Participants
Study participants included both primary care providers and their patients. Eligible health care providers included physicians, nurse practitioners, and physician assistants responsible for performing headache assessments in US primary care practices that did not routinely use a questionnaire to screen headache patients prior to the study.
Eligible patients for Phase 1 were the first 100 consecutive 18- to 65-year-old patients in each practice who agreed to complete the Headache Assessment Quiz. Patients were eligible for Phase 1 regardless of whether they were consulting for headache. Patients from Phase 1 were eligible for Phase 2 if they screened positive for migraine on the Headache Assessment Quiz, had a confirmed clinical diagnosis of migraine meeting IHS criteria 1.1 or 1.2,19 and were willing to remain under the care of the study investigator and to treat headaches with therapy recommended by that investigator for 12 weeks.
Procedures
Phase 1
Primary care providers completed an Accreditation Council for Continuing Medical Education-accredited educational program consisting of a 38-minute DVD on migraine diagnosis and screening. After they completed the educational program, health care providers administered the Headache Assessment Quiz and HIT-6 to a target of 100 consecutively consulting patients regardless of patients’ reason for consulting. For patients who screened positive for migraine on the Headache Assessment Quiz, primary care providers recorded whether or not in their clinical judgment they confirmed a diagnosis of migraine by IHS criteria19 and whether or not patients reported, in response to a question, that they had received a migraine diagnosis from a health care professional before the study.
Phase 2
Primary care providers were asked to recruit up to 10 Phase-1 patients with a confirmed clinical diagnosis of migraine for Phase 2 of the study. At least half of the patients recruited in each practice were to have received their first clinical diagnosis of migraine during the study. All patients provided written, informed consent to participate in Phase 2.
At the beginning of Phase 2, eligible patients received Migraine Care Program educational materials including a migraine diary and a pamphlet about the causes, triggers, symptoms of migraine, and migraine types. They received migraine care for the ensuing 12 weeks under the supervision of the investigator. Investigators could prescribe any pharmacological or nonpharmacological migraine treatment to patients at their discretion.
Measures
In questionnaires administered at the beginning of the study before they initiated the Migraine Care Program (baseline) and again at the end of Phase 2, primary care providers rated the difficulty of assessing and treating patients with headache (0 = not at all difficult; 10 = extremely difficult), the importance of understanding the impact of headaches on a patient’s life when making treatment decisions (on a 7-point Likert scale ranging from very important to very unimportant), and their satisfaction (on a 7-point Likert scale ranging from very satisfied to very dissatisfied) with how well patients describe their headache severity and how well patients describe the physical, emotional, and financial impact of headaches.
For the questions on patient communication about headaches, providers were instructed to respond with respect to their general experience with patients for the baseline questionnaire and with respect to their experience with patients in Phase 2 of the study for the end-of-study questionnaire. The end-of-study questionnaire also contained items on which primary care providers rated satisfaction with the use of the Headache Assessment Quiz to facilitate (a) understanding of the impact of headaches on patients’ lives; (b) treatment decisions; and (c) identification of headache patients requiring better treatment and indicated whether or not they would recommend the Headache Assessment Quiz for use in clinical practice.
In questionnaires administered at the beginning of Phase 2 and again at the end of the study, patients who participated in Phase 2 rated their satisfaction (on a 7-point Likert scale ranging from very satisfied to very dissatisfied) with the medication used to treat migraine headaches and with the quality of medical care received for migraine. In addition, patients rated the bothersomeness of side effects of medication used to treat migraine headaches (on a 5-point categorical scale ranging from not at all to extremely). At the beginning of Phase 2, patients listed the medications they had used during the 3 months before the study to treat headaches. HIT-6, which was first administered at study entry, was also administered at the end of Phase 2.
Responses to the primary care provider and patient questionnaires were summarized with descriptive statistics. The Wilcoxon Signed Ranks Test was used to compare differences between baseline and the end of the study in the distribution of percentages of respondents to each question on satisfaction, bothersomeness, and importance; in median primary care provider ratings of difficulty of assessing and treating headache patients; and in distribution of HIT-6 scores (<50 = little to no impact of headache; 50–55 = some impact; 56–59 = substantial impact; ≥60 = severe impact).