Clinical Decision Rule for Pediatric Intracranial Pathology
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|ClinicalTrials.gov Identifier: NCT02742272|
Recruitment Status : Unknown
Verified April 2016 by Children's Hospitals and Clinics of Minnesota.
Recruitment status was: Recruiting
First Posted : April 19, 2016
Last Update Posted : April 19, 2016
|Condition or disease|
|Migraine Headache Headache|
Background/Question: A significant number of children who present to the Emergency Department (ED) with headache or migraine undergo head imaging with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). However, there is relatively low yield in imaging neurologically normal patients based on prior studies. The goal of this study is to describe the utilization of head CT or MRI among pediatric ED patients with headache and migraine. The investigators plan to evaluate clinical and examination characteristics of these patients, and use this information to develop a clinical decision rule to help providers predict the risk of finding an abnormality that affects patient treatment.
Design: The investigators will perform a study of all children between 6 and 18 years of age who present to the ED with headache or migraine. At the time of the visit providers will be asked to complete a questionnaire regarding exam and history without making any changes to patient care. The investigators will also contact a sub-group of patients who do not undergo MRI or CT, 12-14 weeks after discharge to ask about subsequent headache care after leaving our facility.
Methods: All children age 6-18 years who present to the ED with a chief complaint of headache or migraine will be eligible for the study. Patients will be excluded if they meet any of the following criteria: trauma within 48 hours, previous neurosurgery (shunt included), known tumor, history of cerebral hemorrhage/ischemia, Sickle Cell Disease, thrombophilia, bleeding disorder or non-English speaker. ED Research Assistants and ED staff physicians and nurse practitioners will screen potential candidates and ask providers to review the inclusion criteria. If the eligibility criteria are met, the provider will complete a standardized data collection form regarding exam and history findings. Patient care will not be impacted or altered. Research Assistants will also provide a Parent Information Sheet (either during the visit, or by mail following the ED visit) to the family of those patients who are enrolled informing them they may be contacted following discharge. Medical records will be reviewed for all eligible patients to obtain information on patient demographics, course of treatment and diagnosis. For those patients who do not have any head CT or MRI performed at their visit, the family will be contacted 12-14 weeks later to determine if they have had subsequent care for their headache. If the family is unable to be reached by phone, the patient chart will be reviewed for any other pertinent visits.
Analysis: For each patient characteristic examined, the investigators will look for a statistically significant difference between those patients who have normal head imaging, and those with abnormal imaging. Using the characteristics that are significantly different, the investigators will develop a clinical decision rule to help providers assess the risk of significant findings in an individual patient. The investigators will also develop a decision tree to help aid providers when deciding which patients need head imaging. A sample of patients will have two independent assessments to allow us to look for evidence of inter‐rater reliability in our questionnaires.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Development of a Clinical Decision Rule to Identify Pediatric Patients With Headache at Low Risk for Intra-cranial Pathology|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
ED Headache or Migraine Patients
The investigators will perform a prospective cohort study of patients ages 6-18 years presenting to the ED with a complaint of headache or migraine over a 12 month period.
- Intracranial pathology identified by imaging studies [ Time Frame: within 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742272
|Contact: Meghan Cain, MDemail@example.com|
|Contact: Kristin Frenn, MPHfirstname.lastname@example.org|
|United States, Minnesota|
|Children's Hopsitals and Clinics of Minnesota||Recruiting|
|St. Paul, Minnesota, United States, 55102|
|Contact: Meghan Cain, MD 612-813-6843 Meghan.email@example.com|
|Contact: Kristin Frenn, MPH 612.813.7104 firstname.lastname@example.org|
|Principal Investigator: Meghan Cain, MD|
|Principal Investigator:||Meghan Cain, MD||Children's Minnesota|