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Promoting Informed Decision Making Through Advance Care Planning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02211287
Recruitment Status : Unknown
Verified April 2014 by Kevin Brazil, Queen's University, Belfast.
Recruitment status was:  Not yet recruiting
First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Four Seasons Health Care
Information provided by (Responsible Party):
Kevin Brazil, Queen's University, Belfast

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

Condition or disease Intervention/treatment Phase
Dementia Neurodegenerative Diseases Other: 'Comfort Care at the End of Life for Persons with Dementia' Other: Project Nurse - ACP Facilitator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Official Title: Promoting Informed Decision Making and Effective Communication Through Advance Care Planning for People With Dementia and Their Family Carers
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
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.
Other: '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: Project Nurse - ACP Facilitator
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.

No Intervention: Usual care
Care will continue as usual for the nursing home residents

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. The level of family carer satisfaction with nursing home care [ Time Frame: Baseline up to 2 months ]
    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.

  2. Level of family carer anxiety and depression [ Time Frame: Baseline up to 2 months ]
    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.

  3. The comfort of the resident at the end of life [ Time Frame: Baseline up to 2 months ]
    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.

  4. Number of unnecessary hospitalisations [ Time Frame: Baseline up to 12 months ]
    Assessed through the facility care home administrative records

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02211287

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Contact: Kevin Brazil, PhD 0044 289097 ext 5782

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United Kingdom
Four Seasons Health Care -- Nursing Homes Not yet recruiting
Belfast, United Kingdom
Contact: Jim McCall         
Sponsors and Collaborators
Queen's University, Belfast
Four Seasons Health Care
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Principal Investigator: Kevin Brazil, PhD Queen's University, Belfast

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Responsible Party: Kevin Brazil, Professor, Queen's University, Belfast Identifier: NCT02211287     History of Changes
Other Study ID Numbers: B14/25
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: April 2014

Keywords provided by Kevin Brazil, Queen's University, Belfast:
Advance Care Planning

Additional relevant MeSH terms:
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Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders