FrailtyDelirium Confusional StatePersistent Critical IllnessPost-Intensive Care SyndromeHealth-related Quality of Life
Study summary
Every year, many critically ill patients are admitted to an intensive care unit (ICU). Most stay only a few days, but a smaller group stays much longer. In Sweden, patients treated in the ICU for more than 10 days account for about 35 percent of all ICU days. Little is known about why some patients need prolonged intensive care, or how their lives are affected afterwards.
LIFE-ICU is a planned national observational cohort study of adult patients in general intensive care. This record covers the feasibility study that precedes the main study, including its pilot part.
The feasibility study does not change the care patients receive. About 200 adult patients who have been treated in a general ICU for more than four days will be included consecutively at the participating ICUs. For each patient, a designated next of kin, usually the family member or friend most involved during the ICU stay, is invited to take part. Information is collected from the medical record about health before admission and about the ICU stay, for example organ support, delirium, nutrition and mobilisation. At ICU discharge, patients answer four questions about distressing memories from the ICU.
Six months after final discharge from intensive care, patients are contacted by letter and then by telephone. They answer questions about health status, quality of life, anxiety and depression, post-traumatic stress, fatigue, life satisfaction, frailty, overall function and occupational status. Designated next of kin answer questions about their own life satisfaction, post-traumatic stress and caregiver burden, provided that the patient is alive at the time of follow-up. A selection of patients and next of kin are also invited to an interview about their experiences of intensive care and of recovery. Staff who collect the data answer an anonymous questionnaire about how the data collection worked.
The study compares patients whose total ICU stay is more than 10 days with patients whose stay is more than 4 days and at most 10 days.
The main purpose of the feasibility study is to find out whether the planned data collection works in practice. This is assessed against criteria set in advance: how many of the eligible patients can actually be included, how complete the collected data are, and how many patients and next of kin respond at six months. The pilot part also provides the estimates needed to plan the main study, such as the proportion of patients who stay in the ICU for more than 10 days and how the measured factors are distributed.
Hypothesis: the feasibility study tests the hypothesis that the planned data collection is feasible within routine intensive care and yields data of sufficient completeness and quality to inform the design of the main study. The main study is designed to test the hypothesis that factors present before ICU admission and during the first days of intensive care contribute to a prolonged ICU stay, that some of these factors can be modified, and that they are also associated with worse long-term outcome. The feasibility study is not powered to test this hypothesis.
The long-term goal is better knowledge about prolonged intensive care, so that prognostic information can become more accurate, care can be planned more individually, and patients and next of kin can receive better support during and after the ICU stay.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria for patients:
* ICU stay of more than 4 days (96 hours) in a participating general intensive care unit (ICU)
* Age 18 years or older
* The first full 4 days of the current episode of intensive care were delivered at one or more participating ICUs. Patients transferred in from a non-study ICU during the first 4 days are not eligible.
* No formal decision to withdraw life sustaining treatment taken before 4 days of ICU care
* Consent according to the two step procedure of the study, that is written informed consent from the patient, or, when the patient lacks decision making capacity at inclusion, consultation with the next of kin followed by written informed consent from the patient once decision making capacity is regained
* The next of kin, identified as primary contact in the medical record or by the patient's choice, does not object to the patient's inclusion
* When no next of kin or legal representative can be identified despite documented attempts before 6 days of ICU care have elapsed, the patient may be included without prior consultation, and written informed consent is sought once decision making capacity is regained
Exclusion Criteria for patients:
* 6 days (144 hours) or more since ICU admission at the time of inclusion
* The patient in any form expresses unwillingness to take part
Inclusion Criteria for designated next of kin:
* Age 18 years or older
* Designated next of kin of an included patient, preferably the next of kin most involved in the patient's care in the ICU, or another person in line with the wishes of the patient and next of kin
* Written informed consent, obtained during the ICU stay or, when needed, at the six month follow-up
Exclusion Criteria for designated next of kin:
* The patient died before the designated next of kin was included
* Unable to complete the questionnaires in Swedish
Primary outcome measure(s)
Inclusion rate: proportion of eligible screened patients who are included — From eligibility at more than 4 days of ICU care until inclusion, through the inclusion period of 12 months Denominator is all patients screened during the inclusion period who fulfil the eligibility criteria other than consent and no objection, that is age, timing, ICU episode and treatment limitation. Numerator is those included. Screening is documented in a log at each site with one row per screened patient. Reasons for non-inclusion are categorised as consent requirements not met, patient objects, next of kin objects, decision to withdraw life sustaining treatment taken before eligibility, logistic reasons, and other. The proportion is reported overall and per site with a 95 percent confidence interval. Progression criteria: at least 80 percent, proceed without change. 60 to 79 percent, proceed after revision of screening and consent routines. Below 60 percent, redesign before the main study.
Data completeness: proportion of applicable required fields completed in the electronic case report form — From ICU admission through final ICU discharge within the episode, an estimated average of 14 days Denominator is all required fields, and conditional fields rendered applicable by branching logic, for included patients across the baseline form, the retrospective forms for ICU days 0 to 3, the daily and per shift forms from day 4 until ICU discharge, and the discharge form. Numerator is fields containing a valid value. Completeness is reported overall, per form, per data domain and by inclusion route with a 95 percent confidence interval, together with patterns of missing data and the proportion of patients with a complete record. Progression criteria: at least 95 percent, proceed without change. 85 to 94 percent, proceed after revision of the form and the data collection manual. Below 85 percent, redesign before the main study.
Six month follow-up response rate in patients and designated next of kin — Six months after final ICU discharge within the episode, through the reminder period of 4 weeks Numerator is participants who complete or return at least one follow-up instrument. Denominator for patients is all included patients alive at follow-up, including those unable to complete the questionnaires in Swedish. Denominator for designated next of kin is all identified designated next of kin who have consented and whose patient is alive at follow-up. Contact follows the predefined letter, telephone and reminder routine for each group. Rates are reported separately with 95 percent confidence intervals, together with the proportion completing all instruments, the number of contact attempts, reasons for non-response, and the number of designated next of kin who declined consent at follow-up. Progression criteria for patients: at least 75 percent, proceed. 60 to 74 percent, revise routines. Below 60 percent, redesign. Levels for designated next of kin are 10 percentage points lower.
Trial sites (4)
Facility
City
Region
Status
Falu lasarett, Intensivvårdsavdelningen
Falun
Sweden
Hudiksvalls sjukhus, Intensivvårdsavdelningen
Hudiksvall
Sweden
Mora lasarett, Intensivvårdsavdelningen
Mora
Sweden
Akademiska sjukhuset, Centrala intensivvårdsavdelningen
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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