Advanced Care Planning for the Severely Ill Home-dwelling Elderly
NCT ID: NCT05681585
Last Updated: 2025-04-06
Study Results
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Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2023-10-18
2026-12-31
Brief Summary
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Twelve Norwegian acute geriatric hospital units will participate in the main study, each as one cluster. Of the twelve clusters, half will receive implementation support and training immediately, and the other half will receive similar support after the intervention period. The study includes 1) assessment of implementation outcomes (fidelity) in the participating units,2) health service and clinical outcomes including a) questionnaires to all staff in the units before and after the implementation period, questionnaires to attending clinicians and qualitative interviews with health personnel and local unit leaders b) questionnaires to patients and their relatives, patients records and data from central health registers and qualitative interviews with patients and relatives. Furthermore we will assess barriers and facilitators for advance care planning in 1) a wider health service context, and 2) at the national, regional and municipal level, and do economic analyses.
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Detailed Description
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Severely ill elderly patients and their relatives are often poorly involved in treatment and care decisions. Advance care planning is a well-documented tool to comply with the ethical and legal imperative to involve both the patient and their next of kin in the planning of current and future treatment and care. The overall aim of this project is to improve health services, user involvement and quality of life for severely ill elderly people living at home, and their relatives, in an efficient, sustainable and coordinated way, through better implementation of Advance care planning (ACP).
Setting: Twelve hospital wards providing care to acutely admitted elderly home-dwelling patients, either pure geriatric units or mixed units with specialists in geriatric medicine.
Research questions:
1. What is the current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in the participating clinical units?
2. What are the most important facilitators and barriers among all relevant stakeholders - to implementing ACP at the a) clinical, b) health care service- and c) national, regional and municipal level?
3. What are the most important moral dilemmas and conflicting interests related to ACP, and how can these be resolved?
4. What are the benefits and disadvantages with the implementation support and ACP experienced by the patients, among next of kin, health personnel and implementation teams?
5. Does the implementation support program - compared to no such support - improve a) the implementation of ACP (fidelity), b) quality of communication and decision-making for patients and relatives when approaching the end of life, and c) congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, and other relevant outcomes for patients, relatives, and the attending clinicians?
6. Is the implementation support program associated with changes in health personnel's perceptions, attitudes, self-efficacy, confidence in, and experiences in relation to information giving and involvement of patients and relatives?
7. Is higher level of implementation (fidelity) of ACP associated with improved outcomes for patients, relatives, the staff and the services?
8. Is the implementation support program for ACP a cost-effective intervention?
Hypotheses:
1. The current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in participating clinical units is low.
2. There are important facilitators for and barriers to implementing ACP among all stakeholders at the a) clinical, b) health care service- and c) national and other higher levels.
3. There are important moral dilemmas and conflicting interests related to ACP, and they can be dealt with through systematic approaches and ethics reflection.
4. Patients, among next of kin, health personnel and implementation teams experience both benefits and disadvantages with the implementation support and ACP.
5. The implementation support program - compared to no such support - will improve a) improve the implementation of ACP (fidelity), b) quality of communication and decision-making for patients and relatives when approaching the end of life, and c) congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, and other relevant outcomes for patients, relatives, and the attending clinicians.
6. The implementation support program is associated with changes in health personnel's perceptions, attitudes, self-efficacy, confidence in, and experiences in relation to information giving and involvement of patients and relatives
7. Higher level of implementation (fidelity) of ACP is associated with improved outcomes for patients, relatives, the staff and the services
8. Outcomes for patients, relatives and the public health- and welfare services justify the costs of the implementation support program and of ACP in routine care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
A similar number of patients, relatives and attending clinician will be recruited from both arms in triads for the quantitative sub-study. Data for each patient will be supplemented by health record and register data. Patients, relatives, staff and implementation teams will be recruited from the intervention units to qualitative interviews. All health personnel in the participating units will be recruited to answer a questionnaire twice. We will also interview key stakeholders in a wider context.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention arm
Clusters (medical/geriatric hospital units) in the intervention arm receives a comprehensive implementation support program during the trial period.
Implementation support program
The intervention consists of:
I Implementation strategies:
1.1 Ensuring leadership commitment 1.2 Responsive evaluation 1.3 Whole ward approach 1.4 Train the trainer model 1.5 Sustainability after the study
II Implementation interventions 2.1 Implementation team 2.2 ACP coordinator 2.3 Training and supervision: Kick-off, training of resource persons and health care personnel including practical exercises, network conferences 2.4 Toolkit and shared resources: ACP guideline, teaching material, information leaflets, documentation templates etc. 2.5 Structured fidelity measurements of the implementation level of a) the implementation interventions and b) the clinical intervention, with tailored feedback and supervision
III Clinical intervention: Advance Care Planning 3.1 Routine information and invitation to Advance Care Planning to all eligible patients 3.2 Written information to patients and relatives 3.3 Documentation and collaboration with other health care levels
Control arm
Clusters (medical/geriatric hospital units) in the control arm receives no implementation support program during the trial period.
These units will receive the implementation support program after the trial period.
No interventions assigned to this group
Interventions
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Implementation support program
The intervention consists of:
I Implementation strategies:
1.1 Ensuring leadership commitment 1.2 Responsive evaluation 1.3 Whole ward approach 1.4 Train the trainer model 1.5 Sustainability after the study
II Implementation interventions 2.1 Implementation team 2.2 ACP coordinator 2.3 Training and supervision: Kick-off, training of resource persons and health care personnel including practical exercises, network conferences 2.4 Toolkit and shared resources: ACP guideline, teaching material, information leaflets, documentation templates etc. 2.5 Structured fidelity measurements of the implementation level of a) the implementation interventions and b) the clinical intervention, with tailored feedback and supervision
III Clinical intervention: Advance Care Planning 3.1 Routine information and invitation to Advance Care Planning to all eligible patients 3.2 Written information to patients and relatives 3.3 Documentation and collaboration with other health care levels
Eligibility Criteria
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Inclusion Criteria
* 70 years or older
* Acutely admitted to the participating unit
* Sufficient language proficiency in Norwegian to answer the questionnaire
* Clinical frailty score of 4 or more
* The physician responsible for the patient's medical care answers "no" to "Surprise question" from Gold Standards Framework proactive identification guidance
* Both patient and a close relative (preferably the closest relative) would participate in ACP together if offered
* Both patient and the close relative consent to participate in the research project
* 18 years or older
* Sufficient language proficiency in Norwegian to answer the questionnaire
* Both patient and the close relative consent to participate in the research project
Exclusion Criteria
* The patient is expected to die within 24 hours
* The patient has participated in ACP prior to the current hospital admission
* In the intervention arm
* ACP is not conducted with patient, next of kin and physician before hospital discharge
* The clinician that participated in the ACP conversation has not consented to research participation
* In the control arm
* The patient would not have been able to participate in ACP during hospitalization
* An attending clinician has not consented to research participation
* The relative is not competent to consent to research participation
* In the intervention arm
* ACP is not carried out with the patient, next of kin and attending clinician before hospital discharge
* In the control arm
* The relative would not have been able to participate in ACP during hospitalization
70 Years
ALL
No
Sponsors
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Oslo Metropolitan University
OTHER
Norwegian University of Science and Technology
OTHER
The Research Council of Norway
OTHER
Helse Sor-Ost
OTHER_GOV
Sykehuset Innlandet HF
OTHER
Vestre Viken Hospital Trust
OTHER
Ostfold Hospital Trust
OTHER
The Hospital of Vestfold
OTHER
Hospital of Southern Norway Trust
OTHER
University Hospital, Akershus
OTHER
Oslo University Hospital
OTHER
Diakonhjemmet Hospital
OTHER
University of Oslo
OTHER
Responsible Party
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Reidar Pedersen
Professor
Principal Investigators
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Reidar Pedersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor, Centre for medical ethics, University of Oslo
Locations
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Vestre Viken Hospital Trust, Bærum
Oslo, Bærum kommune, Norway
Hospital of Southern Norway, Arendal
Arendal, , Norway
Vestre Viken Hospital Trust, Drammen
Drammen, , Norway
Innlandet Hospital Trust, Elverum
Elverum, , Norway
Innlandet Hospital Trust, Gjøvik
Gjøvik, , Norway
Vestre Viken Hospital Trust, Kongsberg
Kongsberg, , Norway
Hospital of Southern Norway, Kristiansand
Kristiansand, , Norway
Akershus University Hospital
Lørenskog, , Norway
Diakonhjemmet Hospital
Oslo, , Norway
Oslo University Hospital
Oslo, , Norway
Østfold Hospital Trust
Sarpsborg, , Norway
Vestfold Hospital Trust
Tønsberg, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
Molloy DW, Guyatt GH, Russo R, Goeree R, O'Brien BJ, Bedard M, Willan A, Watson J, Patterson C, Harrison C, Standish T, Strang D, Darzins PJ, Smith S, Dubois S. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA. 2000 Mar 15;283(11):1437-44. doi: 10.1001/jama.283.11.1437.
Lund S, Richardson A, May C. Barriers to advance care planning at the end of life: an explanatory systematic review of implementation studies. PLoS One. 2015 Feb 13;10(2):e0116629. doi: 10.1371/journal.pone.0116629. eCollection 2015.
Rietjens JAC, Sudore RL, Connolly M, van Delden JJ, Drickamer MA, Droger M, van der Heide A, Heyland DK, Houttekier D, Janssen DJA, Orsi L, Payne S, Seymour J, Jox RJ, Korfage IJ; European Association for Palliative Care. Definition and recommendations for advance care planning: an international consensus supported by the European Association for Palliative Care. Lancet Oncol. 2017 Sep;18(9):e543-e551. doi: 10.1016/S1470-2045(17)30582-X.
Weathers E, O'Caoimh R, Cornally N, Fitzgerald C, Kearns T, Coffey A, Daly E, O'Sullivan R, McGlade C, Molloy DW. Advance care planning: A systematic review of randomised controlled trials conducted with older adults. Maturitas. 2016 Sep;91:101-9. doi: 10.1016/j.maturitas.2016.06.016. Epub 2016 Jun 23.
Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med. 2014 Sep;28(8):1000-25. doi: 10.1177/0269216314526272. Epub 2014 Mar 20.
Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014 Dec;174(12):1994-2003. doi: 10.1001/jamainternmed.2014.5271.
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
Romoren M, Hermansen KB, Saevareid TJL, Broderud L, Westbye SF, Wahl AK, Thoresen L, Rostoft S, Forde R, Ahmed M, Aas E, Midtbust MH, Pedersen R. Implementation of advance care planning in the routine care for acutely admitted patients in geriatric units: protocol for a cluster randomized controlled trial. BMC Health Serv Res. 2024 Feb 19;24(1):220. doi: 10.1186/s12913-024-10666-0.
Related Links
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Gold Standards Framework. Advance care planning 2019
Other Identifiers
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NSD 805491
Identifier Type: -
Identifier Source: org_study_id
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