ICU Follow-up After Prolonged Intensive Care Stay

NCT04186468 | Completed

• 4 other identifiers: PINA-2019VF_2016-07601VSF1605619-1522-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

Treatment in the intensive care unit (ICU) for more than five days often leads to chronic physical, cognitive and psychological complaints, such as post-traumatic stress disorders, muscle weakness, depression, anxiety and adjustment disorders. This is referred to as Post Intensive Care Syndrome (PICS). So far, there have been only a few studies investigating this syndrome. The aim of this pilot study is to test the effectiveness and feasibility of an ICU follow-up clinic, which our study team developed in a participatory process involving patients, caregivers, health care providers and researcher. For this purpose, the participants will be randomly assigned to a group with treatment in this follow-up clinic or to a group with usual care. Both groups will then be compared.

Conditions

Critical Illness; PICS; Post Intensive Care Syndrome

Keywords

PICS; ICU; Intensive Care Unit; Post Intensive Care Syndrome; Follow-up clinic; Intensive care unit-acquired weakness; Critical illness polyneuropathy; Health-related quality of life; Critical care; Muscle weakness

Outcome Measures

Primary Outcomes (1)

• Health related quality of life, physical component summary score (HRQOL-PCS)

  HRQOL will be assessed six months after discharge from the intensive care unit (ICU) by the Short Form-12 self-report questionnaire (SF-12) physical component summary score (PCS) (Ware, 1996). The German translation (Bullinger, 1998) will be used. Scores can range between zero and one hundred, with higher values indicating higher HRQOL.

  Six months after ICU discharge

Secondary Outcomes (8)

• Health related quality of life, mental component summary score (HRQOL-MCS)

  Six months after ICU discharge

• Activities of Daily Living (ADL)

  Six months after ICU discharge

• Chair Rise Test

  Six months after ICU discharge

• Hand Grip Strength

  Six months after ICU discharge

• Post-Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10)

  Six months after ICU discharge

Study Arms (2)

ICU follow-up clinic

EXPERIMENTAL

Participants will be invited to visit the ICU follow-up clinic.

Other: ICU follow-up clinic

Usual care

NO INTERVENTION

Participants will solely receive usual care.

Interventions

ICU follow-up clinic OTHER

The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the outpatient clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients.

ICU follow-up clinic

Eligibility Criteria

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

You may qualify if:

• duration of ICU stay more than five days
• sequential organ failure assessment score (SOFA) greater than five
• expected survival time greater than six months
• written informed consent

You may not qualify if:

• minor participants under the age of eighteen
• no written informed consent (unable or unwilling)
• unable to complete questionnaires
• insufficient German language skills

Sponsors & Collaborators

• Otto-von-Guericke University Magdeburg: lead
• University of Regensburg: collaborator
• University Hospital Regensburg: collaborator

Study Sites (3)

Institute of Social Medicine and Health Systems Research

Magdeburg, 39120, Germany

Location

Department for Epidemiology and Preventive Medicine

Regensburg, 93051, Germany

Location

University Hospital

Regensburg, 93053, Germany

Location

Related Publications (14)

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  PMID: 8628042 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• Fuchs J, Busch MA, Gosswald A, Holling H, Kuhnert R, Scheidt-Nave C. [Physical and cognitive capabilities among persons aged 65-79 years in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2013 May;56(5-6):723-32. doi: 10.1007/s00103-013-1684-7. German.

  PMID: 23703491 BACKGROUND

• Cooper R, Kuh D, Cooper C, Gale CR, Lawlor DA, Matthews F, Hardy R; FALCon and HALCyon Study Teams. Objective measures of physical capability and subsequent health: a systematic review. Age Ageing. 2011 Jan;40(1):14-23. doi: 10.1093/ageing/afq117. Epub 2010 Sep 15.

  PMID: 20843964 BACKGROUND

• Weisaeth L. Torture of a Norwegian ship's crew. The torture, stress reactions and psychiatric after-effects. Acta Psychiatr Scand Suppl. 1989;355:63-72.

  PMID: 2624136 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.

  PMID: 10568646 BACKGROUND

• Beaton DE, O'Driscoll SW, Richards RR. Grip strength testing using the BTE work simulator and the Jamar dynamometer: a comparative study. Baltimore Therapeutic Equipment. J Hand Surg Am. 1995 Mar;20(2):293-8. doi: 10.1016/s0363-5023(05)80029-2.

  PMID: 7775773 BACKGROUND

• Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.

  PMID: 31730754 BACKGROUND

• Bullinger M, Kirchberger I. Der SF-36 Fragebogen zum Gesundheitszustand (SF-36). Handbuch für die deutschsprachige Fragebogenversion Göttingen, Hogrefe, 1998.

  BACKGROUND

• Löwe B, Spitzer R, Zipfel S, Herzog W. PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer, 2002.

  BACKGROUND

• Maercker, A. Posttraumatische Stress Skala-10 (PTSS-10) - deutsche Version modifiziert nach Schüffel u. Schade. Unveröffentlichtes Manuskript, Universität Zürich, Klinische Psychologie II, 1998.

  BACKGROUND

• Lubke N, Meinck M, Von Renteln-Kruse W. [The Barthel Index in geriatrics. A context analysis for the Hamburg Classification Manual]. Z Gerontol Geriatr. 2004 Aug;37(4):316-26. doi: 10.1007/s00391-004-0233-2. German.

  PMID: 15338161 BACKGROUND

• Drewitz KP, Hasenpusch C, Bernardi C, Brandstetter S, Fisser C, Pielmeier K, Rohr M, Brunnthaler V, Schmidt K, Malfertheiner MV, Apfelbacher CJ. Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial. BMC Anesthesiol. 2023 Oct 14;23(1):344. doi: 10.1186/s12871-023-02255-1.

  PMID: 37838669 DERIVED

• Rohr M, Brandstetter S, Bernardi C, Fisser C, Drewitz KP, Brunnthaler V, Schmidt K, Malfertheiner MV, Apfelbacher CJ. Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Mar 30;7(1):90. doi: 10.1186/s40814-021-00796-1.

  PMID: 33785064 DERIVED

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome; Polyneuropathies; Muscle Weakness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Christian J Apfelbacher, Prof.Dr.PhD

  Otto-von-Guericke University Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group allocation will be masked during analysis of the primary outcome. Masking and unmasking will be done by a Trust Center by coding both groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute of Social Medicine and Health Systems Research

Model Details: The treatment group will supported by activities of an ICU follow-up clinic. The control group will receive usual care.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: June 11, 2020
• Primary Completion: March 15, 2021
• Study Completion: May 31, 2021
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

DE (3)