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Follow up After Intensive Care. The FUTstudy

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Completed

Conditions

Post Traumatic Stress Symptoms
Post ICU Patient

Treatments

Behavioral: Follow up talks

Study type

Interventional

Funder types

Other

Identifiers

NCT02077244
2012/1715

Details and patient eligibility

About

To investigate the effect of nurse led follow up talks to prevent posttraumatic stress (PTS) symptoms and improve quality of life and sence of coherence after an intensive care unit (ICU) stay.

Secondly:

Investigate level of psychological distress, quality of life, hope and work participation in ICU patients after an ICU stay and factors associated with these outcomes.

Full description

The ICU patient experiences total dependence on health care professionals and technical devices. Some patients report unpleasant memories such as pain, feeling helpless, or delusional experiences from the ICU stay and many report physical or mental symptoms after discharge from the ICU. Return to work rate after ICU treatment differs. Most ICU patients receive analgesics and sedatives to relieve pain and discomfort during the stay. Thus many patients have few memories from their time being critically ill. For patients with few memories from the ICU stay this represents an interruption in the patient's life history. Since personal identity is influenced by the stories we tell about ourselves, loss of memory from a period with critical illness might be experienced as a threat towards self-confidence and sense of coherence. Some patients with traumatic memories from the ICU develop PTS symptoms after discharge.

In order to help the earlier ICU patient to achieve a life with less physical and mental complaints, some ICUs have established a follow up program in outpatient clinics after discharge from hospital, but there is sparse evidence of the effectiveness of this intervention, and what type of follow up that best help the patients.

The primary aim of the study is to:

Investigate if a group of previous intensive care patients receiving nurse led follow up talks three times after discharge from the ICU have less post traumatic stress symptoms, pain, increased sense of coherence and, work participation and health related quality of life (HRQL) three, six and twelve months after discharge from the ICU compared to a control group receiving standard care.

Secondary aim:

Investigate level and predictors of anxiety, depression, PTS symptoms, hope, pain, HRQOL and work participation in intensive care patients ICU patients first year after discharge from ICU.

Enrollment

224 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients with an ICU stay like or above 24 hours who speak and understand Norwegian and who are conscious and cognitively oriented at the time of inclusion. Patients with a score of 25 or more on Post Traumatic Stress Scale 10 (PTSS-10) is randomized to intervention or control group. Patients with a score below 25 on PTSS-10 is included in an observation group.

Exclusion criteria

  • severe psychiatric disorder

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

224 participants in 3 patient groups

Follow up talks
Experimental group
Description:
Patients with a score like or above 25 on Post traumatic stress scale-10 Intensive Care Screen after discharge from the ICU. Nurse led follow up talks at the ward and one and two months later.
Treatment:
Behavioral: Follow up talks
No talks
No Intervention group
Description:
Patients with a score like or above 25 on Post traumatic stress scale-10 Intensive Care Screen after discharge from the ICU. Care as usual
Observation group
No Intervention group
Description:
Patients with a score below 25 on Post traumatic stress scale-10 Intensive Care Screen after discharge from the ICU. Care as usual.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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