Clinical trial NCT05618678: Pilot Testing Decision Making in Aging and Dementia for Autonomy Program in Nursing Homes
Official title: Pilot Testing Decision Making in Aging and Dementia for Autonomy for Preference-Based Care in Nursing Homes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Staff Attitude
Nurse's Role
Nursing Homes
Keywords: Shared Decision Making
Person-Centered Care
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nursing homes are randomized to one of two groups: 1.) DIGNITY Intervention (Protocol Manual, Baseline Education, ECHO Coaching) or 2.) Control Arm - (Infection Control Training - CDC Guidelines, Baseline Education, ECHO Coaching)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria for Nursing Homes:

1. Located in rural Pennsylvania as defined by the Center for Rural Pennsylvania
2. Administrator articulates commitment to delivering person-centered care
3. NH has a dedicated dementia care unit and/or a total bed capacity of 50 beds or more
4. NH has the capacity to participate in the study activities for the term of the study as determined by nursing home leadership
5. NH has a dedicated quality improvement/safety team that meets regularly
6. NH has a stable internet connectivity for program delivery

Exclusion Criteria:

* Nursing Home does not meet inclusion criteria.

Convenience sampling will be used to recruit nursing home staff and residents within nursing homes.

Inclusion criteria for Nursing Home Staff:

1. 18 years or older
2. Employed by the participating nursing home for at least 6 months
3. Fluent in written and spoken English
4. Provides and/or influences direct care delivery to older adults with dementia

Inclusion criteria for Residents:

1. Resides in nursing home study site for at least 3 months
2. English speaking
3. Documented diagnosis of Alzheimer's disease or related dementia (ADRD)
4. Have a stated preference that nursing home staff indicated poses a risk to their health and/or safety
5. Provides consent/assent to be enrolled

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 12 weeks after baseline education on DIGNITY protocol
measure: Staff Behavioral Intent
timeFrame: 12 weeks after baseline education on DIGNITY protocol
measure: Resident Satisfaction
timeFrame: 12 weeks after baseline education on DIGNITY protocol
measure: Intervention Fidelity
timeFrame: 12 weeks after baseline education on DIGNITY protocol
Secondary outcomes:
measure: Staff Self - Efficacy
timeFrame: 12 weeks after baseline education on DIGNITY protocol
measure: Intervention Acceptability
timeFrame: 12 Weeks after baseline education on DIGNITY protocol
Other outcomes:
Locations:
city: State College
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Liza Behrens, PhD
role: PRINCIPAL_INVESTIGATOR
References: