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Randomized Controlled Trial
. 2013 Sep 9;8(9):e74037.
doi: 10.1371/journal.pone.0074037. eCollection 2013.

Educational intervention improves anticoagulation control in atrial fibrillation patients: the TREAT randomised trial

Danielle E Clarkesmith  1 , Helen M Pattison, Gregory Y H Lip, Deirdre A Lane
Affiliations
Randomized Controlled Trial

Educational intervention improves anticoagulation control in atrial fibrillation patients: the TREAT randomised trial

Danielle E Clarkesmith et al. PLoS One. .

Abstract

Background: Stroke prevention in atrial fibrillation (AF), most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0) and is often poorly controlled in practice. Poor patient-understanding surrounding AF and its treatment may contribute to the patient's willingness to adhere to recommendations.

Method: A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients) utilising an "expert-patient" focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605) against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naïve AF patients were randomised to intervention (n=46, mean age (SD) 72.0 (8.2), 67.4% men), or usual care (n=51, mean age (SD) 73.7 (8.1), 62.7% men), stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR); secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions.

Main findings: Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035); at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44). Knowledge increased significantly across time (F (3, 47) = 6.4; p<0.01), but there were no differences between groups (F (1, 47) = 3.3; p = 0.07). At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04). Patients' scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months.

Conclusions: A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients' understanding of the necessity of warfarin and reducing their perception of treatment harm. Improving education provision for AF patients is essential to ensure efficacious and safe treatment. The trial is registered with Current Controlled Trials, ISRCTN93952605, and details are available at www.controlled-trials.com/ISRCTN93952605.

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Conflict of interest statement

Competing Interests: DAL is in receipt of an investigator-initiated educational grant from Bayer Healthcare and has been on the speakers' bureau for Boehringer Ingelheim, BMS/Pfizer, and Bayer Healthcare. She is also a Steering Committee member for the AEGEAN study. The investigator-initiated educational grant from Bayer Healthcare funded the TREAT study. GYHL has served as a consultant for Bayer, Astellas, Merck, Sanofi-Aventis, BMS/Pfizer, Daiichi-Sankyo, Biotronik, Portola, and Boehringer Ingelheim and has been on the speakers' bureau for Bayer, BMS/Pfizer, Boehringer Ingelheim, and Sanofi-Aventis. DEC’s PhD studentship to conduct the TREAT study was partly funded by the Investigator-initiated educational grant awarded to DAL by Bayer Healthcare. HMP has no conflicts of interest to declare in relation to this manuscript. The authors' reported conflicts of interest do not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. CONSORT diagram illustrating recruitment process and follow-up.
See this image and copyright information in PMC

References

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