Return to work with, or following, a health problem is a complex intervention involving many potential stakeholders and levels of influence [22]. As such, a methodology was required that would address this challenge: it was believed that Intervention Mapping (IM) was most appropriate. IM is a framework for developing effective theory- and evidence-based behaviour change interventions [23, 24]. IM was developed for, and is widely used in health promotion, but has also been used in rehabilitation, for example in the management of osteoarthritis and back pain [25] and stroke [26] as well as in work disability prevention [27]. 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 diseases [28] and upper limb conditions [29]. Only one study has focused on return to work following elective surgery [30]. The main characteristics of the IM protocol are to consider the individual within all 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 and execution failures when developing and implementing return to work interventions, with better chances of demonstrating effectiveness.
The OPAL research team, with representation from orthopaedic surgeons, patients, therapists, occupational health and occupational psychology professionals, formed a participatory planning group. The team included one researcher trained in Intervention Mapping. The team met regularly throughout the study, either face-to-face or virtually. The activities of the team were also monitored by an independent committee comprising an orthopaedic surgeon, a trial methodologist and physiotherapist, a patient, a General Practitioner (GP), and a commissioner/retired GP.
The team followed the six-step IM approach to theory, evidence based development and implementation of interventions. This paper reports on the development of the intervention in steps 1 to 4 of the IM process. Steps 1–3 gathered data on current practice and barriers to change using a mixed methods approach (cohort study of patients undergoing THR or TKR, stakeholder interviews, survey of practice, evidence synthesis) and provided a theoretical framework for intervention development. Step 4 used information from steps 1–3 in combination with a Delphi consensus process to develop the intervention and the associated tools and materials to facilitate its delivery.
Step 1
The team conducted a needs assessment to create a logic model of the problem. The needs assessment comprised four elements:
- 1.
A rapid evidence review (PROSPERO registration number CRD42016045235 (Date registered August 2016)) of existing quantitative and qualitative evidence on occupational advice interventions for people undergoing any type of elective surgery or with chronic musculoskeletal problems and a mapping of currently used outcome measures to assess effectiveness. The review included 4 studies of return to work (RTW) interventions relating to elective surgical procedures and 17 systematic reviews of RTW interventions in the wider musculoskeletal literature. Key intervention components effective across previous RTW interventions were identified, including job accommodations, contact with employers, educational programmes and multidisciplinary involvement.
- 2.
A prospective cohort study of patients undergoing total hip or knee replacement from four National Health Service (NHS) trusts was conducted between November 2016 and August 2017. Patients were eligible for inclusion if they were in paid (full-time, part-time, self-employed) or unpaid (volunteers or unpaid carers) work in the 6 months prior to surgery and intended to return to work after surgery. A total of 765 unselected hip and knee patients were screened, of which 196 (25.6%) were eligible for inclusion and 154 provided written consent and baseline data. Questionnaire assessments prior to and following surgery (8, 16, 24 weeks) provided information on patient characteristics, employment details (job roles, hours worked, employer characteristics), workplace assessments, functional outcomes, health utility measures, expectations of recovery, and rates and timing of return to work after surgery.
- 3.
A web-based survey of current practice in the delivery of occupational advice with hospital orthopaedic teams (HOTs) involved in the treatment of hip and knee replacement in the UK. The survey asked respondents about the current delivery, timing and content of RTW advice within the UK health service. The survey was conducted between July 2017 and August 2017 and was disseminated via the National Joint Registry (NJR) for England, Wales and Northern Ireland clinician leads in 149 individual health trusts, the NJR eBulletin and the Scottish Committee for Orthopaedics and Trauma (SCOT). Responses were received from a total of 152 participants from 59 different public and private health providers [20].
- 4.
A qualitative study of different stakeholder groups engaged in the RTW process. This element obtained information about current care related to RTW support, barriers preventing return to work, how these might be overcome, and how to translate this into an occupational advice intervention. Semi-structured interviews were conducted with a purposive sample of 45 patients undergoing THR or TKR at 3 NHS trusts, 25 workplace representatives (managers, human resources, occupational health, and colleagues), 16 GPs and 24 hospital orthopaedic staff between October 2016 and September 2017. Data were analysed using a framework approach that identified key themes relating to the RTW process [31,32,33].
The cohort questionnaires, the survey of current practice and the interview guides used for these interviews were developed specifically for the OPAL study. Examples of the cohort questionnaires and interview schedules are provided in Additional files 1 and 2.
The team summarised the key information developed from IM Step 1 in the context of the wider OPAL study aims [21], based on the PICO format (Population, Intervention, Comparator, Outcome) [34] (Additional file 3). Examples are shown in Table 1.
Table 1 Examples of information developed from Step 1 Having explored the issues relating to return to work for people undergoing hip and knee replacement, the next task was to create a logic model to better understand the problem. Failing to return to work when fit to do some work, or returning to work too soon which may impede full recovery, potentially increases the risk of patients not achieving sustained return to their usual/expected work following THR/TKR. The theory- and evidence- based factors causally related to these patient behaviours include patients’ knowledge and beliefs about the recovery process in relation to return to work; their attitudes to and expectations of return to work; matters related to financial/job security; and their confidence in managing their recovery and RTW. Following the ecological model (Fig. 1), several environmental factors were identified that could directly or indirectly influence these patient behaviours.
These included interpersonal factors such as the influence of friends and family, interpersonal healthcare factors such as the influence and practice of primary care clinicians, organisational healthcare factors such as hospital resources, commissioning decisions, workplace factors such as the availability of modified work, and societal factors such as NHS policies regarding work and health outcome measurement. As the study had neither the remit nor resources to address all of the factors identified, the research team concluded that its main focus would be on the interpersonal (healthcare) factor of work-focused advice and support provided by hospital orthopaedic teams. The theory- and evidence- based factors causally related to the behaviour of hospital orthopaedic teams included their knowledge and skills in offering work-focused advice, attitudes and beliefs about roles and resources and patient need. The logic model (Fig. 2) illustrates in detail the problem under investigation and the relationships and factors associated with it.
It was agreed that the context of the intervention would be NHS Hospital Orthopaedic Teams consisting of surgeons, physiotherapists, occupational therapists, nurses and support staff. The goal was to design and develop an individualised occupational advice intervention that could be offered to any patient undergoing hip or knee replacement irrespective of their access to other occupational services.
Step 2
In Step 2 the research team used the findings from Step 1 to specify who and/or what would need to change in order for patients to make a successful return to work following hip/knee replacement. The stated expected outcomes were agreed as follows:
-
1.
The patient makes a safe and sustained return to usual work following surgery
-
2.
The hospital orthopaedic team provides work-focused advice and support
The needs assessment described in Step 1, indicated that patients would benefit from occupational advice as early as possible in the hospital pathway, starting from the first clinic appointment with the surgeon. It should also involve employers and continue post-discharge. As well as containing generic information and advice, the intervention should also be individually targeted in order to reflect differing job demands and employment situations. A preliminary list of patient performance objectives and at what stage these might take place was drawn up by the research team (Additional file 4). Examples are shown in Table 2.
Table 2 Examples of preliminary patient performance objectives In order for patients to change their behaviour, and thus achieve their performance objectives, staff would also be required to change their behaviour. A preliminary list of staff performance objectives and at what stage these might take place were therefore also drawn up (Additional file 5). Examples are shown in Table 3.
Table 3 Examples of preliminary staff performance objectives Drafting the performance objectives for patients and staff led to a number of unresolved questions (see right hand column of Tables 2 and 3). Uncertainty around these questions formed the basis of the initial draft questions put to a Delphi consensus group in Step 4.
Based on the literature, views and experiences of the research team, and the findings of the needs assessment, the key determinants (factors expected to influence behaviour) selected for both patients and hospital staff were:
The team specified the desired change objectives and built preliminary ‘matrices of change’ for every behaviour, target group and environmental agent that was required to be influenced. The preliminary performance objectives and matrices of change were revised and refined following the Delphi study (see Step 4). An example of the patient change objectives required to achieve a preliminary performance objective is shown in Table 4.
Table 4 Example of a patient change objective An example of the staff change objectives required to achieve a preliminary performance objective is shown in Table 5.
Table 5 Example of a staff change objective A logic model of change was constructed to illustrate the proposed causal relations between theory- and evidence-based change methods, the determinants they were expected to influence, and behavioural and environmental outcomes that would address the problem (Fig. 3).
Step 3
In this step the team consolidated their ideas about the components, scope and sequence of the intervention. Change objectives, organised by determinants in the matrices (factors expected to influence behaviour), were reviewed and theory- and evidence-based methods to influence the determinants in the desired direction were identified, following Intervention Mapping guidance [24, 35]. The parameters for each method were considered and the methods translated into practical applications that matched the target group (patients) (Additional file 6). An example is shown in Table 6.
Table 6 An example of parameters, methods of behaviour change, and practical applications for a patient determinant The same process was followed for Hospital Orthopaedic Team (HOT) staff (Additional file 7). An example is shown in Table 7.
Table 7 An example of parameters, methods of behaviour change, and practical applications for a staff determinant of behaviour Step 4
In Step 4 the team used a three-round modified Delphi process to address the areas of uncertainty around the preliminary patient and staff performance objectives and proposed intervention components.
In total 66 stakeholders including patients, employers, GPs, physiotherapists, occupational therapists and orthopaedic surgeons were invited to participate in the Delphi process. In Round 1 statements relating to the content of the intervention were explored. A total of 43 (65%) participants responded in Round 1, reaching consensus on 36 of the 64 statements presented. In Round 2 the intervention format, delivery, timing and measurement were examined with 26 (39%) participants responding. Consensus was reached for 49 of the 94 statements presented in Round 2. In Round 3 the finalised occupational advice intervention along with selected patient and staff materials were circulated and responses were received from 11 participants.
A detailed report of the Delphi process will be published separately but in summary the findings supported the OPAL intervention being embedded within usual care and with a multi-disciplinary team (MDT) approach. Roles and responsibilities for key staff groups already involved within the care pathway (Outpatient clinic staff, surgeons, ward nurses, ward doctors and therapy teams) were agreed. Additional roles were also created to deliver intervention components that the consensus group agreed were important but that could not be delivered by adapting the work of existing staff. This included the roles of a ‘return to work co-ordinator’ (RTWC) and deputy.