The impact of advance care planning on end of life care in elderly patients: randomised controlled trial.
Karen M Detering, Andrew D Hancock, Michael C Reade...
https://pubmed.ncbi.nlm.nih.gov/20332506Actively Recruiting
Phase Not Applicable
Age: 70Years +
All Genders
ID05681585
Implementing Advanced Care Planning in Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial
Led by University of Oslo · Updated on 2025-04-06
2000
Participants Needed
12
Research Sites
100 weeks
Total Duration
On this page
Sponsors
U
University of Oslo
Lead Sponsor
O
Oslo Metropolitan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a complex intervention to improve advance care planning (ACP) for severely ill elderly people living at home who are acutely admitted to hospital. This cluster randomized study involves twelve Norwegian geriatric hospital units and aims to enhance patient and family involvement in treatment decisions, improve quality of life, and support ethical and legal care planning. The project also explores barriers and facilitators to implementing ACP at clinical, health service, and governmental levels, including economic analyses. The intervention group receives a comprehensive support program that includes leadership commitment, training for staff, implementation teams, ACP coordinators, and practical tools such as guidelines and documentation templates. The control group receives no implementation support during the trial but will be offered the program afterward. The study period includes baseline, 9-month, and 18-month assessments for the intervention group and baseline and 18-month assessments for the control group. Participants will undergo questionnaires and interviews with patients, relatives, clinicians, and staff at multiple time points before, during, and after the implementation. Data from patient records and national health registers will be collected to assess the fidelity of ACP implementation, clinical outcomes, communication quality, and cost-effectiveness. The trial runs until December 2026 and includes various measures to evaluate the impact of the support program on ACP delivery and related outcomes.
CONDITIONS
Brief Title
Advanced Care Planning for the Severely Ill Home-dwelling Elderly
Who Can Participate
Age: 70Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient is 70 years or older
- Patient lives at home
- Patient is acutely admitted to a participating geriatric hospital unit
- Patient has sufficient Norwegian language skills to answer questionnaires
- Patient has a clinical frailty score of 4 or higher
- The responsible physician answers "no" to the "Surprise question" regarding the patient's prognosis
- Both patient and a close relative agree to participate in advance care planning together
- Both patient and close relative consent to participate in the research project
- Relative is 18 years or older
- Relative has sufficient Norwegian language skills to answer questionnaires
- Relative is a close family member willing to participate in advance care planning with the patient
You will not qualify if you...
- Patient is not competent to consent to research participation
- Patient is expected to die within 24 hours
- Patient has participated in advance care planning before the current hospital admission
- In the intervention group: ACP is not conducted with patient, next of kin, and physician before discharge
- In the intervention group: The clinician involved in ACP has not consented to research participation
- In the control group: Patient would not be able to participate in ACP during hospitalization
- In the control group: Attending clinician has not consented to research participation
- Relative is not competent to consent to research participation
- In the intervention group: ACP is not conducted with patient, next of kin, and attending clinician before discharge
- In the control group: Relative would not be able to participate in ACP during hospitalization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 18 months
Participants who undergo routine care are observed to assess the current implementation of Advance Care Planning and related outcomes.
Visits occur at baseline, 9 months, and 18 months in the intervention arm; baseline and 18 months in the control arm
Trial Site Locations
Total: 12 locations
1
Vestre Viken Hospital Trust, Bærum
Oslo, Bærum kommune, Norway
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2
Hospital of Southern Norway, Arendal
Arendal, Norway
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3
Vestre Viken Hospital Trust, Drammen
Drammen, Norway
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4
Innlandet Hospital Trust, Elverum
Elverum, Norway
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5
Innlandet Hospital Trust, Gjøvik
Gjøvik, Norway, 3121
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6
Vestre Viken Hospital Trust, Kongsberg
Kongsberg, Norway, 3121
Actively Recruiting
7
Hospital of Southern Norway, Kristiansand
Kristiansand, Norway
Actively Recruiting
8
Akershus University Hospital
Lørenskog, Norway
Actively Recruiting
9
Diakonhjemmet Hospital
Oslo, Norway, 3121
Actively Recruiting
10
Oslo University Hospital
Oslo, Norway
Actively Recruiting
11
Østfold Hospital Trust
Sarpsborg, Norway
Actively Recruiting
12
Vestfold Hospital Trust
Tønsberg, Norway
Actively Recruiting
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Research Team
R
Reidar Pedersen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial.
D W Molloy, G H Guyatt, R Russo...
https://pubmed.ncbi.nlm.nih.gov/10732933Barriers to advance care planning at the end of life: an explanatory systematic review of implementation studies.
Susi Lund, Alison Richardson, Carl May
https://pubmed.ncbi.nlm.nih.gov/25679395Definition and recommendations for advance care planning: an international consensus supported by the European Association for Palliative Care.
Judith A C Rietjens, Rebecca L Sudore, Michael Connolly...
https://pubmed.ncbi.nlm.nih.gov/28884703Advance care planning: A systematic review of randomised controlled trials conducted with older adults.
Elizabeth Weathers, Rónán O'Caoimh, Nicola Cornally...
https://pubmed.ncbi.nlm.nih.gov/27451328The effects of advance care planning on end-of-life care: a systematic review.
Arianne Brinkman-Stoppelenburg, Judith A C Rietjens, Agnes van der Heide
https://pubmed.ncbi.nlm.nih.gov/24651708Communication about serious illness care goals: a review and synthesis of best practices.
Rachelle E Bernacki, Susan D Block, American College of Physicians High Value Care Task Force
https://pubmed.ncbi.nlm.nih.gov/25330167Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda.
Enola Proctor, Hiie Silmere, Ramesh Raghavan...
https://pubmed.ncbi.nlm.nih.gov/20957426Process evaluation of complex interventions: Medical Research Council guidance.
Graham F Moore, Suzanne Audrey, Mary Barker...
https://pubmed.ncbi.nlm.nih.gov/25791983Barriers and facilitators in implementing advance care planning for frail older patients acutely admitted to geriatric hospital units: a nested qualitative study.
Linn Brøderud, Maria Romøren, Karin Berg Hermansen...
https://pubmed.ncbi.nlm.nih.gov/41479948