Title: Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) Study
Funder: Department of Health and Social Care

Abstract: 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 of life at six months, using the EuroQol (EQ-5D-5L) questionnaire. The primary outcomes for the economic evaluation will be incremental costs, quality-adjusted life years and net monetary benefit.

Lay abstract: More than 100,000 people are treated in intensive care units (ICUs) for life-threatening illnesses every year. Unfortunately, two-thirds of them may suffer disturbing psychological symptoms such as panic or hallucinations during their stay. Doctors believe that these frightening experiences are caused by the effects of illness, drugs, stressful treatments such as being on a breathing machine (ventilator), and by the alien environment of the ICU. Drugs that are given to relieve pain or calm a patient affect the brain, so patients may become delirious. Patients are also distressed by thirst, hunger, unnatural light, being unable to speak, seeing other people die, loud alarms going off in the night or losing track of time. Coming off a ventilator and learning to breathe normally again can also be frightening and lead to feelings of suffocation and panic. There is now strong evidence that these stressful intensive care experiences may trigger longer-term psychological problems for patients. Recent research by our team shows that more than half of patients who survive intensive care develop psychological illnesses such as post-traumatic stress disorder (PTSD), severe depression or anxiety in the months after leaving hospital. These mental health problems may still be present up to two years later. Patients with post-traumatic stress disorder have problems such as anger, insomnia and vivid, frightening flashbacks. The flashbacks suffered by former intensive care patients are frequently of the terrifying hallucinations experienced in intensive care, including paranoid delusions such as torture chambers, religious cults, poisoning or conspiracies to kill patients. Patients with psychological illnesses such as PTSD are also at higher risk of physical ill-health such as heart disease and are much more likely to visit GPs or be admitted to hospital. Research has started to teach us about the many possible causes of this long-term distress, but until now little has been done to prevent intensive care patients from developing mental illness . We are applying for funding so that we can develop and test new psychological approaches to reduce the stress of intensive care patients and prevent them from suffering poor mental health in the future. As there are very few psychologists available to treat people in intensive care, we plan to train intensive care nurses to provide enhanced psychological care for their patients. Intensive care nurses are in constant close contact with their patients, so they are well placed to give patients extra support and care. It can be difficult for ICU nurses to recognise that patients are suffering from distress or hallucinations. Most patients are unable to speak while they are on ventilators with a tube in their throat, while others may be withdrawn and unwilling to express how they feel. Many intensive care nurses also find it stressful to look after patients who are delirious or agitated, as they receive no special training in this type of care. Our psychological training for nurses will have three aims; first, helping them to provide a calm, healing environment for critically ill patients; second, teaching them to detect psychological distress, and finally; teaching experienced nurses how to give psychological therapy to their more distressed patients. Our research will include two steps. The first step will be to design the psychological training courses and try them out with nurses and patients in a pilot study in two hospitals. The second step will be to hold a clinical trial in which intensive care nurses in twelve hospitals will receive psychological training and provide psychological therapy to patients. They will be compared with twelve hospitals where intensive care nurses do not receive the training or provide therapy to patients. These rigorous, scientific methods will tell us if the nurse training and patient therapy help to reduce psychological disorders in patients who have been in ICU. Patients from ICUs where psychological training and therapy take place, will answer questionnaires that detect PTSD, depression and poor quality of life six months after leaving intensive care. Their scores will be compared with patients from ICUs where there was no psychological training or therapy. We will know if the trial has been successful if there are meaningful differences between the two sets of scores. During the trial, all nurses in twelve ICUs will complete an e-learning course about good psychological care of patients and how to detect distress using a new short psychological assessment questionnaire for intensive care (the I-PAT). The I-PAT can be completed with patients in a few minutes and will tell the nurse if the patient has been in pain, anxious, low in mood, panicky, delirious or confused. It will also highlight the patient’s future risk of mental illness. Additionally, three experienced nurses from the 12 ICUs will attend a four-day training course to learn to provide three psychological therapy sessions to distressed patients, and to support their staff in psychological care and assessment. Only these specially trained nurses will provide therapy sessions. The sessions are based on cognitive-behavioural therapy (CBT), a form of psychotherapy that is supported by good evidence. Nurses will be trained to use CBT techniques that are known to help problems such as stress, panic, hallucinations and delusions. The training team will provide the nurses with clear guidelines to use when carrying out therapy. This research will benefit patients by reducing the mental and physical suffering, loss of quality of life or economic hardship (if they are unable to return to work) they may undergo following admission to ICU. It will benefit the NHS by reducing the costs of treating post-ICU mental illness and associated physical illness, in the form of repeat GP visits and hospital admissions. Our research team is highly qualified to carry out this study. It includes internationally-renowned clinical and health psychologists with expertise in the psychological aspects of intensive care and relevant techniques of cognitive behavioural therapy, senior intensive care nurses and doctors, and clinical trial experts who will ensure the research is rigorously carried out.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: MENTAL HEALTH