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Abstract
Introduction Acute psychological stress, as well as unusual experiences including hallucinations and delusions, are common in critical care unit patients and have been linked to post-critical care psychological morbidity such as post-traumatic stress disorder (PTSD), depression and anxiety. Little high-quality research has been conducted to evaluate psychological interventions that could alleviate longer-term psychological morbidity in the critical care unit setting. Our research team developed and piloted a nurse-led psychological intervention, aimed at reducing patient-reported PTSD symptom severity and other adverse psychological outcomes at 6 months, for evaluation in the POPPI trial.
Methods and analysis This is a multicentre, parallel group, cluster-randomised clinical trial with a staggered roll-out of the intervention. The trial is being carried out at 24 (12 intervention, 12 control) NHS adult, general, critical care units in the UK and is evaluating the clinical effectiveness and cost-effectiveness of a nurse-led preventative psychological intervention in reducing patient-reported PTSD symptom severity and other psychological morbidity at 6 months. All sites deliver usual care for 5 months (baseline period). Intervention group sites are then trained to carry out the POPPI intervention, and transition to delivering the intervention for the rest of the recruitment period. Control group sites deliver usual care for the duration of the recruitment period. The trial also includes a process evaluation conducted independently of the trial team.
Ethics and dissemination This protocol was reviewed and approved by the National Research Ethics Service South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). The first patient was recruited in September 2015 and results will be disseminated in 2018. The results will be presented at national and international conferences and published in peer reviewed medical journals.
Trial registration number ISRCTN53448131; Pre-results.
- Critical care
- Intensive care
- ICU
- mental health
- PTSD
- psychological intervention
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Footnotes
Contributors KMR, DW, JWei, CRB, DS, JWel, DHo, MM, DAH, SH, RG and ZS conceived the POPPI trial. KMR led the design, grant application and, as chief investigator, had oversight for the trial. DW, as lead clinical investigator, led development and delivery of the intervention with input from DS, JWel and ARB; PRM, as trial manager, managed the trial with support from ARB; DAH designed and has oversight for the statistical analysis; RG and ZS designed and have oversight for the economic analysis; LME designed and conducted the process evaluation. ARB drafted this manuscript and all authors read and approved the final version.
Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research (HS&DR) Programme (project number: 12/64/124). The Intensive Care National Audit & Research Centre (ICNARC) is the sponsor for the trial. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HS&DR Programme, NIHR, NHS the Department of Health nor the sponsor.
Competing interests None declared.
Patient consent Not required.
Ethics approval The Protocol and other trial-related documentation (and any amendments) received favourable ethical opinion from NRES Committee South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). All participating sites obtained local approvals prior to patient recruitment.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.