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A pragmatic randomised controlled trial of PhysioDirect telephone assessment and advice services for physiotherapy
ISRCTN ISRCTN55666618
DOI 10.1186/ISRCTN55666618
ClinicalTrials.gov identifier
EudraCT number
Public title A pragmatic randomised controlled trial of PhysioDirect telephone assessment and advice services for physiotherapy
Scientific title
Acronym The MRC PhysioDirect trial
Serial number at source G0701575
Study hypothesis To determine:
1. Whether PhysioDirect is at least as effective as usual models of physiotherapy based on patients going onto a waiting list and eventually receiving face-to-face care
2. The cost-effectiveness of PhysioDirect compared with usual care
3. Whether patients prefer PhysioDirect services rather than usual care; whether they find PhysioDirect more convenient and whether it addresses their perceived needs
4. The health outcomes and experiences of different groups of patients (those in different age groups and with different types of problems) when referred to PhysioDirect rather than usual care

Please note that as of 19/01/2010 the target number of participants in this record has been updated; the initial target number of participants was: 1875 patients in total (1250 and 625 patients in the PhysioDirect and usual care arms respectively).
Lay summary Not provided at time of registration
Ethics approval Added 17/02/2009: Southmead Research Ethics Committee (REC) gave approval on the 19th December 2008
Study design Multi-centre pragmatic individually randomised controlled trial. Nested qualitative research.
Countries of recruitment United Kingdom
Disease/condition/study domain Musculoskeletal diseases
Participants - inclusion criteria Current inclusion criteria as of 07/05/2009:
1. Adults (aged 18 years and over), either sex
2. Adults requiring musculoskeletal physiotherapy who are referred by General Practitioners (GPs), other members of the primary health care team, or who are self-referred

Previous inclusion criteria:
1. Adults (aged 18 years and over), either sex
2. Referred by General Practitioners (GPs) for physiotherapy
Participants - exclusion criteria Current exclusion criteria as of 07/05/2009:
1. Children (less than 18 years)
2. Patients referred to physiotherapy by a hospital consultant, emergency department or primary/secondary care interface service
3. Those needing domiciliary physiotherapy
4. Those needing post-operative physiotherapy
5. Those unable to communicate by telephone in English
6. Those needing physiotherapy for non-musculoskeletal problems

Previous exclusion criteria:
1. Children (less than 18 years)
2. Patients referred to physiotherapy by a hospital consultant
3. Those needing domiciliary physiotherapy
4. Those needing post-operative physiotherapy
5. Those unable to communicate by telephone in English
Anticipated start date 15/09/2008
Anticipated end date 14/09/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2143 patients in total (1429 and 714 patients in the PhysioDirect and usual care arms respectively)
Interventions Control:
Usual care involves patients being referred by a GP to a physiotherapist. Patients then wait for an initial face-to-face physiotherapy assessment and then usually have follow-up appointments for several weeks or months.

Intervention:
'PhysioDirect'. As soon as a referral for physiotherapy is received from the GP, the patient is invited to telephone a senior physiotherapist for initial assessment and advice. The physiotherapist will follow a computerised algorithm (as developed in Huntingdonshire) to assess the patient and record findings. In most cases, at the end of the consultation the physiotherapist will print a personalised tailored advice leaflet about exercises (based on 'Physiotools' software) and post it to the patient, inviting them to phone back to report progress after 2 to 4 weeks. At that point they can be given further advice or be booked for a face-to-face consultation if necessary. Alternatively, the initial phone call may establish that more urgent face-to-face care is needed, in which case this will be booked at the outset, or the assessment may establish that physiotherapy is unlikely to be effective and the patient can be given appropriate advice and discharged.

Treatment period:
This will vary for individual patients. In Bristol, the mean number of consultations per patient with traditional physiotherapy is 2.9, over several weeks.
Primary outcome measure(s) Current primary outcome measures as of 07/05/2009:
1. Clinical outcome at 6 months, measured using the physical component summary (PCS) measure from the 36-item short form health survey version 2 (SF-36v2)
2. Incremental cost-effectiveness will be measured in terms of Quality Adjusted Life Years (QALYs), assessed using the EQ5D measure and costs

Outcomes will be assessed at baseline, and 6 weeks and 6 months after randomisation.

Previous primary outcome measures amended in record as of 17/02/2009 (protocol amendment on the 21/11/2008):
1. Clinical outcome at 6 months, measured using the physical component summary (PCS) measure from the 36-item short form health survey version 2 (SF-36v2)
2. Incremental cost-effectiveness will be measured in terms of Quality Adjusted Life Years (QALYs), assessed using the SF-6D measure and costs

Outcomes will be assessed at baseline, and 6 weeks and 6 months after randomisation.

Initial information at the time of registration:
1. Clinical improvement at 6 months, measured using the physical component summary (PCS) measure from the 36-item short form health survey version 2 (SF-36v2) and the Measure Yourself Medical Outcome Profile (MYMOP questionnaire)
2. Incremental cost-effectiveness will be measured in terms of Quality Adjusted Life Years (QALYs), assessed using the SF-6D measure and costs

Outcomes will be assessed at baseline, and 6 weeks and 6 months after randomisation.
Secondary outcome measure(s) Current secondary outcome measures as of 07/05/2009:
1. Costs
2. Quality of life (EQ5D)
3. The individual scales and the mental component summary measure from SF-36
4. Individual overall perception of improvement (seven point Likert scale from 'very much worse' to 'very much better')
5. Waiting times for treatment
6. Time lost from work and usual activities
7. Patient satisfaction with the care provided
8. Preference for telephone or face-to-face assessment
9. Clinical outcome using the Measure Yourself Medical Outcome Profile (MYMOP questionnaire)

Outcomes will be assessed at baseline, and 6 weeks and 6 months after randomisation.

Amended in record as of 17/02/2009 (protocol amendment on the 21/11/2008):
The following secondary outcome was added to this list:
10. Clinical outcome using the Measure Yourself Medical Outcome Profile (MYMOP questionnaire)

Initial information at the time of registration:
1. Costs
2. Quality of life (EQ5D)
3. The individual scales and the mental component summary measure from SF-36
4. Individual overall perception of improvement (seven point Likert scale from 'very much worse' to 'very much better')
5. Waiting times for treatment
6. Time lost from work and usual activities
7. Patients' perceptions of the accessibility of care
8. Satisfaction with care provided (based on CSQ8)
9. Preference for telephone or face-to-face assessment

Outcomes will be assessed at baseline, and 6 weeks and 6 months after randomisation.
Sources of funding Medical Research Council (MRC) (UK) (ref: G0701575)
Trial website
Publications 1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19650913
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23360891
3. 2013 economic evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/24091423
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24479729
Contact name Prof  Chris  Salisbury
  Address Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
  City/town Bristol
  Zip/Postcode BS8 2PS
  Country United Kingdom
  Email c.salisbury@bristol.ac.uk
Sponsor University of Bristol (UK)
  Address c/o Dr Birgit Whitman
Research Governance Manager
Research and Enterprise Development
Senate House
Tyndall Avenue
  City/town Bristol
  Zip/Postcode BS8 1TH
  Country United Kingdom
  Sponsor website: http://www.bristol.ac.uk/
Date applied 30/09/2008
Last edited 14/02/2014
Date ISRCTN assigned 26/11/2008
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