Training for patients in a randomised controlled trial of self management of warfarin treatmentBMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7437.437 (Published 19 February 2004) Cite this as: BMJ 2004;328:437
- Ellen Murray, MRC research fellow ()1,
- David Fitzmaurice, professor of primary care research1,
- Debbie McCahon, research associate1,
- Chris Fuller, research associate1,
- Hardeep Sandhur, research fellow, data management1
- 1Department of Primary Care and General Practice, Medical School, University of Birmingham, Birmingham B15 2TT
- Correspondence to: E Murray
- Accepted 10 October 2003
Self management of warfarin treatment by patients, using a point of care coagulometer for testing international normalised ratios, is comparable to home glucose monitoring and may provide a robust model of service provision.1 2 Self management can lead to improvements in patients' self efficacy, closer adherence to treatment, and increased control of treatment with oral anticoagulants.3
We report data on the effectiveness of the training programme used for a clinical trial (self management of anticoagulation: a randomised trial, SMART) which aimed to evaluate clinical and cost effectiveness of self management compared with routine care. UK guidelines indicated that training to a standard acceptable is essential, although the nature of the training was not clearly defined.2
Participants, methods, and results
Patients aged over 18 with a long term indication for warfarin, from 48 general practices in the West Midlands, were eligible. After giving consent patients were randomly allocated to either self management or routine care. Data on demographics, age, ethnic origin, condition requiring warfarin treatment, and education were collected at consent. Nurses experienced in anticoagulation management, who had attended a course organised by the researchers to ensure standards and consistency, provided training. Patients randomised to self management attended at least two training sessions. Sessions were adapted from a German national programme,4 were practice based, and were held one week apart. The aims of training were to ensure that patients had a theoretical understanding of oral anticoagulation and INR monitoring, that they (or their carers) were able to measure the INR reliably by using a point of care system (Coaguchek S, Roche Diagnostics), and that they were able to interpret the INR in terms of appropriate warfarin dose. We assessed patients individually for competence in undertaking self management in terms of accurately performing an INR test (by using the point of care system), quality control issues, dosing algorithm and adjustment of dosage, and documenting INR results and adverse events. Capable patients were given equipment for home testing, otherwise an additional session was arranged, and if they were still not considered capable of self management they were returned to usual care.
Of 2586 patients invited to participate 608 (24%) provided written consent, with central telephone randomisation to self management (n = 327) and usual care (n = 281). Of the patients randomised to self management 85/327 (26%) did not complete training (table). We defined reasons for dropout during training as either self exclusion of patients themselves or exclusion by the researcher. Of the patients 67/85 (79%) excluded themselves. The primary reason was manual difficulty with the procedure. Altogether 54/67 (81%) patients were generally unhappy with the procedure, and of those 30/54 (56%) gave the reason as trouble in obtaining sufficient capillary blood and placing the sample on to the test strip. In total 242/327 (74%) of patients passed the training assessment and started self management, and of those 212 (88%) completed 12 months of self management.
The participants who completed training were significantly younger than the group that did not complete training (61 v 71 years, P = 0001). Significantly more patients were educated to GCSE or above standard among the patients who completed training (P = 0.003).
Although we used a training programme to train 242 unselected patients successfully in self management of warfarin treatment, 76% (1978/2586) of patients invited chose not to undertake self management and may therefore not consider this a desirable option. To our knowledge this is the first UK trial that invited unselected patients to self manage warfarin and as such may give a real indication of expected uptake. For patients keen to undertake self management three quarters were able to complete training. These patients considered it a convenient and valuable method of controlling their own health and most were enthusiastic to continue after the trial. If self management by patients is to become established standardisation and dissemination of training are needed, accompanied by practical guidelines to encourage back up from clinicians.
Contributors EM managed the study, drafted the paper, and is a lead investigator. DF is principal investigator and critically revised the paper. DMcC and CF were research associates involved in field work, training, and assessing patients' data collection and management, and both reviewed the paper. HS produced the databases supported data cleaning and analysis and reviewed the paper. EM and DF are the guarantors.
Funding Medical Research Council.
Competing interests EM and DF have been reimbursed by Roche Diagnostics for attending several conference and to support educational programmes within the University of Birmingham's Department of Primary Care.
Ethical approval Midland Research Ethics Committee.