Condition category
Musculoskeletal Diseases
Date applied
08/06/2012
Date assigned
31/07/2012
Last edited
04/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Outcomes research is the assessment of what does and does not work in the delivery of healthcare and researchers into medical educational have called for the education of healthcare workers to be measured by whether or not it actually results in better outcomes for patients. This will allow researchers to work out how the education of healthcare workers contributes to the health of individuals and the public. However, so far the call for this research appears to have been largely ignored as there are very few trials examining the link between professional education and patient outcome. Within physiotherapy, studies have looked into mentoring physiotherapists in the clinic environment. This clinical mentoring has been shown to improve physiotherapist performance, but so far no studies have measured whether these improvements in performance mean that the physiotherapists achieve better results with their patients. The aim of this study is to assess how well a mentoring programme for physiotherapists works in achieving better outcomes for patients.

Who can participate?
All qualified physiotherapists working the majority of their working week in the musculoskeletal (MSK) outpatient physiotherapy service of the Cardiff and Vale University Health Board (C&V UHB) will be invited to take part. Members of staff who have already been through this type of mentoring (as part of an external course) and rotational staff who will not be working in the department for long enough for the project will not be able to participate. The patients attending the outpatient MSK physiotherapy service at the C&V UHB for treatment by the participating physiotherapists during times when patient outcomes are collected will be invited to take part. Patients will need to be over 18 years of age, and able to read/write English due to the questionnaires we are using being designed for the English language and for adults.

What does the study involve?
The intervention is a 150-hour clinical mentorship programme. This will be delivered to participating physiotherapists by mentors who are experienced in delivering this kind of mentorship for University courses. The mentoring will take place in the usual clinic of the physiotherapists, and will consist of the mentors watching the physiotherapists assessing and treating patients, and discussing the thoughts and actions of the physiotherapist immediately after the patients leave. During the control stages of the study, participating physiotherapists will receive their usual training, which involves monthly sessions on current physiotherapy research, weekly practical sessions on the skills of physiotherapy, as well as monthly mentoring sessions (1.5 hours per month). This study is using a “stepped wedge design”, which means that all participating physiotherapists will receive the intervention at different times during the study.

What are the possible benefits and risks of participating?
Participating physiotherapists will receive a recognised mentoring programme by a qualified clinical mentor. The potential gains are improved clinical skills and better patient outcomes. There are no risks associated with this study. However, should the mentor observe any practice that is unsafe, they would have a duty to report it.There are no risks associated with this study for patients, who will receive normal physiotherapy treatment.

Where is the study run from?
This study will be run from the six sites of the outpatient MSK physiotherapy service for the C&V UHB: The Barry Hospital, Cardiff Royal Infirmary, University Hospital Llandough, St. David’s Hospital, University Hospital of Wales and Whitchurch Hospital. The lead researcher is based at the University Hospital of Wales.

When is the study starting and how long is it expected to run for?
The study is anticipated to start in July 2012 and is expected to run for 3 years. The trial will recruit physiotherapist participants for about 2 months, and patients will be recruited at four time points over the next 2 years.

Who is funding the study?
Cardiff and Vale University Health Board (UK)

Who is the main contact?
Aled Williams
Physiotherapy.FTR@wales.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Aled Williams

ORCID ID

Contact details

Physiotherapy
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11-CLC-5171

Study information

Scientific title

The effect of work-based facilitation in clinical reasoning on outcome in musculo-skeletal physiotherapy

Acronym

Study hypothesis

There will be a significant difference in the risk-adjusted outcomes of patients whose physiotherapists have received training in clinical reasoning skills via a clinical mentoring programme when compared with those whose physiotherapists have received standard training.

Ethics approval

South East Wales Research Ethics Committee C, 20/04/2012, ref: 12/WA/0078

Study design

Single-centre stepped-wedge cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Musculoskeletal physiotherapy

Intervention

The intervention is a 150-hour clinical mentorship programme, aimed at facilitating clinical reasoning. This will be delivered to participating physiotherapists by mentors who have qualified at Masters level from a higher education establishment, and who have experience in delivering this form of mentorship at post-graduate level. The intervention will be delivered at the start of each time period of the stepped wedge design, to allow for consolidation and application of the programme, before data collection occurs at the end of the time period. This intervention is selected on the basis that the use of mentorship in the context of clinical placement is established practice in Master’s programmes seeking to develop expert practice and has strong support from qualitative literature.

Control
During the control steps of the study, participants will receive their usual training allocation. Usual training for staff in the health board involves monthly in-service training on current evidence applied to physiotherapy practice (4 hours per month), weekly technique sessions on the technical and practical skills of physiotherapy practice (30 minutes per week), as well as monthly mentoring sessions (1½ hours per month). This choice of control is consistent with other studies into educational interventions using crossover methodologies where current or traditional practice is used to compare with new or proposed interventions on the basis that the comparison group needs to be plausible and fair.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Function, measured by The Patient Specific Functional Scale (PSFS) at first assessment, discharge and at 12 months. The PSFS is a numerical rating scale from 0 (unable to perform activity) to 10 (able to perform activity at the same level as before injury or problem).

Secondary outcome measures

1. Health-related quality of life, measured by the EQ-5D-5L
2. Patient satisfaction, measured by the MedRisk instrument
3. Patient activation, measured by the Patient Activation measure

Overall trial start date

01/07/2012

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Physiotherapists - all qualified physiotherapy staff from the Cardiff and Vale University Health Board whose majority of time (i.e. greater than 50% of a whole time equivalent) is practised inside the musculoskeletal outpatient context.
2. Patients - consecutive consenting patients attending the outpatient musculoskeletal physiotherapy service at the Cardiff and Vale University Health Board for treatment by the participating physiotherapists during data collection periods towards the end of each step .

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

12 physiotherapists, 720 patients

Participant exclusion criteria

1. Physiotherapists - members of staff who have already undertaken postgraduate placements as part of Master’s education and so would have received similar mentoring, and rotational staff due to the fact that they will not be present in the department for long enough for both interventions and long-term follow-up.
2. Patients under 18 years of age
3. Patients who are not English-literate due to the validity of the Outcome Measures being established only for the English language and for adults.

Recruitment start date

01/07/2012

Recruitment end date

01/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of Wales
Cardiff
CF14 4XW
United Kingdom

Sponsor information

Organisation

Cardiff and Vale University Health Board (UK)

Sponsor details

Lee Hathaway
R&D Facilitator
R&D Office
2nd Floor TB2
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Cardiff and Vale University Health Board (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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25344736

Publication citations

  1. Protocol

    Williams AL, Phillips CJ, Watkins A, Rushton AB, The effect of work-based mentoring on patient outcome in musculoskeletal physiotherapy: study protocol for a randomised controlled trial., Trials, 2014, 15, 1, 409, doi: 10.1186/1745-6215-15-409.

Additional files

Editorial Notes