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

Primary Purpose

Dementia, Staff Attitude, Nurse's Role

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DIGNITY
Infection Control
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring Shared Decision Making, Person-Centered Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Nursing Homes: 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 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: 18 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 Inclusion criteria for Residents: 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

Sites / Locations

  • Pennsylvania State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Infection Control Training

DIGNITY Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intervention Feasibility
Evidence of Feasibility (Feasibility of Intervention Measure)
Staff Behavioral Intent
Evidence of Staff Intent to Honor Resident's Preference (Investigator developed survey item)
Resident Satisfaction
Evidence of resident satisfaction with preference (Preferences for Everyday Living Inventory)
Intervention Fidelity
Evidence of staff fidelity to the DIGNTY Intervention (Investigator developed DIGNITY Intervention Fidelity Assessment Checklist)

Secondary Outcome Measures

Staff Self - Efficacy
Changes in perceived self-efficacy in Person-Centered Risk Management (Investigator Developed Self Efficacy Survey for Person-Centered Risk Management)
Intervention Acceptability
Staff rate intervention acceptability on the Acceptability of Intervention Measure

Full Information

First Posted
September 22, 2022
Last Updated
September 27, 2023
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT05618678
Brief Title
Pilot Testing Decision Making in Aging and Dementia for Autonomy Program in Nursing Homes
Acronym
DIGNITY
Official Title
Pilot Testing Decision Making in Aging and Dementia for Autonomy for Preference-Based Care in Nursing Homes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Staff Attitude, Nurse's Role, Nursing Homes
Keywords
Shared Decision Making, Person-Centered Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will not be aware of the randomization arm of the NH they are collecting data in.
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infection Control Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
DIGNITY Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DIGNITY
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Infection Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention Feasibility
Description
Evidence of Feasibility (Feasibility of Intervention Measure)
Time Frame
12 weeks after baseline education on DIGNITY protocol
Title
Staff Behavioral Intent
Description
Evidence of Staff Intent to Honor Resident's Preference (Investigator developed survey item)
Time Frame
12 weeks after baseline education on DIGNITY protocol
Title
Resident Satisfaction
Description
Evidence of resident satisfaction with preference (Preferences for Everyday Living Inventory)
Time Frame
12 weeks after baseline education on DIGNITY protocol
Title
Intervention Fidelity
Description
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
Secondary Outcome Measure Information:
Title
Staff Self - Efficacy
Description
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
Title
Intervention Acceptability
Description
Staff rate intervention acceptability on the Acceptability of Intervention Measure
Time Frame
12 Weeks after baseline education on DIGNITY protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Nursing Homes: 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 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: 18 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 Inclusion criteria for Residents: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liza Behrens, PhD
Phone
8148650743
Email
llb237@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liza Behrens, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania State University
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liza Behrens
Email
llb237@psu.edu
Ext
Behrens
Email
llb237@psu.edu
First Name & Middle Initial & Last Name & Degree
Liza Behrens, PhD, RN

12. IPD Sharing Statement

Plan to Share IPD
No

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

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