Clinical trial NCT02767180: Evaluation of an ICU-specific Questionnaire for Patient-reported Outcome Measures
Official title: Evaluation of an Intensive Care Specific Questionnaire for Patient-reported Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recruited six months to three years after discharge from the ICU, and 150 controls who have not been critically ill, matched for age and sex.

Brief summary: An ICU-specific questionnaire for patient reported outcome measures (PROM) after critical care will be tested in a study of 650 patients recruited six months to three years after discharge from the ICU, and 150 controls who have not been critically ill, matched for age and sex. The questionnaire is sent by mail after an invitation letter followed by a phone call and returned in a pre-stamped envelope. It is then scanned and data imported digitally. Medical data from the ICU-stay can be added. Further analyses after comparison with the control population and item reduction will follow.

Detailed description: ICU-patients were interviewed in a semi-structured way, providing detailed information on symptoms and difficulties in all areas of everyday life. The interviews were recorded, transcribed, and the issues were categorized into 13 hypothesised domains.All issues were then rephrased into questions, with care taken to maintain only one issue per question, and adequate scales for frequency, intensity and duration was used. The time frame is usually the last month. This intensive care specific questionnaire for patient reported outcome measures (PROM) after critical care will be tested in a study of 650 patients recruited six months to three years after discharge from the ICU, and 150 controls who have not been critically ill, matched for age and sex. The questionnaire is sent by mail after an invitation letter followed by a phone call and returned in a pre-stamped envelope. It is then scanned and data imported digitally. Medical data from the ICU-stay can be added. Further analyses after comparison with the control population and item reduction will follow.

Eligibility criteria: Inclusion Criteria:

* Patients treated in an intensive care unit at Sahlgrenska University for more than 72 hours and survived are included between 6 months and tre years after discharge from ICU.
* Control persons from the Swedish Population Registry matched for sex and gender are also included.

Exclusion Criteria:

* Patient with acute neurological/neurosurgical conditions and/or anoxic/hypoxic brain damage

Primary outcomes:
measure: Patient reported outcome measured with an ICU-specific questionnaire
timeFrame: Six months to 3 years after intensive care
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Dept of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden
name: Stefan Lundin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
citation: Malmgren J, Waldenstrom AC, Rylander C, Johannesson E, Lundin S. Long-term health-related quality of life and burden of disease after intensive care: development of a patient-reported outcome measure. Crit Care. 2021 Feb 25;25(1):82. doi: 10.1186/s13054-021-03496-7.