DementiaNCT02211287
Promoting Informed Decision Making Through Advance Care Planning
A study testing 'Comfort Care at the End of Life for Persons with Dementia' and Project Nurse - ACP Facilitator in people with Dementia and Neurodegenerative Diseases, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the application of a best-practice Advance Care Planning (ACP) model for individuals living with dementia in a sample of nursing homes in Northern Ireland Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Neurodegenerative Diseases
- What is being tested?
- 'Comfort Care at the End of Life for Persons with Dementia' and Project Nurse - ACP Facilitator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento Aug 2016
- 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
- Family Caregivers
- Family caregivers of a resident who does not have decision making capacity to participate in ACP discussion
- Individuals identified by the nursing home manager as the family member who possess power of attorney for personal care and/or viewed by the nursing home staff as most involved in the care of the resident who does not have decision making capacity.
- Health Care Professionals
- Nursing home managers, registered nursing staff and GPs who:
- are employed, or in the case of GPs, care for residents, in the six nursing homes that were part of the intervention group
- were familiar with the intervention to discuss its strengths and weaknesses in an interview
- are able to speak English as they are required to participate in interviews.
Who cannot join
- Family caregivers and health care professionals who are unable to communicate through written and spoken English.
- Family caregivers who has a family resident considered to have the ability to participate in ACP discussions.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Four Seasons Health Care -- Nursing Homes
Belfast
Jim McCall
About this study
Official title: Promoting Informed Decision Making and Effective Communication Through Advance Care Planning for People With Dementia and Their Family Carers
The purpose of this study is to evaluate the application of a best-practice Advance Care Planning (ACP) model for individuals living with dementia in a sample of nursing homes in Northern Ireland
- Conditions
- Dementia, Neurodegenerative Diseases
- Being tested
- 'Comfort Care at the End of Life for Persons with Dementia', Project Nurse - ACP Facilitator
- Keywords
- Dementia, Decision-making, Communication, Advance Care Planning
- Medical subject headings
- Dementia, Neurodegenerative Diseases, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Comfort Care at the End of Life for Persons with Dementia'Other
A guide for caregivers to provide information on the trajectory of the disease, clinical issues, decision-making processes, and symptom management. The guide is written in a Q\&A form and can help answer frequent family questions.
Project Nurse - ACP FacilitatorOther
A nurse will receive training in the 'Respecting Choices Facilitator Curriculum' - an online program consisting of a series of six critical thinking modules designed for healthcare professionals who want to enhance their ACP facilitation skills. Local training resources in Northern Ireland will supplement.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention will include five key elements: a Project Nurse - ACP facilitator; family education on comfort care at the end of life for individuals with dementia using the 'Comfort Care at the end of life for persons with dementia' booklet; a family meeting with follow-up telephone call; documentation of ACP decisions, and orientation and education directed towards General Practitioners (GPs) and nursing home staff about the intervention. Receives: Other: 'Comfort Care at the End of Life for Persons with Dementia'; Other: Project Nurse - ACP Facilitator |
| Usual care | No intervention | Care will continue as usual for the nursing home residents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of family carer satisfaction in decision making about the care of the resident
Decisional Conflict Scale (DCS). This measures uncertainty and difficulties in the decision making process. The 16 item version measures four domains: a) uncertainty in choosing options; b) unsupported in decision making; c) feeling informed; d) decision is consistent with values
Measured: Baseline, up to 2 months
Secondary outcomes (4)
The level of family carer satisfaction with nursing home care
The Family Perception of Care Scale (FPCS). This instrument will represent a global measure on the quality of nursing home care. It is comprised of four subscales: 1) resident care, 2) family support, 3) communication, and 4) rooming. One can investigate both the total and the subscale scores. Family members will also be asked to identify three of the 25 items in the instrument as the highest priorities for providing quality care in the nursing home. Respondents will also be invited to include written comments.
Measured: Baseline up to 2 months
Level of family carer anxiety and depression
General Health Questionnaire (GHQ-12). This 12-item instrument is a self-report measure of psychological morbidity. It is widely used in clinical practice, epidemiological research and for research in psychology. The GHQ-12 is often used to assess general distress. It is designed to cover four identifiable elements of distress: anxiety, depression, social impairment, and hypochondriasis.
Measured: Baseline up to 2 months
The comfort of the resident at the end of life
Quality of Dying in Long Term Care (QoDLTC). This instrument is a retrospective scale representing psychosocial aspects of quality of dying. The questionnaire contains 11 items with three subscales: personhood (5 items), closure (3 items) and preparatory tasks (3 items). Factor scores (means of item scores within each factor) may be averaged for an overall quality of dying score (range 1 - 5), with a higher score indicating a more positive experience. Individual factor scores may also be used separately.
Measured: Baseline up to 2 months
Number of unnecessary hospitalisations
Assessed through the facility care home administrative records
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Primary completionAug 2015 (estimated)
- Study completionAug 2016 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Four Seasons Health Care
- Responsible party
- Principal investigator, Kevin Brazil, Queen's University, Belfast
- Investigators
- Kevin Brazil, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211287
- Sponsor's protocol ID
- B14/25
- Status last verified
- Apr 2014
- First submitted
- 6 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Informed Decision Making and Effective Communication Through Advance Care Planning for People With Dementia and Their Family Carers
- ClinicalTrials.gov ID
- NCT02211287
- Acronym / sponsor ID
- B14/25
- Conditions
- Dementia, Neurodegenerative Diseases
- Keywords
- Dementia, Decision-making, Communication, Advance Care Planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Four Seasons Health Care
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- 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 evaluate the application of a best-practice Advance Care Planning (ACP) model for individuals living with dementia in a sample of nursing homes in Northern Ireland
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: 'Comfort Care at the End of Life for Persons with Dementia', Other: Project Nurse - ACP FacilitatorThe intervention will include five key elements: a Project Nurse - ACP facilitator; family education on comfort care at the end of life for individuals with dementia using the 'Comfort Care at the end of life for persons with dementia' booklet; a family meeting with follow-up telephone call; documentation of ACP decisions, and orientation and education directed towards General Practitioners (GPs) and nursing home staff about the intervention. |
| Usual care | No intervention | –Care will continue as usual for the nursing home residents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Family Caregivers
- Health Care Professionals
- are employed, or in the case of GPs, care for residents, in the six nursing homes that were part of the intervention group
- were familiar with the intervention to discuss its strengths and weaknesses in an interview
- are able to speak English as they are required to participate in interviews.
Key exclusion criteria (2 listed)
- Family caregivers and health care professionals who are unable to communicate through written and spoken English.
- Family caregivers who has a family resident considered to have the ability to participate in ACP discussions.
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 |
|---|---|---|
| 'Comfort Care at the End of Life for Persons with Dementia'A guide for caregivers to provide information on the trajectory of the disease, clinical issues, decision-making processes, and symptom management. The guide is written in a Q\&A form and can help answer frequent family questions. | Other | Intervention |
| Project Nurse - ACP FacilitatorA nurse will receive training in the 'Respecting Choices Facilitator Curriculum' - an online program consisting of a series of six critical thinking modules designed for healthcare professionals who want to enhance their ACP facilitation skills. Local training resources in Northern Ireland will supplement. | Other | Intervention |
Primary outcome
Level of family carer satisfaction in decision making about the care of the resident
Time frame: Baseline, up to 2 months
Decisional Conflict Scale (DCS). This measures uncertainty and difficulties in the decision making process. The 16 item version measures four domains: a) uncertainty in choosing options; b) unsupported in decision making; c) feeling informed; d) decision is consistent with values
4 secondary outcomes
The level of family carer satisfaction with nursing home care
Time frame: Baseline up to 2 months
Level of family carer anxiety and depression
Time frame: Baseline up to 2 months
The comfort of the resident at the end of life
Time frame: Baseline up to 2 months
Number of unnecessary hospitalisations
Time frame: Baseline up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
Related trials for Dementia
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
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.
Kevin Brazil, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Comfort Care at the End of Life for Persons with Dementia' and Project Nurse - ACP Facilitator in people with Dementia and Neurodegenerative Diseases, run by Queen's University, Belfast at 1 site in United Kingdom.
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 8 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 7 Aug 2014. 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 Kingdom. 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?
Contact Kevin Brazil, PhD (0044 289097 ext. 5782, k.brazil@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of family carer satisfaction in decision making about the care of the resident (time frame: Baseline, up to 2 months). 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 7 Aug 2014.