Clinical trial NCT02077244: Follow up After Intensive Care. The FUTstudy
Official title: A Randomized Controlled Trial to Evaluate the Effect of Nurse Led Follow up After Being a Patient in the Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Symptoms
Post ICU Patient
Keywords: patient
intensive care
follow up
post traumatic stress symptoms
randomized controlled trial
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Those who give their written informed consent will fill out the Post Traumatic Stress Scale 10 Intensive care screen (PTSS 10-I) Patients with a score equal or above 25 (indicating suffering from PTS symptoms) will be randomized to intervention or control group. Randomization will be performed using the computer program WebCRFNTNU. Patients who score below 25 will be included in an observation group and receive questionnaires at the same time points as the intervention and control group.

To be able to detect a difference of 10 between the groups as significant with 80% power and allow for 20% dropout, a total of 250 patients with PTS-10 score like or above 25 have to be included in the randomized part of the study. In the autum 2016 a new statistician in the procject recalculated the power and found the need for 134 randomized patients. The inclusion was then terminated.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post traumatic stress symptoms
timeFrame: 3, 6 and 12 months after baseline
Secondary outcomes:
measure: Sense of coherence (Sense of coherence scale 13)
timeFrame: 3, 6 and 12 months after baseline
measure: Health related quality of life
timeFrame: 3, 6 and 12 months after baseline
measure: Pain (Brief pain inventory)
timeFrame: 3, 6 and 12 months after baseline
measure: Work participation
timeFrame: 3, 6 and 12 months after baseline
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: