Advanced Care Planning for the Severely Ill Home-dwelling Elderly

NCT05681585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-04-06

No results posted yet for this study

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

Interventions

OTHER

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

Sponsors & Collaborators

  • Oslo Metropolitan University

    collaborator OTHER
  • Norwegian University of Science and Technology

    collaborator OTHER
  • The Research Council of Norway

    collaborator OTHER
  • Helse Sor-Ost

    collaborator OTHER_GOV
  • Sykehuset Innlandet HF

    collaborator OTHER
  • Vestre Viken Hospital Trust

    collaborator OTHER
  • Ostfold Hospital Trust

    collaborator OTHER
  • The Hospital of Vestfold

    collaborator OTHER
  • Hospital of Southern Norway Trust

    collaborator OTHER
  • University Hospital, Akershus

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • Diakonhjemmet Hospital

    collaborator OTHER
  • University of Oslo

    lead OTHER

Principal Investigators

  • Reidar Pedersen, PhD · Professor, Centre for medical ethics, University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681585 on ClinicalTrials.gov