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

NCT ID: NCT05149040

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1472 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

very elderly outpatients

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

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

Intervention Type: OTHER

self-administered mailed survey

proxy

next of kin who likely would act as a proxy in a medical emergency, identified by the very elderly respondent

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

Intervention Type: OTHER

self-administered mailed survey

Interventions

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

self-administered mailed survey

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

1. not consenting to participate

2. living in permanent care facility / nursing home

3. not able to complete the questionnaire owing to:

• severely reduced vision / blindness
• high degree of frailty (Clinical frailty scale ≥ 7)
• cognitive impairment

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriele Leonie I Schwarz, MD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

277504

Identifier Type: -

Identifier Source: org_study_id