Analysis of a Short Assessment of Post Intensive Care Syndrome (PICS)

To present a proposal for a set of outcome measurement instruments (OMIs) of post intensive care syndrome (PICS) in settings of outpatient healthcare service.

Study Overview

• Status: Completed
• Conditions: Postintensive Care Syndrome

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Germany
  • Bad Belzig, Germany, 14806
    • Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patienten aged ≥ 18 years, whose intensive care treatment has already been completed from the Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum, Bad Belzig, as well as from the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Description

Inclusion Criteria:

• Patients aged ≥ 18 years, whose intensive care treatment has already been completed

  • The patients were interviewed in the Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum, Bad Belzig, as well as in the pain clinic of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Exclusion Criteria:

Patients with a legal guardian or authorized representative

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Intensive Care Syndrome (PICS)	The composite outcome measure "PICS" of the patient is measured according to Needham et al 2012: new impairment or worsening of health after intensive care unit stay and at the same time clinically significant distress in at least one of the following outcome measurement instruments: Patient Health Questionnaires (PHQ-9, PHQ-8, PHQ-4), Generalized Anxiety Disorder Scale-7 (GAD-7), Impact of Event Scale (IES), Impact of Event Scale Revised (IES-R), MiniCog, Animal Naming Test, Trail Making Test (TMT-A, TMT-B), Repeatable Battery for the Assessment of Neuropsychological Satus (RBANS), Timed Up-and-Go (TUG), Handgrip Strength, 2-Minute Walk Test (2-MWT), Short Physical Performance Battery (SPPB).	06/2018 - 11/2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Health I	Patients were asked to rate their quality of life, measured by EQ-5D-3L	06/2018 - 11/2019
Subjective Health II	Patients were asked to rate their quality of life, measured by EQ-5D-5L	06/2018 - 11/2019
Subjective Health III	Patients were asked to rate their quality of life, measured by WHO Disability Assessment Schedule (WHODAS 2.0)	06/2018 - 11/2019
Mental Health	Mental health of the patient is measured by the sum scores of the following outcome measurement instruments: Patient Health Questionnaire (PHQ-9, PHQ-8, PHQ-4), Generalized Anxiety Disorder Scale-7 (GAD-7), Impact of Event Scale (IES), Impact of Event Scale Revised (IES-R).	06/2018 - 11/2019
Cognition	Cognition is measured by the sum scores of the following outcome measurement instruments: MiniCog, Animal Naming Test, Trail Making Test (TMT-A, TMT-B), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).	06/2018 - 11/2019
Physical Health	Physical health is measured by the sum scores of the following outcome measurement instruments: Timed Up-and-Go (TUG), Handgrip Strength, 2-Minute Walk Test (2-MWT), Short Physical Performance Battery (SPPB).	06/2018 - 11/2019

Collaborators and Investigators

• Sponsor: Claudia Spies

Publications and helpful links

General Publications

• Spies CD, Krampe H, Paul N, Denke C, Kiselev J, Piper SK, Kruppa J, Grunow JJ, Steinecke K, Gulmez T, Scholtz K, Rosseau S, Hartog C, Busse R, Caumanns J, Marschall U, Gersch M, Apfelbacher C, Weber-Carstens S, Weiss B. Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings - Results of an expert consensus and feasibility field test. J Intensive Care Soc. 2021 May;22(2):159-174. doi: 10.1177/1751143720923597. Epub 2020 May 14.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: PICS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No