A pragmatic randomised controlled trial of PhysioDirect telephone assessment and advice services for physiotherapy

ISRCTN	ISRCTN55666618
DOI	https://doi.org/10.1186/ISRCTN55666618
Secondary identifying numbers	G0701575

Submission date: 30/09/2008
Registration date: 26/11/2008
Last edited: 14/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Chris Salisbury
Scientific

Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Email	c.salisbury@bristol.ac.uk

Study information

Study design	Multi-centre pragmatic individually randomised controlled trial. Nested qualitative research.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	The MRC PhysioDirect trial
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).
Ethics approval(s)	Added 17/02/2009: Southmead Research Ethics Committee (REC) gave approval on the 19th December 2008
Condition	Musculoskeletal diseases
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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.
Overall study start date	15/09/2008
Overall study end date	14/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2143 patients in total (1429 and 714 patients in the PhysioDirect and usual care arms respectively)
Participant 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
Participant 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
Recruitment start date	15/09/2008
Recruitment end date	14/09/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Unit of Primary Health Care

Bristol
BS8 2PS
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

c/o Dr Birgit Whitman
Research Governance Manager
Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom

Website	http://www.bristol.ac.uk/
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0701575)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	03/08/2009	Yes	No
Results article	results	29/01/2013	Yes	No
Other publications	economic evaluation	03/10/2013	Yes	No
Results article	results	30/01/2014	Yes	No