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

NCT04175236 | Completed

• 1 other identifier: PICS
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Postintensive Care Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Subjective Health I

  06/2018 - 11/2019

• Subjective Health II

  06/2018 - 11/2019

• Subjective Health III

  06/2018 - 11/2019

• Mental Health

  06/2018 - 11/2019

• Cognition

  06/2018 - 11/2019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with a legal guardian or authorized representative

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (2)

Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum

Bad Belzig, 14806, Germany

Location

Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 34025756 DERIVED

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: June 19, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

DE (2)