An interventional study of DIGNITY and Infection Control in Dementia, Staff Attitude and Nurse's Role, sponsored by Penn State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Penn State University · Not applicable, Interventional, and Health services research
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 4 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Nursing Homes:
Exclusion Criteria:
Convenience sampling will be used to recruit nursing home staff and residents within nursing homes.
Inclusion criteria for Nursing Home Staff:
Inclusion criteria for Residents:
Nursing homes randomized to this arm of the study receive CDC guidelines and evidence based information on infection prevention prevention and control. Nursing home staff implement these standard in everyday resident care. Additionally, nursing home staff are invited to participate in Extension for Community Healthcare Outcomes (ECHO) sessions via real-time interactive videoconferencing software to support the implementation of the CDC guidelines and evidence-based practices.
Behavioral: Infection Control
Nursing homes randomized to this arm of the study receive an evidence based risk assessment and care planning protocol for supporting decision making and aging in dementia for autonomy (DIGNITY). Nursing home staff use this manual to implement risk assessment and care planning for resident preferences that they perceive to carry a risk to the resident's health and/or safety. In addition nursing home staff participate in Extension for Community Healthcare Outcomes (ECHO) sessions via real-time interactive videoconferencing software to support the implementation of the DIGNITY protocol.
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.
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.
Intervention Feasibility
Evidence of Feasibility (Feasibility of Intervention Measure)
Time frame: 12 weeks after baseline education on DIGNITY protocol
Staff Behavioral Intent
Evidence of Staff Intent to Honor Resident's Preference (Investigator developed survey item)
Time frame: 12 weeks after baseline education on DIGNITY protocol
Resident Satisfaction
Evidence of resident satisfaction with preference (Preferences for Everyday Living Inventory)
Time frame: 12 weeks after baseline education on DIGNITY protocol
Intervention Fidelity
Evidence of staff fidelity to the DIGNTY Intervention (Investigator developed DIGNITY Intervention Fidelity Assessment Checklist)
Time frame: 12 weeks after baseline education on DIGNITY protocol
Staff Self - Efficacy
Changes in perceived self-efficacy in Person-Centered Risk Management (Investigator Developed Self Efficacy Survey for Person-Centered Risk Management)
Time frame: 12 weeks after baseline education on DIGNITY protocol
Intervention Acceptability
Staff rate intervention acceptability on the Acceptability of Intervention Measure
Time frame: 12 Weeks after baseline education on DIGNITY protocol
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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