Study protocol
Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250]
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* Corresponding author: Paul Wallace p.wallace@pcps.ucl.ac.uk
1 Department of Primary Care and Population Sciences, Royal Free and University College Medical School, Rowland Hill Street, London NW3 2PF, UK
2 London School of Hygiene and Tropical Medicine, Keppel Street, London WC1, UK
3 University College Hospitals Research and Development Directorate, Hampstead Road, London NW1 UK
4 MRC Biostatistics Unit, Cambridge, UK
5 Centre for Health Informatics, School of Health Science, University of Wales, Swansea, UK
BMC Family Practice 2002, 3:1 doi:10.1186/1471-2296-3-1
Published: 11 January 2002Abstract
Background
Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT), unparalleled in telemedicine research in either scale or range of outcomes. The study investigated the effectiveness and cost implications in rural and inner-city settings of using videoconferencing to perform joint tele-consultations as an alternative to general practitioner referral to the hospital specialist in the outpatient clinic.
Methods
Joint tele-consultation services were established in both the Royal Free Hampstead NHS Trust in inner London, and the Royal Shrewsbury Hospitals Trust, in Shropshire. All the patients who gave consent to participate were randomised either to joint tele-consultation or to a routine outpatients appointment. The principal outcome measures included the frequency of decision by the specialist to offer a follow-up outpatient appointment, patient satisfaction (Ware Specific Questionnaire), wellbeing (SF12) and enablement (PEI), numbers of tests, investigations, procedures and treatments.
Results
A total of 134 general practitioners operating from 29 practices participated in the trial, referring a total of 3170 patients to 20 specialists in ENT medicine, general medicine (including endocrinology, and rheumatology), gastroenterology, orthopaedics, neurology and urology. Of these, 2094 patients consented to participate in the study and were correctly randomised. There was a 91% response rate to the initial assessment questionnaires, and analysis showed equivalence for all key characteristics between the treatment and control groups.
Conclusion
We have designed and performed a major multi-centre trial of teleconsultations in two contrasting centres. Many problems were overcome to enable the trial to be carried out, with a considerable development and learning phase. A lengthier development phase might have enabled us to improve the patient selection criteria, but there is a window of opportunity for these developments, and we believe that our approach was appropriate, allowing the evaluation of the technology before its widespread implementation.