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

Critical Illness Clinical Trial

Official title:

Very Elderly Patients' Treatment Preferences and Participation in Shared Decision-making in the Event of Acute Life-threatening Illness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05149040
• Other study ID #: 277504
• Status: Active, not recruiting
• Start date: November 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 736
• Est. completion date: December 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged, 80 and Over
• Critical Illness

Intervention

Other:
• survey "Intensive care of very elderly: What do they wish for themselves?"
self-administered mailed survey

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Very elderly respondents intensive care experience either as patient or relative	"yes" "know"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Presence of advance directives (verbal or written)	"yes" "no"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Age of the very elderly respondent	years	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Gender of the very elderly respondent	"male" "female" "other"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Marital status of the very elderly respondent	"single" "married" "widowed" "separated/divorced"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Religion of the very elderly respondent	"christian" "other religion" "no religion"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proxy respondents intensive care experience either as patient or relative	"yes" "no"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Age of the proxy respondent	years	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Gender of the proxy respondent	"male" "female" "other"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Marital status of the proxy respondent	"single" "married" "widowed" "separated/divorced"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	Religion of the proxy respondent	"christian" "other religion" "no religion"	within 2 weeks of recruitment / upon completion of the questionnaire
Secondary	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
Secondary	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