Improving advance care planning for elderly patients at home
Implementing Advanced Care Planning in the Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial
This study is testing a new way to help elderly patients living at home plan their future healthcare needs better when they have to go to the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University of Oslo Academic / other |
| Locations | 12 sites (Oslo, Bærum kommune and 11 other locations) |
| Trial ID | NCT05681585 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate an intervention to enhance advance care planning (ACP) for severely ill elderly patients who are living at home and are acutely admitted to hospitals. It employs a cluster randomized design involving twelve Norwegian acute geriatric hospital units, where half will receive immediate implementation support and training while the other half will receive it after the intervention period. The study will assess implementation outcomes, health service and clinical outcomes through questionnaires and qualitative interviews with staff, patients, and their relatives. The goal is to improve user involvement and quality of life for these patients and their families.
Who should consider this trial
Good fit: Ideal candidates for this study are home-dwelling elderly individuals aged 70 or older who are acutely admitted to a participating hospital unit and have a clinical frailty score of 4 or more.
Not a fit: Patients who are not competent to consent, expected to die within 24 hours, or have previously participated in advance care planning may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the involvement of elderly patients and their relatives in treatment and care decisions, leading to improved quality of life.
How similar studies have performed: Other studies have shown success in implementing advance care planning in similar populations, indicating that this approach has potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion and exclusion criteria for patients and relatives the quantitative and triadic sub-study: Inclusion criteria for patients: * 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 * 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 Exclusion criteria for patients: * 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 * The patient would not have been able to participate in ACP during hospitalization * An attending clinician has not consented to research participation Inclusion criteria for relatives: * 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 Exclusion criteria for relatives: * 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
Where this trial is running
Oslo, Bærum kommune and 11 other locations
- 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, Norway (Recruiting)
- Vestre Viken Hospital Trust, Kongsberg — Kongsberg, Norway (Recruiting)
- Hospital of Southern Norway, Kristiansand — Kristiansand, Norway (Recruiting)
- Akershus University Hospital — Lørenskog, Norway (Recruiting)
- Diakonhjemmet Hospital — Oslo, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Østfold Hospital Trust — Sarpsborg, Norway (Recruiting)
- Vestfold Hospital Trust — Tønsberg, Norway (Recruiting)
Study contacts
- Principal investigator: Reidar Pedersen, PhD — Professor, Centre for medical ethics, University of Oslo
- Study coordinator: Reidar Pedersen, PhD
- Email: reidar.pedersen@medisin.uio.no
- Phone: +47 41575987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.