Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02784574
Other study ID # CK1-Survey
Secondary ID
Status Completed
Phase N/A
First received April 20, 2016
Last updated November 8, 2017
Start date May 2016
Est. completion date January 2017

Study information

Verified date November 2017
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date January 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All Intensive Care Units in Denmark treating adult patients.

Exclusion Criteria:

Intensive care units with a specialty field within these four groups:

- Neurology and neurosurgery

- Cardiothoracic surgery

- Pediatrics or neonatology (PICU/NICU)

- Postoperative care units

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Zealand University Hospital Køge

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (12)

Broomhead LR, Brett SJ. Clinical review: Intensive care follow-up--what has it told us? Crit Care. 2002 Oct;6(5):411-7. Epub 2002 Aug 15. Review. — View Citation

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. — View Citation

Engström A, Andersson S, Söderberg 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. — View Citation

Häggström 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. — View Citation

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. — View Citation

Herridge MS, Tansey CM, Matté 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. — View Citation

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. Review. Erratum in: Intensive Care Med. 2015 Jul;41(7):1391. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ICUs offering early aftercare to patients after discharge from ICU The respondent will choose 'yes' or 'no' From May 15th to September 31st 2016
Primary Incidence of ICUs offering late aftercare to patients after discharge from hospital The respondent will choose 'yes' or 'no' From May 15th to September 31st 2016
Secondary Size of hospital (number of beds) From May 15th to September 31st 2016
Secondary Size of ICU (number of beds) From May 15th to September 31st 2016
Secondary Early aftercare: Use of protocol or checklist at patient visit The respondent will choose 'yes' or 'no' From May 15th to September 31st 2016
Secondary Late aftercare: Use of protocol or checklist at patient visit The respondent will choose 'yes' or 'no' From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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 From May 15th to September 31st 2016
Secondary 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. From May 15th to September 31st 2016
Secondary 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? From May 15th to September 31st 2016
Secondary 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? From May 15th to September 31st 2016
Secondary Should aftercare be offered? The respondent will choose on a scale: Totally agree, partially agree, neither agree or disagree, partially disagree, totally disagree From May 15th to September 31st 2016
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness