Back to resultsPromoting Informed Decision Making Through Advance Care Planning
Primary Purpose
Dementia, Neurodegenerative Diseases
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
'Comfort Care at the End of Life for Persons with Dementia'
Project Nurse - ACP Facilitator
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Dementia, Decision-making, Communication, Advance Care Planning
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Sites / Locations
- Four Seasons Health Care -- Nursing Homes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Usual care
Arm Description
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.
Care will continue as usual for the nursing home residents
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Number of unnecessary hospitalisations
Assessed through the facility care home administrative records
Full Information
NCT ID
NCT02211287
First Posted
August 6, 2014
Last Updated
August 6, 2014
Sponsor
Queen's University, Belfast
Collaborators
Four Seasons Health Care
1. Study Identification
Unique Protocol Identification Number
NCT02211287
Brief Title
Promoting Informed Decision Making Through Advance Care Planning
Official Title
Promoting Informed Decision Making and Effective Communication Through Advance Care Planning for People With Dementia and Their Family Carers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Four Seasons Health Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Neurodegenerative Diseases
Keywords
Dementia, Decision-making, Communication, Advance Care Planning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Care will continue as usual for the nursing home residents
Intervention Type
Other
Intervention Name(s)
'Comfort Care at the End of Life for Persons with Dementia'
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Project Nurse - ACP Facilitator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of family carer satisfaction in decision making about the care of the resident
Description
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
Time Frame
Baseline, up to 2 months
Secondary Outcome Measure Information:
Title
The level of family carer satisfaction with nursing home care
Description
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.
Time Frame
Baseline up to 2 months
Title
Level of family carer anxiety and depression
Description
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.
Time Frame
Baseline up to 2 months
Title
The comfort of the resident at the end of life
Description
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.
Time Frame
Baseline up to 2 months
Title
Number of unnecessary hospitalisations
Description
Assessed through the facility care home administrative records
Time Frame
Baseline up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Brazil, PhD
Phone
0044 289097
Ext
5782
Email
k.brazil@qub.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Brazil, PhD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Four Seasons Health Care -- Nursing Homes
City
Belfast
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jim McCall
12. IPD Sharing Statement
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Promoting Informed Decision Making Through Advance Care Planning
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