Follow up After Intensive Care. The FUTstudy

Post Traumatic Stress Symptoms Clinical Trial

— FUT  

Official title:

A Randomized Controlled Trial to Evaluate the Effect of Nurse Led Follow up After Being a Patient in the Intensive Care Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077244
• Other study ID #: 2012/1715
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post ICU Patient
• Post Traumatic Stress Symptoms

Intervention

Behavioral:
• Follow up talks
Nurse led follow up talks at the ward and one and two months later.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post traumatic stress symptoms	Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.	3, 6 and 12 months after baseline
Secondary	Sense of coherence (Sense of coherence scale 13)	Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.	3, 6 and 12 months after baseline
Secondary	Health related quality of life	Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.	3, 6 and 12 months after baseline
Secondary	Pain (Brief pain inventory)	Baseline is measured when the patient has been discharged from the ICU to a ward before leaving the hospital. Change from baseline at 3, 6 and 12 months.	3, 6 and 12 months after baseline
Secondary	Work participation	Baseline is measured when the patient has been discharged from the ICU to a ward. Change from baseline at 3, 6 and 12 months.	3, 6 and 12 months after baseline