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

Completed

• Conditions: Intensive Care Unit Syndrome

• Registration Number: NCT02767180
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-10
• Primary Completion: 2020-04-01
• Study Completion: 2020-09-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported outcome measured with an ICU-specific questionnaire	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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden