ISRCTN - ISRCTN82203145: Training health professionals: a comparison of two methods

Plain English Summary

Background and Aims
A great deal of money is invested in researching new treatments for medical conditions. Not all of these new treatments can be easily used by health care professionals without additional training. This study is concerned with training health professionals to deliver an evidence based treatment for patients with sub-acute or chronic low back pain, called BeST1. The BeST treatment consists of an individual patient assessment and six group treatment sessions (one per week) that use a cognitive behavioural approach to the management of low back pain. Providing a face to face course would be the traditional method of training health professionals to deliver BeST. This method of training has several limitations when looking to deliver it on a wide scale, particularly in relation to the cost of both producing and attending the training, along with limited course spaces and varying geographical locations. Using the internet to deliver such training could enable greater numbers of people to be trained at a much lower cost. This pilot study aims to find out if training health professionals through the internet can be as good as training them through a face-to-face workshop.

Who can participate?
Any health care professional treating low back pain patients who can run the six treatment sessions within their department.

What does the study involve?
Health care professionals will be allocated to receive either a face to face training workshop or an internet based training programme (i-BeST). Those in the face to face training group will need to attend a 1.5 day face-to-face training course delivered by a physiotherapist specialising in cognitive behavioural therapy. Health professionals in this group will also
have access to a website where they can download guides and materials. Those in the other group will be provided with log-in details to access the online course. The online course consists of the same content as that of the face to face course, in a different format. Following the completion of training, health professionals in both groups will complete a
short knowledge test, rate their satisfaction with the training and their confidence to deliver the treatment (BeST). Within three months of the completed training, one treatment session will be audio recorded for each health professional and the competency of the health professional will be measured from this recording.

What are the potential benefits and risks of participating?
Health professionals taking part will receive free training in an evidence based intervention which they can then use in their routine clinical practice. Therefore, participating in this research will increase the skill set of these health care professionals.
There are no risks with either on-line or face-to face training. Therefore, taking part in this study should not pose any risks to the health care professionals.

Where is the study run from?
The lead centre for this study is the University Hospitals Coventry & Warwickshire NHS Trust. Approximately 20 centres will be participating in this study.

When is the study starting and how long is it expected to run for?
January 2013 to June 2013

Who is funding the study?
West Midlands Strategic Health Authority (UK)

Who is the main contact?
Helen Richmond
helen.richmond@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Helen Richmond

ORCID ID

Contact details

The University of Warwick
Warwick Clinical Trials Unit
Division of Health Sciences
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
+44 24 7657 4880
Helen.Richmond@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Training health care professionals to deliver a cognitive behavioural intervention for low back pain: a pilot randomised controlled trial

Acronym

Study hypothesis

A high quality randomised controlled trial (RCT) is needed to ascertain if an Internet based training course (i-BeST) can demonstrate equivalency to a face to face training course for teaching health care professionals to deliver the BeST intervention. The ultimate aim of this pilot study is to establish the feasibility of progressing to such an RCT which would demonstrate definitively whether or not internet based training is a clinically equivalent and cost effective method for training health care professionals. Running such a trial presents several challenges, of which this pilot study will provide valuable information. Randomisation and enrolment procedures can be tested, along with determining the acceptability of training participants with this method. Assumptions underlying the sample size calculation and estimates of recruitment rates can also be examined with this pilot study.

Ethics approval

Biomedical Research Ethics Committee, 05/09/012

Study design

Multi centre parallel group pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Training health professionals to deliver a previously evaluated intervention for the treatment of low back pain

Intervention

Control
A 1.5 day face-to-face training course delivered by a physiotherapist specialising in CBT, who developed the BeST intervention. Participants will also have access to a website where they can download additional forms, such as patient packs or the therapist manual. Therefore this intervention arm will mirror the training that participants received during the BeST trial itself. The online course will consist of the same content as this course, delivered though a different medium.

Intervention:
An on-line training programme with identical content to that given in the control arm, adapted to be delivered over the internet. Participants have three weeks to complete the on-line course, which is expected to take between 8-10 hours to complete.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Therapist competence in delivering the BeST intervention to patients is measured using the Cognitive Therapy Scale Revised Pain tool (CTS-R-Pain).

Secondary outcome measures

1. Participant preference for the intervention or control arm will be recorded prior to randomisation
2. A MCQ, developed from the BeST training material, will be used to assess health care professionals knowledge post intervention.
3. Therapists self-efficacy will be measured using a specific self-efficacy scale. Self-efficacy is a belief in ones ability to achieve a result or perform a specific task and correlates well with motivation and behaviour (Lorig et al, 1996).
4. Satisfaction and acceptance of the intervention will also be assessed using a self-developed MCQ.

User log-ins, duration of log-ins and materials accessed will also be monitored and recorded for participants in the i-BeST group.

Overall trial start date

06/01/2013

Overall trial end date

06/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Health care professional in employment
2. Access to/work with sub-acute/chronic LBP population
3. Have the resources (time and space) to run the BeST groups
4. To be able to make the necessary care pathway changes in order implement the individual assessments and 6 group sessions
5. Access to a computer either at home or at work for completion of the i-BeST program
6. Must be willing to attend workshop for training on a pre-specified date
7. Be willing to receive either form of training

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

06/01/2013

Recruitment end date

06/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

The University of Warwick (UK)

Sponsor details

c/o Peter Hedges
Research Support Services
University House
Coventry
CV4 7AL
United Kingdom