| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN91640245 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0054184076 |
| Public title | A randomised controlled trial to evaluate a novel CD-ROM learning package against the standard lecture - training system for research governance in the teaching of new researchers in an NHS Trust |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Not Applicable: Education |
| Study hypothesis | Is the use of a CD-ROM teaching package more cost effective than traditional lecture methods of teaching Research Governance to new researchers? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Participants will be identified by obtaining lists of staff on Banding 6 & 7 with research as part of their job description. These staff will then be approached by letter also enclosing a study information sheet. Participants will be recruited and consented on attendance at the lecture theatre for the teaching session.
Subject inclusion criteria:
1. Age > 18 years
2. Able to give informed consent
3. Research active
4. Employee of the Cardiothoracic Centre - Liverpool NHS Trust
The sample size has been calculated to detect a £2.50 difference in cost using a 2 sample t test .at 90% power with a mean population wage of £ 20.46 and a standard deviation of 1.8. This will be calculated by taking the direct costs of subject wages per hour spent learning and the unit cost of the teaching method. This provides a sample size of 24 (12 in each arm of the study). To allow for drop outs and to obtain 24 evaluable questionnaires a total of 30 subjects will be enrolled. |
| Participants - exclusion criteria | 1. Unable to take ½ day for teaching and follow-up
2. No access to computer
3. Involved in another study within the last 30 days |
| Patient information material |
|
| Anticipated start date | 01/04/2006 |
| Anticipated end date | 01/06/2006 |
| Status of trial | Completed |
| Target number of participants | 30 |
| Interventions | The purpose of this study is to determine whether a CD-ROM can provide education in research governance to new researchers as effectively but more cheaply and conveniently than routine lecture teaching. A CD-ROM teaching package has been produced that is identical to a Power point teaching presentation. Staff at the Cardiothoracic Centre - Liverpool NHS Trust who have research as part of their job description will be invited to attend a half day study day in the lecture theatre of the hospital and provided with an information sheet to decide if they wish to take part in the study or not.
On arrival in the lecture theatre subjects will be asked to consent to the study. Those who do will be randomised by pre numbered envelopes prepared by the clinical governance department.
1. Those subjects randomised to lecture will remain in the lecture theatre and receive 2 hours of the power point presentation with hand outs and web site addresses so that they have identical information to the CD-ROM group.
2. Those randomised to CD-ROM will be provided with a disc containing the PowerPoint presentation, web links and copies of important documents. They will be able to use this at home or with assistance from the librarian in the library.
All participants will be requested not to discuss source documents with other members of the research group. They will also be requested to return in 2 weeks time for a knowledge multichoice questionnaire and a satisfaction survey. |
| Primary outcome measure(s) | 1. Cost effectiveness will be measured by cost per hour per attendee taking into account only direct costs, with the assumption that the CD-ROM will be used for the same length of time as the lecture. Subjects who do not attend the exam will be considered exam failures and their data will be included in the cost effectiveness. Subjects who attend the exam but obtain less than the 50% pass mark will also be considered exam failures.
2. Satisfaction with the teaching method will be analysed via Lickert scale questions from Price J 2005 and written responses to open ended questions. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Cardiothoracic Centre Liverpool NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mrs H Rogers |
| Contact details | Clinical Trials Unit
The Cardiothoracic Centre
Thomas Drive
Liverpool
United Kingdom
L14 3PE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN91640245 |
| Date last extracted from ISRCTN register | 17/04/2008 |
