Title: Seclusion and psychiatric intensive care evaluation study
Funder: Department of Health (England)

Abstract: We will evaluate the innovations of no seclusion and restricted access to Psychiatric Intensive Care Units (PICUs) by:1. Assessing the outcomes of (a) PICU transfer versus continued acute inpatient care among patients admitted to general adult wards and of (b) seclusion versus no seclusion among PICU patients in terms of: (i) repeated physical violence to others (primary outcome) injury to staff or patients absconding and length of stay; (ii) costs and cost-effectiveness.2. Under innovative vs. traditional organisational systems (differing access to PICU and seclusion): (i) describing how the same patient high risk behaviours are managed; (ii) exploring and identifying differing thresholds for the commencement of severe containment methods (manual restraint rapid tranquillisation seclusion PICU transfer)Study one: We will use anonymised electronic patient records of South London and Maudsley NHS Foundation Trust (14) to derive propensity score-based estimates of the effectiveness and cost-effectiveness of (a) PICU transfer from general adult wards and (b) seclusion on PICUs. Step 1: Using small test datasets develop method to automatically select free-text records containing events potentially relevant to transfer so that these can be manually coded. Develop coding scheme for events of interest based on Overt Aggression Scale (15). Validate on new test dataset of free-text progress notes. Repeat step 1 for seclusion. Step 2: Extract two study datasets: (1) general adult admissions +/- transfer to PICU; (2) PICU admissions +/- use of seclusion; both complete with demographic and other variables. Code relevant selected free-text as above.Step 3: Multivariable analyses of each study dataset leading to calculation of propensity scores for PICU transfer and for seclusion on PICU. Select matched controls using propensity scores.Step 4: Effectiveness analyses for PICU and for seclusion as per objectives above.Step 5: The datasets above will include service use from the time of the assault until 12 months later including time spent on inpatient wards (including the PICU) and where applicable subsequent contacts with mental health professionals in community settings. Costs will be calculated by combining these data with unit costs derived from hospital management accounts and where necessary from published sources (e.g. NHS Reference Costs University of Kent). PICU unit costs will reflect greater staff levels per bed. Cost comparisons will be made between the groups using bootstrap methods if data are skewed. Cost predictors will be identified using regression models with independent variables reflecting clinical and demographic characteristics of patients. Cost-effectiveness will be assessed by combining the cost data with information on further assaults. If one intervention has lower costs and reduced rates of assault then it will be ‘dominant’. Better outcomes at a higher cost will lead to the calculation of incremental cost-effectiveness ratios (ICERs) to indicate the extra cost incurred to produce one fewer assault over the follow-up period. Uncertainty around the ICERs will be assessed by generating cost-effectiveness planes and cost-effectiveness acceptability curves. The latter require a range of hypothetical societal monetary values to be placed on reductions in assaults. The lower bound of this range will by convention be zero. To inform the positive values in the range we will obtain data on fines and penalties associated with assaults and also official data on the estimated costs of assaults. We are not measuring quality-adjusted life years in this study as the main effect of interest reduction in assaults is not directly a patient outcome measure. In theory we could make assumptions about the impact on health-related quality of life of those assaulted (or not) but data are unlikely to be suitable for this. Study two: By conducting interviews of inpatient nurses across multiple sites we will connect four differing organisational solutions to managing high risk patients and behaviours (no seclusion and restricted PICU access; no seclusion and full PICU access; seclusion available and restricted PICU access; seclusion available and full PICU access) with thresholds for the use of alternative containment methods (rapid tranquillisation coerced medication manual restraint etc.) utilising mixed methods combining qualitative and quantitative data. The interview will first be based on vignettes of difficult challenging patients and appropriate management methods. Additional questions will be posed about assessment and transfer processes for PICU care and/or seclusion ease of referral and access. Participants will also complete the Attitude to Containment Methods Questionnaire (11) which compares views on the acceptability of differing containment methods; and the Moylan Progression of Aggression Tool (MAPAT) (16). The MAPAT consists of a video of escalating patient behaviour during which viewers push a button to indicate the point at which they would if present initiate a manual restraint as the leader of a team of three other nurses. The interviews will be recorded transcribed and thematically analysed for interventions and thresholds leading to the formulation of a flow chart on the management of difficult behaviour specific to each service context (PICU/seclusion availability). Nurses choices reasoning and delay to restraint times will also be compared to the availability of seclusion and/or PICU care in their locality.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.2 HEALTH AND WELFARE ECONOMICS
Health categories: MENTAL HEALTH