Advanced Care Planning for the Severely Ill Home-dwelling Elderly

NCT05681585 | Recruiting

• 1 other identifier: NSD 805491
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Advance Care Planning

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

Outcome Measures

Primary Outcomes (4)

• 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).

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

• 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.

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

• 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.

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

• 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

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

Secondary Outcomes (28)

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

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

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

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

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

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

• Clinical effectiveness study 1: Patient-reported seondary outcome 1

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

• Clinical effectiveness study 1: Patient-reported seondary outcome 2

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

Other Outcomes (1)

• Clinical effectiveness study 1: Clinical data about the patient from participating/attending clinician

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

Study Arms (2)

Intervention arm

OTHER

Clusters (medical/geriatric hospital units) in the intervention arm receives a comprehensive implementation support program during the trial period.

Other: Implementation support program

Control arm

NO INTERVENTION

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.

Interventions

Implementation support program OTHER

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

Intervention arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• Home-dwelling
• 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
• 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
• In the control arm

Sponsors & Collaborators

• University of Oslo: lead
• Oslo Metropolitan University: collaborator
• Norwegian University of Science and Technology: collaborator
• The Research Council of Norway: collaborator
• Helse Sor-Ost: collaborator
• Sykehuset Innlandet HF: collaborator
• Vestre Viken Hospital Trust: collaborator
• Ostfold Hospital Trust: collaborator
• The Hospital of Vestfold: collaborator
• Hospital of Southern Norway Trust: collaborator
• University Hospital, Akershus: collaborator
• Oslo University Hospital: collaborator
• Diakonhjemmet Hospital: collaborator

Study Sites (12)

Vestre Viken Hospital Trust, Bærum

Oslo, Bærum kommune, Norway

RECRUITING

Hospital of Southern Norway, Arendal

Arendal, Norway

RECRUITING

Vestre Viken Hospital Trust, Drammen

Drammen, Norway

RECRUITING

Innlandet Hospital Trust, Elverum

Elverum, Norway

RECRUITING

Innlandet Hospital Trust, Gjøvik

Gjøvik, 3121, Norway

RECRUITING

Vestre Viken Hospital Trust, Kongsberg

Kongsberg, 3121, Norway

RECRUITING

Hospital of Southern Norway, Kristiansand

Kristiansand, Norway

RECRUITING

Akershus University Hospital

Lørenskog, Norway

RECRUITING

Diakonhjemmet Hospital

Oslo, 3121, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Østfold Hospital Trust

Sarpsborg, Norway

RECRUITING

Vestfold Hospital Trust

Tønsberg, Norway

RECRUITING

Related Publications (12)

• 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.

  PMID: 20332506 BACKGROUND

• 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.

  PMID: 10732933 BACKGROUND

• 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.

  PMID: 25679395 BACKGROUND

• 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.

  PMID: 28884703 BACKGROUND

• 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.

  PMID: 27451328 BACKGROUND

• 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.

  PMID: 24651708 BACKGROUND

• 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.

  PMID: 25330167 BACKGROUND

• 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.

  PMID: 20957426 BACKGROUND

• 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.

  PMID: 25791983 BACKGROUND

• 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.

  PMID: 41479948 DERIVED

• 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.

  PMID: 41234374 DERIVED

• 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.

  PMID: 38374100 DERIVED

Related Links

• Gold Standards Framework. Advance care planning 2019

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reidar Pedersen, PhD

  Professor, Centre for medical ethics, University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reidar Pedersen, PhD

CONTACT

+47 41575987; reidar.pedersen@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking Patients and next-of-kin will not be informed about the hospital unit's allocation status. However, they may deduce this from the kind of intervention they receive. It's impossible to blind the care providers and for practical reasons we won't be able to blind the investigators or the outcomes assessors.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 12, 2023
• Study Start: October 18, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (12)