Current guidelines recommend oral anticoagulation therapy for patients with atrial fibrillation (AF) with one or more risk factors for stroke; however, anticoagulation control (time in therapeutic range (TTR)) with vitamin K antagonists (VKAs) is dependent on many factors. Educational and behavioural interventions may impact patients’ ability to maintain their international normalised ratio (INR) control. This is an updated version of the original review first published in 2013.
To evaluate the effects of educational and behavioural interventions for oral anticoagulation therapy (OAT) on TTR in patients with AF.
We updated searches from the previous review by searching the Cochrane Central Register of Controlled Trials (CENTRAL) and the Database of Abstracts of Reviews of Effects (DARE) in The Cochrane Library (January 2016, Issue 1), MEDLINE Ovid (1949 to February week 1 2016), EMBASE Classic + EMBASE Ovid (1980 to Week 7 2016), PsycINFO Ovid (1806 to Week 1 February 2016) and CINAHL Plus with Full Text EBSCO (1937 to 16/02/2016). We applied no language restrictions.
We included randomised controlled trials evaluating the effect of any educational and behavioural intervention compared with usual care, no intervention, or intervention in combination with other self-management techniques among adults with AF who were eligible for, or currently receiving, OAT.
Data collection and analysis
Two of the review authors independently selected studies and extracted data. Risk of bias was assessed using the Cochrane ‘Risk of bias’ tool. We included outcome data on TTR, decision conflict (patient’s uncertainty in making health-related decisions), percentage of INRs in the therapeutic range, major bleeding, stroke and thromboembolic events, patient knowledge, patient satisfaction, quality of life (QoL), beliefs about medication, illness perceptions, and anxiety and depression. We pooled data for three outcomes – TTR, anxiety and depression, and decision conflict – and reported mean differences (MD). Where insufficient data were present to conduct a meta-analysis, we reported effect sizes and confidence intervals (CI) from the included studies. We evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.
Eleven trials with a total of 2246 AF patients (ranging from 14 to 712 by study) were included within the review. Studies included education, decision aids, and self-monitoring plus education interventions. The effect of self-monitoring plus education on TTR was uncertain compared with usual care (MD 6.31, 95% CI -5.63 to 18.25, I2 = 0%, 2 trials, 69 participants, very low-quality evidence). We found small but positive effects of education on anxiety (MD -0.62, 95% CI -1.21 to -0.04, I2 = 0%, 2 trials, 587 participants, low-quality evidence) and depression (MD -0.74, 95% CI -1.34 to -0.14, I2 = 0%, 2 trials, 587 participants, low-quality evidence) compared with usual care. The effect of decision aids on decision conflict favoured usual care (MD -0.1, 95% CI -0.17 to -0.02, I2 = 0%, 2 trials, 721 participants, low-quality evidence).
This review demonstrates that there is insufficient evidence to draw definitive conclusions regarding the impact of educational or behavioural interventions on TTR in AF patients receiving OAT. Thus, more trials are needed to examine the impact of interventions on anticoagulation control in AF patients and the mechanisms by which they are successful. It is also important to explore the psychological implications for patients suffering from this long-term chronic condition.
Plain language summary
Educational and behavioural interventions to increase the time in the therapeutic range for patients with atrial fibrillation on anticoagulant therapy
We reviewed the evidence about the effects of educational and behavioural interventions in patients with atrial fibrillation who are taking oral anticoagulant medication.
Atrial fibrillation is characterised by an irregular heartbeat and places people at greater risk of forming blood clots and having a stroke. To reduce stroke risk, medication that ‘thins the blood’ is used, known as oral anticoagulants. For patients taking warfarin, regular patient monitoring assesses the time it takes for blood to clot, known as the international normalised ratio (INR), to ensure that the target therapeutic range of 2.0 to 3.0 is maintained. This is often difficult to achieve due to the many factors that can affect INR control such as alcohol intake, other medications, and food.
Educational and behavioural interventions may play an important role in improving the ability of people with atrial fibrillation to maintain their INR control, by increasing patient knowledge and understanding.
This is an update of the original review first published in 2013. We searched scientific databases in February 2016 and found 11 randomised clinical trials including 2246 adults with atrial fibrillation who were taking oral anticoagulant medication. The trials we found compared education, decision aids, and self-monitoring plus education to usual care, over any length of time.
Few studies had comparable groups and data. There was uncertainty about the effect of self-monitoring plus education on the percentage of time the INR was within the therapeutic range because the proportion or time in the therapeutic range was similar between individuals who received self-monitoring plus education and those who did not. There were small and positive effects on anxiety and depression in individuals who received education compared to those who received usual care. There were small and negative effects on decision conflict in individuals who received decision aids compared to those who received usual care.
Quality of the evidence
The evidence should be interpreted with caution as the quality of the evidence ranged from very low to low across different outcomes because of the limitations of individual studies. It is likely that further high-quality trials may affect these reported results.