Evaluation of an ICU-specific Questionnaire for Patient-reported Outcome Measures

• ClinicalTrials.gov Identifier: NCT02767180
• Recruitment Status: Completed
• First Posted: May 10, 2016
• Last Update Posted: October 22, 2020
• Sponsor: Sahlgrenska University Hospital, Sweden
• Information provided by (Responsible Party): Stefan Lundin, Sahlgrenska University Hospital, Sweden

Study Description

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.

Condition or disease
Intensive Care Unit Syndrome

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 800 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Evaluation of an Intensive Care Specific Questionnaire for Patient-reported Outcome
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: September 1, 2020

Groups and Cohorts

Group/Cohort
Critical care survivors; Former ICU-patients recruited six months to three years after discharge from the ICU
Matched controls; Control patients who have not been critically ill, matched for age and sex.

Outcome Measures

Primary Outcome Measures :

1. Patient reported outcome measured with an ICU-specific questionnaire [ Time Frame: Six months to 3 years after intensive care ]
   An ICU-specific questionnaire will be used which has been developed from interviews of former ICU-patients

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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

Contacts and Locations

Locations

Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden, S-413 45

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

• Principal Investigator: Stefan Lundin, MD PhD; Dept of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Malmgren J, Waldenström 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.

• Responsible Party: Stefan Lundin, Adjunct Professor, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT02767180
• Other Study ID Numbers: LUA-74200
• First Posted: May 10, 2016
• Last Update Posted: October 22, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided