Educational intervention improves anticoagulation control in atrial fibrillation patients: the TREAT randomised trial
Open accessAbstract
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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Several patient-information tools have been developed, largely focusing on oral anticoagulation.
“Several patient-information tools have been developed, largely focusing on oral anticoagulation.[1013][1014][1015][1016]”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [1014]
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- Authors
- Clarkesmith, D. E., Pattison, H. M., Lip, G. Y. H., & Lane, D. A.
- Affiliations
- Aston University (GB)
- Birmingham City Hospital (GB)
- Corresponding author
- Lane, Deirdre A.
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2013-09-09
- Volume
- 8
- Issue
- 9
- Pages
- e74037
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3767671
- OpenAlex
- W2045883381
- Cited by
- 209
- References
- 45
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 6 · 2023: 14 · 2022: 14 · 2021: 19 · 2020: 21 · 2019: 17 · 2018: 20 · 2017: 31 · 2016: 24 · 2015: 19 · 2014: 11
- FWCI
- 12.25
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Aston Publications Explorer (Aston University) (acceptedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Funders
- Pfizer
- Sanofi
- Bayer HealthCare
- University of Birmingham
- Daiichi-Sankyo
- Astellas Pharma
- Aston University
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacy and Medical Practices
- Keywords
- atrial fibrillation, warfarin, anticoagulation management, time in therapeutic range, patient education, educational intervention, stroke prevention, patient knowledge, illness perception, medication beliefs, medication adherence, quality of life, anxiety and depression, theory-based intervention, TREAT trial, patient-centered care
- MeSH terms
- Aged, Aged, 80 and over, Anticoagulants, Anxiety, Atrial Fibrillation, Culture, Depression, Female, Humans, Health Knowledge, Attitudes, Practice, Male, Middle Aged, Patient Education as Topic, Perception, Quality of Life, Time Factors, International Normalized Ratio, Stroke, Medication Adherence
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