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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03861429
Other study ID # IRB_00111417
Secondary ID 1R21AG058094
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2019
Est. completion date January 29, 2021

Study information

Verified date December 2020
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date January 29, 2021
Est. primary completion date January 29, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Marquis Hope Village Assisted Living Canby Oregon
United States Marquis Forest Grove Assisted Living Forest Grove Oregon
United States Marquis Forest Grove Post Acute Rehab Forest Grove Oregon
United States Regency Gresham Nursing and Rehabilitation Center Gresham Oregon
United States Marquis Wilsonville Assisted Living Wilsonville Oregon
United States Marquis Wilsonville Post Acute Rehab Wilsonville Oregon
United States French Prairie Nursing and Rehab Woodburn Oregon
United States Woodland Care Center Woodland Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Utah Brown University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Congruence of preferences observed in video Presence/absence of preferences in video 1) Describe presence/absence of preferences in video Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video
Other Congruence of preferences observed in medical record Presence/absence of preferences in video 1) Describe presence/absence of preferences in medical record via medical record review Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video
Other Congruence of preferences observed in video, medical record, and surveys Presence/absence of preferences in video 1) Describe presence/absence of preferences in surveys via self-report surveys Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video
Primary Communication of preferences Goals of care discussions (change in documentation in medical record, e.g. social work note) Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video
Primary Communication of preferences Self-reported conversations (change in self report: resident, family, staff surveys) Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video
Secondary Confidence of communicating preferences 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) Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video
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