Clinician support in the pilot trial
The iterative development work throughout the initial phases of the programme led to an initial pilot clinician support package being developed to be used to support GPs in delivering stratified care as part of the pilot RCT. The pilot RCT tested the STarT MSK intervention in eight GP practices (four stratified care practices; four control practices); full details of the pilot RCT have been published previously in this journal [12,13]. Figure 2, below gives an overview of the clinician support package; Table 2 provides full details of the structure and content of the training delivered to GPs as part of the pilot trial:
We had already established that affective elements are crucially important to the success of the trial. Due to the complexity of the task, training for intervention practices was delivered by two members of the study team: one GP and one clinical researcher. Most or all GPs in intervention practices attended the training sessions, though a few attended only one of the two linked sessions. Overall, the training was delivered to time and to plan, and GPs participated actively in discussions and practical sessions. Facilitators from the local Clinical Research Network undertook the brief training for control practices in the pilot trial.
The Keele STarT MSK tool was designed so that all selections made on the template were coded within the patient’s medical record. Anonymised data were extracted from each participating practice on a regular basis to facilitate analysis of the tool’s usage at three levels: individual GP, single practice and trial arm. These data were an essential part of evaluating and encouraging GP engagement with the stratified care template. We could identify any under-performing practices or individual GPs at an early stage, intervene and work with them to identify and remedy potential barriers. Examples included GPs not entering clinical codes and thus not triggering the tool, and information about using the tool and matched treatments not being disseminated to new members of staff. On a monthly basis each practice received an audit report on their tool usage at individual GP level.
A key element of the tool was to enable GPs to opt out of using it whilst discouraging the use of the “Esc” key which would have left no further engagement data in the EHR. Instead, GPs opting-out selected reasons; for instance, ‘patient not appropriate’ or ‘no time to complete’, enabling the team to assess the feasibility of using the tool in consultations.
A nested qualitative study was conducted as part of the pilot trial, in which consultations were video or audio recorded and used to stimulate recall in post-consultation interviews with matched pairs of GPs and patients, to explore the acceptability and feasibility of delivering the stratified care intervention . We found difficulties in integrating the intervention in consultations within the standard 10-minute timeframe. However, GPs did report finding this easier with practice throughout the course of the pilot.
A frequent comment was that four hours of GP training was excessive and difficult to accommodate. GPs valued the skills component but felt that less was required on the trial background and recommended that the training be reduced to a single two-hour session for the main trial. They also felt that the team should focus the training on how best to integrate the stratified care approach within a routine MSK consultation. These recommendations were incorporated into the support package and shortened training for the main trial. See Table 5, below, for a summary of the refinements made to the clinician support packages based on pilot trial findings. As a result of direct observation of training simulations, discussion with participating GPs and the qualitative work , we also felt able to be more prescriptive about the best fit of the intervention within a consultation and produced a short video of a simulated consultation to illustrate this. Refinements made to the clinician support package are summarised in Table 3, below:
The revised clinician support package included printed and laminated prompt sheets for GPs, a training log to ensure that no GPs were excluded, and a plan agreed with each practice to cascade the training to any new recruits or locum GPs.
Whilst both GPs and patients felt the Keele STarT MSK tool added value to the consultation, some items, derived from the original self-administered tool in WP1, were judged to be “cumbersome” [See 13 for full detals]. This led to development and validation of a clinical version of the tool, with more conversationally styled questions, including a statement of the construct underpinning each item to help clinicians effectively communicate these to patients . Support materials for the main trial were updated to include the revised tool and the training programme was adjusted to focus on the item constructs and the need to adhere to the exact wording of questions.
From outcome measures and feedback, it was clear that the brief training for control practices was not engaging many GPs and posed a risk of attrition bias. For the main trial we decided to use the same GP and clinical researcher pairs for clinician support in both trial arms, with a one-hour session for control practices focused on the recruitment template and the purpose and importance of the research.
Clinician support in the main trial
The finalised clinician support package comprised face-to-face sessions combining adult-learning principles with behaviour change theory in a multimethod approach, which included group discussion, simulated consultations, patient vignettes and model consultation videos. Clinician support was delivered by the same team at all 24 practices (intervention and control) in the main trial. Figure 3, below, gives an overview of the finalised clinician support package and Table 4 provides full details of the structure and content of the training delivered to GPs as part of the main trial:
Almost all participants attended the single clinician support session and the level of understanding and engagement appeared strong, despite the shortened session. A major change from the pilot trial was the availability of performance data for practices and individual clinicians at monthly intervals throughout the main trial. Each month, the same study team member emailed the lead GP and practice manager, including the performance table (Figure 4), as feedback and for motivation. Besides being an integral part of educational practice, a recent paper  had demonstrated the effectiveness of feedback in reinforcing and encouraging behaviour change in clinicians.
Through weekly data extraction from all practices and monthly analysis and reporting, the study team monitored activity and performance of practices and individual GPs in the trial. This demonstrated a high level of engagement with the tool and use of recommended matched treatment options according to risk stratification of individual patients.