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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Naproxen; Drug: Sumatriptan; Behavioral: Migraine education; Behavioral: Reenforcement of diagnosis; Other: Typical care

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive care; Reinforcement of diagnosis, education, medications, and referral	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
Active Comparator: Typical care; Usual care	Other: Typical care; Care to be determined by attending physician

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 17, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (Estimate): February 19, 2010

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Gout Suppressants; Vasoconstrictor Agents; Naproxen; Sumatriptan
• Other Study ID Numbers: 09-08-248