A proactive approach to migraine in primary care: a pragmatic randomized controlled trial

Background:

Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs.

Methods:

We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participants were prescribed two or more doses of triptan per month. General practitioners in the intervention group received training on treating migraine and invited participating patients for a consultation and evaluation of the therapy they were receiving. Physicians in the control group continued with usual care. Our primary outcome was patients’ scores on the Headache Impact Test (HIT-6) at six months. We considered a reduction in score of 2.3 points to be clinically relevant. We used the Kessler Psychological Distress Scale (K10) questionnaire to determine if such distress was a possible effect modifier. We also examined the interventions’ cost-effectiveness.

Results:

We enrolled 490 patients in the trial (233 to the intervention group and 257 to the control group). Of the 233 patients in the intervention group, 192 (82.4%) attended the consultation to evaluate the treatment of their migraines. Of these patients, 43 (22.3%) started prophylaxis. The difference in change in score on the HIT-6 between the intervention and control groups was 0.81 (p = 0.07, calculated from modelling using generalized estimating equations). For patients with low levels of psychological distress (baseline score on the K10 ≤ 20) this change was ?1.51 (p = 0.008), compared with a change of 0.16 (p = 0.494) for patients with greater psychological distress. For patients who were not using prophylaxis at baseline and had two or more migraines per month, the mean HIT-6 score improved by 1.37 points compared with controls (p = 0.04). We did not find the intervention to be cost-effective.

Interpretation:

An educational intervention for general practitioners and a proactive approach to patients with migraine did not result in a clinically relevant improvement of symptoms. Psychological distress was an important confounder of success. (Current Controlled Trials registration no. ISRCTN72421511.)Migraine is a common, disabling headache disorder that results in lost quality of life and productivity, both during and between attacks.^1–8 Many patients with migraine suffer unnecessarily because they are not using their medications appropriately, or they are unaware of the possibility of prophylactic treatment. In the Netherlands, 3% of patients who take triptans consume 12 or more doses of the drug each month.⁹ These patients account for almost half of the costs associated with triptan use.¹⁰ In addition, although more than 25% of patients with migraine have two or more attacks each month, making them eligible for preventive treatment, only 8%–12% of patients use prophylaxis.^2,3,11–13 More than half of the patients with migraine in Dutch primary care who have an indication for prophylaxis have not discussed that option with their general practitioner.¹³We investigated whether a proactive approach to identifying patients with migraine who are receiving suboptimal treatment (i.e., inviting them to a consultation to evaluate their current treatment regimen and advising them about the options available for treating their migraine) could increase the use of preventive treatment and reduce the overuse of triptans, thereby reducing headache recurrence and associated costs. Our intervention involved educational sessions for general practitioners. Earlier studies aimed at reducing the overuse of other medications in primary care, such as benzodiazepines and acid-repressive drugs, showed that a proactive intervention led to a reduction in the use of medications.^14,15Because most patients with migraine in the Netherlands are treated by their general practitioner, we evaluated the costs and effects of a proactive approach to migraine in primary care. We included patients who had two or more attacks per month, because improvement could be reasonably expected in this group.