Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) Study

The POPPI Study is a 46-month project with the aim to evaluate the clinical and cost effectiveness of a complex psychological intervention in reducing patient-reported post-traumatic stress disorder (PTSD) symptom severity and other reported psychological morbidities and quality of life at six months. The POPPI Study consists of two phases: Phase I feasibility (months 1-18) and Phase II cluster-RCT (months 19-46). During Phase I, the education package (training and associated materials) will be developed: Module 1 (central training course and associated materials) in: how to provide training and support to all critical care unit staff to promote a therapeutic environment to promote calm and minimise stress in critical care; how to provide training and support for bedside critical care nursing staff to assess patients for acute psychological stress and psychosis-like symptoms using the Intensive Care Psychological Assessment Tool (IPAT); and how to deliver one-to-one cognitive behavioural therapy-inspired stress support sessions to patients; Module 2 (e-learning courses and associated materials) in: how to promote calm and minimise stress in critical care and how to assess patients for acute psychological stress and psychosis-like symptoms using the IPAT. Two pilot studies will be conducted, each in two adult general critical care units: one to evaluate each of the four elements of the complex intervention and one to assess the feasibility of the proposed processes and procedures for the cluster-RCT, including the feasibility of collection of the proposed outcomes. At the end of Phase I, there is a formal stop point and a report will be prepared for the NIHR HS&DR programme detailing all results from Phase I for consideration of feasibility and progression to Phase II. The cluster-RCT (Phase II) will be conducted in 24 adult, general critical care units (12 intervention, 12 control - 2,904 recruited patients). Units will commence recruitment in blocks of six (three intervention, three control) every two months. For the first five months (baseline period), all sites will deliver usual care. At the end of the baseline period, there will be a one-month transition (training/‘wash-in’) period during which intervention sites will transition to delivering the intervention. Three POPPI nurses nominated from each intervention site will attend the three-day central training course (Module 1 – part A) and receive accompanying materials. On completion of the course, the POPPI nurses will return to their units to oversee delivery of Module 2 of the education package and deliver one-to-one stress support sessions to patients who consent to take part in the study and are assessed as being stressed and at high risk of psychological morbidity. One month after completing Module 1 (part A), the POPPI nurses will attend the Module 1 (part B), a one-day central course for feedback, supervision and competency testing. Following the one-month transition period, intervention sites will continue to deliver the intervention and control sites will continue to deliver usual care for the remaining five months of recruitment. Consented, eligible patients recruited from intervention sites during the intervention period will be assessed for acute psychological stress and psychosis-like symptoms, using the IPAT, by trained bedside critical care nurses. Patients assessed as being stressed and at high risk of psychological morbidity will receive three, one-to-one stress support from one of the three POPPI nurses. The primary outcome will be patient-reported PTSD symptom severity at six months, measured using the Post traumatic stress Diagnostic Scale (PDS). Secondary outcomes will be: days alive and free from sedation to day 30; duration of critical care unit stay; PDS greater than 18 points at six months; depression at six months, using the short-form of the Center for Epidemiologic Studies Depression (CES-D-10) Scale; and health-related quality o