Condition category
Musculoskeletal Diseases
Date applied
30/09/2008
Date assigned
26/11/2008
Last edited
14/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Salisbury

ORCID ID

Contact details

Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
c.salisbury@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0701575

Study information

Scientific title

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

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/09/2008

Overall trial end date

14/09/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

2143 patients in total (1429 and 714 patients in the PhysioDirect and usual care arms respectively)

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

United Kingdom

Trial participating centre

Academic Unit of Primary Health Care
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.bristol.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0701575)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Protocol

    Salisbury C, Foster NE, Bishop A, Calnan M, Coast J, Hall J, Hay E, Hollinghurst S, Hopper C, Grove S, Kaur S, Montgomery A, 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial., BMC Health Serv Res, 2009, 9, 136, doi: 10.1186/1472-6963-9-136.

  2. 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, 346, f43.

  3. Economic evaluation

    Hollinghurst S, Coast J, Busby J, Bishop A, Foster NE, Franchini A, Grove S, Hall J, Hopper C, Kaur S, Montgomery AA, Salisbury C, A pragmatic randomised controlled trial of 'PhysioDirect' telephone assessment and advice services for patients with musculoskeletal problems: economic evaluation., BMJ Open, 2013, 3, 10, e003406, doi: 10.1136/bmjopen-2013-003406.

  4. Results

    Rathod T, Belcher J, Montgomery AA, Salisbury C, Foster NE, Health services changes: is a run-in period necessary before evaluation in randomised clinical trials?, Trials, 2014, 15, 41, doi: 10.1186/1745-6215-15-41.

Additional files

Editorial Notes