NCT01071317

Trial of Comprehensive Migraine Intervention

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Naproxen	Naproxen 500mg PO bid prn headache
DRUG	Sumatriptan	100mg po q day prn headache
BEHAVIORAL	Migraine education	Educational program available through NIH/ national library of medicine/ X-plain
BEHAVIORAL	Reenforcement of diagnosis	Patient advised has migraine headache and how the headache meets migraine criteria
OTHER	Typical care	Care to be determined by attending physician

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-02-19
• Last updated: 2018-08-31
• Results posted: 2018-07-26

Locations

1 site across 1 country: United States