Trial of Comprehensive Migraine Intervention

Phase 4

Completed

Interventions: Other: Typical care
Drug: Naproxen
Drug: Sumatriptan
Behavioral: Migraine education
Behavioral: Reenforcement of diagnosis

Brief Summary: Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Comprehensive care	Reenforcement of diagnosis	Reinforcement of diagnosis, education, medications, and referral
Typical care	Typical care	Usual care
Comprehensive care	Migraine education	Reinforcement of diagnosis, education, medications, and referral
Comprehensive care	Naproxen	Reinforcement of diagnosis, education, medications, and referral
Comprehensive care	Sumatriptan	Reinforcement of diagnosis, education, medications, and referral

Primary Outcome Measures

Name	Time	Method
Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale	1 month after study enrollment	This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale	1 month after study enrollment	Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.
Number of Participants Who Returned to the Emergency Department for Management of Headache	1 month after study enrollment	We report the number of patient who returned to the emergency department for management of headache
Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale	1 month after study enrollment	Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable