Co-developing, piloting, and evaluating a translational simulation (TS) delivery model for the promotion of psychological trauma-informed care (TIC) to improve service delivery within acute hospital settings: A Research Protocol

Objectives and deliverables

Taken together, the project aim will be achieved through the completion of the following research objectives: (i) co-design a TIC improvement programme for use in acute hospital settings using translational simulation (TS) approaches (TS4TIC), (ii) implement TS4TIC in two acute hospital settings, and (iii) co-evaluate the effectiveness and acceptability of TS4TIC using co-defined outcome, process, and balancing indicators measured across iterative Plan, Do, Study, Act (PDSA) cycles. Table 1 summarises the deliverables that are expected to emerge from these three research objectives, in addition to two additional management and dissemination objectives:

Context

St James’s Hospital (SJH), Dublin, is an inner-city hospital in a catchment area with a high level of socioeconomic deprivation (Conway et al., 2016; Walsh et al., 2004). Within SJH, more than 10% of people attending the Emergency Department (ED) and/or admitted to acute medical wards are experiencing homelessness or otherwise considered under-served and socially excluded populations (Ní Cheallaigh et al., 2017). SJH’s emergency department (ED) and an acute medical admission unit (AMAU) were thus chosen as specific locations identified by both hospital staff and patients as the first touchpoints for many patients with the hospital’s services.

Sample size and sampling strategies

The challenges presented by trying to provide care for patients who have likely experienced complex and prolonged psychological trauma are, from our preparatory discussions with SJH staff, felt by all patient-facing staff. Accordingly, the TS4TIC sampling frame is comprised of all staff working in the ED and AMAU, including receptionists/administrators (n=17), security staff (n=55), nurses and health care attendants (n=145), catering staff (n=4), cleaning staff (n=10), porters (n=4), medical teams (n=73), and health and social care professionals (n=10.5), such as physiotherapists and social workers. All N=318 staff rostered to the ED and the AMUA will thus be informed of the study in months 3-4 and invited to take part in the simulation-based training. Recruitment will be led by members of the existing TS4TIC project team, which consists of representatives from each of these groups, who will act as gatekeepers and invite potential participants to take part in the project. Likewise, collaborators with lived expertise of psychological trauma and those who represent them, who are also represented within the TS4TIC project team, will also be recruited as potential participants.

Study procedures and improvement models

The co-development and subsequent evaluation of TS4TIC will be achieved using a mixed-methods, collaborative approach. Specifically, the IHI Model for Improvement will be used to guide the (i) co-design of a TIC improvement programme using translational simulation (TS) approaches (WP 1), (ii) implementation of TS4TIC in acute hospital settings (WP2), and (iii) co-evaluation (WP3) of the effectiveness and acceptability of TS4TIC using co-defined outcome, process, and balancing indicators measured across two successive Plan, Do, Study, Act (PDSA) cycles.

TS uses team-based, in-situ simulation of challenging staff/patient interaction scenarios to improve patient care and the healthcare systems. Specifically, TS (i) diagnoses safety and performance issues and (ii) delivers simulation-based interventions within relevant context (Nickson et al., 2021). The focus of TS is thus on team behaviours and systems-level learning and change with an increase in individuals’ awareness. Consequently, within TS, the importance of both diagnosing and understanding the context and learning in context are stressed from the outset and changes are made to the system following and through each iterative simulation cycle (see Figure 1).

Figure 1. Stages of implementing translational simulation has been reproduced with permission from (Brazil, 2017).

Taken together, the novel combination of TS with the IHI Model for Improvement and Deming’s PDSA cycles will allow for the co-development of a TS4TIC improvement programme (Plan), to carry out the TS4TIC scenarios (Do), to observe and learn from the processes and outcomes of TS4TIC (Study), and to determine what modifications should be made to the next iteration of the TS4TIC improvement programme (Act). PDSA cycles were chosen as the preferred methodology as (i) they are highly compatible with the stages of TS (Goodyear-Smith et al., 2015) and (ii) when used correctly, they present an externally valid and pragmatic scientific method for testing changes in complex systems (Braithwaite et al., 2018; Taylor et al., 2014). Moreover, while recent calls (Nickson et al., 2021) have been made to combine TS with PDSAs to achieve greater system change, to the best of our knowledge, this is the first study to trial this approach (see Figure 2).

Figure 2. Adapted from the Institute for Health Improvement (IHI) model for improvement.

The IHI model of improvement figure was adapted by converting the improvement steps to black and white for a clear readability. The PDSA circle and the model for improvement phases in the table above it remained unchanged.

Important to note here that consistent with participatory approaches, all research procedures are subject to change as a result of ongoing learning and extensive participant consultation. And while preliminary discussions with key stakeholders’ groups took place to inform the initial design of the project, we acknowledge the possibility of changes occurring to this study’s protocol as the research unfolds. In its initial design, however, TS4TIC’s research objectives and deliverables are expected to be achieved through the completion of three research-specific work packages (WP1-3). The activities planned under each of these work packages are described in greater detail below:

Work Package (WP) 1: To co-design a translational simulation-based trauma-informed awareness, training, and improvement programme (TS4TIC) for use within an acute hospital setting

PDSA Cycle 1, Step 1 - Plan

Comparable to the diagnosis stage of TS, the first PDSA Cycle will focus on co-designing (i) scenarios to include in the initial version of the TS4TIC improvement programme (towards achieving research objective 1) and (ii) the evaluation procedures to assess the impact and acceptability of implementing the TS4TIC improvement programme (towards achieving research objective 3). In addition to the planning already underway as a result of early engagement with collaborators, further activities that will take place during PDSA Cycle 1, Step 1 include:

(1.1) Completion of a scoping review (Month 4) to clarify: What do we mean by trauma-informed care within acute hospital settings? This review will be used to (i) improve conceptual clarity and (ii) ensure a shared understanding of TIC amongst the study team.

(1.2) Completion of an internal review of existing quality and safety issues related to psychological trauma within SJH, delivered in Month 6. The internal review will be achieved through (i) a review of existing Adverse Incident Report (AIR) data and historic patient experience feedback data (Months 2-3) and (ii) we have hosted our first of five Workshop Series with participants (Months 4-6). The content of TS4TIC will thus be identified through ‘system probing’ (Brazil, 2017) approaches, where latent threats are identified, adverse events are recreated, culture and professionalism issues are identified, and patient experiences are explored.

(1.3) Using the results from the scoping review and internal review, we will co-design pre-brief materials, with accompanying co-designed simulation scenarios. Again, participant consultations during a second workshop hosted in Months 5-7 will ask: Which of these challenge(s) do we prioritise solving to achieve measurable improvement? Consistent with TS approaches, possible challenges may include issues with relationships and culture, handover systems, team training, guidelines, pathways, and technical and non-technical skills. These suggested challenges will thus inform the content of 15-20 participant-driven simulation scenarios designed to highlight the importance of psychological trauma-awareness/ sensitive leading to TIC. The simulation scenarios will particularly focus on ‘diagnosis’, e.g., identifying system factors along the patient journey from the door of ED to the AMAU which impact negatively on the experience of care for patients with lived experience of psychological trauma. These may include challenges with tasks, tools, technologies, individuals, team, organisation and environmental factors. Together, these pre-brief materials and accompanying scenarios will form an initial version of the TS4TIC Toolkit.

(1.4) Once the initial content of the TS4TIC Toolkit is developed, we will identify which facilitators, participants, and observers are most appropriate to take part within each co-designed scenario (Month 7). Here, we ask: Which stakeholder(s) should be represented within each co-designed scenario? Different scenarios may, for example, require the participation of various staff including security, reception, triage nurse, doctor, nurses, Health and Social Care Professionals (HSCPs), and porters, among others. Careful attention will be paid to ensuring ethnicity and gender balances appropriate representation across the scenarios. The inclusion of hospital staff as co-applicants will ensure that scenario facilitators, participants, and observers are easily and rapidly engaged.

(1.5) A set of common evaluation measures for use as part of TS4TIC’s co-evaluation procedures (i.e., in fulfilment of research objective 2) will be agreed upon. This activity thus asks: What changes, or degree of change, would we need to observe to deem the TS4TIC intervention a success? Consistent with the TS systems approach, participants will be encouraged to draw on the results of the scoping review and internal review, to develop indicators of success, including indicators of effectiveness and acceptability, at individual (i.e., service user, service provider), team, unit, organisational, and system levels. In addition, indicators will be developed as part of process, outcome, and balancing (i.e., knock-on effects or unintended consequences to other parts of the health system) evaluations, again co-designed from the outset with both Socially Excluded Persons (SEP) and Health Care Workers (HCWs) involvement. These indicators will thus inform the measurement tools adopted throughout the evaluative component of TS4TIC (i.e., in fulfilment of research objectives 2 and 3) and will eventually inform the development of the TS4TIC Compendium of Improvement Indicators as a component of the TS4TIC Toolkit.

(1.6) A baseline assessment will take place during Months 8-9, based on the indicators co-identified and described under Activity 1.5, will take place with all participants prior to the commencement of any simulation-based activities.

WP 2: To iteratively implement TS4TIC in an ED and AMAU setting

PDSA cycles of improvement will take place. Here we give an outline of what the first two cycles might look like. Further cycles-within-cycles will also emerge through the research.

PDSA Cycle 1, Step 2 - Do

(2.1) Finalised research protocol is being submitted to HRB Open Research, for consideration as an open access publication.

(2.2) Implementation of the scenarios, co-designed under Activity 1.3, will take place within SJH between Months 10-12, at locations and times agreed in advance. Aligned with TS approaches, the four main types of learning targeted by the scenarios will be: Individual, Team, Unit-Level and/or Organisational learning. Each of these learning levels will therefore be reflected in our evaluation (see: PDSA Cycle 1 - Step 3 - Study). Implementation of these scenarios will follow a general format, aligned with broader TS approaches, as outlined below. Approximately 7-10 participants and at least one actor will take part in each scenario, with each scenario lasting 20 minutes. The scenarios will take place in or adjacent to the clinical spaces. It is envisaged that approximately 15-20 scenarios will be run in this step.

Scenarios will run as follows:

Firstly, all scenarios will include a safety check, whereby clinical nurse managers (CNMs)/shift leaders will be identified and will be asked to confirm that they agree for the simulation to proceed, and staff participation will also be confirmed. Consistent with TS principles, this ensures that simulation scenarios offer a safe place for participants, allowing behaviours and practices to take place without interfering with departmental work or procedures, while also ensuring staff and patient privacy. A final safety check to ensure that there are no potential serious risks from proceeding (e.g. that staff are not required for a major emergency) will be done before commencing, in order to create a psychological safe environment for all stakeholders (Rudolph et al., 2014). Participants will have been asked to sign a nondisclosure agreement (NDA) and the importance of confidentiality will be reiterated before the scenario begins, to prevent information on this study from being shared with others which ultimately protects the confidentiality subscribed to in this intervention.

Secondly, each scenario will follow a 5/7/8 Model, designed as a total of 20 minutes of learning. As part of the 5/7/8 Model, the first five minutes are spent completing a simulation pre-brief, which might include introductions, a discussion of the objectives, roles, and expectations of the simulation, a confidentiality reminder, a reminder of the resources available should a participant become distressed, and the completion of a ‘fiction contract’, whereby the latter involves seeking a voluntary contract from the learner, or participant, to act as if the simulation were real. The next seven minutes are then spent in the simulation, whereby all participants act in their authentic roles. For ethical reasons, we envisage that actors with lived experience of social exclusion will act the part of patients with lived experiences of trauma. Pre- and de-briefing and psychological support for the actors and health staff will be provided by the co-authors. With the permission of participants, all simulations will be video recorded for data collection purposes. Participants are given the opportunity to pause and repeat parts of the simulation if desired (i.e., Time Out).

Finally, the last eight minutes are spent on reflective practices and recapping what occurred during the simulation (Eppich & Cheng, 2015). The facilitators will clarify that the reflective sessions or practices focus on systems rather than individuals, and the analysis phase will ultimately be used to focus on a variety of performance domains which may include decision-making, communication, resource utilisation, situational awareness, and teamwork. The debrief, as with other elements of the simulation, remains confidential within the team. During the debriefing and recap, participants (including actors) will be asked to summarise the case, identify things that went well, areas and opportunities for improvement, and points for actions and responsibilities. Moreover, participants will be asked to reflect on (i) what can the team learn? (ii) what can the unit learn? and (iii) what can the hospital or organisation learn? Finally, participants will be asked to reflect on how the simulation may have differential implications for men and women, ensuring that gender is considered across the various scenarios. The debriefing and recap will also be used to inform future TS cycles, such that the scenarios themselves can also be further adapted to maximise the learning experience. In this way, the TS cycles very much mirror the PDSA cycles, as complementary approaches.

Smaller improvement projects will fall out of the TS and these will be run through smaller iterative PDSA cycles where appropriate.

WP 3: To co-evaluate the effectiveness and acceptability of TS4TIC in improving quality of care within an acute hospital setting

PDSA Cycle 1 - Step 3 - Study

Co-evaluating the effectiveness and acceptability of (TS4TIC) for use within an acute hospital setting will involve the analysis and synthesis of a series of agreed upon (i) process, (ii) outcome, and (iii) balancing measures across Individual (staff and patients), Team, Unit and/or Organisational levels. Here, balancing measures are included to explore the potential, unintended, or unforeseen effects of introducing TS4TIC, including across the wider hospital system. Step 3 of the first PDSA cycle is thus marked by the following activities:

(3.1) In keeping with co-design principles, researchers and key stakeholders including persons with lived experiences of trauma, front-line staff, hospital and Health Services Executive (HSE) management and the study team, will co-determine how the TS4TIC training is evaluated (Goodyear-Smith et al., 2015). For indicative purposes, we will include a list of potential indicators and, where applicable, accompanying validated measures that may be used to assess the efficacy and acceptability of TS4TIC, in fulfilment of our research objective 3. These are, however, subject to change following the outcome of Activity 1.5 (i.e., agreement on a set of common evaluation measures). Ultimately, these indicators will thus form the basis of the TS4TIC Compendium of Improvement Indicators, the initial version of which will be delivered in Month 13.

(3.2) Participants (recruited from a potential N=318 participants) who will have taken part in the baseline evaluation will complete a follow-up questionnaire containing indicators measured using scale-based tools by Month 14.

(3.3) Key informant interviews with individuals taking part in the simulations will take place by Month 15. Interviews will focus on participants’ experiences of having taken part in the scenarios, what they found worked to reinforce their learning, and how the process of developing TS4TIC could be improved. Individuals will be asked to provide feedback on TIC patient interactions in the clinical environment following simulation training.

(3.4) Expert interviews (e.g., senior management, the hospital Patient Representative Group (PRG), Patient Experience Lead) will take place with other stakeholders by Month 15, who, after reviewing the recordings of the simulation, will be asked to consider whether and if so, how, the various simulations might be improved in order to enhance individual, team, unit-level and organisational learning. Interviewees will also be asked to consider where, within their existing practices and workflows, might the TS4TIC improvement programme best be implemented.

(3.5) Analysis of observational data collected during the implementation of the various scenarios as part of TS4TIC, including observations made during the debriefing and recap step. Together, data will be used to evaluate learnings of the team, diagnosis of the system, identify any suggested changes to the context, as well as the perceived impact on the quality of the care experience for patients and staff.

(3.6) Data will be analysed using the data analysis methods described under PDSA Cycle 2, Step 3, below by Month 15, and written up across a minimum of two manuscripts for submission to peer-reviewed journals.

WP4: To co-produce and disseminate a TS4TIC Toolkit for the acute hospital sector

PDSA Cycle 1 - Step 4 - Act

Initial results from the analysis of initial outcome, process, and balancing data will then be discussed through:

(4.1) Workshop Series 3 in Months 16-17, which aims to collect and collate feedback and reflection. Specifically, the purpose of these workshops will be to identify suggestions of key practical and procedural changes to current practices emerging from the learnings of the scenarios that participants believe will lead to improvements in quality of care. Here, we ask: What changes do we need to make to improve the delivery of care experienced by patients and staff who have experienced psychological trauma? These changes will be explored using ED patient journeys, which involve several interactions, including with other patients and various staff including security, reception, triage nurse, doctor, nurses, HSCPs, and porters, among others. Possible changes may occur at the level of handover systems, training, guidelines, pathways, and technical and non-technical skill building. These may also include changes to tasks, tools, and technologies.

PDSA Cycle 2 - Step 1 - Plan

A second PDSA Cycle will then take place to further inform and refine the content of the TS4TIC improvement programme. A key outcome of this step is therefore a revised version of the simulation scenarios for inclusion in the TS4TIC Toolkit, co-produced with continued user and stakeholder involvement. Key questions for all participants at this stage include: What are we trying to accomplish? How will we accomplish it? and how will we know when we have accomplished it? Therefore, whereas the first PDSA cycle was used to generate simulation scenarios based on existing challenges, this second PDSA cycle is ‘solution-based’, whereby simulation scenarios focus on implementing solutions to the problems identified in PDSA Cycle 1. In keeping with a participatory methodology, and the collaborative nature of TIC, this second planning stage will also include a series of workshops to:

(5.1) Prioritise which change(s) to current practices should be carried out. The purpose of this step is thus to build consensus on the order in which changes need to occur to improve quality of care using a psychological trauma-aware or trauma-sensitive approach with the view of becoming trauma-informed. The outcome of this activity will be used to generate a Road Map for making SJH a “Trauma-Informed Hospital”.

(5.2) Make iterations and improvements to the co-designed pre-brief materials and accompanying simulation scenarios. These refined scenarios will thus result in the co-developed TS4TIC Toolkit, in fulfilment of research objective 1. Consistent with TS approaches, these revised simulations will focus on improving systems and processes (e.g., different behavioural approaches, communication styles or workflows), rather than individual or team knowledge and skills, such that learning is translational.

(5.3) Where appropriate, we will identify whether changes are needed to the facilitators, participants, and observers to take part within each revised scenario. This may require the recruitment of additional participants to the research.

(5.4) Revising the list of indicators used to determine the effectiveness and acceptability of the TS4TIC improvement programme in order to co-produce the TS4TIC Compendium of Improvement Indicators, as a component of the TS4TIC Toolkit.

PDSA Cycle 2 - Step 2 - Do

(6.1) The second ‘do’ step of TS4TIC will therefore consist of a series of revised simulation-based scenarios, refined based on the outcomes of PDSA Cycle 2 in fulfilment of research objective 2. These revised scenarios will focus on implementing the solutions identified in PDSA Cycle 1 Step 4 and will again be implemented as described in PDSA Cycle 1 - Step 2.

Importantly, these simulations will be intervention-based simulations and will focus on changing and improving the ED and AMAU systems of care. While some of the prioritised changes will be made possible through simulation; others will be ‘Just Do It’ type changes; some will require their own PDSA cycles and others still will be notified to the SJH management team as large-scale system changes.

PDSA Cycle 2 - Step 3 - Study

The second ’study’ step of TS4TIC will consist of:

(7.1) Re-administering the evaluation measures, as described in PDSA Cycle 1 Step 3, with a particular focus on the longer-term sustainability of TS4TIC and on the implementation of systems-level changes identified as necessary in PDSA Cycles 1 and 2.

Data analysis

(7.2) Analysing data. As evaluation measures will likely include a mixture of quantitative (i.e., scale-based questionnaires) and qualitative (i.e., key informant interviews, focus group discussions) approaches, potential data analysis across outcome, process, and balancing data may include:

Questionnaire data will be analysed using structural equation modelling (SEM) procedures, using a robust maximum likelihood (MLR) (Schafer & Graham, 2002), as an estimation process to assess within arm (i.e., SJH participants) changes over time across the various indicators of success. Data analysis will be done using Mplus Version 8.2 (Muthén & Muthén, 2017). Specifically, within arm changes will be assessed across baseline and follow-up assessments, with a minimum of two assessments and changes over time will be assessed by comparing a null or ‘constrained’ model where all variable means are constrained to be equal to a second, ‘unconstrained’ model where means are freely estimated. Improvement in model fit will be tested using the loglikelihood difference test, whereby a significant chi-square (X²) result is indicative that an unconstrained model is better than the constrained model, meaning that the null hypothesis of equal means can be rejected (Hoffman, 2015). The ‘model test’ feature in Mplus, which allows constraints to be tested using the Wald X2 test, will then be used to test pairwise comparisons across the assessment periods. Analyses will be conducted considering the stratification and clustering of the data at unit-level (i.e., TS simulation groups) using the ‘complex analysis’ function.

Interview data will be analysed using content analysis (CA), where the aim is to organise, generate meaning, and produce conclusions based on arrangements of the data. All interview transcripts will be transcribed verbatim and imported into NVivo for analysis. CA was chosen as it can be used to analyse various written data sources and because its methods are flexible and non-epistemologically circumscribed and can therefore be performed within different research traditions (Bengtsson, 2016). Here, CA will be conducted inductively and concerned with identifying common content across the different hospital staff and patient groups and to get a sense of the common preference for specific recommendations such that the results generated are applicable to SJH as an overall organisation, and therefore relevant to other acute hospital settings. First, interview transcripts and observational data will be used to create initial content codes to form a coding scheme, not guided by any theoretical framework, by reading through and taking notes, as an initial, informal coding process. Next, related codes will be merged to form a content category as part of a broader categorisation process based on them reflecting related ideas or opinions that were discussed across interviews and therefore deemed as relevant themes. The final coding list containing more general and overarching themes and accompanying explanations of each theme will be created and data summarised under these broader themes for the purposes of feeding back to participants.

The results from both interview and questionnaire data will tell us if TIC awareness has potential for improvement through this intervention (Brazil, 2017; Nickson et al., 2021) and ultimately improving patient care and the healthcare system at large. We are hoping to learn also from the results if the intervention can be replicated within other hospitals that include consultations with service users to improve their patients’ outcome through a TIC awareness with all hospital staff.

Ethical statement

This intervention has been approved by the School of Psychology, Research Ethics Committee from Trinity College Dublin, University of Dublin [Approval No. SPREC032022-03] and the St James’s Hospital (SJH)/TUH joint research ethics committee [Approval No. 2515]. Consent will be obtained from participants either electronically (in the case of the surveys being completed online) or in paper form (in the case of interviews or where surveys are completed in person). Quantitative surveys will be anonymised, and data will only be entered using each participant’s unique identification number. Qualitative data will be pseudo-anonymised by assigning respondents a pseudonym and by redacting any references to names, job titles, and specific locations.

Plan for dissemination

Aligned with our anticipated impact and leveraging the interdisciplinarity and cross-sector nature of our wide network of collaborators, our dissemination plan emphasises knowledge translation at a local, national, and international scale across health, educational, academic, and political settings. Accordingly, dissemination of findings arising from TS4TIC as well as the final TS4TIC Toolkit will take place on a continuous basis through our group’s ongoing participation across a range of conferences, committees, and associations. This includes, but is not limited to, dissemination at the All-Ireland Inclusion Health Forum, DoH National Patient Safety Conference, the National Emergency Programme and Acute Medicine Programme’s annual scientific meetings, National Acute Medicine Conference, Safety in Health Systems network, the UK Faculty of Homelessness and Inclusion Health, and the Royal College of Physicians and of Surgeons of Ireland. Knowledge will also be translated into improved practices for both health and education. This will occur through improved training within the National Emergency Programme and Acute Medicine Specialist Registrar training, among undergraduates in TCD’s School of Medicine, and within the post-graduate training and continuing professional development programmes delivered by the Royal College of Physicians and the Royal College of Surgeons of Ireland; through imparting the knowledge of how to conduct TS and related PDSA cycles within ED and AMAU, such that this approach can be sustained within the organisation; through the design and delivery of a publicly available, co-led workshop on ‘How to co-create and co-deliver research with people with lived experiences of psychological trauma?’ in Month 23, through regular discussion within internal hospital meetings (i.e. Medical and Nursing Grand Rounds, Clinical Nurse Manager Monthly Meetings); and through the growing national and international community engaged in translational simulation (or transformational simulation as it is called in the NHS). Findings will also be shared to inform practices and responses within other acute contexts (i.e., humanitarian emergencies) through the Research Network of the International Federation of the Red Cross Red Crescent-National Societies. Academically, knowledge and findings generated from this work will inform novel theoretical and methodological approaches within the patient safety community. Work will also be presented at the National Patient Safety Conference and results will be submitted for a minimum of three publications within high-impact, Open Access peer-reviewed journals, and disseminated at a minimum of two international health systems conferences (i.e., Health Systems Global). Politically, some co-authors engage extensively with policy makers in the Department of Health (DoH) in Ireland and with politicians at Ministerial level, have given seminars on Inclusion Health (DoH), contributed to policy documents on Inclusion Health and homelessness (DoH), and have engaged with Sláintecare. These channels will continue to be used to ensure the findings of the study are reflected in national policy development.

(7.3) Preparation of co-authored publication(s) reporting on the evidence for the effectiveness and acceptability of TS4TIC, in fulfilment of research objective 3.

(8.1) Results from further analysis of outcome, process, and balancing data will again be discussed to solicit further feedback and reflection sessions. The purpose of these latter sessions will be to identify further changes that need to be integrated into the final version of the TS4TIC Toolkit. This step will thus build on the findings of PDSA cycles 1 and 2 to finalise the translational simulation improvement programme for trauma-informed care (TS4TIC) for improved quality of care experience for both patients and staff in acute hospital settings, in fulfilment of our research aim.

(8.2) If needed, the Quality and Safety Improvement Directorate in SJH will support testing out additional changes in sub-project PDSA cycles. For example, the two cycles may result in the identification of areas that need to be addressed at an organisational level (e.g., organisational wide risks), issues that require intervention at a unit level (e.g., environmental factors), or areas that would benefit from a future PDSA approach. Given that participants will have obtained first-hand knowledge and experience carrying out the PDSA cycles and designing the TS scenarios, they will have the skills required to conduct additional sub-project PDSA cycles outside of the grant period.

(8.3) Publication of the final, freely available, TS4TIC Toolkit and finalisation of accompanying materials (i.e., training materials, compendium of indicators, to an open access platform (i.e., TS4TIC Website) for wider use and uptake.

(8.4) Dissemination of the TS4TIC Toolkit through our network of co-applicants and collaborators.

(8.5) Delivery of a workshop on how to co-create and co-deliver research with persons with lived experiences of psychological trauma.

The above activities will be undergirded by a Management Work Package (WP5) and by a commitment to the highest possible ethical standards (WP6).

4.5 Public and Patient and Carer Involvement

Inclusion and empowerment of people who have experienced trauma and social exclusion is at the core of Inclusion Health (IH), and participatory approaches used in this study include their participation in the SJH, IH, and QI group and the development of the Homeless Health Peer Advocate (HHPA) programme. Key aspects to consider include awareness of the imbalance power dynamic, possible issues with literacy and the need to prove practical and psychological support to persons with lived experiences of trauma to ensure that they are fully empowered to participate (Ní Shé et al., 2019). TS4TIC also addresses the needs of front-line health workers, and they are also involved in all phases of the project. Details of PPI involvement (done and planned) across all work packages are detailed in Table 2 below.