Advanced Care Planning for the Severely Ill Home-dwelling Elderly (NCT05681585) | Clinical Trial Compass
RecruitingNot Applicable
Advanced Care Planning for the Severely Ill Home-dwelling Elderly
Norway2,000 participantsStarted 2023-10-18
Plain-language 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.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 toge…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning
Timeframe: 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
Timeframe: During the intervention period (10-18 months after the start of the implementation support)
3
Clinical effectiveness study 2: Relative-reported outcome
Timeframe: During the intervention period (10-18 months after the start of the implementation support)
4
Clinical effectiveness study 3: Clinician outcome
Timeframe: During the intervention period (10-18 months after the start of the implementation support)