Article Text
Abstract
Introduction Around 17% of general practitioner (GP) consultations are for musculoskeletal conditions, which will rise as the population ages. Patient direct access to physiotherapy provides one solution, yet adoption in the National Health Service (NHS) has been slow.
Setting A pilot, pragmatic, non-inferiority, cluster randomised controlled trial (RCT) in general practice and physiotherapy services in the UK.
Objectives Investigate feasibility of a main RCT.
Participants Adult patients registered in participating practices and consulting with a musculoskeletal problem.
Interventions 4 general practices (clusters) randomised to provide GP-led care as usual or the addition of a patient direct access to physiotherapy pathway.
Outcomes Process outcomes and exploratory analyses of clinical and cost outcomes.
Data collection Participant-level data were collected via questionnaires at identification, 2, 6 and 12 months and through medical records.
Blinding The study statistician and research nurses were blinded to practice allocation.
Results Of 2696 patients invited to complete study questionnaires, 978 participated (intervention group n=425, control arm n=553) and were analysed. Participant recruitment was completed in 6 months. Follow-up rates were 78% (6 months) and 71% (12 months). No evidence of selection bias was observed. The direct access pathway was used by 90% of patients in intervention practices needing physiotherapy. Some increase in referrals to physiotherapy occurred from one practice, although waiting times for physiotherapy did not increase (28 days before, 26 days after introduction of direct access). No safety issues were identified. Clinical and cost outcomes were similar in both groups. Exploratory estimates of between group effect (using 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS)) at 6 months was −0.28 (95% CI −1.35 to 0.79) and at 12 months 0.12 (95% CI −1.27 to 1.51).
Conclusions A full RCT is feasible and will provide trial evidence about the clinical and cost-effectiveness of patient direct access to physiotherapy.
Trial registration number ISRCTN23378642.
- Patient direct access
- musculoskeletal
- physiotherapy
- feasibility and pilot trial
- PRIMARY CARE
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Statistics from Altmetric.com
Footnotes
Contributors AB helped plan the trial, contributed to the funding application, chaired the Trial Management Group (TMG) and led the writing of this paper. ROO developed the analysis plan and performed the quantitative analyses. SJ developed the health economic data collection and analysis plan and supervised JK who conducted the health economic analysis. ST was responsible for trial coordination, supporting the TMG, the general practices and physiotherapy service. JP provided general practice expertise and contributed to the training of physiotherapists offering the direct access pathway. EMH provided senior trials leadership, expertise and oversight. CS helped design the trial and provided general practice expertise. NEF led the design of the trial and the funding application, and provided senior trials leadership and oversight. All authors contributed to this paper and approved the final version.
Funding The STEMS pilot trial was funded by the Chartered Society of Physiotherapy Charitable Trust (SRP (11)2). NEF and AB are funded through a National Institute of Health Research (NIHR) Research Professorship awarded to NEF (NIHR-RP-011-015). NEF is an NIHR senior investigator. The North Staffordshire Primary Care Research Consortium provided additional funding for GP and Physiotherapy Research Facilitators to advise on the engagement and recruitment of GP practices and physiotherapists in the STEMS pilot trial.
Disclaimer The views and opinions expressed are those of the authors and do not necessarily reflect those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Ethics approval NRES North West—Preston Preston in February 2013 (REC reference 13/NW/0053).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.