Clinical trial NCT03915977: Patterns of PTSD in Adult Patients After Intensive Care
Official title: Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Hillerod Hospital, Denmark
First posted: 2019-04-16
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive care patients (survivors)

Brief summary: This study aims to describe adult patients' patterns of Post-traumatic stress disorder (PTSD) at discharge, 3, and 12 months after intensive care.

Detailed description: The present study is a secondary analysis of the RAPIT-trial study treating data from patients on Post-traumatic stress disorder (PTDS) (Jensen et al., 2016).

Design Observational study based on data from the RAPIT trial that is a non-blinded, multicentre, parallel-group RCT conducted between December 2012-2015, at 10 intensive care units (ICUs) in four out of five regions in Denmark.

Participants Patients were consecutively recruited during the first 18 months of the study. We included Danish-speaking adults (≥18 years) who received mechanically ventilated ≥48 hours and did not meet the baseline criteria of dementia. We excluded delirious patients unable to give informed consent at randomization, or patients, who were enrolled in other studies. A total of 386 adult patients were randomized to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC).

Outcomes In this study, we will describe variations in patients, who experience symptoms of PTSD at ICU-discharge, 3 and 12 months after intensive care based on the data collection in the RAPIT-trial (Jensen et al., 2016). We will report trial participants' symptoms of PTSD at baseline, three months and twelve months after Intensive care using the Harvard Trauma Questionnaire (HTQ) supplemented with descriptions of patients' experiences of PTSD. Symptoms of anxiety and depression were collected at 3 and 12 months, and utilization of healthcare services including mortality were obtained from hospital charts combined with self-reported data from patients. We will use descriptive statistical methods to analyze data.

Symptoms of PTSD by HTQ-IV consisted of 17 items covering three core symptoms corresponding to DSM-IV criteria for PTSD: re-experience (5 items), avoidance (7 items), and arousal (5 items). This was supplemented by four additional items: one functional and three related to stress. We used a total score, and a cut-off of ≥40 is categorized as "positive PTSD". Symptoms of anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) covering two dimensions: anxiety (7 items) and depression (7 items); subscale scores were 0-21 with higher scores reflecting greater psychological distress.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Non-invasive or invasive ventilation ≥ 48 hours ( Non-ivasive ventilation (NIV) from current guidelines)
* Undiagnosed dementia

Exclusion Criteria:

* Delirium at randomization (positive CAM-ICU score)
* Participations in scientific projects which include patient interviews
* Not speaking or understanding danish.

Primary outcomes:
measure: Post traumatic stress disorder (PTSD)
timeFrame: 12 months
Secondary outcomes:
measure: Anxiety
timeFrame: 12 months
measure: Anxiety
timeFrame: 3 months
measure: Depression
timeFrame: 12 months
measure: Depression
timeFrame: 3 months
measure: PTSD
timeFrame: Baseline
measure: PTSD
timeFrame: 3 months
measure: PTSD
timeFrame: Over time at baseline, 3 and 12 months
measure: Anxiety
timeFrame: Over time at 3 and 12 months
measure: Depression
timeFrame: Over time at 3 months and 12 months
Other outcomes:
Locations:
city: Holbæk
country: Denmark
facility: Holbæk Hospital
state: Sjælland
Study officials:
affiliation: Holbaek Sygehus and Hillerod Hospital
name: Janet F Jensen
role: STUDY_DIRECTOR
References:
citation: Jensen JF, Overgaard D, Bestle MH, Christensen DF, Rattray J, Egerod I. Intervention fidelity in postintensive care follow-up consultations at ten sites in the RAPIT-trial: A mixed-methods evaluation. J Adv Nurs. 2019 Apr;75(4):862-875. doi: 10.1111/jan.13949. Epub 2019 Feb 12.
citation: Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.