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
Verified date | May 2023 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | University of Bergen |
Norway,
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 |
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