Prognostication of Need for Rehabilitation and Special Support in ICU Survivors

NCT02679157 | Completed DMC

• 1 other identifier: EPN 2015/1799-31
• Study Type: observational
• Target: 573
• Locations: 3 countries
• Sites: 10

Brief Summary

Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care Unit Stay - a multinational, observational study Objectives:

1. 1.To investigate associations between potential risk factors (premorbid factors, in-ICU treatments/diagnoses and patient status at ICU discharge) and three-month physical and psychological outcome in ICU survivors.
2. 2.Based on the associations between identified risk factors and adverse outcomes, create and validate instruments, to be used at ICU discharge, predicting new-onset physical or psychological problems three months after ICU discharge.

Conditions

Physical Disability; Depression; Posttraumatic Stress Disorder; Anxiety

Keywords

Posttraumatic stress disorder; Depression; Anxiety; ADL; Health-related quality of life; ICU survivorship

Outcome Measures

Primary Outcomes (2)

• Adverse psychological outcome

  Caseness defined as PTSS-14 part B score above 45 or HADS subscale score above 10

  Three months post-ICU

• Adverse physical outcome

  Caseness defined as Reduction in Barthel Index (0-100) by 10 points or more

  Three months post-ICU

Secondary Outcomes (1)

• Health-related quality of life assessed with Short Form -36 in patients

  In first three months post-ICU

Eligibility Criteria

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

Study Population

Adult ICU patients

You may qualify if:

• ICU stay\>24 hours for postoperative patients and \>12 hours for other ICU admissions

You may not qualify if:

• Previously documented cognitive impairment (e.g. dementia or intellectual development disorder resulting in poor understanding/compliance in outcome assessment)
• No home address
• Unable to read and write in language spoken at local study site (Swedish/Danish/Dutch)/used in questionnaires
• Patient declines participation
• Moribund patient or with more than one limitation of therapy
• Need for neurointensive care due to head trauma, intracranial hemorrhage or infarction AND GCS never better than 13 in the first 48 hours
• Transfer to other ICU before discharge to ward
• Solely in ICU for elective procedure (eg central line, epidural)

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Region Stockholm: collaborator

Study Sites (10)

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

University Medical Centre Radboud

Nijmegen, Netherlands

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

Östersund Hospital

Östersund, Jämtland County, Sweden

Location

Umeå University Hospital

Umeå, Västerbotten County, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Stockholm South Hospital

Stockholm, Sweden

Location

Dept of Anesthesia and Intensive Care, Uppsala Akademiska

Uppsala, Sweden

Location

Related Publications (11)

• Rhodes A, Ferdinande P, Flaatten H, Guidet B, Metnitz PG, Moreno RP. The variability of critical care bed numbers in Europe. Intensive Care Med. 2012 Oct;38(10):1647-53. doi: 10.1007/s00134-012-2627-8. Epub 2012 Jul 10.

  PMID: 22777516 BACKGROUND

• Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

  PMID: 21946660 BACKGROUND

• Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011 Feb;39(2):371-9. doi: 10.1097/CCM.0b013e3181fd66e5.

  PMID: 20959786 BACKGROUND

• Modrykamien AM. The ICU follow-up clinic: a new paradigm for intensivists. Respir Care. 2012 May;57(5):764-72. doi: 10.4187/respcare.01461. Epub 2011 Dec 8.

  PMID: 22152275 BACKGROUND

• Cuthbertson BH, Rattray J, Campbell MK, Gager M, Roughton S, Smith A, Hull A, Breeman S, Norrie J, Jenkinson D, Hernandez R, Johnston M, Wilson E, Waldmann C; PRaCTICaL study group. The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ. 2009 Oct 16;339:b3723. doi: 10.1136/bmj.b3723.

  PMID: 19837741 BACKGROUND

• Jones C, Skirrow P, Griffiths RD, Humphris GH, Ingleby S, Eddleston J, Waldmann C, Gager M. Rehabilitation after critical illness: a randomized, controlled trial. Crit Care Med. 2003 Oct;31(10):2456-61. doi: 10.1097/01.CCM.0000089938.56725.33.

  PMID: 14530751 BACKGROUND

• Schandl A, Bottai M, Hellgren E, Sundin O, Sackey P. Gender differences in psychological morbidity and treatment in intensive care survivors--a cohort study. Crit Care. 2012 May 14;16(3):R80. doi: 10.1186/cc11338.

  PMID: 22578016 BACKGROUND

• Schandl A, Bottai M, Hellgren E, Sundin O, Sackey PV. Developing an early screening instrument for predicting psychological morbidity after critical illness. Crit Care. 2013 Sep 24;17(5):R210. doi: 10.1186/cc13018.

  PMID: 24063256 BACKGROUND

• Schandl A, Bottai M, Holdar U, Hellgren E, Sackey P. Early prediction of new-onset physical disability after intensive care unit stay: a preliminary instrument. Crit Care. 2014 Jul 31;18(4):455. doi: 10.1186/s13054-014-0455-7.

  PMID: 25079385 BACKGROUND

• Sackett DL. Why randomized controlled trials fail but needn't: 2. Failure to employ physiological statistics, or the only formula a clinician-trialist is ever likely to need (or understand!). CMAJ. 2001 Oct 30;165(9):1226-37. No abstract available.

  PMID: 11706914 BACKGROUND

• Milton A, Schandl A, Soliman IW, Meijers K, van den Boogaard M, Larsson IM, Brorsson C, Ostberg U, Oxenboll-Collet M, Savilampi J, Paskins S, Bottai M, Sackey PV. Development of an ICU discharge instrument predicting psychological morbidity: a multinational study. Intensive Care Med. 2018 Dec;44(12):2038-2047. doi: 10.1007/s00134-018-5467-3. Epub 2018 Nov 22.

  PMID: 30467678 DERIVED

Related Links

• NICE Guidelines for ICU follow-up

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Peter V Sackey, MD, PhD

  Karolinska University Hospital

  STUDY CHAIR

• Anna Milton, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 10, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6); DK (2); NL (2)