Clear benefits to patients. For 42% of patients with migraine, providers adjusted the pre-study medication regimens—most often by adding a migraine-specific triptan. On post-study surveys, significantly more patients said they were satisfied or very satisfied with the effectiveness of medication and with the overall quality of migraine care compared with the beginning of the study. The impact of headache on patients’ lives as determined from HIT-6 scores was less at the end of the study compared with the beginning.
A subgroup analysis among Phase 2 patients confirmed the value of the program. Phase 2 patients reporting no pre-study diagnosis of migraine were significantly less satisfied with care and medication at baseline than patients reporting a pre-study migraine diagnosis—even though patients reporting no pre-study diagnosis had less severe migraine at baseline. Patients with previously unrecognized migraine responded well to care in our study. Though satisfaction increased and headache impact decreased from baseline to the end of Phase 2 for both sets of patients, improvement was greater for those without a prior diagnosis.
Migraine and barriers to medical care
Migraine affects 18% of women and 7% of men in the United States.1 A large body of research conducted over the past decade contradicts the historical conception of migraine as a trivial illness and has established it as a disabling condition warranting aggressive management.10-13 Concurrently, understanding of the pathophysiology of migraine has evolved; and new, migraine-specific treatments that can relieve pain and restore patients’ functional ability have been introduced.14,15 Despite these advances, several barriers to optimizing migraine care remain. Perhaps the most significant obstacle to effective migraine care, failure to recognize and diagnose migraine occurs alarmingly often.2,6,7,16,17 In a 1999 US population-based survey, less than half (48%) of those meeting International Headache Society (IHS) diagnostic criteria for migraine reported having received a physician diagnosis of migraine.1 Frequency of physician diagnosis of migraine in 1999 did not increase appreciably from diagnosis rates in 1989 although consultations for headache tripled over the 10-year period. Underrecognition and suboptimal management of migraine may be particularly problematic in the primary care setting, where the majority of migraine sufferers consult.
The suboptimal nature of migraine care is also reflected in patients’ assessments of medical care. In a recent study of patients with primary headache diagnoses in three geographically diverse primary care institutions in the United States, 1 of 4 patients with severe headaches reported dissatisfaction with their headache care; and 3 of 4 reported moderate or severe problems with headache management.18
Limitations of the study. First, patients were enrolled only if they agreed to complete the Headache Assessment Quiz. Thus, regarding characteristics relevant to study assessments, selection bias may have occurred if patients who agreed to take the quiz differed systematically from those who did not.
Second, attrition during Phase 2—though relatively low for a naturalistic study that, unlike a clinical trial, did not use incentives such as provision of study medication—might have biased the results of patient assessments at the end of the study. Attrition could have inflated the patient-satisfaction and other end-of-study ratings of medication and migraine care if dissatisfied patients were more likely to withdraw prematurely from the study than were satisfied patients.
Third, the study lacked a control group because of the difficulty in blinding investigators in a naturalistic study.
Strengths of the study. Among several disease management programs for migraine, the Migraine Care Program is unique in being one of the few whose effects on migraine care have been assessed. In this study, application of the Migraine Care Program was evaluated in the “real-world” clinical setting and as used by providers (physicians, nurse practitioners, physician assistants) typically responsible for headache care in primary care centers across the US. These characteristics enhance the probability that the results reflect those achievable in actual clinical practice. The comprehensive nature of the study assessments, which involved both primary care providers and patients, supports the benefits of the program.
Methods
This prospective, observational study had 2 phases. During Phase 1, primary care providers were introduced to the Migraine Care Program, and they administered the Headache Assessment Quiz to consulting patients who agreed to complete it. During Phase 2, a subset of patients who screened positive for migraine on the Headache Assessment Quiz in Phase 1 and whose migraine diagnosis was confirmed by their primary care provider received 12 weeks of additional treatment for migraine under the care of that primary care provider.