Trial of Comprehensive Migraine Intervention

Study Overview
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Brief Summary
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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.

Official Title
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A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: Naproxen
* Drug: Sumatriptan
* Behavioral: Migraine education
* Behavioral: Reenforcement of diagnosis
* Other: Typical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine, Baseline migraine related disability of mild or worse, No current or past triptan use, Not satisfied with current headache care. Exclusion Criteria: Allergy or contraindication to study medications, Daily or near daily analgesic medication use.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive care<br>Reinforcement of diagnosis, education, medications, and referral | Drug: Naproxen<br>* Naproxen 500mg PO bid prn headache<br>Drug: Sumatriptan<br>* 100mg po q day prn headache<br>Behavioral: Migraine education<br>* Educational program available through NIH/ national library of medicine/ X-plain<br>Behavioral: Reenforcement of diagnosis<br>* Patient advised has migraine headache and how the headache meets migraine criteria<br>|
| Active Comparator: Typical care<br>Usual care | Other: Typical care<br>* Care to be determined by attending physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale | 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 | 1 month after study enrollment | 

Secondary Outcome Measures

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