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

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Critical Illness; Aged, 80 and Over
• Intervention / Treatment: Other: survey "Intensive care of very elderly: What do they wish for themselves?"

• Study Type: Observational
• Enrollment (Actual): 736

Contacts and Locations

• Study Contact: Name: Gabriele Leonie Schwarz, MD; Phone Number: 0047-55876850; Email: gabriele.leonie.schwarz@helse-bergen.no
• Study Contact Backup: Name: Margrethe Schaufel, PhD; Email: margrethe.aase.schaufel@helse-bergen.bo

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 78 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria: Outpatients aged 80 years or older who register for appointment at the ophthalmologic, ear-nose-and-throat, and orthopaedic outpatient clinic at Haukeland University Hospital, Bergen, Norway.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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?"; 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	Other: survey "Intensive care of very elderly: What do they wish for themselves?"; self-administered mailed survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very elderly respondents treatment preferences in an event of acute life-threatening illness warranting ICU admission	"I wish ICU admission" "I do not wish ICU admission" "I do not wish to engage in the decision"	within 2 weeks of recruitment / upon completion of the questionnaire
Proxies prediction of the very elderly participants treatment preferences in an event of acute life-threatening illness	"She/he wishes ICU admission" "She/he does not wish ICU admission" "She/he does not wish to engage in the decision"	within 2 weeks of recruitment / upon completion of the questionnaire

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very elderly respondents preference whether to engage their next-of-kin into the decision process	"yes" "no" "do not know"	within 2 weeks of recruitment / upon completion of the questionnaire
Confidence of very elderly respondent in their next-of-kins ability to predict their preferences	5 degrees of certainty / uncertainty	within 2 weeks of recruitment / upon completion of the questionnaire
Very elderly respondents intensive care experience either as patient or relative	"yes" "know"	within 2 weeks of recruitment / upon completion of the questionnaire
Presence of advance directives (verbal or written)	"yes" "no"	within 2 weeks of recruitment / upon completion of the questionnaire
Age of the very elderly respondent	years	within 2 weeks of recruitment / upon completion of the questionnaire
Gender of the very elderly respondent	"male" "female" "other"	within 2 weeks of recruitment / upon completion of the questionnaire
Marital status of the very elderly respondent	"single" "married" "widowed" "separated/divorced"	within 2 weeks of recruitment / upon completion of the questionnaire
Religion of the very elderly respondent	"christian" "other religion" "no religion"	within 2 weeks of recruitment / upon completion of the questionnaire
Educational level of the very elderly respondent	4 levels: primary school, secondary school, vocational school, high school / university	within 2 weeks of recruitment / upon completion of the questionnaire
Profession of the very elderly respondent	2 categories: health care profession, non-health care related profession	within 2 weeks of recruitment / upon completion of the questionnaire
Comorbidity of the very elderly respondent	Charlson Comorbidity Index, self-reported, score 0 to 24, with 24 indicating highest severity.	within 2 weeks of recruitment / upon completion of the questionnaire
Frailty of the very elderly respondent	Clinical Frailty Scale, self-assessed, score 1 to 9, with 9 indicating the highest degree of frailty.	within 2 weeks of recruitment / upon completion of the questionnaire
Health related quality of life of the very elderly respondent	EuroQOL 5D-5L, self-completed, visual analogue scale 0 to 100, with 100 indicating highest health related quality of life	within 2 weeks of recruitment / upon completion of the questionnaire
Proxy respondents preference whether to engage into the decision process	"yes" "no" "do not know"	within 2 weeks of recruitment / upon completion of the questionnaire
Confidence of the proxy respondent in his / her ability to predict very elderly participants treatment preferences	5 degrees of certainty / uncertainty	within 2 weeks of recruitment / upon completion of the questionnaire
Proxy respondents intensive care experience either as patient or relative	"yes" "no"	within 2 weeks of recruitment / upon completion of the questionnaire
Proxy respondents knowledge regarding the presence of advance directives (verbal or written) by the elderly participant	"yes" "no"	within 2 weeks of recruitment / upon completion of the questionnaire
The very elderly participants health as perceived by their proxy	Charlson Comorbidity Index, reported by proxy, score 0 to 24, with 24 indicating highest severity.	within 2 weeks of recruitment / upon completion of the questionnaire
The very elderly participants frailty as perceived by their proxy	Clinical Frailty Scale, assessed by proxy, score 1 to 9, with 9 indicating the highest degree of frailty.	within 2 weeks of recruitment / upon completion of the questionnaire
The very elderlies health related quality of life as perceived by their proxy	EuroQOL 5D-5L, completed by proxy, visual analogue scale 0 to 100, with 100 indicating highest health related quality of life	within 2 weeks of recruitment / upon completion of the questionnaire
Age of the proxy respondent	years	within 2 weeks of recruitment / upon completion of the questionnaire
Gender of the proxy respondent	"male" "female" "other"	within 2 weeks of recruitment / upon completion of the questionnaire
Marital status of the proxy respondent	"single" "married" "widowed" "separated/divorced"	within 2 weeks of recruitment / upon completion of the questionnaire
Religion of the proxy respondent	"christian" "other religion" "no religion"	within 2 weeks of recruitment / upon completion of the questionnaire
Educational level of the proxy respondent	4 levels: primary school, secondary school, vocational school, high school / university	within 2 weeks of recruitment / upon completion of the questionnaire
Profession of the proxy respondent	2 categories: health care profession, non-health care related profession	within 2 weeks of recruitment / upon completion of the questionnaire

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Gabriele Leonie I Schwarz, MD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): March 31, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 31, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: shared decision making; consent; goals of treatment; proxy accuracy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 277504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No