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

Intensive Care Unit Syndrome Clinical Trial

Official title:

Evaluation of an Intensive Care Specific Questionnaire for Patient-reported Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767180
• Other study ID #: LUA-74200
• Status: Completed
• Start date: April 2016
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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 cognitiv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcome measured with an ICU-specific questionnaire	An ICU-specific questionnaire will be used which has been developed from interviews of former ICU-patients	Six months to 3 years after intensive care