DementiaDIGNITYNCT05618678
Pilot Testing Decision Making in Aging and Dementia for Autonomy Program in Nursing Homes
A study testing DIGNITY in people with Dementia and Staff Attitude, run by Penn State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Staff Attitude, Nurse's Role
- What is being tested?
- DIGNITY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
- 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
Who cannot join
- Nursing Home does not meet inclusion criteria.
- Convenience sampling will be used to recruit nursing home staff and residents within nursing homes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
State College, Pennsylvania, 16803
About this study
Official title: Pilot Testing Decision Making in Aging and Dementia for Autonomy for Preference-Based Care in Nursing Homes
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.
Read the 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.
- Conditions
- Dementia, Staff Attitude, Nurse's Role, Nursing Homes
- Being tested
- DIGNITY, Infection Control
- Keywords
- Shared Decision Making, Person-Centered Care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIGNITYBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: DIGNITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Evidence of Feasibility (Feasibility of Intervention Measure)
Measured: 12 weeks after baseline education on DIGNITY protocol
Staff Behavioral Intent
Evidence of Staff Intent to Honor Resident's Preference (Investigator developed survey item)
Measured: 12 weeks after baseline education on DIGNITY protocol
Resident Satisfaction
Evidence of resident satisfaction with preference (Preferences for Everyday Living Inventory)
Measured: 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)
Measured: 12 weeks after baseline education on DIGNITY protocol
Secondary outcomes (2)
Staff Self - Efficacy
Changes in perceived self-efficacy in Person-Centered Risk Management (Investigator Developed Self Efficacy Survey for Person-Centered Risk Management)
Measured: 12 weeks after baseline education on DIGNITY protocol
Intervention Acceptability
Staff rate intervention acceptability on the Acceptability of Intervention Measure
Measured: 12 Weeks after baseline education on DIGNITY protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start24 Jan 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liza Behrens, PhD, RN, Penn State University
- Investigators
- Liza Behrens, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618678
- Sponsor's protocol ID
- 00020594
- Acronym
- DIGNITY
- Status last verified
- Feb 2024
- First submitted
- 22 Sep 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing Decision Making in Aging and Dementia for Autonomy for Preference-Based Care in Nursing Homes
- ClinicalTrials.gov ID
- NCT05618678
- Acronym / sponsor ID
- DIGNITY / 00020594
- Conditions
- Dementia, Staff Attitude, Nurse's Role, Nursing Homes
- Keywords
- Shared Decision Making, Person-Centered Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Infection Control Training | Active comparator | Behavioral: Infection ControlNursing 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. |
| DIGNITY Intervention | Experimental | Behavioral: DIGNITYNursing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- Nursing Home does not meet inclusion criteria.
- Convenience sampling will be used to recruit nursing home staff and residents within nursing homes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIGNITYDIGNITY 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. | Behavioural | DIGNITY Intervention |
| Infection ControlThis 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. | Behavioural | Infection Control Training |
Primary outcome
Intervention Feasibility
Time frame: 12 weeks after baseline education on DIGNITY protocol
Evidence of Feasibility (Feasibility of Intervention Measure)
Staff Behavioral Intent
Time frame: 12 weeks after baseline education on DIGNITY protocol
Evidence of Staff Intent to Honor Resident's Preference (Investigator developed survey item)
Resident Satisfaction
Time frame: 12 weeks after baseline education on DIGNITY protocol
Evidence of resident satisfaction with preference (Preferences for Everyday Living Inventory)
Intervention Fidelity
Time frame: 12 weeks after baseline education on DIGNITY protocol
Evidence of staff fidelity to the DIGNTY Intervention (Investigator developed DIGNITY Intervention Fidelity Assessment Checklist)
2 secondary outcomes
Staff Self - Efficacy
Time frame: 12 weeks after baseline education on DIGNITY protocol
Intervention Acceptability
Time frame: 12 Weeks after baseline education on DIGNITY protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liza Behrens, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIGNITY in people with Dementia and Staff Attitude, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: 12 weeks after baseline education on DIGNITY protocol). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.