Effectiveness of a follow-up clinic for ICU survivors on long term outcome: A stepped wedge cluster randomised controlled trial.

Rationale:

Gradually more Intensive Care Units (ICUs) provide a follow-up clinic for ICU survivors, but it is unclear whether these clinics contribute to better long-term outcomes.



Objective:

To evaluate the effectiveness of a follow-up clinic for ICU survivors on their risk of post traumatic stress disorder (PTSD) and health related quality of life, 12 months after admission to a mixed level 3 intensive care unit.



Study design:

Cluster randomised controlled trial (stepped wedge design).



Study population:

Patients admitted for more than 48 hours to the ICU of the University Medical Center Utrecht.
Intervention: Follow-up clinic for ICU survivors, two months after ICU discharge with possible referral and treatment of PTSD by a psychiatrist.



Main study parameters/endpoints:

PTSD assessed with the Impact of Events questionnaire.

Secondary endpoints: Quality of life, cognitive impairment, impairment in daily activities, (other) anxiety disorders, depression.

A follow-up clinic for intensive care units (ICU) survivors reduces the incidence of post traumatic stress disorder (PTSD) after 1 year of follow-up.

1. Baseline questionnaire for family;

2. Questionnaire 1 month after ICU discharge;

3. Primary and secondary outcomes: Questionnaire 1 year after ICU discharge.

Visit to a follow-up clinic 2 months after ICU discharge.

Patients will recieve 1 month after discharge (= 1 month prior to their visit) a questionnaire with the Hospital Anxiety and Depression Scale (HADS), the Impact of Event Scale (IES) and the Cognitive FailuresQuestionnaire (CFQ).

Patients who score 12 or more on the HADS, above 27 on the IES and/or above 40 on the CFQ are offered a referral for thorough diagnostics and treatment if neccesary.

Moreover, the intensivist can offer referral to other specialisms, e.g. to an otolaryngologist if he believes it could benefit the patient.