Overview
To our knowledge, the OPAL study was the first such research study to develop a tailored, occupational advice intervention to be delivered in the UK NHS to patients returning to work after hip or knee replacement surgery. The feasibility of delivering the developed intervention alongside usual-care pathways was subsequently tested. The study methodology allowed the OPAL investigators to collect a wide variety of data and perspectives across a number of NHS sites. It provided pertinent information about the target population and delivery of usual care, and explored outcomes of importance for this patient group, in keeping with the objectives defined at the beginning of the study (see Chapter 1, Objectives). In this section, the main findings of the study are summarised and discussed in the context of relevant published literature, and, based on the findings of the study, recommendations are made for further research.
Intervention mapping methodology
The IM approach proved complex and time-intensive, but did support the development of a clearly justified and structured intervention.
Several studies have reflected that IM is time- and resource-consuming.66,69,158,159 Wolfers et al.160 recommend a more flexible application of the method to make it more applicable in practice. Meng et al.161 employed a ‘modified’ approach to IM, using ‘action plans’ as ‘a more practically feasible alternative to the matrices of change objectives’, which have been highlighted as particularly time-consuming by McEachen et al.159 However, the main challenge reported when applying IM is the implementation of the action plans developed with this methodology.
OPAL experienced similar challenges with implementation (IM stage 5), particularly in the context of a feasibility study (IM stage 6). In stages 2–4, the investigators developed the performance and change objectives, methods, applications and materials for delivering the occupational advice intervention in a hospital setting. However, in the context of a research setting, these were not always appropriate as there was overlap in the tasks related to ‘intervention activity’ (as laid out in the POs) and ‘research activity’ (as required to fulfil ethics requirements). For example, in delivering the occupational advice intervention, the identification of RTW patients would have been the role of the outpatient clinic team, whereas in the feasibility study this was undertaken by a research nurse. Other implementation issues included the complexity of training a range of staff in several different processes, in a short space of time, to deliver the intervention to a very small number of patients. These issues are discussed further in Strengths and limitations.
In OPAL, it became clear that the occupational advice intervention could address outcomes based at only the individual and interpersonal levels of the ecological model; it could not address outcomes based at organisational, community or societal levels. For example, it could not address NHS commissioning or primary care practice. It could not directly influence employer or workplace practice; however, it had the potential to indirectly make changes at these levels driven by changes in the individuals’ (employees’) behaviour. In their systematic review, Fassier et al.63 concluded that IM is not a ‘magic panacea to prevent theory and/or implementation failures of work disability prevention interventions’. They have suggested that the limited number of effective interventions in work disability prevention indicates that IM needs to be adapted to reflect the complex interaction between health care and the workplace. They also recommend exploring the value of the use of alternative paradigms to RCTs in the evaluation of interventions in this field, such as the theory-driven realist evaluation approach.162 Given the complexity of the health-care setting, as well as the complexity of the intervention, evaluation methods that are sensitive to the adaptation of interventions in different health-care settings may be most appropriate,163,164 such as the use of dynamic logic models.165
Given the complexity of the IM approach, the study might have benefited from a greater number of ‘participatory planning group’ meetings. At times, the amount of information generated, particularly in IM stage 1, was overwhelming. Having three different teams based at different locations leading on complementary aspects of this stage (cohort study and survey: South Tees; evidence synthesis: University of York; patient and stakeholder interviews and IM approach: University of Nottingham) added to the complexities of project management, and facilitating greater communication between the research teams may have made the overall process easier.
Future research
Is a future clinical trial feasible?
The feasibility study demonstrated that it was possible to collect relevant data to answer the research question and that an economic analysis could be conducted alongside a future definitive trial. The OPAL study has defined and clarified the following key components for a future trial.
Population
Information collected about patients returning to work after hip or knee replacement defined the target population for a future randomised control trial. The cohort study, structured interviews, evidence synthesis, Delphi consensus process and feasibility study provided information that allowed this population to be characterised and their needs assessed, and barriers to and facilitators of RTW after surgery to be defined. The findings confirmed that this population had varied and complex needs, which supported the use of an individualised approach to managing their RTW. Information collected from key stakeholders (employers, surgeons, AHPs, nurses and GPs) generated a more complete picture of this patient group. These interviews demonstrated that health-care teams and workplaces may not be prepared to, or understand how to, facilitate their patients’/employees’ RTW after surgery. The information generated has supplemented the previous literature20–49 to further define the target population that would benefit from an occupational advice intervention.
Intervention
An intervention was developed that addressed the key aspects of the commissioning brief; that is, it was based in hospital, started prior to surgery, was individualised, provided target support, was proactive and was designed in a pragmatic fashion to support delivery alongside routine care in an NHS setting. The intervention was designed using an iterative process using the IM approach,55–59 which allowed the OPAL investigators to revisit, revise and adapt the intervention as new information became available.
The intervention had a strong theoretical background and was underpinned by biopsychosocial models that supported behaviour change in the target groups (patients and stakeholders in the RTW process). It was manualised as a set of patient and staff POs that defined its content, format, delivery and timing while maintaining pragmatism in the ability for participating sites to administer the intervention alongside standard care. Central to the intervention was the development of an interactive patient workbook that supported the self-directed development of a RTW plan, similar to other recently developed RTW interventions.166 Implementation during the feasibility stage highlighted specific issues relating to the introduction of a complex intervention. The OPAL intervention was generally well received by patients and stakeholders: positive feedback was received throughout and the developed study materials were reported to be informative and helpful. There was good evidence from the completed patient workbooks that the intervention supported individualised care and, through the development of a RTW plan, acted as a decision aid167–170 enabling shared decision-making in line with best practice.171,172 The intervention also shared many of the characteristics of the occupational advice interventions identified in the rapid evidence synthesis, including advice about job accommodation; mechanisms to support workplace visits and contact with the employer; education and advice; counselling and guidance through the RTWC; and involvement of the multidisciplinary team.
Furthermore, the OPAL intervention has similarities to another recently tested occupational advice intervention.166 Grunfeld et al.166 recently reported on the feasibility and acceptability of a theoretically led workbook intervention designed to support patients with cancer returning to work and confirmed the feasibility of undertaking a definitive trial in this setting.
There is some overlap between the content of the written materials developed in OPAL and those available through the Royal College of Surgeons of England website (example at www.rcseng.ac.uk/patients/recovering-from-surgery/total-hip-replacement/returning-to-work; accessed 26 May 2020). The Royal College of Surgeons of England provides generic written resources covering recovery after both hip and knee replacement. Within these are sections providing information about RTW and timelined guides for recovery after surgery. Because they are designed for all patients, they do not provide the level of detail available in OPAL and cannot provide the individualised support that our phase 1 interviews suggest is needed. The structure, format and delivery of the OPAL intervention has been specifically designed to empower patients to take responsibility for their RTW and provides tools for them to develop an individualised RTW plan. It also encourages active engagement with employers and health-care teams via the OPAL booklets and RTWC role.
Comparison
Usual care that would be the comparator in a future definitive trial was evaluated in the cohort study, patient and stakeholder interviews and survey of practice. This demonstrated a haphazard approach to the delivery of RTW information and significant variation in the way preoperative services were configured. Most patients received little or no information about RTW from their HOT or GP, and only one-third of patients had access to occupational health support at work. These findings were counter to best practice as defined by NICE guideline 138171 and NICE quality standard 15172 (patient experience), which describe the need to ensure that ‘patients experience care that is tailored to their needs and personal preferences, taking into account their circumstances, their ability to access services and their coexisting conditions’ (© NICE 2012. Patient Experience in Adult NHS Services.172 Available from www.nice.org.uk/guidance/qs15. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication). Many patients did not have workplace contact until they returned to work. Despite this, a significant proportion of patients felt that current care was sufficient. This may reflect the fact that they returned to work (if they returned to work, this was seen as success) rather than any indication of the quality or timing of their RTW.
Outcome
The measurement of RTW is complex and the evidence synthesis demonstrated that there is currently no standardised method of recording it. Different approaches to measuring RTW were explored during the Delphi process and suggested that a number of complementary measures are needed. Dichotomous recording of work status is blunt and does not address important aspects of behaviour, such as how patients return, use of phased and adapted returns, timing of RTW and secondary sickness absence. Measures such as the Work Limitations Questionnaire135,153–155 and Readiness to Return to Work Scale157 were assessed during the feasibility stage. They provided useful information about time lost at work and information about where patients felt they were in their RTW process.
Study delivery and design
Approximately one-quarter of patients approached for the cohort and feasibility studies were eligible for inclusion, and consent rates for eligible patients were > 80%. This suggests that there are substantial numbers of patients willing to participate in research examining RTW after hip or knee replacement. The response rates for the questionnaires, which reduced with extended follow-up as participants returned to work, highlight a need to put additional efforts into improving the proportion of participants who return questionnaires.
The utility and resource use measures that were included in the questionnaires appear to have been appropriate for the purpose of collecting the health-related quality-of-life and cost data that fed into the economic analysis. The responses to such resource use and EQ-5D questions can be used to inform and improve the design of questionnaires in future research. For instance, participants reported that they had minimal or zero resource use for some items, which could be considered for removal from future questionnaires in order to reduce questionnaire completion burden for participants. Mean utility scores and EQ VAS scores increased over time, in line with what would be expected, which supports the face validity of using the EQ-5D measure.
Health-care resource use was broadly similar for the cohort and feasibility participants, with common key cost drivers; the most notable cost difference was for knee replacement participants over the period of baseline to 8 weeks, when the costs associated with inpatient stay and day-case visits were higher for cohort participants than for those in the feasibility study (who received the intervention). The cost associated with productivity loss following surgery was lower for the feasibility participants (£5929 per feasibility participant vs. £7983 per cohort participant). This cost saving has the potential to offset the cost associated with the intervention and the difference in health-care resource utilisation. It should be noted that, because there were only a small number of participants in the feasibility element, and the feasibility and cohort groups were not randomised to facilitate meaningful comparisons, firm conclusions could not be drawn here. However, a definitive trial would enable robust conclusions to be made regarding the cost-effectiveness of the RTW intervention.
The cost of training, which fed into the intervention cost (as part of the feasibility study), was based on the time spent by the RTWCs at the participating sites. It is acknowledged that this is a simplification of the costs involved, but owing to the variation in training across the sites and additional data not being available, the RTWC time was the focus for the training cost. As part of a definitive trial, more detailed information could be collected in order to estimate the training cost more accurately.
Other research recommendations
There are a number of opportunities for further research. Further research to define the optimal method of implementing the OPAL intervention would be essential before the intervention is formally tested in a RCT (see further discussion in Strengths and limitations).
Additional research could focus on how the intervention might integrate with primary care. This could allow RTW planning to start earlier and may provide support to additional patients seeking to remain in work who have symptomatic osteoarthritis below the threshold requiring joint replacement. If proven to be effective in a definitive trial, there is also the potential to investigate how the OPAL intervention could be implemented in other elective orthopaedic surgery and other surgical specialties undertaking planned surgical procedures. A significant proportion of the developed intervention has transferable content and the needs assessment conducted in OPAL is likely to be generalisable more widely to other specialties and settings, making this an important area for future research.
Strengths and limitations
Intervention mapping stages 1–4
Because our evidence synthesis followed rapid review methodology, there was a restriction on the range of databases that were searched. However, our searches were undertaken by an experienced information specialist in order to capture the most relevant databases, given this restriction. Preliminary results from the rapid evidence synthesis found only four papers for the elective surgery population. This finding was discussed with the Trial Steering Committee, which advised including the musculoskeletal literature even though this included patients with a range of chronic musculoskeletal conditions, not representative of our target population. This approach yielded useful results that were applicable to our hip and knee replacement patients.
We were initially unable to set up the cohort study within the planned time scales in the three originally proposed sites. To mitigate issues posed by the delays, we opened an additional site, which helped achieve our target recruitment and provided additional support during the feasibility study. Despite approaching all hip and knee replacement patients awaiting surgery at the study sites, we were able to identify only six patients intending to retire after surgery; this was a group we intended to examine. As a consequence, this part of the analysis was not carried out. Interestingly, 10% (n = 9) of patients at the 8-week follow-up stated that they no longer intended to return to work. It may be that these patients intended to retire after surgery but, for reasons that are unclear, did not state this during the baseline assessment.
The cohort study followed all patients until 16 weeks post surgery and a subset of patients for 24 weeks. Only 50% (n = 78) returned to work within the follow-up period. Extended follow-up studies have shown improvements in the observed rates of RTW;44,45 however, we were restricted by the study duration. Extended follow-up would be useful as part of a larger trial as it could evaluate other complementary aspects of RTW. These include evaluating RTW over time to understand whether or not it was sustained, periods of secondary sickness absence and whether or not patients returning to work on phased or adapted returns get back to full duties and the time frame for this. The study participant group included only a small number of black and minority ethnic patients. Their views and experiences were therefore not adequately represented in the cohort, patient interviews and feasibility testing, and the findings of these elements may not be generalisable to these patient groups. Consideration needs to be given to how black and minority ethnic patients are represented in a future trial.
Follow-up rates for the cohort study were 75% (n = 104) at 16 weeks and were lower at other time points. Similar issues with follow-up and dropout were observed during the feasibility study. Once patients had returned to work, they disengaged with follow-up procedures, instead seeming to focus on their work role. This may be a specific issue when conducting research on working patients who are possibly least likely to have time to participate in research and needs to be considered when designing a future study. We had initially hoped to use data to stratify patients into high and low risk of failed RTW as part of a tiered intervention. However, the failure to identify predictors, alongside the results from the Delphi consensus group and advice from the Trial Steering Committee, led us to design an intervention for everyone. The advantage of this approach was that the intervention was available for all patients, allowing engagement based on their individual need (described in Chapter 9).
The interviews demonstrated that current ‘usual care’ was frequently not following best practice in relation to the use of workplace adjustments and partial RTW, and the use of the fit note to advise on this. This suggests that there is room for improvement in how patients are supported in returning to work. Unfortunately, we were able to interview only a small number of self-employed patients. This meant that we were unable to provide a comprehensive commentary on the needs and behaviour of this group and to investigate whether or not they behave differently to those in other types of employment (e.g. because of lack of sick pay, pressure to get back to work sooner than employed patients, more options for workplace adaption and phased returns for employed people). Recruiting employers and GPs to interview was difficult. However, using a variety of strategies,173 we were able to achieve the recruitment required in IM stage 1, although we were unable to replicate this in the feasibility study. Whether or not interviews are conducted on a group or one-to-one basis is likely to change the dynamics of the interaction between researchers and participants. This may have influenced the nature of clinicians’ contributions and the data collected, and may thus be a limitation of the study.
Overall participation in the Delphi consensus process decreased from round 1 to round 3. Attrition through the Delphi process is well recognised;151,174 hence, various strategies were employed that were known to enhance response rates.175,176 By round 3, fewer than 20% of our invited participants remained, and employers and GPs were poorly represented in the final two rounds. Round 3 responses comprised feedback from only one employer and one GP. To mitigate the potential response bias introduced by a stakeholder group being not represented,177 an employer representative (Unison, London, UK) was approached, who provided structured feedback on the intervention outside the Delphi process. This information was used alongside the comments from other participants to finalise the intervention prior to feasibility testing.
Intervention mapping stages 5 and 6
OPAL is a complex intervention that required considerable planning for its implementation and sufficient time to put in place the facilitators to embed it into practice and to remove potential barriers to its effectiveness.178 Having developed the intervention using the IM framework, it was extremely challenging to effectively implement it within the time scale of the feasibility study. For it to be successfully embedded at each site, there was a need to involve all members of the HOT. However, in reality, owing to the limited time available for implementation and feasibility, it was difficult to train all staff and implement the intervention as intended. Consequently, some staff had no training or did not receive the training as intended.
The feasibility study suggested that patient experience of the intervention was positive and there was high adherence to the patient POs. However, some of the staff POs showed lower adherence. This may reflect that data sources were unable to ascertain if these POs had been adhered to but also may reflect the challenges of incorporating new behaviours and procedures into current health-care professional roles. It suggested that some of the implementation processes presented challenges and barriers to effective adoption. For future implementation and research studies, these barriers to implementation could be viewed within the Consolidated Framework for Implementation Research,179 which could help with understanding and overcoming them.
Throughout OPAL, and particularly in the Delphi study, we found evidence of reluctance among health-care professionals to take on the role of the provider of occupational advice: an ‘anyone but me’ attitude. This reluctance suggests that sufficient time needs to be provided to change the attitudes, norms and behaviours necessary to embed the roles and responsibilities for occupational advice in the OPAL intervention. Disappointingly, we were unable to interview GPs and therapy team members during the feasibility stage, which might have provided greater detail about their attitudes towards the OPAL intervention and might help to identify potential improvements. Time is also needed to prepare patients’ expectations with respect to the provision of RTW advice as part of routine health care.
The RTWC role was not fulfilled in all settings in the way we had expected. It is a key role in the OPAL intervention, delivering or facilitating a number of the POs. It would take a considerable time for someone to adapt and learn the competencies required for this role unless they had been recruited to specifically fulfil the required criteria for the role. There were contrasting experiences of the recruitment of the RTWCs. In one centre, there was uncertainty about whether or not funding was available to backfill posts, meaning that the local team found it difficult to predict how much time and resource would be required. By contrast, at another centre an experienced and enthusiastic senior nurse with a background in patient experience could be identified. Interviews suggested that some RTWCs accepted the role with reluctance. RTWCs were also required to be good clinical practice trained because the role was in the context of a research study, causing delays in their appointment. The feasibility study demonstrated that some members of staff were not fully committed to the intervention. However, evidence from the feasibility interviews suggested that if the occupational advice intervention were to be an agreed and funded component of routine treatment, a greater level of acceptance and adherence to delivery would be expected.
During the feasibility study, some of the trained staff rotated to other departments (junior doctors and AHPs), and others went on leave. This highlighted the need for ongoing training if the intervention was to become embedded and sustained in a department. In addition, some departments (e.g. outpatient departments) were reluctant to take on additional duties as they were already ‘overstretched’.
The barriers described above relate to the ‘readiness for implementations’ in the inner settings constructs of the Consolidated Framework for Implementation Research,179 suggesting that increased commitment and engagement among staff need to be ensured prior to implementation of the OPAL intervention. Given the time scales for implementation in the feasibility study, it is not surprising that the intervention was not fully embedded and that there were signs of a lack of commitment, resource issues and lack of awareness in some teams. However, these are all factors relating to the inner setting for implementation that could be improved on for a larger trial or full adoption of the intervention in a service. There was also variation among patients in understanding and perception of the aims of the OPAL intervention, which suggests that the intervention may need to be presented more clearly. This links into the Consolidated Framework for Implementation Research179 concept of intervention design quality and packaging, and is an area for further consideration beyond the OPAL study.
In hindsight, it may have been beneficial to pause the project after IM stage 4 once the final intervention had been drafted. This would have allowed time to develop a more robust implementation strategy that provided the necessary training and support to deliver individual, organisational and cultural change in the local orthopaedic teams. However, this was not an option given the protocol and the need to make recommendations about the feasibility of a future clinical trial as per the original commissioning brief. Other studies have similarly reported difficulties with applying IM stage 5. In a systematic review of interventions to prevent work disability developed using an IM approach,63 reviewers were unable to report the IM stage 5 outcomes because they were insufficiently reported in the studies they reviewed.
It is important to consider how a future study would evaluate the cost-effectiveness of a RTW intervention in terms of the study design and data collection considerations. The OPAL study found challenges around obtaining accurate cost information (e.g. cost of training) and achieving sufficient participant numbers to allow meaningful conclusions around the cost-effectiveness findings. Rather than the feasibility and cohort groups that were summarised here, a future definitive study should aim to randomise participants using a robust RCT design to enable a full comparison to be made.
The final intervention
The feasibility study and Delphi round 3 provided an opportunity for patients and stakeholders to comment on the intervention. Based on this feedback, the intervention will be further refined and updated. However, this has not yet happened as the follow-up for the feasibility study closed on 22 March 2019.
In the developed intervention, all patient and staff POs were equally important. Further review of the intervention may reveal key core POs that are essential to delivery and could define the essence of OPAL with supplementary peripheral POs that could be more flexibly delivered. This approach may further support adoption and ‘scaling up’ as teams have the ability to adapt the intervention so that it is fit for purpose in their own clinical settings. This fits with the approach already taken not to be overly prescriptive about the intervention and to allow pragmatism in delivery.
Content and format issues have also been identified, including the need to adapt the workbooks to include information for patients undergoing partial knee replacement procedures, requiring further detail on returning to driving and insurance after surgery, and further information for self-employed patients to make the workbooks more relevant for this group. The feasibility interview participants expressed some disappointment that their expectations around OPAL were not met/achieved or that they did not fully understand its purpose. This finding will also need to be addressed to provide clarity across the intervention and associated patient-facing materials.
Currently, a number of NHS patients are treated in the private sector. These patients are more likely to be younger and fitter and less likely to be obese;22,23 therefore, a greater proportion of patients than observed in this study could be expected to be working at the time of surgery. Furthermore, they often do not have to wait as long for surgery. Although it would have been beneficial to assess this patient group, it was not possible because of the challenges of conducting research in the private sector due to a lack of research infrastructure and research delivery support. We could not establish whether or not the needs or behaviours of this patient group differ from those of the observed NHS cohort. However, the OPAL intervention was designed to support delivery across a range of NHS settings and it is sympathetic to the variations in practice inherent in the NHS. Therefore, we feel confident that it should be possible to translate the intervention to patients having surgery in the private sector once its effectiveness has been established with further research.
Conclusions
OPAL had two key objectives: (1) to develop a multidisciplinary occupational advice intervention for working adults undergoing primary, elective, hip and knee replacement, and (2) to assess the delivery of the intervention and make recommendations about its further evaluation in a clinical trial. Both of these objectives were met. An IM approach was used to develop the RTW intervention and a series of methodologies were employed to underpin the development of the intervention and to test its feasibility clinically.
The OPAL intervention developed is an individualised RTW plan that is tailored to patients’ needs and involves them in decisions about their care, which supports best practice.171,172 It was feasible to deliver the OPAL intervention with high levels of fidelity in current NHS care settings, although further preparatory research on implementation is still required. The effectiveness and cost-effectiveness of the OPAL intervention then needs to be formally tested in a definitive multicentre pragmatic RCT. Further research is warranted given that there are currently between 40,000 and 50,000 patients who might be eligible for a RTW intervention every year in the UK18,180 who could potentially benefit from the OPAL intervention.