMID: 34962157DERIVED

Limitations and Caveats

Randomization at site level and despite, randomizing in blocks, our sites differed. Small sample size: Primary outcome (goals of care conversations) without the power to detect statistical significance. Findings may be muted or underestimated because we measured documentation; conversations may occur without being documented. Majority of participants being of one racial group (white) and one geographic region limits generalizability.

Results Point of Contact

Title
Dr. Gail Towsley
Organization
University of Utah
gail.towsley@nurs.utah.edu
801-585-9085

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 19, 2019

First Posted

March 4, 2019

Study Start

April 9, 2019

Primary Completion

January 29, 2020

Study Completion

January 29, 2021

Last Updated

June 26, 2024

Results First Posted

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(8)