Senior Research Fellow The MRC PhysioDirect trial: A pragmatic RCT of 'PhysioDirect' telephone assessment and advice services versus usual care for musculoskeletal problems Dr Annette Bishop Senior Research Fellow Keele University

The MRC PhysioDirect Trial was a collaboration between University of Bristol and Keele University NHS physiotherapy departments in Bristol, Somerset, Stoke-on-Trent, Central and East Cheshire Recruited July-December 2009

Background Healthcare systems challenge of meeting demand within limited resources Burden of musculoskeletal conditions Telephone based approaches had been introduced to assess and advise patients with a wide range of problems in primary care, although have rarely been rigorously evaluated Telephone based approaches may be particularly appropriate for musculoskeletal conditions

Design Pragmatic individually randomised controlled trial, incorporating economic analysis and a nested qualitative interview Comparing PhysioDirect approach and Usual Care Designed to assess equivalence between the 2 arms in the primary clinical outcome

Setting Conducted in 4 typical community physiotherapy services Included patients from 94 general practices Covering a range of geographical areas and population demographics

Patients Inclusion criteria Exclusion criteria Adults referred to physiotherapy from GP or self referred with musculoskeletal disorders Exclusion criteria Very urgent cases; unable to speak English; consultant referrals; needing domiciliary physiotherapy; unable to contact

Follow-up at 6 weeks and 6 months PhysioDirect trial Usual care: Wait for appointment for face-to-face care PhysioDirect 2256 patients with MSK conditions Patients randomised in 2:1 ratio to PhysioDirect or Usual care, minimised by age-group, gender, presenting complaint, PCT Our sample size calculation was based on 95% power to detect equivalence (2 points on SF36 PCS) And we needed to recruit 2143 patients, allowing for 30% loss to follow-up We recruited 2256 patients Follow-up at 6 weeks and 6 months

PhysioDirect intervention Participants allocated to PhysioDirect invited to telephone senior physiotherapist Assessment of whether patient needs face-to-face treatment, and how urgently Provision of telephone advice and written advice about self- management and exercise Telephone follow-up generally offered Those not improving advised to phone back, given face-to-face consultation or signposted to other services Computerised assessment templates and training provided by physiotherapy team in Huntingdonshire

Clinical Outcomes Primary Secondary SF36 Physical Component Summary Generic measure of physical health status, applicable to wide range of musculoskeletal conditions Secondary MYMOP Quality of life (EQ5D) Waiting times Time lost from work Satisfaction DNA rates Overall rating of improvement Costs

Results

GP referrals to physiotherapy Flow of participants GP referrals to physiotherapy 6870 Eligible 4523 (66%) Randomised 2256 (50%) PhysioDirect 1513 (67%) 6 week response 1341 (89%) 6 month response 1287 (85%) Usual Care 743 (33%) 657 (88%) 634 (85%) 98% referred by GPs

Patient Baseline Characteristics Randomised Patients n=2,249 (100%) Usual Care n=743 (33%) PhysioDirect n=1,506 (67%) Gender Female 58.9 59.5 Age Years 48.2 48.3 Referral problem % Cervical 12 Thoracic 2 Lumbar 27 Upper limb 23 Lower limb 30 Widespread pain 1 Multiple MSK 4 Other MSK Preference % Usual care 33 31 PhysioDirect 35 36 No preference 32 34

Adjusted difference in means Primary outcome SF36 PCS Usual Care n=743 PhysioDirect n=1506 Adjusted difference in means 95% CI p Baseline 37.72 36.81 6 weeks 41.81 41.57 0.42 -0.42, 1.12 0.24 6 months 44.18 43.5 -0.01 -0.80, 0.79 0.99 Value are means *Regression analysis adjusted for PCS at baseline, gender, age, referral problem, PCT Robust to sensitivity analyses taking account of baseline imbalance, missing data, clustering by PCT and practice

Economic analysis Mean cost of physiotherapy Mean total NHS costs £4.28 (-£1.12 to £9.69) greater in PhysioDirect than usual care Phone consultations only slightly shorter (29mins phone versus 34mins face to face) Cost per hour of phone consultation time was higher because of non-contact time and physiotherapists were on higher bandings Mean total NHS costs £7.24 greater in PhysioDirect than usual care

Economic analysis QALYs Higher in the PhysioDirect group by 0.009 Equates to about 3.3 extra days of full health over a year Small extra cost of caring for patients in PhysioDirect arm compensated by the extra QALY gain Incremental cost per QALY gained was £2889

Other outcomes Patient satisfaction: Overall satisfaction very slightly higher for Usual Care (0.19 points on a 6 point scale) Waiting times: 7 days to first assessment for PhysioDirect vs 34 for Usual Care Number of consultations: 2.87 in PhysioDirect vs 3.25 in Usual Care Patients managed by telephone alone = 47% DNA rate (of all face to face appointments booked): PhysioDirect 10% Usual care 11% No adverse events identified

Qualitative research – ‘headlines’ Patients Patients described the PhysioDirect telecare service as quick, efficient, convenient and preferable to the long waits for physiotherapy face-to-face care But Some found it impersonal and difficult to communicate the complexities of pain by telephone Evidence of trade-offs

Physiotherapists Need to adapt the way of working using visualisation and enhanced communication skills Generalised rather than individualised treatment Effective at providing self-management Impact on the physiotherapist - patient relationship Impairs continuity of care Professional identity and skills

General practitioners General ambivalence about PhysioDirect Perception of physiotherapy as a face-to-face service Commissioning perspective Importance of waiting time as a quality indicator Relative priority given to physiotherapy services Assumption that PhysioDirect would be cheaper

Conclusions With respect to patient outcomes at 6 weeks and 6 months, PhysioDirect is equivalent to usual care PhysioDirect Reduces the number of consultations Provides faster access to advice Is safe (there were NO adverse events) Broadly acceptable, but patients are not more satisfied with ‘improved’ access Is slightly more costly than usual care but QALY gain makes it cost-effective

Conclusions Safe and equivalent service Provides patient choice Combined with self-referral the benefits of initial telephone assessment and advice may be greater

Acknowledgements This research was funded by the MRC and managed by the NIHR on behalf of the MRC-NIHR partnership. The views expressed in this presentation are those of the authors and not necessarily those of the MRC, NHS, NIHR or the Department of Health. Supported by the Arthritis Research UK Primary Care Centre now

Publications Protocol Salisbury C, Foster NE, Bishop A et al. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial. BMC Health Serv Res 2009;9:136 Main results Salisbury C, Montgomery AA, Hollinghurst S, Hopper C, Bishop A, Franchini A, Kaur S, Coast J, Hall J, Grove S, Foster NE. Effectiveness of PhysioDirect telephone assessment and advice services for patients with musculoskeletal problems: pragmatic randomised controlled trial. BMJ 2013 Jan 29:346:f43. doi: 10.1136/bmj.f43 HTA report C Salisbury, NE Foster, C Hopper, A Bishop, S Hollinghurst et al. Pragmatic cluster randomised trial of PhysioDirect telephone assessment and advice services for physiotherapy. Health Technol Assess 2013;17(2) Training and support for physiotherapists Bishop A, Gamlin J, Hall J, Hopper C, Foster NE. PhysioDirect: Supporting physiotherapists to deliver telephone assessment and advice services within the context of a randomised trial. Physiotherapy 2013 99 (2013) 113–118 Health economics Hollinghurst S, Coast J, Busby J, et al. A pragmatic randomised controlled trial of ‘PhysioDirect’ telephone assessment and advice services for patients with musculoskeletal problems: economic evaluation. BMJ Open 2013;3:e003406. doi:10.1136/bmjopen-2013-003406