Patient direct access to NHS musculoskeletal physiotherapy in primary care: The STEMS pilot cluster randomised trial
Problem
Despite the suggested benefits of patient direct access to NHS physiotherapy, including decreases in GP musculoskeletal workload, reduced imaging rates and high patient satisfaction, progress towards direct access in the NHS in England has been slow. This may be due to the lack of clinical and cost-effectiveness data from controlled trials. The evidence to date is limited to observational and non-randomised studies and direct access needs to be evaluated in a randomised controlled trial (RCT) that considers the full range of patient and resource outcomes. The STEMS pilot trial assessed the feasibility of a future large RCT to test the clinical and cost-effectiveness of the addition of direct access to NHS physiotherapy to usual GP-led care for adults with musculoskeletal problems.
Approach
In a pilot cluster RCT, 4 general practices were randomised to either control (GP-led care as usual) or intervention (GP-led care plus the addition of patient direct access to NHS physiotherapy for adults with musculoskeletal conditions). Data were collected through patient self-completed questionnaires immediately following contact with the general practice or physiotherapy service, at 2, 6 and 12 months and medical record review. Pilot RCT success criteria included the feasibility of establishing a direct access physiotherapy service that can respond to demand, research recruitment and follow-up rates, patient-reported pain and function, quality of life and healthcare resource use. The analysis focused on feasibility of a main trial and analyses of clinical and cost outcomes were exploratory. The RCT is registered with the current controlled trials database ISRCTN23378642.
Findings
Of 2,696 patients invited to take part in the research, 978 (36%) returned a baseline questionnaire and consented to follow-up data collection. Recruitment was completed in 6 months. Follow-up rates were 74% at 2-months, 78% at 6-months and 71% at 12-months. Comparison of baseline characteristics of participants showed no evidence of selection bias. Overall, costs and clinical outcomes between the intervention and control group were similar.The direct access service was successfully marketed to patients in the intervention practices resulting in over 90% of patients who accessed physiotherapy using self-referral. No increase in referrals to the physiotherapy service was noted and physiotherapy waiting times were similar to levels before the trial. There was no evidence of safety concerns due to direct access.
Consequences
A future main RCT is feasible and will provide high quality trial evidence for patients, clinicians and funders of health services. The ageing population and the challenges of meeting demand in primary care means alternatives to GP-led care should be investigated. In particular, a main trial needs to test whether direct access to NHS physiotherapy can reduce burden on GPs, provide patients with improved access and lead to cost-savings in terms of further healthcare use.