Pilot Testing Decision Making in Aging and Dementia for Autonomy Program in Nursing Homes

Dementia Clinical Trial

— DIGNITY  

Official title:

Pilot Testing Decision Making in Aging and Dementia for Autonomy for Preference-Based Care in Nursing Homes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05618678
• Other study ID #: 00020594
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Nurse's Role
• Nursing Homes
• Staff Attitude

Intervention

Behavioral:
• DIGNITY
DIGNITY is a multi-component, multi-level intervention that guides shared decision-making in nursing homes to support person-centered dementia care. Based in theory, this intervention targets nursing home staff attitudes and behaviors around assessing and judging whether to engage in risk situations to support resident preferences for everyday living and care despite cognitive decline due to dementia. It includes a protocol manual, baseline training on how to implement the DIGNITY strategy, and six ECHO sessions to help frontline staff negotiate intrinsic and cultural factors in preference situations that carry a risk to residents' health and safety.
• Infection Control
This is an attention control intervention with similar dose of educational content and attention from interventionist. It includes distribution of links to the CDC Infection Control Practice Guidelines for nursing homes, a baseline training on infection control practices for frontline workers, and six ECHO coaching sessions.

Locations

Country	Name	City	State
United States	Pennsylvania State University	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Feasibility	Evidence of Feasibility (Feasibility of Intervention Measure)	12 weeks after baseline education on DIGNITY protocol
Primary	Staff Behavioral Intent	Evidence of Staff Intent to Honor Resident's Preference (Investigator developed survey item)	12 weeks after baseline education on DIGNITY protocol
Primary	Resident Satisfaction	Evidence of resident satisfaction with preference (Preferences for Everyday Living Inventory)	12 weeks after baseline education on DIGNITY protocol
Primary	Intervention Fidelity	Evidence of staff fidelity to the DIGNTY Intervention (Investigator developed DIGNITY Intervention Fidelity Assessment Checklist)	12 weeks after baseline education on DIGNITY protocol
Secondary	Staff Self - Efficacy	Changes in perceived self-efficacy in Person-Centered Risk Management (Investigator Developed Self Efficacy Survey for Person-Centered Risk Management)	12 weeks after baseline education on DIGNITY protocol
Secondary	Intervention Acceptability	Staff rate intervention acceptability on the Acceptability of Intervention Measure	12 Weeks after baseline education on DIGNITY protocol