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Critical IllnessNCT02784574

Post ICU Follow up: A Questionnaire Survey of Aftercare in Denmark

An observational study of Critical Illness and Intensive Care Unit Syndrome, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate current aftercare activities in Denmark after intensive care unit (ICU) treatment. The hypothesis is that a large number of hospitals offer aftercare, and these interventions are heterogenic and differ between hospitals and regions. Read more about this study

Who is it for?
Any age
How many people
31 participants
Where
1 siteDenmark
Study dates
May 2016to Jan 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All Intensive Care Units in Denmark treating adult patients.

Who may be able to join

  • All Intensive Care Units in Denmark treating adult patients.

Who cannot join

  • Intensive care units with a specialty field within these four groups:
  • Neurology and neurosurgery
  • Cardiothoracic surgery
  • Pediatrics or neonatology (PICU/NICU)
  • Postoperative care units

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Zealand University Hospital

    Køge, 4600

Other trials in Denmark

About this study

Official title: Follow-up After Intensive Care Treatment: a Questionnaire Survey of Intensive Care Aftercare in Denmark.

This study aims to investigate current aftercare activities in Denmark after intensive care unit (ICU) treatment. The hypothesis is that a large number of hospitals offer aftercare, and these interventions are heterogenic and differ between hospitals and regions.

This study is an electronic questionnaire survey that aim to describe and map Danish aftercare activities, and future development plans in this field.

Read the detailed description

Annually, more than 30,000 patients are admitted for treatment at Danish intensive care units (ICUs). These critically ill patients are some of the most vulnerable in the health care system.

For years, focus has primarily been on treatment and survival of this patient group. As treatment effectiveness has gradually increased, the overall survival rate is now above 80%. Consequently, the period following ICU discharge has gained increasing focus and follow up interventions in the period after ICU treatment have become more common. These different follow up interventions has given name to the concept of 'aftercare'. Aftercare activities includes both early rehabilitation initiated during the continued hospital admission and also the following rehabilitation after hospital discharge.

Complications after intensive care treatment are numerous, including both physical, cognitive and psychological impairments, e.g. depression, muscle weakness, anxiety and social isolation. Together these symptoms are defined as post intensive care syndrome (PICS).

While it is clear that a need for aftercare exists, the optimal evidence based activities remains to be determined. The current follow-up activities are established as local initiatives and the methods vary greatly. Examples of present aftercare interventions include use of diaries, follow-up consultations, revisiting the ICU and assessment of quality of life.

A recent systematic review examined these different rehabilitation efforts, without finding significant effects of the present interventions, although usage of ICU-diaries had a minor preventive effect on post-traumatic stress syndrome (PTSD). A Danish meta-analysis from 2015 on follow-up consultations showed similar results.

Aftercare is a rapidly developing area and it is necessary to further investigate this important topic. Therefore, the investigators want to describe the current level of aftercare with a new mapping of activities in all Danish ICUs. Hereby, the investigators hope to create a better and up-to-date foundation for further development within Danish aftercare. Furthermore, the investigators wish to research on the clinician-experienced (the participants) attitude towards and limitations for aftercare activities, in order to discuss directions for future development.

Keywords
Rehabilitation, Aftercare
Medical subject headings
Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ICUs offering early aftercare to patients after discharge from ICU

    The respondent will choose 'yes' or 'no'

    Measured: From May 15th to September 31st 2016

  2. Incidence of ICUs offering late aftercare to patients after discharge from hospital

    The respondent will choose 'yes' or 'no'

    Measured: From May 15th to September 31st 2016

Secondary outcomes (22)

  1. Size of hospital (number of beds)

    Measured: From May 15th to September 31st 2016

  2. Size of ICU (number of beds)

    Measured: From May 15th to September 31st 2016

  3. Early aftercare: Use of protocol or checklist at patient visit

    The respondent will choose 'yes' or 'no'

    Measured: From May 15th to September 31st 2016

  4. Late aftercare: Use of protocol or checklist at patient visit

    The respondent will choose 'yes' or 'no'

    Measured: From May 15th to September 31st 2016

  5. Early aftercare: Selection of patients offered aftercare

    The respondent will choose from a list of options: All patients, Depending of length of stay, days with mechanical ventilation, or other: the respondent will specify

    Measured: From May 15th to September 31st 2016

  6. Late aftercare: Selection of patients offered aftercare

    The respondent will choose from a list of options: All patients, Depending of length of stay, days with mechanical ventilation, or other: the respondent will specify

    Measured: From May 15th to September 31st 2016

  7. Early aftercare: Time from ICU-discharge to first contact

    The respondent will choose from a list of options: How many hours to days until the patient is contacted at the general wards

    Measured: From May 15th to September 31st 2016

  8. Late aftercare: Time from hospital discharge to first contact

    The respondent will choose from a list of options: How many months from discharge, until the patient is contacted

    Measured: From May 15th to September 31st 2016

  9. Early aftercare: Aftercare team members

    The respondent will choose from a list of options: The personnel participating in the aftercare: Doctor, nurse, occupational therapist, physical therapist, pharmacist, psychologist or other

    Measured: From May 15th to September 31st 2016

  10. Early aftercare: Consumption of time

    The respondent will choose from a list of options: How much time is spent (in minutes) pr. contact with the patient

    Measured: From May 15th to September 31st 2016

  11. Late aftercare: Aftercare team members

    The respondent will choose from a list of options: The personnel participating in the aftercare: Doctor, nurse, occupational therapist, physical therapist, pharmacist, psychologist or other

    Measured: From May 15th to September 31st 2016

  12. Late aftercare: Consumption of time

    The respondent will choose from a list of options: How much time is spent (in minutes) pr. contact with the patient

    Measured: From May 15th to September 31st 2016

  13. Early aftercare: Type of aftercare interventions during general ward stay

    The respondent will be choosing interventions from a list, and also be able to specify other interventions not present on the list

    Measured: From May 15th to September 31st 2016

  14. Late aftercare: Type of aftercare interventions after hospital discharge

    The respondent will be choosing interventions from a list, and also be able to specify other interventions not present on the list

    Measured: From May 15th to September 31st 2016

  15. Early aftercare: Type of screening tools or other methods used for patient assessment

    The respondent will be choosing screening tools and methods from a list, and also be able to specify other screening tools and methods not present on the list

    Measured: From May 15th to September 31st 2016

  16. Late aftercare: Type of screening tools or other methods used for patient assessment

    The respondent will be choosing screening tools and methods from a list, and also be able to specify other screening tools and methods not present on the list

    Measured: From May 15th to September 31st 2016

  17. Late aftercare: Contact method

    The respondent will choose from a list of options: How the ICU contacts the patient after hospital discharge. By phone, by letter, by mail, by digital inbox

    Measured: From May 15th to September 31st 2016

  18. Late aftercare: Participation of family members

    The respondent will choose from a list: Whether the family is invited to participate in the consultation with the patient or not. Yes/No

    Measured: From May 15th to September 31st 2016

  19. Classifications of reasons for not having an aftercare programme at ICUs without an aftercare programme

    The respondent will choose from a list of options: Not enough money, resistance from the general wards, not an important subject, and also be able to write their own answer.

    Measured: From May 15th to September 31st 2016

  20. The responsible party for the financing of aftercare

    The respondent will choose from a list of options: The ICU itself, the general ward, the region or through funds?

    Measured: From May 15th to September 31st 2016

  21. The respondent's own assessment of how aftercare will be prioritized at their ICU in one year.

    The respondent will choose on a scale: More aftercare? Same level of aftercare? Less aftercare?

    Measured: From May 15th to September 31st 2016

  22. Should aftercare be offered?

    The respondent will choose on a scale: Totally agree, partially agree, neither agree or disagree, partially disagree, totally disagree

    Measured: From May 15th to September 31st 2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionAug 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784574
Sponsor's protocol ID
CK1-Survey
Status last verified
Nov 2017
First submitted
20 Apr 2016
Last updated
9 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Haggstrom M, Asplund K, Kristiansen L. How can nurses facilitate patient's transitions from intensive care?: a grounded theory of nursing. Intensive Crit Care Nurs. 2012 Aug;28(4):224-33. doi: 10.1016/j.iccn.2012.01.002. Epub 2012 Mar 3.

    PubMed 22386583

  • Broomhead LR, Brett SJ. Clinical review: Intensive care follow-up--what has it told us? Crit Care. 2002 Oct;6(5):411-7. doi: 10.1186/cc1532. Epub 2002 Aug 15.

    PubMed 12398780

  • 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.

    PubMed 21946660

  • Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.

    PubMed 12594312

  • Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

    PubMed 21470008

  • Wolters A, Bouw M, Vogelaar J, Tjan D, van Zanten A, van der Steen M. The postintensive care syndrome of survivors of critical illness and their families. J Clin Nurs. 2015 Mar;24(5-6):876-9. doi: 10.1111/jocn.12678. Epub 2014 Dec 1. No abstract available.

    PubMed 25441007

  • Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

    PubMed 24088092

  • Mehlhorn J, Freytag A, Schmidt K, Brunkhorst FM, Graf J, Troitzsch U, Schlattmann P, Wensing M, Gensichen J. Rehabilitation interventions for postintensive care syndrome: a systematic review. Crit Care Med. 2014 May;42(5):1263-71. doi: 10.1097/CCM.0000000000000148.

    PubMed 24413580

  • Jensen JF, Thomsen T, Overgaard D, Bestle MH, Christensen D, Egerod I. Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Intensive Care Med. 2015 May;41(5):763-75. doi: 10.1007/s00134-015-3689-1. Epub 2015 Mar 3.

    PubMed 25731633

  • Egerod I, Risom SS, Thomsen T, Storli SL, Eskerud RS, Holme AN, Samuelson KA. ICU-recovery in Scandinavia: a comparative study of intensive care follow-up in Denmark, Norway and Sweden. Intensive Crit Care Nurs. 2013 Apr;29(2):103-11. doi: 10.1016/j.iccn.2012.10.005. Epub 2013 Jan 20.

    PubMed 23340012

  • Engstrom A, Andersson S, Soderberg S. Re-visiting the ICU Experiences of follow-up visits to an ICU after discharge: a qualitative study. Intensive Crit Care Nurs. 2008 Aug;24(4):233-41. doi: 10.1016/j.iccn.2008.03.002. Epub 2008 Apr 22.

    PubMed 18434156

  • Van Der Schaaf M, Bakhshi-Raiez F, Van Der Steen M, Dongelmans DA, De Keizer NF. Recommendations for intensive care follow-up clinics; report from a survey and conference of Dutch intensive cares. Minerva Anestesiol. 2015 Feb;81(2):135-44. Epub 2014 May 14.

    PubMed 24824957

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Intensive Care Unit Syndrome, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ICUs offering early aftercare to patients after discharge from ICU (time frame: From May 15th to September 31st 2016). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784574, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.

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