Prospective ED Headache Cohort Study

Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache

The purpose of this study is to determine how often headaches recur and to learn how to predict continued suffering from headache after emergency department discharge.

Study Overview

• Status: Completed
• Conditions: Headache

Detailed Description

The majority of the 5 million people who arrive at Emergency Departments (ED) with a headache every year are suffering from an acute exacerbation of a chronic, recurrent headache disorder. The role of the ED in treating these patients has been ill-defined. Often emergency physicians will treat the acute exacerbation and will not attend to the natural history of the disease. However, about two thirds of primary headache patients will suffer a recurrent headache in the 24 hours after discharge from the ED. And, many patients will continue to suffer recurrent headaches for months after their ED discharge.

The purpose of this study is to learn how often headaches recur and to try to find a way to predict who will have a recurrent headache after ED discharge.

After standard ED treatment for headache, participants in the study will be asked to answer questions about prior headaches and medical history, and some census-like questions about race/ethnicity, salary, and education via a 20-minute interview with a research associate. The researchers will follow-up with 10-minute telephone calls to each participant's home in 24 hours and in 3 months with additional questions. Total length of time for study participation is approximately 40 minutes.

• Study Type: Observational
• Enrollment (Actual): 477

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center, 111 East 210th Street

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Convenience sample of ED patients

Description

Inclusion Criteria:

• Emergency Department patients who present primarily for headache.
• Need to consent to and be available for follow-up

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge	Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain	24 hours after Emergency Department (ED) discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal	Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.	3 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Benjamin Friedman, MD, MS, Department of Emergency Medicine, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2004
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: April 10, 2006
• First Submitted That Met QC Criteria: April 10, 2006
• First Posted (Estimate): April 12, 2006

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: emergency department; headache; migraine; recurrent headache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 04-03-077E