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

NCT01071317 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Montefiore Medical Center
Phase	Phase 4
Status	COMPLETED
Enrolment	50
Start date	2010-02
Completion	2012-01

Conditions

• Migraine

Interventions

• Naproxen
• Sumatriptan
• Migraine education
• Reenforcement of diagnosis
• Typical care

Primary outcomes

• 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

Countries

United States