Intensive Care of Elderly: What do They Wish for Themselves?

NCT05149040 | Active Not Recruiting Results

• 1 other identifier: 277504
• Study Type: observational
• Target: 1,472
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Aged, 80 and Over; Critical Illness

Keywords

consent; goals of treatment; proxy accuracy; shared decision making

Outcome Measures

Primary Outcomes (1)

• 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 1. Wishing ICU admission 2. Not wishing ICU admission 3. Not wanting to decide

  within 2 weeks of recruitment / upon completion of the questionnaire

Study Arms (2)

very elderly outpatients

outpatients (eyes, ear-nose-and throat, orthopaedic outpatient clinics at Haukeland University Hospital, Bergen, Norway) aged 80 years and older

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

Other: survey "Intensive care of very elderly: What do they wish for themselves?"

Interventions

survey "Intensive care of very elderly: What do they wish for themselves?" OTHER

self-administered mailed survey

proxy; very elderly outpatients

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community dwelling very elderly outpatients in the catchment area of Haukeland University Hospital, i.e. Greater Bergen Region, Western Norway.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. G.L. Schwarz
• Organization: Helse Bergen

gabriele.leonie.schwarz@helse-bergen.no

0047-55976850

Study Officials

• Gabriele Leonie I Schwarz, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: December 8, 2021
• Study Start: November 15, 2021
• Primary Completion: March 31, 2023
• Study Completion: December 1, 2025
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)