Psychological Outcomes Following a Nurse-led Preventative Psychological Intervention for Critically Ill Patients Trial: Statistical and Health Economic Analysis Plan

Overview

Journal J Intensive Care Soc

Publisher Sage Publications

Specialty Critical Care

Date 2018 Dec 6

PMID 30515237

Citations 3

Authors

Jerome Wulff

Zia Sadique

Richard Grieve

David Howell

Paul Mouncey

Dorothy Wade

Kathryn M Rowan

David A Harrison

Affiliations

Soon will be listed here.

Abstract

The Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients trial is a cluster-randomised controlled trial of the clinical and cost-effectiveness of a complex nurse-led preventative psychological intervention compared with usual care in reducing patient-reported post-traumatic stress disorder symptom severity, and other reported psychological morbidities, at six months among Level 3 (intensive care) patients in adult general critical care units in England, Wales and Northern Ireland. This paper describes the proposed statistical and health economic analyses for the Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients trial. It is important to complete and publish this plan before inspecting and locking the trial data to ensure that post hoc and data-derived decisions are avoided. ISRCTN53448131.

Citing Articles

A framework for extending trial design to facilitate missing data sensitivity analyses.

Mason A, Grieve R, Richards-Belle A, Mouncey P, Harrison D, Carpenter J BMC Med Res Methodol. 2020; 20(1):66.

PMID: 32183708 PMC: 7076973. DOI: 10.1186/s12874-020-00930-2.

Multiple session early psychological interventions for the prevention of post-traumatic stress disorder.

Roberts N, Kitchiner N, Kenardy J, Robertson L, Lewis C, Bisson J Cochrane Database Syst Rev. 2019; 8:CD006869.

PMID: 31425615 PMC: 6699654. DOI: 10.1002/14651858.CD006869.pub3.

Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients: A Randomized Clinical Trial.

Wade D, Mouncey P, Richards-Belle A, Wulff J, Harrison D, Zia Sadique M JAMA. 2019; 321(7):665-675.

PMID: 30776295 PMC: 6439605. DOI: 10.1001/jama.2019.0073.

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