Condition category
Musculoskeletal Diseases
Date applied
02/11/2006
Date assigned
14/11/2006
Last edited
09/11/2011
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
University of Bristol
25-27 Belgrave Road
Bristol
BS8 2AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Compared with usual physiotherapy care, a 'Physio Direct' service offering initial assessment and advice via telephone provides equivalent patient outcomes but with lower costs and shorter waiting times for patients.

Please note, this pilot study is complete and details of the main trial can be found at www.controlled-trials.com/ISRCTN55666618.

Ethics approval

Ethical approval obtained from Southmead Research Ethics Committee (REC no: 06/Q2002/47) on the 2nd August 2006.

Study design

Pilot and feasibility study for a cluster randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal conditions requiring physiotherapy in Primary Health Care

Intervention

The unit of randomisation is the General Practice. The unit of analysis is the patient. The pilot study will involve developing the intervention, assessing rates of recruitment and retention, testing outcome measures and piloting research procedures.

Intervention Arm: 'Physio Direct'
Patients referred for musculoskeletal physiotherapy and allocated to 'Physio Direct' will be invited to telephone the physiotherapy services for an initial assessment and advice at their convenience. A senior physiotherapist will assess the patient over the telephone and give appropriate education and advice. They may decide that a face-to-face consultation is necessary, on an urgent or routine basis. If the patient requires an urgent appointment they will organise this over the phone and routine appointments will be added to the 'Physio Direct' waiting list. A tailored advice leaflet sent the same day in the post will supplement this telephone assessment. Patients will be invited to phone back a few weeks later after they have undertaken the exercises or advice recommended, if they do not improve. When they phone back they will have another assessment and if a face-to-face consultation is required, their name will be added to the 'Physio Direct' waiting list. If at any time the patient feels they would prefer to see a physiotherapist face-to-face instead of receiving telephone advice, they will be seen in due course on the 'Physio Direct' waiting list.

Control Arm: 'Usual Care'
Patients in the control arm will receive usual care that mirrors the current process for accessing physiotherapy in primary health care in Bristol. When patients are referred by their GP their name will be placed on a 'usual care' waiting list. When they reach the top of the list they will be invited to telephone a physiotherapy department to book an appointment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Designating primary and secondary outcomes is provisional since one aspect of this pilot study is to identify the best measures. Provisionally, the primary outcome is Measure Yourself Medical Outcome Profile (MYMOP2).

Secondary outcome measures

1. Patient health status (using Short Form health survey [SF-36] and EuroQoL instrument [EQ-5D]).
2. Patient perception of accessibility of care.
3. Patient perception of improvement in symptoms.
4. Patient satisfaction with care provided.
5. Time lost from work due to the health problems for which physiotherapy is indicated.
6. Patient preference for telephone or face-to-face assessment.
7. Waiting times for treatment, based on service data.
8. Did Not Attend (DNA) rates.

Overall trial start date

23/10/2006

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adults consulting a General Practitioner (GP) in one of the general practices in the study and referred for musculoskeletal physiotherapy

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

124 (provisionally aiming to include 62 patients in each arm)

Participant exclusion criteria

1. Children (aged under 18 years)
2. Patients referred to physiotherapy by a hospital consultant
3. Patients requiring domiciliary physiotherapy (indicated by their GP)
4. Patients excluded by the referring GP or the senior physiotherapist, based on the referral form. This includes patients who appear unlikely to be able to complete a questionnaire in English. This is likely to include people with severe learning difficulties, dementia, or where the referral form indicated the patient would need an interpreter. Reasons for exclusion will be recorded
5. Patients excluded by a senior physiotherapist because their problem is too urgent to allow time for recruitment

Recruitment start date

23/10/2006

Recruitment end date

01/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

Avon Primary Care Research Collaborative (APCRC) Project Grant (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

No publication intended as of 09/11/2011

Publication citations

Additional files

Editorial Notes