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.
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
- Conditions the study is for
- Critical Illness, Intensive Care Unit Syndrome
- 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.
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.
- Conditions
- Critical Illness, Intensive Care Unit Syndrome
- 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.
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
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)
Size of hospital (number of beds)
Measured: From May 15th to September 31st 2016
Size of ICU (number of beds)
Measured: From May 15th to September 31st 2016
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted27 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cilia KW Kjer, Bach.med, Principal investigator, Køge Hospital
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 22386583Broomhead 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 12398780Needham 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 21946660Herridge 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 12594312Herridge 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 21470008Wolters 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 25441007Pandharipande 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 24088092Mehlhorn 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 24413580Jensen 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 25731633Egerod 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 23340012Engstrom 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 18434156Van 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up After Intensive Care Treatment: a Questionnaire Survey of Intensive Care Aftercare in Denmark.
- ClinicalTrials.gov ID
- NCT02784574
- Acronym / sponsor ID
- CK1-Survey
- Conditions
- Critical Illness, Intensive Care Unit Syndrome
- Keywords
- Rehabilitation, Aftercare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Intensive Care Units in Denmark treating adult patients.
Key inclusion criteria (1 listed)
- All Intensive Care Units in Denmark treating adult patients.
Key exclusion criteria (5 listed)
- Neurology and neurosurgery
- Cardiothoracic surgery
- Pediatrics or neonatology (PICU/NICU)
- Postoperative care units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of ICUs offering early aftercare to patients after discharge from ICU
Time frame: From May 15th to September 31st 2016
The respondent will choose 'yes' or 'no'
Incidence of ICUs offering late aftercare to patients after discharge from hospital
Time frame: From May 15th to September 31st 2016
The respondent will choose 'yes' or 'no'
22 secondary outcomes
Size of hospital (number of beds)
Time frame: From May 15th to September 31st 2016
Size of ICU (number of beds)
Time frame: From May 15th to September 31st 2016
Early aftercare: Use of protocol or checklist at patient visit
Time frame: From May 15th to September 31st 2016
Late aftercare: Use of protocol or checklist at patient visit
Time frame: From May 15th to September 31st 2016
Early aftercare: Selection of patients offered aftercare
Time frame: From May 15th to September 31st 2016
Late aftercare: Selection of patients offered aftercare
Time frame: From May 15th to September 31st 2016
Early aftercare: Time from ICU-discharge to first contact
Time frame: From May 15th to September 31st 2016
Late aftercare: Time from hospital discharge to first contact
Time frame: From May 15th to September 31st 2016
Early aftercare: Aftercare team members
Time frame: From May 15th to September 31st 2016
Early aftercare: Consumption of time
Time frame: From May 15th to September 31st 2016
Late aftercare: Aftercare team members
Time frame: From May 15th to September 31st 2016
Late aftercare: Consumption of time
Time frame: From May 15th to September 31st 2016
Early aftercare: Type of aftercare interventions during general ward stay
Time frame: From May 15th to September 31st 2016
Late aftercare: Type of aftercare interventions after hospital discharge
Time frame: From May 15th to September 31st 2016
Early aftercare: Type of screening tools or other methods used for patient assessment
Time frame: From May 15th to September 31st 2016
Late aftercare: Type of screening tools or other methods used for patient assessment
Time frame: From May 15th to September 31st 2016
Late aftercare: Contact method
Time frame: From May 15th to September 31st 2016
Late aftercare: Participation of family members
Time frame: From May 15th to September 31st 2016
Classifications of reasons for not having an aftercare programme at ICUs without an aftercare programme
Time frame: From May 15th to September 31st 2016
The responsible party for the financing of aftercare
Time frame: From May 15th to September 31st 2016
The respondent's own assessment of how aftercare will be prioritized at their ICU in one year.
Time frame: From May 15th to September 31st 2016
Should aftercare be offered?
Time frame: From May 15th to September 31st 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Background: PubMed 22386583Haggstrom 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.
- Background: PubMed 12398780Broomhead 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.
- Background: PubMed 21946660Needham 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.
- Background: PubMed 12594312Herridge 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.
- Background: PubMed 21470008Herridge 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.
- Background: PubMed 25441007Wolters 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.
- Background: PubMed 24088092Pandharipande 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.
- Background: PubMed 24413580Mehlhorn 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.
- Background: PubMed 25731633Jensen 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.
- Background: PubMed 23340012Egerod 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.
- Background: PubMed 18434156Engstrom 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.
- Background: PubMed 24824957Van 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.
- Database DI. DID's - Alle mortalitetsmål. 2014 1-10.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cilia KW Kjer, Bach.med principal investigator
Køge Hospital
1 site in 1 country: see every site and its status.
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.