Paediatric early rehabilitation and mobilisation during intensive care study approach to patient and public involvement and engagement

Introduction

Designing and conducting research within the PICU context are recognised to be extremely challenging.114 The PERMIT study team therefore set out from the outset to ensure the study was designed in collaboration with parents of a child who has experienced a PICU admission. We needed co-applicants who really understood the perspective of what it was like to have a child admitted to PICU and the role rehabilitation and mobilisation could play in recovery. SL and her daughter Darcy (D) agreed to join the team. They have direct experience of PICU and with JMen (our PPIE lead) can ensure PPIE has been woven through the study, building on information gained through each phase.

Study management

The PPIE work throughout Phases 1, 2, 3 and 4 was led by JMen and SL (our PPIE co-applicant). The study management group inputted into protocol designs, ethics application scope and drafting of the PPIE report.

Overview of patient and public involvement and engagement work

• In Phase 1 our PPIE co-applicant endorsed the importance of understanding current practice surrounding ERM through a survey of practice with healthcare professionals and understanding the published literature. The area that was felt to require focus was PPIE work to support the design and conduct of the observational study.
• In Phase 2 the focus was on the development of an Early Rehabilitation and Mobilisation Manual: the intervention for the Phase 3 feasibility study. PPIE activity was envisaged to be about co-designing the manual and identifying relevant trial outcome measures. PPIE work was conducted to inform the Research Ethics Submission. Unfortunately, following ethics review and approval, all non-COVID-related research was suspended. Following discussion with the NIHR HTA funder, it was agreed that some elements of Phase 2 would not be conducted and modifications to the Phase 3 feasibility study design were made to include some components of the aims and objectives from Phase 2 as well as related PPIE activity.
• In Phase 3 PPIE work was therefore essential to ensure the trial was feasible and acceptable. Activities focused on the trial design, conduct and duration and the appropriate model for informed consent, as well as all the study-related patient-facing material.
• In Phase 4 the purpose is to draw together all the key messages from the three phases and develop consensus about a future ERM RCT. PPIE elements to this are to ensure that the key messages from the Phase 3 work are correct and endorsed by parents/legal guardians.

Objectives for each phase are outlined in Table 31.

Our approach to patient and public involvement and engagement

There are three key domains to conducting patient and public involvement (PPIE) work – planning, supporting and recording and evaluating.115

Planning patient and public involvement and engagement – developing a plan for patient participation, involvement and engagement in a trial

The study team adopted an approach based on consultation, where people are asked for their views, which are then used to inform decision-making.116 Although this is regarded as the lowest rung of the patient form of involvement117 this was felt to be appropriate given the nature of the research context and the specific remit of the NIHR funding. The team were keen to contribute to the knowledge base surrounding PPIE within the PICU context118 and highlight the impact of PPIE at each stage. A plan was therefore made, although this had to be adapted significantly due to COVID.

Planning patient and public involvement and engagement – identifying parent contributors

Researchers are advised to approach patients and public through formal patient groups, charities, community groups, national directories such as ‘People in Research’ or Health and Social Care patient advisory panels.119 Partnership with parents who are in a similar situation to potential study participants is vital to ensure that important aspects of the research question have been considered.120 However, there is recognition that there can be challenges with identifying appropriate contributors.121,122 The concept of ‘similar situation’ is challenging in the PICU context as the service provision is for all CYP aged 0–<18 years and there is a broad case mix of underlying diseases and diagnosis.123 In addition, the PERMIT team faced a challenge in accessing a formal established group. There were no pre-established groups in existence within the Clinical Research Network (CRN), the affiliated Trusts for the research (Birmingham Women’s and Children’s NHS Foundation Trust and Southampton Children’s Hospital), and none within the two sites’ PICUs. There were also no national groups of parents with experience of PICU established,118,124 a situation which continues to the current day. In these circumstances identifying people through personal contact or recommendation is therefore acceptable.119 Our PPIE co-applicant SL and her daughter both felt that it was important that we made efforts to engage with parents who had experience of a child being admitted to PICU. Families without this experience might not understand the extreme emotions parents experience during the first few days of a PICU admission. This approach is supported by other national PICU studies.120,125–127

Planning patient and public involvement and engagement – impact of COVID

The plan to recruit to a PERMIT-specific parent advisory group made up of parents who had experience of their child being in a PICU was then compounded by COVID. The PERMIT team were re-deployed to clinical work, contact with families was hindered through the wearing of personal protective equipment (PPE) impairing communication and there were the additional challenges of restricted visiting and parental exclusion if parents were symptomatic.128

In addition, there was an added challenge to speaking to parents with experience of deciding about research participation in PICU because of research suspension. Despite fewer children with COVID-19 admitted to hospital and even fewer admitted to ICUs, PICUs experienced the same disruption to clinical research as adult ICUs. Seventy-five per cent of PICU/ICUs internationally suspended recruitment to some if not all research during 2020.100 Suspension of research recruitment reduced the number of studies which were open and recruiting and reduced researchers contact with families. This created additional challenges for the PPIE lead to speak to parents with experience of being recruited to research.

There were therefore challenges to the number of parents we could engage with for PPIE. INVOLVE (2012)129 recommend a minimum of two PPIE participants and there is growing recognition that the available number of participants with the relevant experience may be low.119 We therefore did not set a specific number of PPIE participants, but aimed to involve parents with as varied experience as possible.

Planning patient and public involvement and engagement – children and young people

Conducting PPIE work with CYP was also challenging. A previous review had identified that few PICU studies had managed to conduct PPIE work with CYP with experience of PICU.118 Although there are excellent Young People’s Advisory Groups available through the NIHR130 and locally131 their membership at the time included no CYP with experience of a PICU admission. Previous studies have consulted with siblings of CYP who have had experience of PICU132,133 However, COVID meant there were no sibling visitors allowed on site within the hospital (still the situation currently) and the YPAG groups were suspended for a period of time.

The decision was therefore made to conduct ‘standalone’ PPIE – identifying and liaising with parents/carers as required for each of the phases. The team also had extensive wider PPIE and qualitative research experience from related studies which were drawn on. Pre-COVID efforts were made to engage with CYP and siblings where possible but this was not possible from 2020 onwards.

One of the concerns of the study, especially pertinent given the additional challenges of COVID, was to ensure that we facilitated parents/legal guardians to have the opportunity to shape and influence research. In a study which was designed to be relevant to all patients admitted to PICU it was vital that we considered equality, diversity and inclusivity in our PPIE. Study materials were specifically developed with graphics to help those for whom English was not their first language, those with dyslexia and those with lower literacy levels. PPIE was also conducted across more than one site to ensure there was representation of parents from a wide geographical area as well as families who lived locally in Birmingham and London. A variety of methods were used to assist with families’ engagement. Face-to-face introductions helped to explain that this was to inform research design, rather than to participate in research. Short information leaflets were provided about what was required. Parents could provide feedback face to face with the PPIE lead or a member of the local research team or by writing responses and returning them in a stamped addressed envelope. PPIE activity could happen within the hospital or within the home environment (if it coincided with other research activity).

Planning patient and public involvement and engagement – allocating appropriate costs

Historically PPIE participants have not always received any payment for their time and involvement; however, this payment is now recognised as good practice.134 All PPIE activities were costed in line with NIHR (2018) guidance on reward and recognition for public contributors and participants appropriately rewarded.135

Planning patient and public involvement and engagement – managing the expectations of public contributors

The PERMIT PPIE co-applicant and the parent representative on the Trial Steering Committee were prepared for their roles with clear guidance on the role and what was required. PPIE participants were provided with information about the consultation work by the staff member approaching them. The expectations of their role were identified and as they were involved with ‘standalone’ PPIE there was no ongoing commitment.

Supporting patient participation, involvement and engagement

For patients new to a PPIE role, support to develop their abilities and confidence to express their views and question researchers may be relevant. In order to support our parent co-applicant and the parent representative recruited to the Study Oversight Group both were offered access to appropriate training via a number of resources. Materials supplied included guidance on involvement in PPIE,136 links to local resources within the West Midlands CRN and on-line training available through NIHR.137 In addition, SL attended a national one-day UK symposium about PICU outcomes and rehabilitation (2017) with members of the PERMIT team in order to help her understand the wider perspective.

There are many PPIE tasks where training is not necessary, where a different perspective or experience of a healthcare condition is the required expertise.119,134 In line with this PPIE participants within PERMIT did not receive any formal training.

Recording and evaluating patient participation, involvement and engagement

While there is consensus that PPIE has considerable potential to benefit clinical trials, there has been little formal evaluation of its impact.115 None of the PICU studies in a UK review provided an objective measurement of the impact of PPIE.118 The PERMIT team were therefore keen to create a clear picture of when and where PPIE happened, what impact this had on the trial, the nature of PPIE activities and the impact of the activity on the trial design and conduct.138 This is captured in the report above, with specific examples of what changed as a result of consultation detailed below.

Impact of patient and public involvement and engagement: the PERMIT team collaborators

Researchers who conduct PPIE often report on the experiential learning and positive impact it has for them as a researcher.139 As a research team we would therefore like to report the positive impact PPIE had for us as a team. Despite all the challenges encountered, particularly due to COVID, we felt that that we were able to engage with parents and obtain meaningful insights which made an impact on the design and conduct of the study; particularly the models of consent utilised in Phases 1 and 3. We would also like to acknowledge the impact for SL and D, our co-applicants. They have linked up with PICU, BCH, to help with all things ERM (outside of the PERMIT study). From featuring on posters promoting ERM on the unit, to pictures on online training material, to reviewing local documents such as an information leaflet about ERM for elective surgical patients, they have both taken an active role. D is now in secondary school. She recently contacted the PPIE lead to provide some feedback about the leaflet and expressed how she was wondering if there was anything else she could do to help promote rehabilitation and help other children:

Being as I had some experience with the same things other may go through, I was talking to my mum about maybe coming to PICU to help others, if its allowed? I’d really like to help other children.

We are now working with SL and D to develop videos and guides to help guide children, parents and family members about ERM activities. In addition, D has joined the local Young Person’s Advisory Group (YPAG) and is contributing to their wider work within the Trust.