Introduction
Early rehabilitation and mobilisation in PICU, like most rehabilitation interventions, is a complex intervention, in relation to the diverse actions, reasoning, and resources embedded in enacting ERM in intensive care, as well as the diversity of PICU contexts. Following the Medical Research Council (MRC) guidance on developing complex interventions,68–70 we anticipated that our intervention development work would involve learning from and adapting elements of existing ERM interventions, as they are already in use in some PICU settings internationally and a few sites in the UK. In this chapter, we show how we used the results from our survey, observational study and scoping review (see Chapters 1, 2 and 3), together with a range of other evidence and expertise, to design the ERM intervention manual, called the PERMIT manual (Figure 12). The intervention manual is a detailed prototype specifying the content of ERM for diverse patient populations and setting out how ERM can be implemented in varied paediatric intensive care settings. The feasibility and acceptability of the manual, and core elements of clinical trial designs for evaluating ERM, were subsequently explored across three PICUs (see Chapter 5).
FIGURE 12 Overview of the intervention development process. (Figure not reproduced here; see the original article.)
Study management
Phase 2 was co-led by co-applicants JMc, RF and TR (the core intervention development team). Two research associates (Dr Laura Cutler and Dr Olivia Craw, Faculty of Medical Sciences, Newcastle University) supported the organisation of the workshops and literature-based work. The study management group provided input into protocol, ethics application design and data interpretation.
Important changes to protocol
The PERMIT protocol planned a Phase 2a, Health Research Association (HRA) approved, workshop with parents and children. In discussion with and approval of National Institute for Healthand Care Research (NIHR) Health Technology Assessment (HTA) funder, this subphase was not started due to the impact of the COVID19 pandemic.
Methods and results
In developing the proposed ERM intervention, alongside the MRC frameworks we also drew on a range of conceptual resources from implementation science – notably Normalisation Process Theory (NPT),71,72 Theoretical Framework of Acceptability (TFA),73 Expert Recommendations for Implementing Change (ERIC),74 behaviour change Theory and Technique Tool75 – as well as the Person-Based Approach (PBA) to intervention development.76 PBA emphasises:
prioritising and incorporating user perspectives wherever possible, while ensuring the intervention retains all the elements that theory and evidence suggest will be effective.77
In line with PBA, the development of our ERM intervention prototype(s) has been intimately shaped by the involvement of key target users of the manual – multidisciplinary clinical stakeholders. Throughout the development process, we worked with clinical stakeholders within the wider PERMIT research team as well as healthcare professionals across the UK and international PICU clinicians. However, due to the evolving COVID context, planned workshops with parents/carers and CYP were not possible.
As outlined in Figure 12, the intervention development process initially involved establishing key messages and areas of uncertainty from our survey, observational study, and scoping review. We then explored the potential dimensions of the intervention with clinical stakeholders and iteratively refined prototypes of the intervention manual in relationship to evidential, practice-based and theoretical ideas.
Patient and public involvement and engagement
For an overview of the approach to PPIE adopted throughout the study, please see Chapter 8. Within this intervention development element of the study, PPIE work was only conducted to inform the Research Ethics Submission. We had planned to undertake PPIE work with parents with direct experience of involvement in PICU research studies in relation to discussing potential trial designs as well as patient-centred outcomes, but the research suspension imposed in response to directives to prioritise COVID-related research78 created a challenge. As outlined in Chapter 8, suspension of research recruitment reduced the number of studies which were open and recruiting and reduced researchers’ contact with families. Additionally, there were no pre-established local or national groups of parents with experiences of PICU. This created challenges for the PPIE lead to speak to parents with experience of being recruited to research. We decided to delay that element of the PPIE work until the feasibility study in Phase 3.
Formal reflection – establishing core issues
Purpose: to formally describe and synthesise the key messages, assumptions and uncertainties that emerged from our prior Phase 1 work to guide our intervention development work.
Methods: we reviewed the results of the survey, observational study and scoping review (see Chapters 1, 2 and 3), and undertook discussions with the wider PERMIT research team. We further refined and conceptualised the core findings of this process by aligning them to elements of the template for intervention description and replication (TIDieR) checklist.79
Results: as outlined in Table 9, people see the potential value of ERM for the diverse patient populations within PICU and are willing to support its (safe) delivery but are uncertain how best to deliver it. The current evidence base and analysis of existing practice demonstrate that ERM is defined and enacted in multiple ways, ranging from more formal referral processes (directing patients only to specific allied health professionals), to a range of mobilisation and non-mobilisation activities, to being seen as encompassing everyday standards of good practice in PICU care. Core questions remain unresolved in relation to the conceptualisation of ERM, the pragmatics of operationalisation (e.g. how ‘early’ should ERM be delivered), and how best to measure the delivery and potential impact of ERM.
| What is the underpinning rationale, theory or goal of ERM? |
| Wide range of views on what ERM encompasses from a narrow focus on movement and mobilisation to a broader focus on adapting the environment and optimising medication.Boundary is not well defined between broader conceptualisations of ERM and ‘good general PICU care’.Existing specifications are often vague. Where more specificity is provided, underpinning conceptual/theoretical coherence and definition are often lacking.No consensus on key mechanisms of action or essential elements/active ingredients of ERM.Might be especially challenging to conceptualise ERM and differentiate it from usual care in very young patients. |
| Which patient populations are eligible for ERM? |
| Traditional emphasis on ERM for certain diagnoses (e.g. acute traumatic brain injury). However, this is now acknowledged as too restrictive.Desire to bring ERM to (nearly) all patients. However, there is an awareness of extreme heterogeneity and associated challenges: Majority of PICU patients are young (<4 years) or very young (<1 year)Wide variety of underlying medical conditions and reasons for admissionChildren with pre-existing cognitive and other impairments are over-represented in the PICU population – developmental/cognitive level may be delayed compared to chronological age.Disagreement between clinicians about patient suitability is a barrier to ERM both in general and in relation to individual patients and particular patient groups.LOS is an important consideration – there is support for use of an (undefined) minimum LOS threshold to ‘make ERM worthwhile’. |
| When is ERM initiated? |
| Agreement that consideration of – and consensus on need for – rehabilitation and mobilisation increase with LOS. However, this is at odds with the goal of ‘early’ rehabilitation and mobilisation.Uncertainty and wide variation in suggested time points for starting ERM (24 hours to >7 days).Uncertainty as to whether timing should be based on day of admission or clinical recovery milestones (stage in critical illness recovery trajectory). Both are important to people – can these be standardised?Support for the idea of a minimum LOS – many patients are discharged within 24–48 hours and the majority have a LOS <7 days. ERM may be unnecessary in very short admissions.Support for the concept of ‘ERM as early as the patient’s clinical condition allows’ – physiological stability is seen as the most important patient factor influencing ERM timing. However, there is slow recognition of patient readiness for ERM, which conflicts with this concept.Need a decision-making process that includes consideration of whether and when ERM is appropriate/possible for each patient with clarity around responsibility for this decision-making. |
| What processes and materials are involved in ERM? |
| Wide variety of conceptualisations of ERM:ERM as ‘mere referral’ for PT, OT, speech and language (i.e. ERM as an undefined ‘black box’ intervention). Timing of these referrals seen as a key component of ERM.ERM as mobilisation activities and non-mobilisation activities. However, there is enormous variability in terms of wide-ranging activity categories and individual activities.Mobilisation activities include a very wide range of in- and out-of-bed exercises. There is a lack of clarity on dimensions such as active versus passive mobilisation activities (e.g. where do positioning, stretching, seating fit?).Non-mobilisation activities include sedation protocols, analgesia, sleep hygiene, delirium screening/reduction, cuddles, nutrition, and chest PT. Are these vital ‘co-interventions’ (often a part of usual care) or are they within the scope of ERM? They are often poorly reported, although they are understood to influence delivery of ERM.ERM as ‘more than just activities’ – important to also normalise and enrich the wider environment.Again, lack of clarity over relationship between ERM and ‘good general PICU care’. Is ERM different to usual care or is ERM usual care delivered earlier? There is also no consensus on usual care.Availability of specialist equipment and resources is very variable and an important constraint. |
| Where is ERM delivered? |
| Physical space in which to deliver ERM (e.g. at bedside) is very variable and an important constraint. |
| How much ERM is delivered? |
| Clinicians want to be guided by a protocol that is flexible rather than prescriptive and sets out optimal timing, intensity, frequency and duration of ERM. However, no evidence base exists to determine optimal timing, dose or progression of ERM.How important is intensity (e.g. minutes/hours per day)? Is it as important as timing (i.e. days since admission)?Twice-daily ERM sessions are commonly discussed. However, would this be a realistic goal or minimum standard given major staffing concerns? |
| How is ERM tailored? |
| ERM is typically personalised to the individual patient and not standardised. However, strategies for personalising and tailoring ERM are not clearly reported.Clinicians want a protocol that is flexible rather than prescriptive.ERM should be graded. However, criteria for how and when to progress ERM (i.e. how to make it more challenging as a patient’s condition/tolerance improves) are vague and variable.Uncertainty as to how to best monitor tolerance of ERM. Currently, this is done very informally and subjectively based on monitoring of individual patients’ physiological parameters, behaviour and AEs. |
| Who delivers ERM? |
| ERM delivery is multidisciplinary. Doctors have a role in assessing appropriateness. Nurses and physiotherapists are especially important in delivery.ERM may be viewed as a ‘physiotherapist role’. However, nurses are the only profession present 24/7 and they do the majority of ERM delivery, particularly in the context of wider conceptualisations of ERM.Depending on the setting, ERM delivery may also include OTs, SLTs, play therapists, psychologists or dieticians.Parents are important in ongoing ERM delivery and their role could be enhanced. They are usually present when ERM is happening.Staffing is frequently raised as an issue – staff capacity fluctuates and is frequently insufficient.Inadequate training is a barrier to ERM delivery. |
| How is ERM delivered safely? |
| Objective data indicate low AE rates in ERM. However, safety is a real concern for people, especially tube and line dislodgement (including accidental extubation) and especially mobility and out-of-bed ERM activities.Range of possible safety considerations have been identified – which are most relevant and how can these be monitored and managed?Need an approach for stratifying patient acuity levels to guide ERM delivery.Need more formal guidelines for assessing patient safety and tolerance. |
| What other factors influence implementation of ERM? |
| Strong support in the UK for ERM – ERM is considered a priority.ERM implementation processes have not been described in detail or theorised. However, multiple barriers to ERM delivery and adherence have been reported.Clinicians want implementation support to address modifiable barriers to ERM delivery.Organisation-wide strategies and culture change may be important for supporting ERM implementation.Lack of champions to lead ERM implementation is seen as a barrier.A phased approach (i.e. gradually introducing ERM) may be needed to build acceptability. |
| What are the proposed outcomes of ERM? |
| No current agreement on the purpose of ERM/important outcomes.A range of patient-centred, clinical, and economic outcomes are important to clinical stakeholders, including reduced LOS in PICU; reduced days of MV; participation, function and activities of daily living; mobility and strength; cognitive, emotional and psychological outcomes; QoL; and family functioning and parent/caregiver stress. |
User development – generating guiding principles for the intervention
Purpose: to explore clinical stakeholders’ views and experiences of ERM for different populations, including feasible and acceptable content, delivery, implementation and important outcomes of ERM.
Methods: we took forward the key messages and uncertainties from Phase 1 into interactive workshops with UK NHS healthcare professionals and international ERM experts. The workshops received ethical approval from Newcastle University (NU Reference 14224/2018). We also planned to conduct workshops and interviews with parents and CYP in Spring 2020. These received HRA approval (IRAS 270791) but were unable to proceed as NHS Research and Development were not allowing non-COVID research at the time.
Sampling and recruitment: we recruited a multidisciplinary group of NHS healthcare professionals with diverse experience of ERM in PICU settings. We recruited from those who had participated in the Phase 1 survey and agreed to be approached about further work. They were approached via e-mail and a total of 18 professionals from 5 PICUs were included – 3 consultant doctors, 3 senior nurses, 5 physiotherapists (including 2 clinical specialists), 5 OTs (including 1 clinical specialist), 1 dietician and 1 play specialist. We also recruited a multidisciplinary group of international experts leading research and quality improvement on ERM in paediatric and adult intensive care settings. We recruited individuals who are active in the ERM community, identified from reviewing recent published work and from the team’s clinical and research networks. These people were approached via e-mail and a total of three were included from Europe and the USA – a senior clinical academic doctor, a senior clinical academic nurse and a senior physiotherapist.
Data collection: we undertook three face-to-face workshops with NHS healthcare professionals and one online workshop with international experts. Initial workshop plans were designed to explore the key reflections from Phase 1 and examples of existing ERM protocols. Plans evolved through findings from prior workshops shaping the focus of the next. The workshops were audio recorded and transcribed and facilitators recorded contemporaneous fieldnotes. The workshops lasted for between 90 minutes and 2 hours.
Data analysis: we drew on standard procedures from rigorous qualitative analysis80 including coding, constant comparison, memoing and team debrief sessions. The core intervention development team (JMc, RF, TR) reviewed, discussed, organised and summarised the analytic work. Following ideas from PBA,76 we focused on generating ‘guiding principles’ in relation to:
- Intervention design objectives – what an ERM manual must do to address the needs of target users and enhance engagement.
- Key features of the intervention – how these design objectives may be achieved in practice.
These guiding principles were critically discussed and revised with the wider PERMIT research team.
Results: as outlined in Table 10 ERM can be conceptualised as patients engaging in progressive movement and mobility in the context of individually meaningful and purposeful activities and a supportive environment that promotes familiar and orientating daily routines. Several discrete interventions can be legitimately conceptualised as either closely related to or a core part of ERM and these topics are being investigated in their own right (e.g. sedation, ventilation, delirium, nutrition and mental health).66,81–84 A specific focus on progressive movement and mobility within PERMIT would add to the current research and further advance the overall goal of improving PICU care. Clinical stakeholders perceive that ERM is relevant for most patients and can be actively considered from the second morning of admission for those anticipated to still be on the unit the following day. However, clinicians especially require safety guidelines for delivering ERM to the most severely ill and complex patients. Factors influencing the implementation of ERM vary according to unit, team, individual clinician and individual patient. Therefore, both ERM activities and ERM implementation support need to balance flexibility (so they can be highly tailored) and specificity (so they can be differentiated from usual care, implemented and evaluated). Clinicians’ views on the potential impact of ERM seem to converge on a small cluster of key clinical, functional, psychological, family-related, QoL and economic outcomes.
| Design objectives – what an ERM intervention must do to address the needs of target users and enhance engagement | Key features – how ERM design objectives may be achieved in practice |
|---|---|
| What is the underpinning rationale, theory, or goal of ERM? | |
| Progressive movement and mobility are key active ingredients of ERM. They need to be specified practically and meaningfully for clinicians (the target users). They are also the key mechanism generating patient benefits. | The International Classification of Functioning, Disability, and Health can be used as a practical starting point for specifying progressive movement and mobility in the context of meaningful and purposeful activities such as sensory experiences, self-care, education, recreation and leisure, play and interaction. |
| However, a focus solely on movement and mobility is too narrow for clinicians. ERM needs to convey a holistic perspective and a rehabilitation ‘mindset’ by: (1) contextualising movement and mobility within activities that are meaningful and purposeful to individual patients, considering their age, developmental level, and reason for admission, and (2) emphasising the role of a supportive environment that enables engagement in movement and mobility in the context of familiar and orientating daily routines. | Developmental care, neonatal therapy and early intervention can be used as a relevant theoretical and practical starting point for specifying aspects of ERM for very young patients. There are some examples of implementation in paediatric intensive care, providing proof of concept that these approaches may be feasible and acceptable in this setting. |
| Adult intensive care has influenced ERM in the PICU setting. However, given the very young age and early developmental level of many paediatric patients, ERM in PICU needs to incorporate developmental approaches. | |
| There is a desire amongst clinicians to interpret ERM broadly and include many aspects of wider good clinical practice. This is motivated by a desire that these aspects should not be forgotten or side-lined. But there is also recognition that ERM needs to be carefully differentiated from other aspects of care to enable evaluation and implementation. | Many interventions related to ERM are being investigated in their own right (e.g. sedation, ventilation, delirium and nutrition). Early and progressive movement and mobility is a core element of ERM. A specific focus on this element can advance the overall goal of improving usual PICU care. However, this will not address all elements of all clinicians’ conceptualisations of ERM. |
| Several key interventions can be legitimately conceptualised as either closely related to or a core part of ERM (e.g. interventions for pain, sedation, ventilation, delirium, nutrition, sleep, communication, mental health and family support). An ERM intervention manual needs to be explicit about where these interventions fit. | |
| Which patient populations are eligible for ERM? | |
| ERM has potential benefits for most patients. An intervention manual needs to be relevant for diverse patient groups in terms of severity of illness (acuity), age, developmental level and reason for admission. | ERM is less relevant to the high proportion of patients with very short lengths of stay (24–48 hours). |
| Routinely screening all patients for eligibility makes it easier to embed ERM across the whole PICU and make it part of usual care. An intervention manual needs to enable unit-wide implementation.Patient acuity is the main factor guiding eligibility for ERM. Clinicians need a means of describing acuity levels that enables decision-making about ERM eligibility for individual patients. | ERM is inappropriate for patients receiving palliative or end-of-life care. Although some features of wider good practice typically associated with ERM may be relevant and should be available (e.g. prevention of pain, confusion and agitation) care for these patients is conceptualised differently to ERM and goals are communicated differently to families. |
| However, ERM is also guided by the experience and intuition of clinicians and parents/carers and the wider unit context (e.g. how confident and skilled staff are with ERM). An intervention manual needs to encourage and enable sensitive, individualised decision-making. | Several existing ERM protocols describe patient acuity levels in terms of specific central nervous, cardiovascular and respiratory system parameters, and presence of lines, tubes etc. Acuity levels are then linked to specific ERM activities that may be appropriate. This enables team communication and decision-making, is popular with clinicians, and can be further developed. |
| Clinicians need explicit guidance on ERM for the most severely ill and complex patients who are thought to have a lot to gain from ERM but for whom implementation is particularly challenging. | In most PICU settings, the morning ward round can be used as a focal point for building ERM decision-making into the daily routine. |
| Patient acuity fluctuates and is not a straightforward trajectory of improvement. The type of ERM that is appropriate (if any) may change daily or more frequently. Clinicians need a routine process for continuously making and reviewing decisions about ERM eligibility. | Each PICU is unique. Individual units differ in their patient populations, the resources they have available, and their views and practical experience of ERM. Specific guidance needs to be balanced with a flexible approach to implementation as blanket rules and prescriptive approaches are not likely to be feasible or acceptable. |
| When is ERM initiated? | |
| ‘Early’ initiation of progressive movement and mobility is a critical element that generates benefits for patients and differentiates ERM from usual care. Guidance on when to initiate ERM needs to consider both day of admission and patient acuity level. | In most PICU settings, the morning ward round can be used as a focal point for building ERM decision-making into the daily routine. |
| Clinicians need a routine process for actively screening all patients and making timely decisions about initiating ERM. | ERM can be actively considered from the second morning of admission for patients anticipated to still be on the unit the following day. This can be legitimately considered ‘early’ (and is earlier than typical current practice), avoids ERM for very short admissions (24–48 hours), and may be feasible and acceptable in practice. |
| Existing approaches to acuity levels can be used to guide what ERM can be considered on day 2 of admission even for the most severely ill and complex patients. | |
| What processes and materials are involved in ERM? | |
| ERM can be conceptualised as patients engaging in progressive movement and mobility in the context of individually meaningful and purposeful sensory, self-care, education, recreation and leisure, play and interaction activities, and a supportive environment that enables engagement and promotes familiar and orientating daily routines. Clinicians need practical specification of these core ERM concepts. | The International Classification of Functioning, Disability, and Health can be used as a starting point for specifying progressive movement and mobility in the context of activities such as self-care and play. |
| An intervention manual needs to enable clinicians to sensitively select specific ERM activities appropriate to acuity, age, developmental level, the experience and intuition of clinicians and parents/carers, and the wider unit context (e.g. how confident and skilled staff are with ERM). | The concept of ‘progressive’ can incorporate several practical aspects that clinicians find important and useful, including passive → active movement, more → less assistance with mobility, and activities in → out of bed. |
| Several existing ERM protocols suggest ERM activities that may be appropriate for different levels of patient acuity. This approach provides ERM activities to aim for (‘goals’), enables the team to make decisions and select activities, is popular with target users, and can be further developed. | |
| Where is ERM delivered? | |
| While ERM is delivered within the PICU setting, it is relevant to and embedded within the wider hospital setting. | In the first instance, the primary focus for clinicians is enabling delivery within PICU settings. |
| How much ERM is delivered? | |
| Amongst clinicians, there is a general sense of ‘any ERM is better than none’ but there are no established rules of thumb for dosage of ERM. | At this point, the primary issues for clinicians are achieving ‘early’ initiation, enabling safe delivery for the most severely ill and complex patients, and the feasibility of daily implementation in busy PICU settings with no additional staffing capacity. |
| How is ERM tailored? | |
| ERM delivery is highly tailored to the individual patient and ERM implementation is highly tailored to the individual paediatric intensive care setting. | Clinicians need a flexible intervention manual that sets out which elements of ERM can be tailored (and how) and which should be retained because theory and evidence suggest they will be effective. Specific guidance needs to be balanced with a flexible approach to implementation as blanket rules and prescriptive approaches are not likely to be feasible or acceptable. |
| Who delivers ERM? | |
| Doctors, nurses and physiotherapists are essential to ERM delivery. Doctors create a supportive unit culture, take overall responsibility for safety and include ERM decision-making in morning ward rounds. Nurses are highly sensitised to individual patients and families, are present at the bedside 24/7 and ensure delivery of ERM. Physiotherapists have expertise in progressive movement and mobility and can build confidence and skills in ERM delivery, including with the most severely ill and complex patients. | Beliefs and traditions about the roles and responsibilities of different professions vary between units and there is variation in which professional groups are available. An intervention manual needs to specify ERM tasks and responsibilities but be flexible about which professional group(s) should carry them out.Named individual ERM champions leading on implementation is important and useful. |
| An intervention manual needs to support the confidence and skills of staff delivering ERM, considering that many units experience a high staff turnover.Parents/carers and siblings should be given opportunities to participate in ERM as they often feel very impotent in PICU settings. However, sensitivity to their emotional situation is required and wishes not to be involved should be respected. | Parents/carers – need permission to contribute to ERM and roles to perform but also space and permission to step back if necessary. |
| How is ERM delivered safely? | |
| A specific ERM protocol needs to help create a culture in which PICU staff feel safe and feel that they are not doing something wrong.Clinicians need strategies for addressing negative emotions that restrain ERM delivery (e.g. staff anxiety, fear of causing harm, worry about getting into trouble) and accentuating positive emotions that facilitate delivery (e.g. feeling that ERM is worthwhile, enjoyable, and raises the quality of care). | A clear and consistent decision-making tool for planning and monitoring ERM could increase confidence and skills for safe delivery.Safety guidelines could ensure nurses feel confident to implement ERM and should consider the patient diversity and variation in PICU. |
| What other factors influence implementation of ERM? | |
| ERM implementation factors will vary by unit, team, individual clinician and individual patient. Every PICU is different and is at a different point in their implementation journey. Clinicians need implementation support, but this should be able to be highly tailored to the individual unit – flexibility is key to feasibility and acceptability.Clinicians identified important contextual factors that may influence and/or be influenced by ERM: pain, sedation, delirium, nutrition, sleep and communication. | ERM implementation can be progressed by getting all stakeholders on board (including funders, managers and sceptics), getting organised to do ERM every day (e.g. by fitting it into existing routines and processes), phasing it in gradually, and working out how it can be sustained in the unit after initial efforts and enthusiasm peter out. |
| What are the proposed outcomes of ERM? | |
| ERM is important for different patients for different reasons. As with many rehabilitation interventions, progressive movement and mobility in ERM generate a wide range of patient benefits. Clinicians need to see this diversity reflected in an intervention manual. | Clinicians’ views seem to converge on a small cluster of key outcome constructs: duration of MV; LOS in paediatric intensive care and hospital overall; movement function and mobility capacity and participation at discharge relative to pre-admission; activities of daily living capacity and participation at discharge relative to pre-admission; body functions (i.e. cognitive, respiratory and muscle functioning/strength); patient and family psychological well-being; QoL; and family satisfaction with care. |
Literature-based work – developing a prototype intervention manual
After the workshops, we conducted a range of literature-based work to identify available concepts, tools and resources to develop and shape the form and content of a prototype ERM intervention manual. This work took place alongside formal and informal meetings with clinical members of the wider PERMIT research team (see user development – reported below) and had an iterative relationship.
Reviewing existing ERM interventions
Purpose: to review existing ERM interventions and compare them to our ERM guiding principles.
Methods: we used a rapid pragmatic approach to identify, characterise and understand existing PICU ERM interventions and compared the intervention components to the guiding principles we developed. We identified existing interventions by hand-searching the literature, through topic experts in the wider research team and from the Phase 1b survey (see Chapter 2). We focused on coding, memoing and team debrief sessions.
Results: we explored ERM systematic reviews and practice recommendations55,85,86 along with six UK paediatric ERM protocols provided by participants in the Phase 1 survey, some of which had been adapted from the PICU Up! early mobilisation programme in the United States.17 Three key elements emerged:
- Focus on enabling progressive movement and mobility in diverse patient groups – several existing interventions involve matching ERM activity levels to a patient’s acuity levels, as opposed to focusing on one specific piece of ERM equipment. Many also focus on delivering ERM to diverse population groups over one type of patient. These approaches echo those in the guiding principles. The interventions also offer a range of tried-and-tested materials (e.g. checklists and safety thresholds) that can be used or adapted.
- Lack of specificity around key activities – existing practice recommendations specify progressive movement and mobility activities; however, this specificity is often lacking in locally adapted ERM protocols that appear to rely more on tacit knowledge of staff and have been expanded to include elements of usual care. Broad concepts such as neurodevelopmental play and activities of daily have been included as ERM activities; however, the guiding principles outline that PICU teams need practical specification of all core ERM concepts. Existing interventions consistently emphasise the importance of developmentally appropriate and individualised ERM; however, more practical guidance is required on how to operationalise these principles in the context of multidisciplinary delivery of ERM.
- Implementation support is missing – existing interventions offer very little guidance or support on how to introduce and embed ERM into a specific setting. The guiding principles outline how clinical stakeholders want and need support with initial implementation work, from getting initial staff buy-in to sustaining ERM over time.
Current ERM interventions offered a useful and important base. However, implementation issues need to be considered as early as possible to improve the design and sustainability of ERM interventions and reduce the chance of implementation failure.87 Two of the core implementation issues in ERM are making sure that adequate support and guidance are offered in the day-to-day delivery of ERM activities and that all activities are both flexible (to enable tailoring for individual units and patients) and specific (to enable differentiation from usual care, implementation, and evaluation).
Specifying the bedside bundle
Purpose: to specify the essential clinical materials needed to plan and deliver ERM for individual patients.
Methods: we used a rapid pragmatic approach to identify, characterise and understand existing PICU ERM clinical materials. We identified existing materials by hand-searching the literature, through topic experts in the wider research team and from the Phase 1b survey (see Chapter 2). We focused on coding, memoing and team debrief sessions.
Results: we identified existing clinical materials that were tried-and-tested for delivering ERM in different PICU contexts and could be adapted to achieve key design objectives within the guiding principles. These were patient acuity levels, ERM activity levels, safety and tolerance criteria and a daily ERM flowchart. They were further developed and specified to form the first part of a prototype ERM intervention manual – the beside bundle (Table 11).
| Bedside bundleThe essential clinical materials needed to do ERM with individual patients | Implementation toolkitA step-by-step guide to putting the bedside bundle into practice across a PICU | Training and support materialsFlexible resources for tailoring the bedside bundle and implementation toolkit to an individual unit |
|---|---|---|
| Patient Acuity Levels – a table displaying four levels of patient acuity ranging from the lowest (level 1) to the highest (level 4) level of clinical stability. Levels are based on specific clinical parameters related to the central nervous system, cardiovascular system, respiratory system and other factors (e.g. lines, tubes etc.). | PICU preparation: | Guidance on using and tailoring the patient acuity levels.Additional explanation of each clinical parameter in the patient acuity levels and their implications for ERM. |
| Take stock – make an overall assessment of the unit’s readiness to implement ERM (i.e. where the unit is currently at with ERM and the next steps required to put the bedside bundle into practice). | ||
| ERM Activity Levels – a table displaying four increasingly challenging levels of ERM activity. ERM activity levels focus on patients engaging in progressive movement and mobility in the context of individually meaningful and purposeful activities and a supportive environment that promotes familiar and orientating daily routines. | Build the team – bring together a group of multidisciplinary ERM champions within the unit. These are people who can support and market ERM, drive it through, and overcome any indifference or resistance. | Guidance on selecting an individual patient’s ERM activity level and specific ERM activities.Guidance on using and tailoring the ERM activity levels and progressing individual patients towards more challenging ERM activities. |
| Pause and Re-assess Criteria – a list of clinical parameters that should be monitored before, during and after ERM activities. The criteria should be personalised based on the clinical team’s judgement and discretion about acceptable deviations from the individual patient’s baseline status. | Get buy-in – build a shared understanding across the unit of what ERM is all about (i.e. what the bedside bundle involves, how ERM is supposed to work, and what are the potential benefits and intended outcomes for patients). | Guidance on how the pause and re-assess criteria were developed, how they can be personalised to individual patients and how they can be incorporated into existing checklists in the unit. |
| Daily ERM Flowchart – a graphic used during ward rounds to prompt key actions for each patient every day 2, including: screen for ERM eligibility, assign patient acuity level, assign ERM activity level, select specific ERM activities, decide who is leading the ERM and how the parent/carer will be involved, and feedback from previous day’s ERM activities. | Get ready – tailor the bedside bundle to make it as workable as possible for the staff and systems already in place in the unit. | Guidance on using and tailoring the daily ERM flowchart.Self-assessment checklist for taking stock and assessing the unit’s readiness to implement ERM. |
| Patient delivery: | Resources to help ERM champions present the evidence for ERM, persuade colleagues about the benefits and reassure them about safety.Slide set to support getting buy-in (e.g. information about ERM to share in team meetings that can be tailored to fit in with how the unit is approaching implementation). | |
| Make it work – gradually put the bedside bundle into practice in the unit until it is fully implemented with all patients. This is when the unit goes live with ERM, tests things out and gets feedback on how things are working. | ||
| Keep it going – come together as a unit to review the bedside bundle, decide how it could be working better and plan how ERM can be sustained over the next 6–12 months. | Guidance on creating a unique local ERM identity to help increase engagement in, and understanding and recognition of, ERM. |
Patient acuity levels
Several existing ERM interventions already set out patient acuity levels that describe the full spectrum of clinical stability across diverse patient populations ranging from the least to the most stable. The levels are based on central nervous, cardiovascular and respiratory system parameters, as well as other factors such as the presence of lines or tubes. They are then linked to corresponding levels of ERM activities that may be safe and appropriate. This approach was pioneered in paediatric intensive care by the PICU Up! programme17 and has been further adapted within UK PICU settings. We compared and contrasted existing patient acuity levels along with specific contraindications, exclusions, precautions and eligibility criteria from other ERM interventions identified in our literature-based work (reported above).
Based on the existing interventions, we drafted four levels of patient acuity that were further refined by clinical members of the wider PERMIT research team (see user development – reported below). We developed comprehensive guidance for the patient acuity levels that includes an explanation of each clinical parameter and a description of how it should be considered in shaping ERM delivery, including for the most severely ill and complex patients. The guidance encourages tailoring of the patient acuity levels to fit in with practice in a particular unit. For example, it sets out how users can remove clinical parameters that are not relevant to their patient population, add clinical parameters that are particularly relevant, or change parameters to fit in with local practice standards.
ERM activity levels
We set out to specify the three core elements in our conceptualisation of ERM (see Table 10) – ‘progressive movement and mobility’ carried out within a ‘supportive environment that promotes familiar and orientating daily routines’ and delivered with the context of ‘individually meaningful and purposeful activities that into account the patient’s age, developmental level and reason for admission’. We extracted practical examples of these elements from the ERM interventions identified in our literature-based work (reported above) and supplemented them with examples from the International Classification of Functioning Disability and Health88 and adult ERM literature.89–93 We were mindful of identifying examples that related to the more severely ill and complex patients for whom adaptive positioning in bed and gentle sensory experiences would be most relevant. We were also mindful of the very young age and early developmental level of many paediatric patients and so we drew on examples from developmental care interventions, neonatal therapy and early intervention, specifically about protecting sleep, developmentally supportive activities of daily living, infant positioning, family-centred care and controlling light and noise in the environment.94–96
The core intervention development team compared, contrasted and further specified the examples, removing duplicates and prioritising examples more closely aligned to the key design objectives within the guiding principles. Following the tried-and-tested structure of the PICU Up! programme,17 we arranged this content into four levels of ERM activities to correspond with our four levels of patient acuity. The activity levels were then further refined by clinical members of the wider PERMIT research team (see user development – reported below).
Activity level 1 focuses on positioning the patient to maintain ROM, avoid triggering of maladaptive tonic neurological reflexes, particularly in children with pre-existing neuro-disability, prevent pressure ulcers and other complications of immobility, and optimise respiratory and gut function. Level 2 focuses on assisting the patient to practise different activities. Level 3 focuses on progressing to more challenging activities. Level 4 focuses on preparing the patient for transition off the unit by regaining as much of their pre-admission levels of independence as possible. The levels are progressively more challenging for the patient and each level includes a minimum recommended dosage of ERM activities. Across the levels, there is an emphasis on orientating the patient to themselves, others, place, and time, and on protecting their sleep. We also developed comprehensive guidance for the activity levels that includes:
- An overall explanation of the activity levels and how ERM has been conceptualised in the PERMIT intervention manual.
- An explanation of each of the four activity levels, including the main aim of each level, a description of the type of patient for whom each level is usually appropriate, guidance on specific activities within each level, and suggestions for who may need to lead or be involved in delivering activities at each level (e.g. allied health professional, nurse, parent/carer).
- How to select meaningful and purposeful ERM activities for an individual patient, considering their acuity, pre-admission characteristics (e.g. age, pre-existing developmental level, pre-existing impairments or limitations, favourite toys and activities), the ERM confidence and skills of the multidisciplinary team at that point in time, and parent/carer intuition about what their child enjoys, dislikes, and may be able to tolerate.
- How to progress patients to more challenging activities within a specific level as well as progressing up through the four activity levels.
As with the patient acuity levels, the guidance encourages tailoring of the activity levels to fit in with practice in an individual unit. For example, it sets out how users can specify who should lead certain ERM activities depending on the staff groups that are usually available and users can add specific activities that are available in their unit or add/remove activities they especially do/do not want to be considered for certain patient populations or levels of acuity.
Safety and tolerance criteria
Our literature-based work (reported above) highlighted a range of tried-and-tested safety checklists used just before initiating ERM activities and safety criteria used during activities to monitor patient tolerance and guide decisions about whether ERM should be paused, altered, continued or stopped. These clinical materials include key indicators of cardiorespiratory and central nervous system instability, pain or discomfort, and concern for the integrity of critical lines and tubes. We compared and contrasted safety and tolerance criteria identified through our literature-based work and supplemented these with examples from adult ERM literature.53,97,98
Through discussion between the core intervention development team and clinical members of the wider PERMIT research team, we initially considered and ruled out three approaches to specifying safety and tolerance criteria:
- Define explicit safety thresholds by age and illness category. Age-related normal values for cardiovascular, respiratory and central nervous system parameters are widely established. However, in a PICU setting many patients’ observations will be outside normal thresholds and a priori specification of thresholds in all scenarios would not be feasible given the heterogeneity of the clinical population.
- Use a ‘triggered alarm’ approach. Bedside nurses frequently review and adjust alarm limits for oxygen saturation, heart rate, arterial blood pressure monitoring etc. However, false alarms are common (e.g. brief, insignificant perturbations, particularly in more awake patients) and therefore strict application of a triggered alarm approach may not be feasible.
- Define thresholds in terms of percentage change relative to a patient’s baseline (e.g. change in heart rate of >20%). While this approach to individualising safety and tolerance criteria is attractive, it may not be feasible to calculate a meaningful and useful baseline. For example, clinicians do not routinely calculate an average heart rate over the last 4 hours and to do so before initiating ERM activities may be burdensome and open to discretion about how to interpret periods of elevated heart rate during procedures over those 4 hours.
We determined that, as part of a routine risk assessment conducted just before ERM activities are carried out, clinicians should use their judgement to prospectively define individualised safety and tolerance criteria that are meaningful and useful for a given patient [e.g. acceptable upper and lower thresholds for heart rate, respiratory rate, saturation, intracranial pressure (ICP)]. If observations exceed these limits the ERM activity should be paused and the appropriateness of further activities should be re-assessed. Our rationale was that clinicians have intuitions of acceptable bounds on physiological parameters for a given patient, based on their routine observations to date, knowledge of the patient’s condition etc. Patient acuity level can change rapidly during the day and between procedures. Therefore, clinicians are accustomed to reviewing the appropriateness of any intervention before it is carried out and monitoring how the patient is responding throughout and afterwards. The same principle may apply to ERM. In the ERM intervention manual, we set out the safety and tolerance (‘pause and re-assess’) criteria that clinicians should prospectively define and monitor for individual patients before, during and after ERM activities. The manual also includes guidance on incorporating the criteria into a unit’s existing documentation and processes and provides a practical example of implementation in one unit (Birmingham Women and Children’s NHS Foundation Trust) for clinicians to use as a model.
ERM daily flowchart
Having specified the essential clinical materials needed to deliver ERM, we set out to identify an approach to planning and organising delivery on a daily basis across a PICU. In line with the guiding principles, we needed a mechanism for prompting routine screening of all patients across the unit for ERM eligibility, ensuring timely initiation of ERM on the second morning of admission for patients anticipated to still be on the unit the following day, assigning acuity levels, selecting meaningful and purposeful ERM activities for individual patients, deciding who would support each patient’s ERM on a given day and how parents/carers would be involved, and feeding back on the patient’s tolerance of ERM to inform subsequent team decision-making.
Our literature-based work identified an existing ERM intervention – MOVE4WARD – that included a tried-and-tested daily flowchart used in the morning ward round to plan and organise ERM delivery. MOVE4WARD is the ERM programme at Birmingham Women and Children’s NHS Foundation Trust and was adapted from the PICU Up! programme.17 We further specified the MOVE4WARD daily flowchart and developed guidance on how to use it and tailor it to fit in with practice in a particular unit. For example, we encourage users to change the design and layout, insert their own language and terminology for local processes and documentation, and add more detail such as the specific people who will be carrying out certain tasks.
Specifying the implementation toolkit
Purpose: to specify the second part of a prototype ERM intervention manual – a step-by-step guide to putting ERM into practice across a unit.
Methods: we used a rapid pragmatic approach to identify, characterise, and understand literature focusing on the implementation of ERM interventions in PICU settings and conceptualised the core findings in relation to implementation theories.
Search strategy and study selection: we included all the papers from the Phase 1 scoping review as well as those that were excluded on the basis of sample size or study design. We updated the searches to identify more recent work in paediatric intensive care. We also identified published systematic reviews, meta-analyses, and scoping reviews of ERM in adult intensive care.
Data extraction: we extracted information on determinants (i.e. barriers and facilitators) to introducing, embedding, and sustaining implementation of ERM as well as strategies used to overcome those identified determinants.
Analysis: we coded the determinants against theoretical concepts from NPT71,72 and TFA73 and strategies against those identified by ERIC,74 and the behaviour change Theory and Technique Tool.75 We reviewed and discussed the findings. Through an iterative process, we developed a step-by-step toolkit and related resources to support tailored implementation of ERM within individual and diverse units. This was further refined by clinical members of the wider PERMIT research team (see user development – reported below).
Results: Table 11 includes an overview of the implementation toolkit and related resources. We identified six steps towards ERM implementation – four geared towards preparing the PICU for ERM delivery and two geared towards actual delivery of ERM to patients. PICU preparation involves: taking stock – making an overall assessment of where the unit is currently at with ERM and deciding the next steps; building the team – bringing together a group of multidisciplinary ERM champions to lead implementation; getting buy-in – building a shared understanding across the unit of what ERM is all about; and getting ready – tailoring the bedside bundle to make it as workable as possible for the staff and systems already in place in the unit. Patient delivery involves: making it work – gradually putting the bedside bundle into practice in the unit until it is fully implemented with all patients; and keeping it going – coming together as a unit to review the bedside bundle, decide how it could be working better, and plan how ERM can be sustained over the next 6–12 months. Table 12 sets out a more detailed theoretical overview of the implementation toolkit.
| Implementation steps | What does it mean? | Theoretical processes | Why does it matter? | Theoretical processes | What’s involved? (corresponding ERIC strategies) |
|---|---|---|---|---|---|
| TAKE STOCK | Making an overall assessment of where the unit is currently at with ERM and decide the next steps to be taken.Creating a tailored action plan for delivering the bedside bundle across the unit, focusing time and effort on the areas that most need support. | Communal appraisal (NPT)Interactional workability (NPT) | Focusing on a tailored action plan makes ERM feel more manageable for everybody.It is harder to change practice if clinicians believe they are already doing all aspects of ERM. Therefore, it helps to specify exactly where the bedside bundle is not happening or needs to be improved. | Burden (TFA)Differentiation (NPT) | The manual includes a self-assessment checklist for taking stock. (Assess for readiness and identify barriers and facilitators.)From the self-assessment, the next steps for progressing ERM can be prioritised. Be specific about who will do what, with and for whom, and when. This is the action plan. (Tailor implementation strategies) |
| BUILD THE TEAM | Bringing together multidisciplinary champions to support and market ERM, drive it through and overcome any indifference or resistance. | Initiation (NPT) | Leadership from a credible, representative and organised group of multidisciplinary clinicians makes people trust ERM and feel more positive about it.ERM champions with a good understanding of the different roles, expertise and personalities in the unit can allocate tasks and responsibilities to those with the right skills. | Affective attitude (TFA)Relational integration (NPT)Skill-set workability (NPT) | Champions should represent the multidisciplinary team and include a lead doctor, nurse and physiotherapist as a minimum. (Identify and prepare champions)The manual includes resources to help champions prepare for presenting the evidence for ERM and persuading colleagues about its benefits and safety. (Identify and prepare champions) |
| Champions should organise weekly team meetings to plan, monitor and review ERM and support one another’s learning. (Organise clinician implementation team meetings) | |||||
| GET BUY-IN | Building a shared understanding across the unit of what ERM is all about – what the bedside bundle involves, how it is supposed to work, and what are the potential benefits and intended outcomes for patients.Achieving agreement that ERM fits in with the unit’s values of providing the best possible care. | Communal specification (NPT)Intervention coherence (TFA)Internalisation (NPT)Ethicality (TFA) | When clinicians buy-in to ERM, they understand how they can contribute to ERM and feel comfortable that it can be done safely. They can see where the bedside bundle is currently working well, where it is not happening, and where it needs to be improved. They are willing to make it happen.When unit managers buy-in, they make it clear that they support ERM. | Legitimation (NPT)Affective attitude (TFA)Differentiation (NPT)Contextual integration (NPT) | Get everybody in the unit involved in discussions about ERM to start building positive feelings and understanding. (Conduct local consensus discussions)Get people actively involved in problem-solving around ERM. For example, what are their concerns around patient safety and staffing? How do they think ERM should fit in with sedation and nutrition practices? (Facilitation) |
| Share examples of successful ERM and positive patient and parent/carer feedback. (Obtain and use patient/family feedback)Ask unit managers to make it clear that ERM is a priority and that they support implementation. (Mandate change) | |||||
| GET READY | Tailoring the bedside bundle to make it workable for the staff and systems already in place in the unit. Specifically, this means allocating ERM tasks and responsibilities appropriately and fitting the bedside bundle into the current ways of ordering, recording, communicating, and monitoring patient care. | Enrolment (NPT)Skill-set workability (NPT)Individual specification (NPT)Systematisation (NPT) | When clinicians understand their role in the bedside bundle and prepare for carrying out their allocated tasks and responsibilities, they feel more confident and positive about ERM.Building the bedside bundle into existing systems makes ERM feel more manageable. | Self-efficacy (TFA)Burden (TFA) | The manual includes guidance on tailoring the bedside bundle to an individual unit. (Promote adaptability)It is easier to deliver the bedside bundle if units are specific about who does what and when. (Revise professional roles)Consider how to use existing systems (e.g. ward round checklists, electronic records, whiteboards). (Change record systems) |
| Plan training sessions to show people how the bedside bundle works. Make sessions interactive and tailored to the needs of different clinicians. (Conduct educational meetings; Make training dynamic) | |||||
| MAKE IT WORK | Gradually putting the bedside bundle into practice until it is fully delivered with all patients. The unit tests out ERM and gets feedback on how it is working (e.g. have tasks and responsibilities been allocated appropriately, is it fitting into existing systems?). | Interactional workability (NPT)Skill-set workability (NPT)Systematisation (NPT) | Gradual implementation provides time and space for clinicians to build confidence in their own and each other’s skills.As they gain first-hand experience of safe delivery, clinicians feel more positive and less worried about ERM. | Self-efficacy (TFA)Relational integration (NPT)Affective attitude (TFA)Individual appraisal (NPT) | Phase-in the bedside bundle and very gradually move to a unit-wide rollout. (Stage implementation scale-up)Consider rostering an ERM champion onto every shift to help implement the bedside bundle, solve problems, and monitor quality. (Facilitation) |
| As they gradually gain more experience, clinicians are able to give feedback about the impact of ERM on themselves, their workload, patients, and the unit overall. | Build in reminders that prompt clinicians about the bedside bundle and help them remember what exactly they need to do. (Remind clinicians)Put in place a system for getting feedback about ERM from clinicians, patients (where possible), and parents/carers. (Obtain and use patient/family feedback) | ||||
| KEEP IT GOING | Coming together as a unit to review the bedside bundle, decide how it could be working better, and plan how ERM can be sustained over the next 6–12 months. | Communal appraisal (NPT)Reconfiguration (NPT)Activation (NPT) | Ongoing evaluation of the bedside bundle combined with comprehensive feedback for clinicians builds trust and confidence in the effectiveness of ERM. | Relational integration (NPT)Perceived effectiveness (TFA)Skill-set workability (NPT)Self-efficacy (TFA) | Review how the unit is doing with the bedside bundle. (Purposely re-examine implementation)Provide feedback to the overall unit, clinician groups, and individuals about how ERM is going. (Audit and provide feedback)Conduct spot checks on different parts of the bedside bundle and provide feedback to the overall unit, clinician groups, and individuals. (Audit and provide feedback) |
| Staff turnover in the unit means that who is delivering the bedside bundle changes over time. Permanent staff also change as they develop their confidence and skills in ERM. Ongoing evaluation and training should consider these changes. | Plan ongoing training sessions to refresh permanent staff and show new staff how the bedside bundle works. (Conduct ongoing training)The manual includes guidance on creating a unique identity for the locally tailored bedside bundle and spreading the word about ERM through posters, newsletters, events and social media to help create a positive buzz and maintain interest. (Use mass media) |
The six steps towards implementation form a flexible framework that can enable both those units new to ERM to get started and more experienced units to renew their efforts and build on the ERM they have already been doing. The steps are not conceptualised as a linear or sequential process. We suggest in the intervention manual that it makes sense for users to start off with taking stock and thinking through their unit’s readiness for implementing ERM. Otherwise, given that implementation factors vary between units and that every PICU is at a different point in their ERM journey, we envisage that settings will focus their implementation efforts on the steps most in need of attention locally.
Reviewing outcomes
In the workshops with clinical stakeholders, we collected information about potential outcomes of ERM and incorporated these into our guiding principles (see Table 10). We planned to conduct a rapid literature review to identify related patient-centred outcome measurement tools and potentially incorporate these into the prototype ERM intervention manual. However, prior to starting the review work, we learnt that Fink et al. were developing a PICU core outcome set and core outcome measurement set – a PERMIT co-applicant had been invited to join that study’s International Steering Committee.99 Rather than repeat this work, we reviewed the outcomes within our guiding principles against the published PICU core outcome set47 (Table 13) and developed our ERM logic model accordingly (see logic model – reported below).
| Outcomes of ERM proposed by clinical stakeholders | Corresponding global outcomes considered for the PICU COS | Included in PICU COS | Included in PICU COS – Extended | Excluded from PICU COS | Corresponding specific outcomes considered for the PICU COS | Included in PICU COS | Included in PICU COS – Extended | Excluded from PICU COS |
|---|---|---|---|---|---|---|---|---|
| Duration of MV | Healthcare utilisation | X | New technological supports (tracheostomy, gastrostomy tube, oxygen, etc.) | X | ||||
| LOS in paediatric intensive care and hospital overall | Healthcare utilisation | X | Cost of care | X | ||||
| Movement function and mobility capacity and participation at discharge relative to pre-admission | Physical function | x | Physical mobility | X | ||||
| Activities of daily living capacity and participation at discharge relative to pre-admission | Overall health | X | Activities of daily living | X | ||||
| Social function | X | Child participation | X | |||||
| Body functions – respiratory | Physical function | X | Organ function | X | ||||
| Body functions – muscle functioning/strength | Physical function | X | Medical frailty | X | ||||
| Body function – cognitive | Cognitive function | X | ||||||
| Patient psychological well-being | Emotional health and function | X | Mood and feelings | X | ||||
| Post-traumatic stress | X | |||||||
| Family psychological well-being | Family function | X | Parent/legal guardian emotional function | X | ||||
| Patient QoL | Overall health | X | Child QoL | X | ||||
| Family satisfaction with care | n/a | n/a |
User development – refining the prototype intervention manual
Purpose: to refine the prototype ERM intervention manual through exploring clinical stakeholders’ views on acceptability and feasibility.
Methods: we took forward key topics and outstanding issues and uncertainties emerging from the ERM intervention manual development process into a series of formal and informal meetings with clinical members of the wider PERMIT research team. These meetings took place alongside the literature-based work (reported above) and had an iterative relationship.
Sampling and recruitment: we worked with existing members of the wider PERMIT research team. They represented a multidisciplinary group of NHS healthcare professionals with diverse experience of ERM in PICU settings. A total of 13 professionals from three PICUs took part in the process – four consultant doctors (three paediatric intensivists and one paediatric neurologist), two senior nurses (one clinical academic and one PICU lead) and seven senior physiotherapists.
Data collection: we undertook nine online group meetings. Meeting focus evolved with findings of literature-based work and insights from prior meetings shaping the focus of the next. The core intervention development team would present materials from the bedside bundle and implementation toolkit and/or facilitate the discussion and the clinical team members would support, refine and challenge elements of the manual. Members of the intervention development team recorded contemporaneous fieldnotes. The meetings lasted for 60 minutes. We also undertook additional formal and informal smaller meetings, with specific people, to further explore or refine difficult issues, as well as to undertake ‘walk-throughs’ of manual processes and explore reactions.
Data analysis: we focused on reviewing fieldnotes, memoing and debrief sessions within the core intervention development team. We reviewed, discussed and summarised the meetings, and worked to adapt the manual in an iterative fashion focusing on maximising potential successful introduction and embedding of the intervention.
Results: Table 11 summarises the content of the PERMIT ERM intervention manual. The key feedback points that were used to refine the prototype manual and improve its overall feasibility and acceptability can be summarised as follows:
- Introduction and orientation – tell the user what is in the manual, where to start and how to work through the different sections.
- Layout and formatting – introduce the bedside bundle first as this is of primary importance to users. Keep the manual brief, simple and accessible by ensuring that each of the clinical materials in the bedside bundle and each of the steps in the implementation toolkit fits onto one side of A4. Minimise the burden of flipping between sections in the manual by clearly separating the bedside bundle and implementation toolkit from the lengthier training and support materials.
- Language and tone – use labels that are already familiar and acceptable, for example a ‘checklist’ for implementing the pause and re-assess criteria evokes more confidence and positive emotion than a ‘risk assessment’. When providing instructions, ensure the tone comes across as flexible and enabling – clear and straightforward instructions may inadvertently come across as too prescriptive or authoritarian.
- Promote and enable ownership – make it explicit how the bedside bundle builds on systems, processes and expertise that are already in place across a unit. Empower users by highlighting where the intervention manual can be tailored to fit in with local practice and actively encourage them to tailor and take ownership of the materials and resources.
- Minimise extra burdens and manage expectations – remove unnecessary detail from the tables and flowchart within the bedside bundle. Make it clear which training and support materials are provided within the manual and clarify any materials that will need to be developed or tailored locally by the unit. Take advantage of all opportunities to build the manual into existing documentation rather than introducing new paperwork to the unit.
- Create a positive buzz and maintain interest – consider providing branded promotional materials such as pens, stickers etc.
In addition, the wider research team identified several key topics that warranted further exploration in our subsequent feasibility study (see Chapter 5): for example, the practicalities around recording ERM intervention data within existing documentation systems and processes, the impact of different clinical perspectives about how to deliver ERM to particular patient populations such as those on ECMO, and the acceptability of our conceptualisation and specification of ERM to diverse stakeholders beyond the PERMIT research team and study participants.
Logic model – refining our understanding
Purpose: to refine a PERMIT ERM logic model.
Methods: we had already developed a preliminary ERM logic model based on current literature and the clinical expertise within the research team. We reviewed and refined our logic model in relation to findings from the manual development process, the correspondence between the outcomes within our guiding principles and the published PICU core outcome set,47 and through discussions within the wider PERMIT research team.
Results: the refined logic model is presented in Figure 13. It provides an overview of the proposed intervention components and implementation processes set out in the refined ERM intervention manual, as well as the proposed outcomes of ERM and the key contextual factors thought to influence its implementation and potential effectiveness.
FIGURE 13 Logic model of PERMIT. (Figure not reproduced here; see the original article.)
Summary of findings to inform the PERMIT study
We know that ERM is currently defined and enacted in multiple ways and that people see the potential value for the diverse patient populations within PICU and are willing to support the (safe) delivery of ERM but are uncertain how best to deliver it.
- We developed core guiding principles around the potential shape and content of the intervention. For example, everyone in PICU, including but not limited to doctors, nurses, physiotherapists and parents, are all essential for ERM delivery – everyone should take some ownership. Also, ERM needs to be as inclusive as possible, with a focus on promoting movement and mobility as early as possible and with progressive increases over time.
- We developed a prototype ERM manual that is focused on both the (safe) delivery of ERM for each patient as well as the introduction and embedding of an ERM approach within a PICU. Centrally, the proposed PERMIT ERM manual is informed by current evidence, experience and theory. It offers a flexible, progressive, approach to the delivery of ERM, with resources including essential clinical materials – the ‘bedside bundle’ – that consist of patient acuity levels, ERM activity levels, pause and re-assess criteria, and an ERM daily flowchart. It also includes a step-by-step guide to putting ERM into practice – the ‘implementation toolkit’ – that focuses on building ERM leadership, generating staff buy-in, making ERM workable and keeping it going over time.