[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658423":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":76,"studyPopulation":77,"armGroups":78,"interventions":72,"overallOfficials":88,"centralContacts":94,"locations":102,"responsibleParty":157,"collaborators":159,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":169,"sex":175,"minAge":176,"maxAge":72,"enrollmentInfo":177,"targetDuration":72,"studyType":180,"phases":72,"briefSummary":181,"conditions":182,"keywords":188,"overallStatus":202,"whyStopped":72,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"Uppsala University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":72},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Inclusion rate: proportion of eligible screened patients who are included","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.","From eligibility at more than 4 days of ICU care until inclusion, through the inclusion period of 12 months",{"measure":14,"description":15,"timeFrame":16},"Data completeness: proportion of applicable required fields completed in the electronic case report form","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.","From ICU admission through final ICU discharge within the episode, an estimated average of 14 days",{"measure":18,"description":19,"timeFrame":20},"Six month follow-up response rate in patients and designated next of kin","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.","Six months after final ICU discharge within the episode, through the reminder period of 4 weeks",[22,25,28,32,36,40,43,47,51,54,58,61,65,69],{"measure":23,"description":24,"timeFrame":16},"Timeliness of data entry into the electronic case report form","Days from generation of a data item at the bedside to entry of that item in REDCap, reported as median and interquartile range overall, per form and per site. Timeliness is interpreted together with data completeness when the data collection routines of the main study are specified.",{"measure":26,"description":27,"timeFrame":16},"Proportion of patients with a total ICU length of stay of more than 10 days","Proportion of included patients whose total ICU length of stay is more than 10 days (240 hours), reported with a 95 percent confidence interval. Total ICU length of stay comprises all consecutive ICU care within the same continuous episode of critical illness, including care at non-study ICUs after transfer. This proportion is the main input for the sample size calculation of the main study. Distributions of candidate predictors and confounders, their variances and correlations, and exploratory regression estimates are reported separately as described in the detailed description.",{"measure":29,"description":30,"timeFrame":31},"Record linkage to the Swedish Intensive Care Registry","Proportion of included patients for whom a corresponding record can be retrieved from the Swedish Intensive Care Registry using the secondary key, reported with a 95 percent confidence interval. Reasons for failed linkage are categorised. The proportion of patients whose total ICU length of stay could only be established through registry data, that is patients transferred to a non-study ICU, is also reported.","At completion of follow-up, approximately 20 months after the first inclusion",{"measure":33,"description":34,"timeFrame":35},"Distribution of inclusion routes","Proportion of included patients in each inclusion route, that is written informed consent from the patient at inclusion, consultation with the next of kin, or inclusion without prior consultation because no next of kin or legal representative could be identified despite documented attempts. Reported with 95 percent confidence intervals, overall and per site. Patients included without prior consultation are compared with the remaining cohort as described in the detailed description.","At inclusion, within 6 days of ICU admission",{"measure":37,"description":38,"timeFrame":39},"Consent outcome in patients not able to give written informed consent at inclusion","Among patients included after consultation with the next of kin or without prior consultation, the proportion who subsequently provided written informed consent, the proportion who declined, and the proportion who never regained decision making capacity. Reported with 95 percent confidence intervals. For patients who declined, the proportion who allowed use of data already collected is reported.","From inclusion through six months after final ICU discharge within the episode",{"measure":41,"description":42,"timeFrame":39},"Proportion of included patients with a designated next of kin eligible for six month follow-up","Proportion of included patients for whom a designated next of kin was identified, consented and remained eligible for follow-up, that is the patient was alive at follow-up. Reasons for loss are reported in the same categories, that is no designated next of kin identified, not included or declined, unable to complete the questionnaires in Swedish, and patient died before follow-up. This proportion defines the achievable denominator for outcomes reported by designated next of kin in the main study.",{"measure":44,"description":45,"timeFrame":46},"Ascertainment of the date of final ICU discharge after transfer to a non-study ICU","Among included patients transferred to a non-study ICU during the episode, the proportion for whom the date of final ICU discharge could be established from the medical record in time for group assignment and for scheduling of the six month follow-up. The proportion of included patients transferred to a non-study ICU is reported alongside.","From ICU admission through registry linkage after final ICU discharge, up to 24 months",{"measure":48,"description":49,"timeFrame":50},"Difference between the site recorded and the registry recorded date of final ICU discharge","Difference in days between the date of final ICU discharge established by the site and the date retrieved from the Swedish Intensive Care Registry, reported as median and range, together with the number of patients with discordant dates and the number in whom the discordance changes group assignment.","At registry linkage after final ICU discharge, up to 24 months",{"measure":52,"description":53,"timeFrame":16},"ICU mortality","Proportion of included patients who die during intensive care, reported with a 95 percent confidence interval. Death in the ICU truncates ICU length of stay and is a competing risk in analyses of prolonged ICU stay. The proportion informs the extent of competing risk, the sample size calculation and the analysis plan of the main study. The feasibility study is not powered for comparison between groups.",{"measure":55,"description":56,"timeFrame":57},"Mortality at six months","Proportion of included patients who have died six months after final ICU discharge, reported with a 95 percent confidence interval. The proportion informs event frequencies and the sample size calculation of the main study, and determines how many designated next of kin remain eligible for follow-up. The feasibility study is not powered for comparison between groups.","Six months after final ICU discharge within the episode",{"measure":59,"description":60,"timeFrame":57},"Completeness of patient reported outcome instruments","Proportion of items containing a valid response among all items applicable to responding patients, reported per instrument with a 95 percent confidence interval. The instruments are EQ-5D-5L with EQ-VAS, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory (MFI-20), Life Satisfaction Questionnaire (Lisat-11), Glasgow Outcome Scale Extended, Clinical Frailty Scale, Post-Traumatic Stress Syndrome-14 (PTSS-14) Parts A and B, and occupational status compared with before ICU admission. The proportion of responding patients who complete each instrument, and the mode of administration, that is self report or assisted by telephone, are reported alongside. Score distributions are reported as described in the detailed description.",{"measure":62,"description":63,"timeFrame":64},"Completeness of instruments reported by designated next of kin","Proportion of items containing a valid response among all items applicable to responding designated next of kin, reported per instrument with a 95 percent confidence interval. The instruments are the Life Satisfaction Questionnaire (Lisat-11), the Caregiver Burden Scale and Post-Traumatic Stress Syndrome-14 (PTSS-14) Part B, together with background questions including occupational status. They are administered only when the patient is alive at follow-up. Score distributions are reported as described in the detailed description.","Six months after the patient's final ICU discharge within the episode",{"measure":66,"description":67,"timeFrame":68},"Staff rated feasibility of the data collection","Proportion of respondents who agree with each statement on clarity of instructions, workload and practical feasibility, rated on a four point scale in an anonymous paper questionnaire and reported per step of the data collection. Part A is answered by nurses, physicians and physiotherapists who recorded bedside data and is reported by site. Parts B1 and B2 are answered by research nurses and local investigators for the ICU period and the six month follow-up and are pooled across sites to preserve anonymity. Free text responses are categorised by content.","At the end of the inclusion period and at completion of the six month follow-up, up to 24 months",{"measure":70,"description":71,"timeFrame":68},"Time spent on data collection reported by staff","Time spent per step of the data collection as reported by staff in the anonymous questionnaire, reported as median and interquartile range per step. Part A covers bedside data collection per shift. Parts B1 and B2 cover screening, inclusion, data entry and six month follow-up per patient. Results are interpreted together with staff rated feasibility when the resource requirement of the main study is estimated.",null,{"allocation":72,"interventionModel":72,"interventionModelDescription":72,"primaryPurpose":72,"observationalModel":74,"timePerspective":75,"maskingInfo":72},"COHORT","PROSPECTIVE","Background and rationale\n\nPatients with an ICU stay of more than 10 days make up about 5 percent of admissions to Swedish general ICUs but account for approximately 35 percent of all ICU days. Comorbidity and frailty contribute to prolonged intensive care, and other suggested factors include age, sex, severity of illness, prolonged mechanical ventilation, acute kidney injury, malnutrition, ICU acquired weakness and delirium. Prospective Swedish data are lacking, in particular on care processes that may be modifiable and on long-term recovery. LIFE-ICU is designed as a national prospective cohort study to address this gap. A feasibility study is required before the main study in order to test the data collection and to generate the estimates needed for the sample size calculation.\n\nObjectives\n\nThe feasibility study has two parts. The primary objective, addressed by the feasibility part, is to assess the feasibility of the planned data collection process, covering screening and consent procedures, bedside daily data capture, entry into the electronic case report form, six month follow-up of patients and designated next of kin, and record linkage to the Swedish Intensive Care Registry. Feasibility is assessed against predefined progression criteria for inclusion rate, data completeness and six month response rate.\n\nThe secondary objective, addressed by the pilot part, is to describe the distribution of exposures, candidate predictors and confounders in relation to prolonged ICU stay, and to obtain estimates of proportions, variances and correlations required for the sample size calculation and for the specification of multivariable models in the main study.\n\nDesign and setting\n\nProspective, multicentre, observational cohort feasibility study with a pilot part, sponsored by Uppsala University. The study is non-interventional and no clinical management is dictated by the protocol. Inclusion is performed at general ICUs only, defined at unit level according to the unit classification of the Swedish Intensive Care Registry. Specialised units, that is cardiothoracic, neurointensive, burn and paediatric intensive care units, do not include patients. Patients are eligible irrespective of admission diagnosis. The planned inclusion period is approximately 12 months.\n\nDefinitions and timing\n\nAll time intervals are calculated from the time of ICU admission, and thresholds are exclusive. Eligibility requires that the first full 4 days of the current episode of intensive care were delivered at one or more participating ICUs, since daily data for ICU days 0 to 3 are collected retrospectively from the medical record. Patients become eligible when \\>4 days (\\>96 hours) of ICU care have elapsed and must be included before 6 days (144 hours) have elapsed.\n\nTotal ICU length of stay comprises all consecutive ICU care within the same continuous episode of critical illness, including care delivered at non-study ICUs following transfer, ascertained from the medical record or from the Swedish Intensive Care Registry. The episode ends when the patient is discharged from ICU care without a subsequent ICU admission during the same hospital episode. Prolonged ICU stay is defined as \\>10 days (\\>240 hours) and intermediate ICU stay as \\>4 days (\\>96 hours) and ≤10 days (≤240 hours). Group assignment is made at final ICU discharge within the episode, irrespective of vital status at discharge.\n\nPatients transferred to another participating ICU keep their study identifier and data collection continues. When data collection is not feasible at a non-study ICU, ICU care is captured through the Swedish Intensive Care Registry, and the responsible site monitors the medical record to establish the date of final ICU discharge.\n\nNext of kin and designated next of kin\n\nThe next of kin is the person who represents the patient's interests during the ICU stay, identified as primary contact in the medical record, and is consulted when the patient lacks decision making capacity. The designated next of kin is the person invited to take part in the study in their own right, 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. The two roles are usually, but not necessarily, held by the same person.\n\nScreening and consent\n\nAll patients in participating general ICUs are screened consecutively once the ICU stay exceeds 4 days. Each site keeps a screening log with one row per screened patient, recording sex, age in years, the date on which the eligibility criteria were met, the reason for non-inclusion and, for included patients, the study identifier. 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 log contains no name and no personal identity number and is kept at the site. Only aggregated counts per category are transferred.\n\nBecause reduced decision making capacity is common in this population, consent follows a two step procedure. Patients who lack decision making capacity at inclusion are included after consultation with the next of kin. The patient is not included, or is withdrawn if already included, if the next of kin objects or if the patient in any form expresses unwillingness to take part. Written informed consent is sought from the patient as soon as decision making capacity is regained. A patient who does not consent is asked whether data already collected may be used. An interpreter is used for information and consent when needed.\n\nWhen 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, in accordance with Swedish legislation on ethical review. Written informed consent is sought as soon as decision making capacity is regained. If a next of kin or legal representative is identified later during the ICU stay, consultation is held at that point. If a patient never regains decision making capacity, data already collected are retained and analysed, unless the patient expressed unwillingness to take part or a later identified next of kin or legal representative objects.\n\nThe designated next of kin is identified and approached during the ICU stay. Written informed consent is obtained during the ICU stay or, when needed, at the six month follow-up, when the questionnaires are completed. Designated next of kin who cannot complete the questionnaires in Swedish are not included.\n\nData collection during intensive care\n\nBaseline data include age, sex and gender, body mass index, admission diagnosis, severity of illness according to SAPS 3, comorbidity according to the Charlson Comorbidity Index, premorbid frailty according to the Clinical Frailty Scale, tobacco habits, alcohol habits according to AUDIT, educational level, civil status and occupational status. Several premorbid variables are reported by the patient or next of kin. The electronic case report form records the inclusion route, that is written informed consent from the patient, consultation with the next of kin, or inclusion without prior consultation. Daily data for ICU days 0 to 3 are collected retrospectively at inclusion.\n\nFrom day 4 until ICU discharge, data are recorded per nursing shift and per day. The daily data set includes organ dysfunction according to SOFA-2, ability to communicate, level of consciousness and sedation, delirium screening with CAM-ICU, Nu-DESC or 4AT, sedative and analgesic drugs, pain assessment, sleep, invasive and non-invasive ventilatory support and weaning, tracheostomy, vasopressor and inotropic support, arrhythmia, transfusions, pressure ulcers, infection parameters and antibiotics, nutrition and fluid balance, elimination and renal replacement therapy, drains, mobilisation and physical function according to CPAx, support from next of kin, examinations, transports and surgery, routine laboratory values, and treatment limitation decisions. Gender and years of ICU experience of the nurse and physician responsible for each shift are also recorded.\n\nAt ICU discharge, administrative data, venous and arterial thrombosis or embolism, positive cultures and PCR results, ICU diagnoses from the medical record and vital status are recorded, and patients complete Part A of the Post-Traumatic Stress Syndrome-14 questionnaire (PTSS-14).\n\nDuring the feasibility study, a paper based bedside form is used and adapted, and data are then entered into the electronic case report form in REDCap. Each field is classified as required or conditional, conditional fields applying only when the corresponding treatment, assessment or event occurred.\n\nFollow-up at six months\n\nFollow-up takes place six months after final ICU discharge within the episode, irrespective of where the care was delivered.\n\nPatients are first contacted by letter containing information, self report questionnaires and a proposed time for a telephone call. During the call, a study nurse or investigator reviews the questionnaires and records vital status, occupational status and assessor rated instruments. If the patient cannot be reached, two further call attempts are made on separate days. If there is no response two weeks after the first letter, a reminder letter is sent, followed by one final call. No further contact is made thereafter. The number of contact attempts is recorded. Patients are included irrespective of language, and inability to complete the questionnaires in Swedish is recorded as a reason for non-response.\n\nPatient instruments cover health status (EQ-5D-5L with EQ-VAS), anxiety and depression (Hospital Anxiety and Depression Scale), fatigue (Multidimensional Fatigue Inventory, MFI-20), life satisfaction (Lisat-11), post-traumatic stress (PTSS-14 Parts A and B), frailty (Clinical Frailty Scale), overall function (Glasgow Outcome Scale Extended) and occupational status compared with before ICU admission, together with a voluntary open question.\n\nDesignated next of kin are followed up provided that the patient is alive at the time of follow-up. They receive a letter with information, questionnaires and a return envelope. If no response has been received after two weeks, they are contacted by telephone, and the call is repeated once after another two weeks. No further contact is made thereafter. The instruments cover life satisfaction (Lisat-11), caregiver burden (Caregiver Burden Scale) and post-traumatic stress (PTSS-14 Part B), together with background questions including occupational status and a voluntary open question. When the patient has died, no questionnaires are sent, as described in the participant information. The instruments presuppose an ongoing caregiving relationship, and next of kin are supported through routine clinical follow-up. Data already collected are retained and reported descriptively.\n\nQualitative interviews\n\nA strategic selection of patients and designated next of kin is invited to semi structured individual interviews about experiences of prolonged intensive care, recovery, effects on everyday life and support needs. Interviews are audio recorded, transcribed and de-identified, and analysed using thematic analysis. Participants are recruited across the feasibility study and the main study until data saturation is reached.\n\nStaff questionnaire on feasibility\n\nAt the end of the inclusion period, and at completion of follow-up at each site, an anonymous paper questionnaire is distributed to the staff who carried out the data collection. Part A is answered by nurses, physicians and physiotherapists who recorded bedside data. Parts B1 and B2 are answered by research nurses and local investigators and cover the ICU period and the six month follow-up. For each step of the data collection, respondents rate clarity of instructions, workload and practical feasibility on a four point scale and report time spent. No names or other identifying data are recorded.\n\nRecord linkage\n\nAt completion of the feasibility study, study data are linked to the Swedish Intensive Care Registry to capture intensive care delivered at units outside the study and to verify discharge dates. Linkage uses a secondary key that is destroyed once data have been retrieved. Linkage to national health, population and social insurance registries is planned for the main study and is not part of this record.\n\nSample size and analysis\n\nApproximately 200 patients are included, together with their designated next of kin. The number is based on feasibility within the planned inclusion period and on the need for sufficient observations to describe distributions of exposures and outcomes, to estimate effect sizes, variances and correlations, to evaluate loss to follow-up and missing data, and to assess data quality and logistics. The feasibility study is not powered to demonstrate a specific association.\n\nFeasibility measures are reported as proportions with 95 percent confidence intervals and assessed against the progression criteria. Analyses in the pilot part are descriptive and exploratory. Distributions of exposures, confounders and outcomes are described, and crude and adjusted associations are estimated with regression models appropriate to the outcome type, in order to quantify the influence of candidate confounders on effect estimates. Patterns and mechanisms of missing data are examined, and completeness, internal consistency and timeliness of data collection are assessed. Patients included without prior consultation are compared with the remaining cohort, and data completeness is reported by inclusion route. Non-response at six months is reported by reason. ICU length of stay is subject to competing risk from death in the ICU, handled as specified in the statistical analysis plan. Staff questionnaire responses are summarised per data collection step, with responses from research staff pooled across sites to preserve anonymity. Reporting follows STROBE with the RECORD extension, and COREQ for the qualitative component. Results inform the sample size calculation, the statistical analysis plan and the design of the main study. Age and sex of screened patients are compared with those of included patients. Patients included without prior consultation are compared with the remaining cohort with respect to age, sex, SAPS 3, comorbidity, ICU length of stay and mortality, and data completeness is reported by inclusion route, since several premorbid variables are proxy reported. For each instrument reported by patients and by designated next of kin, score distributions and variances are described, together with correlations between candidate predictors. These descriptive estimates are exploratory and are used to specify the sample size calculation and the multivariable models of the main study.\n\nData management\n\nData are entered into REDCap within a secure IT environment. Each participant is assigned a study identifier, and names and personal identity numbers are replaced by a code. The code key is kept separately at each site with restricted access. Coded research data are stored for 10 years. All handling complies with the General Data Protection Regulation. Data controller responsibility is allocated between Uppsala University and the participating regions by written agreement.","Adult patients cared for in general intensive care units at participating university, county and district hospitals in Sweden, delivering mixed medical, surgical and trauma intensive care. All patients whose ICU stay exceeds 4 days are screened consecutively during the inclusion period, irrespective of admission diagnosis, so that the cohort reflects the case mix of routine Swedish general intensive care rather than a selected diagnostic group. Specialised units, that is cardiothoracic, neurointensive, burn and paediatric intensive care units, do not include patients. Designated next of kin of included patients take part in their own right, preferably the next of kin most involved in the patient's care in the ICU.",[79,82,85],{"label":80,"type":72,"description":81,"interventionNames":72},"Intermediate ICU stay (more than 4 to 10 days)","Adult patients included after more than 4 days (96 hours) of care in a participating general ICU whose total ICU length of stay is more than 4 days (\\>96 hours) and at most 10 days (≤240 hours). Total ICU length of stay comprises all consecutive ICU care within the same continuous episode of critical illness, including care at non-study ICUs after transfer. Group assignment is made at final ICU discharge within the episode, irrespective of vital status at discharge.",{"label":83,"type":72,"description":84,"interventionNames":72},"Prolonged ICU stay (more than 10 days)","Adult patients included after more than 4 days (96 hours) of care in a participating general ICU whose total ICU length of stay is more than 10 days (\\>240 hours). Total ICU length of stay comprises all consecutive ICU care within the same continuous episode of critical illness, including care at non-study ICUs after transfer. Group assignment is made at final ICU discharge within the episode, irrespective of vital status at discharge.",{"label":86,"type":72,"description":87,"interventionNames":72},"Designated next of kin","Adults taking part in their own right as designated next of kin of patients included in either patient cohort, preferably the next of kin most involved in the patient's care in the ICU. The designated next of kin is identified and approached during the ICU stay, and written informed consent is obtained during the ICU stay or, when needed, at the six month follow-up. Participation requires ability to complete the questionnaires in Swedish. Six months after the patient's final ICU discharge, designated next of kin complete questionnaires on life satisfaction, post-traumatic stress and caregiver burden, provided that the patient is alive at the time of follow-up. A strategic selection is invited to a semi structured interview. When the patient has died, no questionnaires are sent.",[89,92],{"name":90,"affiliation":5,"role":91},"Ing-Marie Larsson, RN, PhD","PRINCIPAL_INVESTIGATOR",{"name":93,"affiliation":5,"role":91},"Björn Ahlström, MD, PhD",[95,99],{"name":90,"role":96,"phone":97,"phoneExt":72,"email":98},"CONTACT","+46 72 210 1833","ing-marie.larsson@uu.se",{"name":93,"role":96,"phone":100,"phoneExt":72,"email":101},"+46 23 490 131","bjorn.ahlstrom@uu.se",[103,118,132,146],{"facility":104,"status":72,"city":105,"state":72,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Falu lasarett, Intensivvårdsavdelningen","Falun","79182","Sweden","SE",{"type":110,"coordinates":111},"Point",[112,113],15.62597,60.60357,{"lat":113,"lon":112},[116],{"name":117,"role":96,"phone":100,"phoneExt":72,"email":101},"Björn Ahlström, PhD",{"facility":119,"status":72,"city":120,"state":72,"zip":121,"country":107,"countryCode":108,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Hudiksvalls sjukhus, Intensivvårdsavdelningen","Hudiksvall","824 81",{"type":110,"coordinates":123},[124,125],17.10558,61.72744,{"lat":125,"lon":124},[128],{"name":129,"role":96,"phone":130,"phoneExt":72,"email":131},"Caroline Lördal Sidenbladh, MD","+46 650 920 00","caroline.lordal.sidenbladh@regiongavleborg.se",{"facility":133,"status":72,"city":134,"state":72,"zip":135,"country":107,"countryCode":108,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Mora lasarett, Intensivvårdsavdelningen","Mora","792 85",{"type":110,"coordinates":137},[138,139],14.54316,61.00704,{"lat":139,"lon":138},[142],{"name":143,"role":96,"phone":144,"phoneExt":72,"email":145},"Olof Brattström, MD, PhD","+46 250 493 000","olof.brattstrom@regiondalarna.se",{"facility":147,"status":72,"city":148,"state":72,"zip":149,"country":107,"countryCode":108,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Akademiska sjukhuset, Centrala intensivvårdsavdelningen","Uppsala","751 85",{"type":110,"coordinates":151},[152,153],17.63889,59.85882,{"lat":153,"lon":152},[156],{"name":90,"role":96,"phone":97,"phoneExt":72,"email":98},{"type":158,"investigatorFullName":72,"investigatorTitle":72,"investigatorAffiliation":72,"oldNameTitle":72,"oldOrganization":72},"SPONSOR",[160,162,164],{"name":161,"class":6},"Region Gävleborg",{"name":163,"class":6},"Dalarna County Council, Sweden",{"name":165,"class":166},"Region Uppsala Public Health and Care","OTHER_GOV","100658423","patients-with-long-stay-at-icu-factors-and-evaluation---feasibility-study-100658423",false,"NCT07851974","Patients With Long-stay at ICU: Factors and Evaluation - Feasibility Study","Patients With Long-stay at ICU: Factors and Evaluation (LIFE-ICU) - A Feasibility Study for a National Prospective Cohort Study","LIFE-ICU","Inclusion Criteria for patients:\n\n* ICU stay of more than 4 days (96 hours) in a participating general intensive care unit (ICU)\n* Age 18 years or older\n* 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.\n* No formal decision to withdraw life sustaining treatment taken before 4 days of ICU care\n* 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\n* 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\n* 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\n\nExclusion Criteria for patients:\n\n* 6 days (144 hours) or more since ICU admission at the time of inclusion\n* The patient in any form expresses unwillingness to take part\n\nInclusion Criteria for designated next of kin:\n\n* Age 18 years or older\n* 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\n* Written informed consent, obtained during the ICU stay or, when needed, at the six month follow-up\n\nExclusion Criteria for designated next of kin:\n\n* The patient died before the designated next of kin was included\n* Unable to complete the questionnaires in Swedish","ALL","18 Years",{"count":178,"type":179},300,"ESTIMATED","OBSERVATIONAL","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.\n\nLIFE-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.\n\nThe 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.\n\nSix 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.\n\nThe 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.\n\nThe 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.\n\nHypothesis: 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.\n\nThe 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.",[183,184,185,186,187],"Frailty","Delirium Confusional State","Persistent Critical Illness","Post-Intensive Care Syndrome","Health-related Quality of Life",[189,190,191,192,193,194,195,196,197,198,199,200,201],"Prolonged ICU stay","Long-stay ICU patients","Prospective cohort study","Patient reported outcome measures","Fatigue","ICU length of stay","Critical care","Next of kin","Family caregivers","Post intensive care syndrome, family","Health-related quality of life","Post-traumatic stress","Feasibility study","NOT_YET_RECRUITING","2026-09-25",{"date":205,"type":206},"2026-10-01","ACTUAL",{"date":208,"type":179},"2026-10",{"date":210,"type":179},"2028-10",{"name":5,"class":6},4]