NCT02211287

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 7, 2014

Status Verified

April 1, 2014

First QC Date

August 6, 2014

Last Update Submit

August 6, 2014

Conditions

Keywords

DementiaDecision-makingCommunicationAdvance Care Planning

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, up to 2 months

Secondary Outcomes (4)

  • The level of family carer satisfaction with nursing home care

    Baseline up to 2 months

  • Level of family carer anxiety and depression

    Baseline up to 2 months

  • The comfort of the resident at the end of life

    Baseline up to 2 months

  • Number of unnecessary hospitalisations

    Baseline up to 12 months

Study Arms (2)

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.

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

Interventions

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

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Four Seasons Health Care -- Nursing Homes

Belfast, United Kingdom

Location

MeSH Terms

Conditions

DementiaNeurodegenerative DiseasesCommunication

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Kevin Brazil, PhD

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Brazil, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 7, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2016

Last Updated

August 7, 2014

Record last verified: 2014-04

Locations