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Advanced Care Planning for the Severely Ill Home-dwelling Elderly

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Jun 2024 to Dec 31, 2024
    • Site details revised at 1 of 12 sites
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 20, 2023 to Oct 18, 2023
    • Site details revised at 12 of 12 sites
    v4
  3. Primary completion date: May 2027 to Jun 2024v3 Show 6 more changesShow less
    • Start date: May 2023 to Oct 20, 2023
    • Primary endpoints: 3 to 4
    • Study completion date: Apr 19, 2032 to Dec 2026
    • Eligibility criteria expanded, about 148 words
    • Secondary endpoints: 6 to 28
    • Study description expanded, about 222 words
  4. Study title shortened, about 1 wordv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05681585
Lead Sponsor University of Oslo
Collaborators: Oslo Metropolitan University, Norwegian University of Science and Technology, The Research Council of Norway, Helse Sor-Ost, Sykehuset Innlandet HF, Vestre Viken Hospital Trust, Ostfold Hospital Trust, The Hospital of Vestfold, Hospital of Southern Norway Trust, University Hospital, Akershus, Oslo University Hospital, Diakonhjemmet Hospital
Conditions
(from sponsor)		 Advance Care Planning
Related terms Death
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov