- Chris Salisbury, professor of primary healthcare1,
- Alan A Montgomery, reader in health services research2,
- Sandra Hollinghurst, senior lecturer in health economics1,
- Cherida Hopper, trial manager1,
- Annette Bishop, research fellow3,
- Angelo Franchini, research methods training fellow2,
- Surinder Kaur, research associate1,
- Joanna Coast, professor of health economics4,
- Jeanette Hall, operational lead for outpatient physiotherapy5,
- Sean Grove, clinical lead physiotherapy5,
- Nadine E Foster, professor of musculoskeletal health in primary care 3
- 1Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK
- 2Bristol Randomised Controlled Trials Collaboration, University of Bristol, UK
- 3Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Keele, UK
- 4Health Economics Unit, School of Health and Population Sciences, University of Birmingham, Birmingham, UK
- 5Musculoskeletal Outpatient Department, Bristol Community Health, Bristol, UK
- Correspondence to: C Salisbury
- Accepted 19 December 2012
Objectives To assess the clinical effectiveness, effect on waiting times, and patient acceptability of PhysioDirect services in patients with musculoskeletal problems, compared with usual care.
Design Pragmatic randomised controlled trial to assess equivalence in clinical effectiveness. Patients were individually randomised in a 2:1 ratio to PhysioDirect or usual care.
Setting Four physiotherapy services in England.
Participants Adults (aged ≥18 years) referred by general practitioners or self referred for musculoskeletal physiotherapy.
Interventions PhysioDirect services invited patients to telephone a physiotherapist for initial assessment and advice, followed by face-to-face physiotherapy if necessary. Usual care involved patients joining a waiting list for face-to-face treatment.
Main outcome measures Numbers of appointments, waiting time for treatment, and non-attendance rates. Primary outcome was physical health (SF-36v2 physical component score) at six months. Secondary outcomes included four other measures of health outcome, mental component score and scales from the SF-36v2, time lost from work, and patient satisfaction and preference. Participants were not blind to allocation, but outcome data were collected blind to allocation.
Results Of 1506 patients allocated to PhysioDirect and 743 to usual care, 85% provided primary outcome data at six months (1283 and 629 patients, respectively). PhysioDirect patients had fewer face-to-face appointments than usual care patients (mean 1.91 v 3.11; incidence rate ratio 0.59 (95% confidence interval 0.53 to 0.65)), a shorter waiting time (median 7 days v 34 days; arm time ratio 0.32 (0.29 to 0.35)), and lower rates of non-attendance (incidence rate ratio 0.55 (0.41 to 0.73)). After six months’ follow-up, the SF-36v2 physical component score was equivalent between groups (adjusted difference in means −0.01 (−0.80 to 0.79)). Health outcome measures suggested a trend towards slightly greater improvement in the PhysioDirect arm at six week follow-up and no difference at six months. There was no difference in time lost from work. PhysioDirect patients were no more satisfied with access to physiotherapy than usual care patients, but had slightly lower satisfaction overall at six months (difference in satisfaction −3.8% (−7.3% to −0.3%); P=0.031). PhysioDirect patients were more likely than usual care patients to prefer PhysioDirect in future. No adverse events were detected.
Conclusions PhysioDirect is equally clinically effective compared with usual care, provides faster access to physiotherapy, and seems to be safe. However, it could be associated with slightly lower patient satisfaction.
Trial registration Current Controlled Trials ISRCTN55666618.
We thank the patients who contributed to this research; the physiotherapists, administrative staff, managers, and commissioners who supported the set up and delivery of the trial in the four primary care trusts; participating general practices; the research support staff in Bristol and Keele; members of the trial steering committee and data monitoring committee; and Jill Gamlin and Nick Deane who developed the PhysioDirect software used in this trial.
Contributors: CS was the chief investigator, and did the drafting and final editing of paper. AAM advised about the trial design and supervised the statistical analysis. SH contributed to the study design, outcome assessment, and analysis. CH was the trial manager. AB participated in recruitment, data collection, and coordination in sites near Keele. JC was involved in the study design and analysis. SK was involved in recruitment, data collection, and coordination in sites near Bristol. AF undertook statistical analysis. JH and SG were involved in the design and implementation of PhysioDirect services and the trial. NEF contributed to the trial design and was the principal investigator for the Stoke-on-Trent and Cheshire sites. All authors contributed to the final version of the paper. CS is the guarantor.
Funding: The research was funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership. The funder had no role in the study design; the collection, analysis, or interpretation of data; the writing of the report; or the decision to submit the paper for publication. The researchers are all independent of the funders. All researchers had access to all the data.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: all authors had financial support from the MRC for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Multisite research ethics approval was obtained from Southmead research ethics committee, reference 08/H0102/95. All participants gave informed written consent.
Data sharing: Participants did not give informed consent for data sharing but the data are anonymised and the risk of identification is low. Data from the trial may be available from the corresponding author atsubject to agreement about the use of the data.
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