Trial of Comprehensive Migraine Intervention

Condition(s) targeted: Migraine

Intervention: Naproxen (Drug); Sumatriptan (Drug); Migraine education (Behavioral); Reenforcement of diagnosis (Behavioral); Typical care (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Montefiore Medical Center

Overall contact:
Benjamin W Friedman, MD, MS, Phone: 718-920-6626, Email: befriedm@montefiore.org

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. We intend to enroll 21 patients in each arm of this study for a total of 42 patients. Using headache surveys, we will determine if the protocol improves migraine-related pain and functional disability one month after the ER visit.

Official title: An RCT of a Comprehensive Migraine Intervention at the Time of Discharge From the ED After Treatment for Acute Migraine

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Headache Impact Test 6 (HIT6) scale

Secondary outcome:

Satisfaction with care

Migraine Disability Assessment Scale (MIDAS)

Comfort with disease management

Healthcare use

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Benjamin W Friedman, MD, MS, Phone: 718-920-6626, Email: befriedm@montefiore.org

Montefiore Medical Center, Bronx, New York 10467, United States; Recruiting
Benjamin W Friedman, MD, MS, Phone: 718-920-6626, Email: befriedm@montefiore.org

Starting date: February 2010
Last updated: April 15, 2011