Prognostication of Need for Rehabilitation and Special Support in ICU Survivors (PROGRESS-ICU)

February 12, 2018 updated by: Peter Sackey, Karolinska University Hospital

Prognostication of Need for Rehabilitation and Special Support in ICU Survivors. Two Studies Prognosticating Adverse Physical or Psychological Outcome

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

Objectives:

  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. 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.

Study design:

Prospective, observational multi centre (10 centres) cohort studies

Outcomes:

Adverse psychological outcome three months after ICU discharge (Posttraumatic Stress Syndrome-14 (PTSS-14) part B score >45 or Hospital Anxiety and Depression Scale (HADS) subscale score >10). New-onset physical disability, defined as a reduction in Barthel Index ≥10 points compared with 2 weeks prior to hospital admission.

Study duration:

Recruitment of patients during 2-4 months in the ten study sites. Follow-up of primary endpoints 3 months after ICU discharge.

Number of subjects:

The aim is to screen all eligible patients and include 600-1000 ICU survivors during the recruitment period. The final number of included patients depends on case-mix in the units and potential exclusions.

Population:

Adult patients (18 years or older) discharged from ICU.

Study Overview

Status

Completed

Conditions

Detailed Description

Every year, an estimated 5 million patients are treated in European Intensive Care Units (ICUs) yearly, with 40 000 in Swedish ICUs alone (1,2). As many as 50 % of ICU survivors suffer from new-onset physical, psychological or cognitive problems in the months or even years after ICU discharge, irrespective of the reason for ICU admission (3-5). These problems are major hurdles for patients discharged from the ICU to return to life as it was prior to hospitalisation, but often remain unrecognised by healthcare providers (3-5). Follow-up led by ICU clinicians is increasingly recognised as an addendum to critical care (5,6). Yet, interventions in large and unselected groups of ICU survivors have failed to demonstrate meaningful improvements (7,8) except in vulnerable subgroups (9,10). Dilution of treatment effects is a recognised problem in interventional studies (11). Thus, identifying patients with risk for adverse outcome is an important enrichment step prior to evaluation of new interventions. The importance has recently been highlighted at a stakeholders meeting regarding post-ICU syndrome (12). Pilot studies from our research group indicate that risk prediction instruments for ICU survivors with fairly good accuracy can be developed and used in clinical practice (13,14) but predictors need to be assessed and validated in a larger sample.

Data collection All data will be entered in coded form to a web-based, electronic Case Report Form (Pheedit eCRF) supplied by the Central Steering Committee. The eCRF will be accessible with a username and password at all computers with internet access. All data can be entered in the eCRF. Each centre will keep a safely placed and locked patient ID and study code list, separate from the study data.

Potential risk factors:

Patient characteristics Age Sex Educational level** Working/school/parental leave/retired/unemployed/sick-leave** Physical comorbidities (Charlson Comorbidity Index & SAPS III box 1) (supplement) History of psychological problems before ICU stay, including substance abuse) Caretaker of a child <18 years old** Barthel Index-100 prior to falling ill, reported by patient, and/or proxy together with medical chart review

In-ICU diagnoses/treatments/status Admission diagnosis (medical/surgical/trauma) Acute/elective hospital admission Admission severity of illness (APACHE II) Pelvic fracture Fractures (other than pelvic) ICU length of stay (hours) Severe sepsis/septic chock* Days with coma (for any reason) Days with invasive ventilator treatment Agitation/agitated delirium during ICU stay**

Patient status at ICU discharge Depressive symptoms with PHQ2 questions (two questions, supplement)** Chelsea Critical Care Physical Assessment Tool (CPAx) Questions 1-5 (supplement) within 24 hours prior to discharge* PTSS-14 Part A (four questions, supplement)** Social support (one question, supplement)

Three months post-ICU discharge Hospital Anxiety and Depression Scale (HADS) (supplement) Posttraumatic Stress Symptoms 14 (PTSS-14) (supplement) Barthel Index (supplement) Short Form 36 Health Survey (supplement) Health utilization questionnaire

Questionnaires will be sent by postal mail to all patients, together with an information letter about participation in the studies and a consent form to sign for those unable to give consent at inclusion. A phone number will be supplied, for patients with questions or who wish to know more regarding their ICU stay. Ten-fourteen days after questionnaires have been sent out, a reminder telephone call will be made to patients who have not returned the questionnaires.

Consent Patients will be asked for consent at study inclusion. If unable to consent, patients will be asked for consent at three months post ICU, when questionnaires are being sent out.

Inter-rater reliability Risk factors that are assessed by observation, where no validated instruments are available, will undergo interrater reliability testing within the study. Ten patients per centre will be assessed in parallel by two independent observers, blinded to each other´s assessment. Specifically, the factors are the items of CPAx.

Outcome measures:

Two primary outcome measures:

  1. Adverse psychological outcome at three months post-ICU discharge is defined as a subscale score >10 in the Hospital Anxiety and Depression Scale (HADS), indicative of clinically significant depressive or anxiety symptoms, AND/OR a Posttraumatic Stress Symptoms -14 (PTSS-14) part B score >45 indicative of clinically significant posttraumatic stress symptoms.
  2. Adverse physical outcome (new-onset physical disability) three months post-ICU discharge is defined as a worsening of the Barthel Index-100 by 10 points or more, compared to the reported Barthel Index-100 two weeks prior to hospitalisation.

Study Type

Observational

Enrollment (Actual)

573

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet Copenhagen
      • Odense, Denmark
        • Odense University Hospital
  • Netherlands
      • Nijmegen, Netherlands
        • University Medical Centre Radboud
      • Utrecht, Netherlands
        • University Medical Centre Utrecht
  • Sweden
      • Stockholm, Sweden
        • Stockholm South Hospital
      • Stockholm, Sweden, 171 76
        • Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
      • Uppsala, Sweden
        • Dept of Anesthesia and Intensive Care, Uppsala Akademiska
      • Örebro, Sweden
        • Örebro university hospital
    • Jämtland
      • Östersund, Jämtland, Sweden
        • Östersund Hospital
    • Västerbotten
      • Umeå, Västerbotten, Sweden
        • Umea University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse psychological outcome
Time Frame: Three months post-ICU
Caseness defined as PTSS-14 part B score above 45 or HADS subscale score above 10
Three months post-ICU
Adverse physical outcome
Time Frame: Three months post-ICU
Caseness defined as Reduction in Barthel Index (0-100) by 10 points or more
Three months post-ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life assessed with Short Form -36 in patients
Time Frame: In first three months post-ICU
Health-related quality of Life domains in relation to adverse outcomes
In first three months post-ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Region Stockholm

Investigators

  • Study Chair: Peter V Sackey, MD, PhD, Karolinska University Hospital
  • Principal Investigator: Anna Milton, MD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN 2015/1799-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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