|- candidate number||14015|
|- NTR Number||NTR3716|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-nov-2012|
|- Secondary IDs||12-418/C METC of UMC Utrecht|
|- Public Title||Effectiveness of a follow-up clinic for ICU survivors on long term outcome: A stepped wedge cluster randomised controlled trial.|
|- Scientific Title||Effectiveness of a follow-up clinic for ICU survivors on long term outcome: A stepped wedge cluster randomised controlled trial.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD), Quality of life|
|- Inclusion criteria||ICU stay longer than 48 hours.|
|- Exclusion criteria||1. Mortality during treatment or 2 months after ICU discharge;|
2. ICU admission with an indication primarily for neurology/neurosurgery;
3. Patients less than 18 years;
4. Patients (or authorised relatives) who do not consent to participate.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||19-nov-2012|
|- planned closingdate||7-apr-2014|
|- Target number of participants||390|
|- Interventions||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.
|- Primary outcome||Incidence of PTSD at one year follow-up.|
|- Secondary outcome||1. Quality of life at 1 year follow-up;|
2. Cognitive impairment at 1 year follow-up;
3. Impairment in daily activities at 1 year follow-up;
4. (Other) anxiety disorders at 1 year follow-up;
5. Depression at 1 year follow-up.
|- Timepoints||1. Baseline questionnaire for family;|
2. Questionnaire 1 month after ICU discharge;
3. Primary and secondary outcomes: Questionnaire 1 year after ICU discharge.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. Diederick Dijk, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Diederick Dijk, van|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht, Division of Vital Functions|
|- Brief summary||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.
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.
Cluster randomised controlled trial (stepped wedge design).
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.
|- Main changes (audit trail)|
|- RECORD||21-nov-2012 - 5-dec-2012|