The OPAL study employed an intervention mapping (IM) framework to deliver the objectives listed in Chapter 1, Objectives.
Intervention mapping
Intervention mapping is a framework for developing effective theory- and evidence-based behaviour change interventions.55–59 IM was developed for, and is widely used in, health promotion, but the process has also been applied to many other fields, including traffic safety and energy conservation.60 It has also been used in rehabilitation, for example in the management of osteoarthritis and back pain61 and stroke,62 as well as in work disability prevention.63
The IM framework was first used in work disability prevention in 2007. Interventions developed using this methodology have included self-management at work of chronic diseases64 and upper limb conditions,65 but the majority (six separate interventions) have been designed to promote RTW.66–71 However, only one study has focused on RTW following surgery.68 Furthermore, in three of these studies69–71 an intervention has been designed but has yet to be implemented/evaluated.
Only three of the interventions to assist RTW developed using an IM framework have been formally evaluated in a randomised controlled trial (RCT); these are van Oostrom et al.,72 Vermeulen et al.73 and Vonk Noordegraaf et al.68 The details of these studies are described in Chapter 3 and they suggest that the IM framework being employed in the OPAL study can facilitate the development of an effective occupational advice intervention.
Intervention mapping is a useful approach as it acknowledges that health is a function of individuals and their environments. Many health-related behaviours are dependent on individual knowledge, motivation and skills, but are also determined by the actions of decision-making groups, such as organisations and health authorities. RTW interventions are complex and thus at higher risk of theory and/or implementation failure than simpler interventions, such as medication delivery or hospital-based rehabilitation. The main characteristics of the IM protocol are to consider the individual within all of the different levels of their environment, and to make explicit use of theories when defining the problem, the intended changes and how these changes will be achieved. In this way, IM has the potential to prevent both theory failures and execution failures when developing and implementing RTW interventions, with better chances of demonstrating effectiveness.
Intervention mapping is a stepwise approach to theory, evidence-based development and implementation of interventions. It consists of six stages: (1) needs assessment, (2) identification of intended outcomes and performance objectives (POs), (3) selection of theory-based methods and practical strategies, (4) development of intervention components, (5) development of an adoption and implementation plan, and (6) evaluation and feasibility testing.
The OPAL intervention mapping process
The OPAL study followed the six-stage IM approach (Figure 1). Stages 1–3 (phase 1) addressed objectives 1–6 (see Chapter 1, Objectives) by gathering information on current practice and barriers to change; stages 1–3 also provided a theoretical framework for intervention development. Stages 4–6 (phase 2) addressed objectives 7–9 (see Chapter 1, Objectives). An overview of the activity within each stage of the IM process is provided below, and further details can be found in each of the corresponding chapters.
FIGURE 1 Overview of the OPAL IM methodology. (Figure not reproduced here; see the original article.)
Intervention mapping stage 1: needs assessment (see Chapters 3–6)
Intervention mapping stage 1 established the rationale for an occupational advice intervention within the target population by evaluating the discrepancy between current and desired practice. It utilised a variety of approaches including a rapid evidence synthesis (see Chapter 3), a cohort study (see Chapter 4), a national survey of practice (see Chapter 4) and patient (see Chapter 5) and stakeholder (see Chapter 6) interviews. This information was then used to create a logic model of the problem considering how the behaviours of the target population increase the risk, prevalence, incidence and burden of the problem and how interpersonal, organisational, community and societal factors influence RTW directly or through influence on the behaviour of the target population. These behavioural and environmental factors were then mapped to specific theory- and evidence-based factors and determinants to help provide an overview of the problem and a framework to address it.
Intervention mapping stage 2: identify intended outcomes and performance objectives (see Chapter 7)
Stage 2 used the findings from stage 1 to specify who and/or what needs to change for patients to make a successful RTW following hip/knee replacement. A provisional matrix of POs for key stakeholder groups was constructed outlining the personal determinants, external determinants and expected outcomes for each objective.
Intervention mapping stage 3: selecting theory-based methods and practical strategies (see Chapter 7)
In stage 3, a list of possible components matched to each performance objective/determinant was generated. Using theory, evidence, experience and consensus, the most practical ways to implement these interventions were identified. These intervention ‘components’ formed the basis of the statements presented to stakeholders as part of the Delphi consensus process (see the next section on IM stage 4) and helped to develop the first iteration of the developed occupational advice intervention.
Intervention mapping stage 4: development of intervention components (see Chapters 8 and 9)
Stage 4 used the information and associated occupational advice strategies identified in the first three IM stages to develop specific tailored tools and materials. To help refine these components, a multistakeholder intervention development group was created to reach agreement about the design, content, delivery, format and timing of the proposed occupational advice intervention. To facilitate this process, a modified three-round Delphi consensus process was employed. Information from the Delphi consensus process was then used to refine and finalise the occupational intervention.
Intervention mapping stage 5: adoption and implementation plan (see Chapter 10)
In stage 5, strategies for the implementation and adoption of the intervention were developed. This stage ran concurrently with the final stages of intervention development as the content, format and method of delivery became finalised. The implementation plan focused on the delivery of the intervention within the realities of the NHS. Therefore, the intervention and the associated implementation plan had to be adaptable to current practice, infrastructure and staffing at each of the three feasibility sites. This flexibility permitted delivery alongside current ‘standard’ care while stipulating the achievement of specified POs, against which the fidelity of the intervention was assessed.
To facilitate the implementation and adoption of the intervention, education and training materials were developed for each of the staff groups involved in its delivery. Appropriate support and training systems were developed and an implementation plan was constructed to assist adoption at each site, which included a site visit and ongoing support from the OPAL investigators.
Intervention mapping stage 6: evaluation plan and feasibility testing (see Chapter 10)
The final stage of the IM process evaluated the intervention by assessing four complementary aspects of its delivery and performance:
- assessment of intervention fidelity – quantitative evidence that the intervention was delivered against specific POs for both the hospital orthopaedic team (HOT) (staff objectives) and the patient (patient objectives)
- assessment of intervention quality – qualitative assessment of the intervention delivery obtained by interviewing patients and staff groups about what worked and what did not, why it did not work or why it went well
- assessment of feasibility data – preliminary comparison of outcomes using data obtained from IM stages 1 (pre intervention) and 6 (post intervention)
- assessment of economic data – approximate cost estimates for the intervention using derived health economic data.
In addition, the feasibility stage collected information that would help to shape the design and development of a future clinical trial by assessing screening, recruitment, consent and follow-up procedures and rates at each of the study sites. A formal pilot study was not undertaken at this stage as per the commissioning brief.
The OPAL IM approach described above is outlined in Figure 1 and a diagram describing development of the OPAL occupational advice intervention is shown in Figure 2.
FIGURE 2 Diagram of the stages of development of the OPAL occupational advice intervention. (Figure not reproduced here; see the original article.)
Stakeholder engagement strategy
Five key stakeholder groups central to the development of an occupational advice intervention were identified: (1) patients, (2) employers and their associated occupational health departments, (3) allied health professionals (AHPs) (occupational therapists and physiotherapists) and nurses, (4) orthopaedic surgeons and (5) general practitioners (GPs).
To maximise engagement with these stakeholder groups, nominated OPAL investigators were responsible for the identification and engagement of stakeholders within their area of expertise. This included stakeholder recruitment from a number of professional bodies and employment institutions, providing the breadth of opinion and insight required to ensure generalisability and acceptability of findings and assist with dissemination of findings at various stages of the study (Table 1).
| Stakeholder group | Nominated OPAL investigator | Participants recruited via |
|---|---|---|
| Patients | Mrs J Fitch | NJR patient network British Orthopaedic Association Patient Liaison Group Patients identified from the cohort/interviews in phase 1 |
| Employers and occupation health services | Professor S Khan | Federation of Small Businesses Make UK, The Manufacturers’ Organisation Confederation of British Industry Trades Union Congress Department for Work and Pensions Fit for Work The Work Foundation The Society of Occupational Medicine Institution of Occupational Safety and Health Society of Occupational Health Nurses Employers identified from the interviews in phase 1 |
| Orthopaedic surgeons | Mr I McNamara | British Hip Society British Association for Surgery of the Knee British Orthopaedic Association Surgeons identified from the interviews in phase 1 |
| AHPs and nurses | Dr D McDonald and Dr C Coole | Association of Chartered Physiotherapists in Occupational Health and Ergonomics Chartered Society of Physiotherapy Occupational therapy networks (e.g. Royal College of Occupational Therapists Specialist Sections in Work and Trauma and Orthopaedics) Royal College of Nursing AHPs and nurses identified from the interviews in phase 1 |
| GPs | Mr P Baker and Professor A Rangan | Local medical committees Royal College of General Practitioners Local Clinical Commissioning Groups GPs identified from the interviews in phase 1 |
Data collection and handling
Personal data collected during the trial were handled and stored in accordance with the 199875 and 2018 Data Protection Acts.76 All electronic patient-identifiable information was held on a secure, password-protected database accessible to only essential study personnel. Only OPAL investigators (University of York and University of Nottingham), the sponsor (South Tees Hospitals NHS Foundation Trust) and the recruiting NHS trust had access to the personal data. Written consent was taken for collected data to be linked to routinely collected health data stored in national databases (via NHS Number), although this activity did not form part of this research project.
Project management
The South Tees Hospitals NHS Foundation Trust was the sponsor for this project. This study was compliant with the research governance framework77 and Medical Research Council good clinical practice guidance.78 The Trial Steering Committee, which met approximately 6-monthly during the OPAL study, oversaw the study.
Ethics approval
The OPAL study was approved by the East Midlands – Derby Research Ethics Committee (Integrated Research Application System ID 200852) on 18 August 2016. The employer/workplace representative interviews were approved by the University of Nottingham Ethics Committee on 25 July 2016. Health Research Authority approval was received on 4 October 2016. For ethics approvals and Health Research Authority correspondence documents, see www.journalslibrary.nihr.ac.uk/programmes/hta/152802/#/ (accessed 2 May 2020).
Project registration
- Current Controlled Trials ISRCTN27426982 (date registered: 20 December 2016); URL: www.isrctn.com/ISRCTN27426982 (accessed 16 April 2019).
- International prospective register of systematic reviews (PROSPERO) registration number CRD42016045235 (date registered: 4 August 2016).
Protocol management and version history
See study protocol version 4.0, which has been published.54 Protocol version history is provided in Appendix 1.
Patient and public involvement
Active patient and public involvement (PPI) was ensured throughout the study. During the development of the grant application, PPI was sought from the NJR patient network and the British Orthopaedic Association (BOA) Patient Liaison Group. Six patients who had a joint replacement contributed to the initial proposal.
A recurring concern during initial discussions with patients was that a ‘one size fits all’ approach could be too generic. Other issues raised were variations across hospitals in the support provided; the needs of specific occupational groups, such as self-employed; different expectations among people about RTW; and the impact of the employer perspective, coupled with concerns about how early RTW interventions may result in pressure for people to return too early.
To address these concerns, the OPAL study specifically assessed individual patients’ experiences to enable an individualised intervention to be developed. Patient interviews explored individual patients’ needs, concerns and expectations related to the RTW process. This information, along with information from other stakeholders, shaped the development of the intervention during the rest of the study. In phase 2, patients were included in the Delphi consensus process, ensuring that we understood and addressed issues pertinent to them within the intervention. In addition to patients, engagement from other stakeholders was ensured during both phases of the OPAL study as part of the study design, maximising their engagement in the design and development of the intervention.
The study investigators included a patient representative as co-applicant (Mrs Judith Fitch). Mrs Fitch was involved in the ongoing management of the study through her involvement with the Trial Management Group, and intervention development meetings. In addition, a lay member sat on the Trial Steering Committee. Throughout the project, we continued to work with the NJR PPI group and the BOA patient network as well as PPI groups local to the sponsor site (South Tees). These groups helped us to develop study materials for the cohort study, patient interviews, Delphi consensus process and feasibility elements of the OPAL study. This included refining the study screening and consent processes, and developing the content of all patient-facing materials, ensuring that they were ethically sound, participant friendly and acceptable to the patient population. PPI members had the opportunity to contribute to the OPAL study via face-to-face meetings with the investigators and via telephone, e-mail or post. The costing for all PPI activity was calculated using the guidelines on the INVOLVE website.79 PPI members were informed of the various resources and opportunities available for patient and public engagement with the NHS and research.
Once the study was complete, the chief investigator held a patient and public focus group meeting at which an outline of the study and the study outcomes were presented; this meeting included hip and knee arthroplasty patients, a carer and a patient ambassador. The intervention that was developed and its associated resources (patient and employer workbooks, and POs) were discussed and queries about specific aspects of the study findings and intervention were answered. The group agreed that the designed intervention was highly valuable to the patient population. They agreed that it should be tested in a larger setting and commented on its potential to be adapted to other areas. The group also discussed dissemination plans for the research findings and future research. The Plain English summary in this report was reviewed and edited by the group.