Patterns of PTSD in Adult Patients After Intensive Care

Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial

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

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Syndrome
• Intervention / Treatment: Behavioral: Post ICU recovery program

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.

• Study Type: Observational
• Enrollment (Actual): 386

Contacts and Locations

Study Locations

• Denmark
  • Sjælland
    • Holbæk, Sjælland, Denmark, 4300
      • Holbæk Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Intensive care patients (survivors)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post traumatic stress disorder (PTSD)	Harvard Trauma Questionnaire, Range 18-72	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21	12 months
Anxiety	Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21	3 months
Depression	Hospital Anxiety and Depression Scale (HADS) covering Depression (7 items) Range: 0-21	12 months
Depression	Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21	3 months
PTSD	Harvard Trauma Questionnaire, Range 18-72	Baseline
PTSD	Harvard Trauma Questionnaire, Range 18-72	3 months
PTSD	Change score using Harvard Trauma Questionnaire, Range 18-72	Over time at baseline, 3 and 12 months
Anxiety	Change score Using Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21	Over time at 3 and 12 months
Depression	Change score using Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21	Over time at 3 months and 12 months

Collaborators and Investigators

• Sponsor: Holbaek Sygehus
• Collaborators: Hillerod Hospital, Denmark
• Investigators: Study Director: Janet F Jensen, Holbaek Sygehus and Hillerod Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Homepage for project collaborators

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 18-000080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No