Aged, 80 and OverNCT05149040
Intensive Care of Elderly: What do They Wish for Themselves?
An observational study of Aged, 80 and Over and Critical Illness, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Do very elderly adults wish intensive care in the event of acute life-threatening illness and are their next of kin able to predict these preferences? Very elderly patients are a steeply increasing patient population in intensive care units (ICUs), but the overall benefit of intensive care for these patients remains… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Aged, 80 and Over, Critical Illness
- What is being tested?
- survey "Intensive care of very elderly: What do they wish for themselves?"
- How many people
- 1,472 participants
- Where
- 1 siteNorway
- Study dates
- 15 Nov 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Community dwelling very elderly outpatients in the catchment area of Haukeland University Hospital, i.e. Greater Bergen Region, Western Norway.
Who may be able to join
None listed.
Who cannot join
- not consenting to participate
- living in permanent care facility / nursing home
- not able to complete the questionnaire owing to:
- severely reduced vision / blindness
- high degree of frailty (Clinical frailty scale ≥ 7)
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Very Elderly Patients' Treatment Preferences and Participation in Shared Decision-making in the Event of Acute Life-threatening Illness
Do very elderly adults wish intensive care in the event of acute life-threatening illness and are their next of kin able to predict these preferences?
Very elderly patients are a steeply increasing patient population in intensive care units (ICUs), but the overall benefit of intensive care for these patients remains controversial. Will ICU admission improve survival and quality of life, or will it prolong suffering and delay natural death? Little is known about very elderly Norwegians life sustaining treatment (LST) preferences in these situations where treatment benefit is uncertain.
Read more
This project aims to improve critically ill very elderly patients' ICU trajectories by bringing forth knowledge about their treatment preferences, their family members' ability to predict these preferences, and by directing attention to the challenges of consent to critical care in cases of medical uncertainty.
A selv administered, mailed survey will be distributed among 400 outpatients aged 80 years or older and their next of kin. Respondents will be recruited at the ophthalmologic, ear-nose-and-throat and orthopaedic outpatient clinics at Haukeland University Hospital Bergen, Norway.
The investigators developed and validated a survey tool for this purpose, containing 3 hypothetical scenarios of acute life-threatening illness. The scenarios are randomly chosen from 20 hypothetical patient histories and are representative for ICU admission diagnoses in Norway and Europe. The participants will be asked for treatment choices, i.e. wishing admission to intensive care or not. A response option 'not wishing to engage in the treatment decision' is also provided.
Furthermore, the questionnaire includes factors that may influence elderlies' treatment preferences and proxies' ability to predict these preferences including: demographics, religion, previous experience with and / or communication about critical illness, comorbidity, frailty, quality of life, and projections (i.e. the proxy's own treatment preferences).
The respondents are requested to explain their choices by free-text comments after each scenario. They are also asked to elaborate how they wish next-of-kin should contribute to decision making in these cases. Additional space for free-text comments is provided in the end of the questionnaire.
The study design is exploratory. Responses will be analysed with both quantitative statistics and qualitative methods.
- Conditions
- Aged, 80 and Over, Critical Illness
- Being tested
- survey "Intensive care of very elderly: What do they wish for themselves?"
- Keywords
- consent, goals of treatment, proxy accuracy, shared decision making
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey "Intensive care of very elderly: What do they wish for themselves?"Other
self-administered mailed survey
| Study group | Role | What they receive |
|---|---|---|
| very elderly outpatients | outpatients (eyes, ear-nose-and throat, orthopaedic outpatient clinics at Haukeland University Hospital, Bergen, Norway) aged 80 years and older Receives: Other: survey "Intensive care of very elderly: What do they wish for themselves?" | |
| proxy | next of kin who likely would act as a proxy in a medical emergency, identified by the very elderly respondent Receives: Other: survey "Intensive care of very elderly: What do they wish for themselves?" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Older Respondents Treatment Preferences in an Event of Acute Life-threatening Illness Warranting ICU Admission as Stated by Themselves and by Their Next of Kin Acting as Proxy
Three mutually exclusive answer options in three randomly assigned clinically scenarios of acute critical illness in advanced age
- Wishing ICU admission
- Not wishing ICU admission
- Not wanting to decide
Measured: within 2 weeks of recruitment / upon completion of the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Nov 2021
- Primary completion31 Mar 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aged, 80 and OverStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Gabriele Leonie I Schwarz, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149040
- Sponsor's protocol ID
- 277504
- Status last verified
- Dec 2024
- First submitted
- 31 Oct 2021
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwarz GL, Sjobo BA, Skaar E, Miljeteig I, Kvale R, Flaatten H, Burns KEA, Han PKJ, Schaufel M. Intensive care under uncertainty: a qualitative study of how older patients and their relatives wish to contribute to decision-making. Eur Geriatr Med. 2026 Jun 18. doi: 10.1007/s41999-026-01523-w. Online ahead of print.
PubMed 42315742
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Elderly Patients' Treatment Preferences and Participation in Shared Decision-making in the Event of Acute Life-threatening Illness
- ClinicalTrials.gov ID
- NCT05149040
- Acronym / sponsor ID
- 277504
- Conditions
- Aged, 80 and Over, Critical Illness
- Keywords
- consent, goals of treatment, proxy accuracy, shared decision making
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,472 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Do very elderly adults wish intensive care in the event of acute life-threatening illness and are their next of kin able to predict these preferences?
Very elderly patients are a steeply increasing patient population in intensive care units (ICUs), but the overall benefit of intensive care for these patients remains controversial. Will ICU admission improve survival and quality of life, or will it prolong suffering and delay natural death? Little is known about very elderly Norwegians life sustaining treatment (LST) preferences in these situations where treatment benefit is uncertain.
This project aims to improve critically ill very elderly patients' ICU trajectories by bringing forth knowledge about their treatment preferences, their family members' ability to predict these preferences, and by directing attention to the challenges of consent to critical care in cases of medical uncertainty.
A selv administered, mailed survey will be distributed among 400 outpatients aged 80 years or older and their next of kin. Respondents will be recruited at the ophthalmologic, ear-nose-and-throat and orthopaedic outpatient clinics at Haukeland University Hospital Bergen, Norway.
The investigators developed and validated a survey tool for this purpose, containing 3 hypothetical scenarios of acute life-threatening illness. The scenarios are randomly chosen from 20 hypothetical patient histories and are representative for ICU admission diagnoses in Norway and Europe. The participants will be asked for treatment choices, i.e. wishing admission to intensive care or not. A response option 'not wishing to engage in the treatment decision' is also provided.
Furthermore, the questionnaire includes factors that may influence elderlies' treatment preferences and proxies' ability to predict these preferences including: demographics, religion, previous experience with and / or communication about critical illness, comorbidity, frailty, quality of life, and projections (i.e. the proxy's own treatment preferences).
The respondents are requested to explain their choices by free-text comments after each scenario. They are also asked to elaborate how they wish next-of-kin should contribute to decision making in these cases. Additional space for free-text comments is provided in the end of the questionnaire.
The study design is exploratory. Responses will be analysed with both quantitative statistics and qualitative methods.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| very elderly outpatients | – | Other: survey "Intensive care of very elderly: What do they wish for themselves?"outpatients (eyes, ear-nose-and throat, orthopaedic outpatient clinics at Haukeland University Hospital, Bergen, Norway) aged 80 years and older |
| proxy | – | Other: survey "Intensive care of very elderly: What do they wish for themselves?"next of kin who likely would act as a proxy in a medical emergency, identified by the very elderly respondent |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community dwelling very elderly outpatients in the catchment area of Haukeland University Hospital, i.e. Greater Bergen Region, Western Norway.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- not consenting to participate
- living in permanent care facility / nursing home
- not able to complete the questionnaire owing to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey "Intensive care of very elderly: What do they wish for themselves?"self-administered mailed survey | Other | proxy, very elderly outpatients |
Primary outcome
Older Respondents Treatment Preferences in an Event of Acute Life-threatening Illness Warranting ICU Admission as Stated by Themselves and by Their Next of Kin Acting as Proxy
Time frame: within 2 weeks of recruitment / upon completion of the questionnaire
Three mutually exclusive answer options in three randomly assigned clinically scenarios of acute critical illness in advanced age 1. Wishing ICU admission 2. Not wishing ICU admission 3. Not wanting to decide
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42315742Schwarz GL, Sjobo BA, Skaar E, Miljeteig I, Kvale R, Flaatten H, Burns KEA, Han PKJ, Schaufel M. Intensive care under uncertainty: a qualitative study of how older patients and their relatives wish to contribute to decision-making. Eur Geriatr Med. 2026 Jun 18. doi: 10.1007/s41999-026-01523-w. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Leonie I Schwarz, MD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged, 80 and Over and Critical Illness, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Older Respondents Treatment Preferences in an Event of Acute Life-threatening Illness Warranting ICU Admission as Stated by Themselves and by Their Next of Kin Acting as Proxy (time frame: within 2 weeks of recruitment / upon completion of the questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.