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| [ Print-friendly version ] |
| Training health professionals – a comparison of two methods |
| ISRCTN | ISRCTN82203145 |
| DOI | 10.1186/ISRCTN82203145 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Training health professionals – a comparison of two methods |
| Scientific title | Training health care professionals to deliver a cognitive behavioural intervention for low back pain: a pilot randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| 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. |
| Lay 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? The study will start in January 2013 and will run for six months or until the required number of 40 health care professionals have been recruited and trained. Who is funding the study? This study will be conducted as part of a fellowship funded by the West Midlands Strategic Health Authority. Who is the main contact? Helen Richmond helen.richmond@warwick.ac.uk |
| Ethics approval | Biomedical Research Ethics Committee, 05 September 2012 |
| Study design | Multi centre parallel group pilot randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Training health professionals to deliver a previously evaluated intervention for the treatment of low back pain |
| Participants - 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 |
| Participants - exclusion criteria | Does not meet inclusion criteria |
| Anticipated start date | 06/01/2013 |
| Anticipated end date | 06/06/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 |
| Interventions |
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. |
| Primary outcome measure(s) | The primary outcome measure for the pilot RCT will be therapist competence in delivering the BeST intervention to patients. This will be measured using the Cognitive Therapy Scale – Revised – Pain tool (CTS-R-Pain). The scale has been modified though a Delphi consensus from the CTS-R (a commonly used CBT competency scale) in order to assess competency in delivering therapy with a CB approach. It was used in the BeST trial itself to assess the competency of the therapists and has been shown to have good inter and intra-rater reliability (intra-class correlation coefficient for intra-rater reliability = 0.92 (0.79; 0.97) and inter-rater reliability amongst 4 raters = 0.82 (0.30; 0.99)). The scale has also been found to have high internal consistency (Cronbachs α = 0.99 ). |
| Secondary outcome measure(s) |
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 one’s 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. |
| Sources of funding | West Midlands Strategic Health Authority (UK) |
| Trial website | |
| Publications | |
| Contact name | Miss Helen Richmond |
| Address |
The University of Warwick
Warwick Clinical Trials Unit Division of Health Sciences Warwick Medical School |
| City/town | Coventry |
| Zip/Postcode | CV4 7AL |
| Country | United Kingdom |
| helen.richmond@warwick.ac.uk | |
| Sponsor | The University of Warwick (UK) |
| Address |
c/o Peter Hedges
Research Support Services University House |
| City/town | Coventry |
| Zip/Postcode | CV4 7AL |
| Country | United Kingdom |
| Sponsor website: | http://www2.warwick.ac.uk/ |
| Date applied | 03/09/2012 |
| Last edited | 04/12/2012 |
| Date ISRCTN assigned | 04/12/2012 |
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