AzTrials
AzTrials

Advance Care PlanningNCT05681585

Advanced Care Planning for the Severely Ill Home-dwelling Elderly

A study testing Implementation support program in people with Advance Care Planning, run by University of Oslo at 12 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will develop and evaluate a complex intervention to implement advance care planning for severely ill home-dwelling elderly acutely admitted to hospital, by using a cluster randomized design. Twelve Norwegian acute geriatric hospital units will participate in the main study, each as one cluster. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Advance Care Planning
What is being tested?
Implementation support program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
12 sitesNorway
Study dates
18 Oct 2023to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Home-dwelling
  • 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
Show all 12Show fewer
  • 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
  • A close relative of a patient who fulfill all inclusion criteria and no exclusion criteria; and who would be willing to participate in ACP together with the patient if offered
  • 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

Who cannot join

  • The patient is not competent to consent to research participation
  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Reidar Pedersen, PhD contact

+47 41575987

reidar.pedersen@medisin.uio.no

12 sites in 1 country

Norway12 sites, 12 recruiting

  • Hospital of Southern Norway, Arendal

    Arendal

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Vestre Viken Hospital Trust, Drammen

    Drammen

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Innlandet Hospital Trust, Elverum

    Elverum

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Innlandet Hospital Trust, Gjøvik

    Gjøvik, 3121

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Vestre Viken Hospital Trust, Kongsberg

    Kongsberg, 3121

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Hospital of Southern Norway, Kristiansand

    Kristiansand

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Akershus University Hospital

    Lørenskog

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Vestre Viken Hospital Trust, Bærum

    Oslo, Bærum kommune

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Diakonhjemmet Hospital

    Oslo, 3121

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Oslo University Hospital

    Oslo

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Østfold Hospital Trust

    Sarpsborg

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

  • Vestfold Hospital Trust

    Tønsberg

    Maria Romøren, 91377693, maria.romoren@medisin.uio.no

    Recruiting

Other trials in Norway

About this study

Official title: Implementing Advanced Care Planning in the Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial

This study will develop and evaluate a complex intervention to implement advance care planning for severely ill home-dwelling elderly acutely admitted to hospital, by using a cluster randomized design.

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.

Read the detailed description

Background:

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.
Being tested
Implementation support program
Keywords
Implementation science, Decision-making processes, Hospital, Geriatric, Next of kin, Clinical ethics, Qualitative methods, Cluster randomized clinical trial, Complex intervention, Health services for the aged, End of life
Medical subject headings
Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation support programOther

    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

Study groups in NCT05681585
Study groupRoleWhat they receive
Intervention armOtherClusters (medical/geriatric hospital units) in the intervention arm receives a comprehensive implementation support program during the trial period.
Receives: Other: Implementation support program
Control armNo interventionClusters (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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning

    Change in fidelity (sum score) measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).

    Measured: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  2. Clinical effectiveness study 1: Patient-reported outcome

    Quality of communication and decision-making when the patient is approaching the end of life. 4 items, scale 0-9.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  3. Clinical effectiveness study 2: Relative-reported outcome

    Quality of communication and decision-making for the patient and the next-of-kin when approaching the end of life. 4 items, rated 0-9.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  4. Clinical effectiveness study 3: Clinician outcome

    Congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, 4 items, scales: 0-9, 0-2, 0-9, 7 alternative answers, respectively

    Measured: During the intervention period (10-18 months after the start of the implementation support)

Secondary outcomes (28)

  1. Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 1

    Change in fidelity subscale - Organizational implementation - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).

    Measured: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  2. Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 2

    Change in fidelity subscale - Quality of ACP - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).

    Measured: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  3. Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 3

    Change in fidelity subscale - Penetration - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).

    Measured: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  4. Clinical effectiveness study 1: Patient-reported seondary outcome 1

    Communication about preferences for information and involvement, providers' current compliance with these preferences, and trust in future compliance. 5 items, rated 0-9.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  5. Clinical effectiveness study 1: Patient-reported seondary outcome 2

    Satisfaction with information and involvement concerning health care provided during admittance and that will be provided after discharge, and with information about the patient's state of health, discharge, prognosis and future health care needs. 10 items, rated 0-9

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  6. Clinical effectiveness study 1: Patient-reported seondary outcome 3

    Self-efficacy in communicating with next-of-kin and health care professionals about future deterioration, preferences for life-prolonging treatment in such a situation, and health care when approaching the end of life. 9 items, rated 0-3

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  7. Clinical effectiveness study 1: Patient-reported seondary outcome 4

    Problem causing admittance solved, satisfaction with arrival, stay, and discharge at the hospital, and trust in necessary health care in the future. 5 items, rated 0-9

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  8. Clinical effectiveness study 1: Patient-reported seondary outcome 5

    Concrete preferences for information and who should participate in important decisions about health care, and assessment of the amount of information given. 4 items, scales: 0-9, 0-2, 0-9, 7 alternative answers, respectively

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  9. Clinical effectiveness study 1: Patient-reported seondary outcome 6

    General life satisfaction (ref. OECD. (2013). OECD guidelines on measuring subjective well-being). 1 item, rated 0-10.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  10. Clinical effectiveness study 1: Patient registry data 1 - Number of hospital admissions

    Retrieved from national registries

    Measured: From 18 months before to 18 months after inclusion (or until death)

  11. Clinical effectiveness study 1: Patient registry data 2 - Other use of health care services and use of medication

    Retrieved from national registries

    Measured: From 18 months before to 18 months after inclusion (or until death)

  12. Clinical effectiveness study 1: Patient registry data 3 - Time before death (for patients dying before 18 months after inclusion)

    Retrieved from national registries

    Measured: From inclusion to 18 months after inclusion

  13. Clinical effectiveness study 1: Patient health records data

    Documentation concerning ACP and other similar conversations, palliative care plan, the patient's life stance or religious beliefs, and life prolonging treatment and palliative care given and any decisions to limit such treatment or care, and similarly for hospital admittance.

    Measured: From 18 months before to 18 months after inclusion (or until death)

  14. Clinical effectiveness study 2: Relative-reported seondary outcome 1

    Satisfaction with information and involvement concerning the patient's health care provided during admittance and that will be provided after discharge, with information about the patient's state of health, discharge, prognosis, future health care needs, and with the providers' understanding of the next-of-kin's situation. 11 items, rated 0-9

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  15. Clinical effectiveness study 2: Relative-reported seondary outcome 2

    Self-efficacy in communicating with the patient and health care professionals about future deterioration, the patient's preferences for life-prolonging treatment in such a situation, and health care when the patient is approaching the end of life. 9 items, rated 0-3.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  16. Clinical effectiveness study 2: Relative-reported seondary outcome 3

    Problem causing admittance solved, satisfaction with arrival, stay, and discharge at the hospital, trust in necessary health care for the patient in the future, and make sure that the patient receives needed health care in the time to come. 6 items, ratet 0-9.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  17. Clinical effectiveness study 2: Relative-reported seondary outcome 4

    Next-of-kin's concrete preferences for information and assessment of the amount of information given, the patient's preference for information and who should participate in important decisions about health care. 4 items, scales: 0-9, 0-2, 0-9, 7 alternative answers, respectively

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  18. Clinical effectiveness study 2: Relative-reported seondary outcome 5

    Next-of-kin's tasks and burdens. 7 items with various scales/response alternatives.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  19. Clinical effectiveness study 2: Relative-reported seondary outcome 6

    Informal carer's care-related quality of life (ref. CarerQoL-7D (Brouwer et al. 2006)). 7 items, rated 0-2

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  20. Clinical effectiveness study 2: Relative-reported seondary outcome 7

    General life satisfaction (ref. OECD. (2013). OECD guidelines on measuring subjective well-being). 1 item, rated 0-10.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  21. Clinical effectiveness study 3: Clinician secondary outcome 1

    Self-confidence in matching involvement of patient and next-of-kin and future decision-making to patient's preferences. 4 items, rated 0-10

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  22. Clinical effectiveness study 3: Clinician secondary outcome 2

    Self-efficacy in communicating about future deterioration, preferences for life-prolonging treatment in such a situation, for future care (at home or in a nursing home), and for health care when approaching the end of life, with the patient, next-of-kin, and other providers. 16 items, rated 0-3.

    Measured: During the intervention period (10-18 months after the start of the implementation support)

  23. Clinical effectiveness study 4: All staff - 1

    Patients' and relatives' preferences for information and involvement. 7 questions.

    Measured: Baseline and 18 months in both intervention and control arm

  24. Clinical effectiveness study 4: All staff - 2

    Whether information, involvement and health care provided is concordant with the patients' and relatives' preferences, and reasons for discordance. 9 questions.

    Measured: Baseline and 18 months in both intervention and control arm

  25. Clinical effectiveness study 4: All staff - 3

    Decision making authority - clinical realities and ideals. 16 questions.

    Measured: Baseline and 18 months in both intervention and control arm

  26. Clinical effectiveness study 4: All staff - 4

    Self-efficacy in ACP-relevant information and involvement tasks.17 questions.

    Measured: Baseline and 18 months in both intervention and control arm

  27. Clinical effectiveness study 4: All staff - 5

    Self-confidence in ACP-relevant information and involvement tasks. 7 questions.

    Measured: Baseline and 18 months in both intervention and control arm.

  28. Economic sub-study: Increased costs related to implementing and practicing ACP

    Increased costs related to implementing and practicing ACP in the clinical units in the intervention arm. Compared to normal costs before baseline. Differences in costs will be compared to the primary outcomes (differences measured as percentage point) and selected secondary outcomes.

    Measured: Measured before baseline and then throughout the implementation period (0-18 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start18 Oct 2023
  3. Primary completion31 Dec 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a cluster RCT, with a complex intervention containing implementation interventions and strategies, and a clinical intervention (ACP). Twelve clusters were recruited and stratified into two strata according to number of beds and randomized to intervention or control arms (allocation ratio of 1:1). The six hospital units in the intervention arm will receive a comprehensive implementation support program, whereas the control units receive no support in the intervention period. 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.
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05681585
Sponsor's protocol ID
NSD 805491
Status last verified
Dec 2024
First submitted
3 Jan 2023
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymized data and documents from all sub-studies can be made available to other researchers upon request after project end, in the period April 19 2032 - April 19 2037. What types of analyses and with what mechanism data will be made available will be planned if relevant.

Publications

  • 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.

    PubMed 20332506

  • 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.

    PubMed 10732933

  • 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.

    PubMed 25679395

  • 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.

    PubMed 28884703

  • 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.

    PubMed 27451328

  • 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.

    PubMed 24651708

  • 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.

    PubMed 25330167

  • 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.

    PubMed 20957426

  • 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.

    PubMed 25791983

  • Hermansen KB, Saevareid TJL, Pedersen R, Alnes RE, Broderud L, Romoren M, Midtbust MH. Ethical challenges in acute geriatric care and advance care planning: a nested qualitative study. Eur Geriatr Med. 2026 Jul 28. doi: 10.1007/s41999-026-01563-2. Online ahead of print.

    PubMed 42521921

  • Hermansen KB, Saevareid TJL, Pedersen R, Alnes RE, Broderud L, Romoren M, Midtbust MH. Healthcare professionals' experiences of advance care planning conversations with frail older adults admitted to acute geriatric hospital units: a nested qualitative study. BMC Health Serv Res. 2026 Jul 15. doi: 10.1186/s12913-026-15112-x. Online ahead of print.

    PubMed 42458423

  • Broderud L, Romoren M, Hermansen KB, Saevareid TJL, Thoresen L, Pedersen R. Barriers and facilitators in implementing advance care planning for frail older patients acutely admitted to geriatric hospital units: a nested qualitative study. Front Health Serv. 2025 Dec 17;5:1646541. doi: 10.3389/frhs.2025.1646541. eCollection 2025.

    PubMed 41479948

  • Westbye SF, Romoren M, Ahmed M, Hermansen KB, Broderud L, Wahl AK, Saevareid TJL, Thoresen L, Pedersen R. Measuring the level of implementation of advance care planning - a fidelity-based cross-sectional study. Front Health Serv. 2025 Oct 29;5:1629242. doi: 10.3389/frhs.2025.1629242. eCollection 2025.

    PubMed 41234374

  • 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.

    PubMed 38374100

Questions about this trial

What is this clinical trial studying?

A study testing Implementation support program in people with Advance Care Planning, run by University of Oslo at 12 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reidar Pedersen, PhD (+47 41575987, reidar.pedersen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning (time frame: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05681585, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in