Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05618678 |
Other study ID # |
00020594 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 24, 2023 |
Est. completion date |
May 2024 |
Study information
Verified date |
February 2024 |
Source |
Penn State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to adapt, pilot test, and evaluate the feasibility,
acceptability, and preliminary effectiveness of DIGNITY (Decision-making In aGing and
demeNtIa for auTonomY) for Preference-Based Care in Nursing Homes as a new evidence-based
intervention to support nursing home staff to safely honor care and activity preferences of
residents' living with dementia in rural, typically under resourced nursing home communities.
Description:
Of 6.5 million older Americans are living with Alzheimer's disease and related forms of
dementia (ADRD), two thirds will die in a nursing home (NH) where staff are not prepared to
deliver a minimal level of federally mandated care. Care in NHs is delivered by an
ever-changing workforce of 1.3 million staff members who are responsible to provide
person-centered care (PCC)- that is care based on knowing and honoring residents preferences
for care and activities of daily living. NH residents have reported they are not satisfied
with efforts to honor their preferences for everyday living and care activities. For
residents living with ADRD this can lead to a loss of dignity, anger, agitation, isolation,
depression, and negative social interactions between residents ultimately reducing quality of
life. A prominent, known barrier to honoring residents' preferences is the predominantly risk
adverse attitudes and behaviors of NH staff. DIGNITY (Decision-making in aging and dementia
for autonomy) is novel multi-level intervention based in theory and evidence aimed at
empowering nursing home staff to negotiate residents' risky preferences by addressing
intrinsic and system barriers to safely honoring a resident's preferences with decision aids,
care planning, and staff coaching/education. In the proposed project, we will implement
DIGNITY in a pilot cluster randomized trial of 120 nursing home staff and residents across
four rural nursing homes located in Pennsylvania. Our aims are to: 1.) To explore stakeholder
perspectives on the relevance and feasibility of implementing the DIGNITY intervention in
rural, underserved nursing home communities; and 2.) examine the feasibility, acceptability,
and preliminary effectiveness of DIGNITY within four rural, underserved nursing homes.
Outcomes will be evaluated at baseline and 12 weeks following baseline education on the
DIGNITY protocol. This study is a critical next step in developing evidence-based
interventions that target gaps in direct-care workforce skills needed to enhance quality of
care delivery to persons with ADRD living in NHs.