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

NCT05618678 | Active Not Recruiting

• 1 other identifier: 00020594
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Shared Decision Making; Person-Centered Care

Outcome Measures

Primary Outcomes (4)

• Intervention Feasibility

  Evidence of Feasibility (Feasibility of Intervention Measure)

  12 weeks after baseline education on DIGNITY protocol

• Staff Behavioral Intent

  Evidence of Staff Intent to Honor Resident's Preference (Investigator developed survey item)

  12 weeks after baseline education on DIGNITY protocol

• Resident Satisfaction

  Evidence of resident satisfaction with preference (Preferences for Everyday Living Inventory)

  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)

  12 weeks after baseline education on DIGNITY protocol

Secondary Outcomes (2)

• Staff Self - Efficacy

  12 weeks after baseline education on DIGNITY protocol

• Intervention Acceptability

  12 Weeks after baseline education on DIGNITY protocol

Study Arms (2)

Infection Control Training

ACTIVE COMPARATOR

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

DIGNITY Intervention

EXPERIMENTAL

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

Interventions

DIGNITY BEHAVIORAL

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.

DIGNITY Intervention

Infection Control BEHAVIORAL

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.

Infection Control Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Convenience sampling will be used to recruit nursing home staff and residents within nursing homes.
• years or older
• Employed by the participating nursing home for at least 6 months
• Fluent in written and spoken English
• Provides and/or influences direct care delivery to older adults with dementia
• Resides in nursing home study site for at least 3 months
• English speaking
• Documented diagnosis of Alzheimer's disease or related dementia (ADRD)
• Have a stated preference that nursing home staff indicated poses a risk to their health and/or safety
• Provides consent/assent to be enrolled

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Pennsylvania State University

State College, Pennsylvania, 16803, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Infection Control

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Liza Behrens, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not be aware of the randomization arm of the NH they are collecting data in.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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)

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: November 16, 2022
• Study Start: January 24, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)