ORIGINAL RESEARCH CONTRIBUTION
A Randomized Controlled Trial of a Comprehensive Migraine Intervention Prior to Discharge From an Emergency Department Benjamin W. Friedman, MD, MS, Clemencia Solorzano, DrPh, Jennifer Norton, DO, Victoria Adewumni, MD, Caron M. Campbell, MD, David Esses, MD, Polly E. Bijur, PhD, Seymour Solomon, MD, Richard B. Lipton, MD, and E. John Gallagher, MD
Abstract Objectives: Patients who use an emergency department (ED) for acute migraine headaches have higher migraine disability scores, lower socioeconomic status, and are unlikely to have used a migrainespecific medication prior to presentation to the ED. The objective was to determine if a comprehensive migraine intervention, delivered just prior to ED discharge, could improve migraine impact scores 1 month after the ED visit. Methods: This was a randomized controlled trial of a comprehensive migraine intervention versus typical care among patients who presented to an ED for management of acute migraine. At the time of discharge, for patients randomized to comprehensive care, the research team reinforced their diagnosis, shared a migraine education presentation from the National Library of Medicine, provided them with six tablets of sumatriptan 100 mg and 14 tablets of naproxen 500 mg, and if they wished, provided them with an expedited free appointment to the institution’s headache clinic. Patients randomized to typical care received the care their attending emergency physicians (EPs) felt was appropriate. The primary outcome was a between-group comparison of the Headache Impact Test (HIT-6) score, a validated headache assessment instrument, 1 month after ED discharge. Secondary outcomes included an assessment of satisfaction with headache care and use of migraine-specific medication within that 1-month period. Results: Over a 19-month period, 50 migraine patients were enrolled. One-month follow-up was successfully obtained in 92% of patients. Baseline characteristics were comparable. One-month HIT-6 scores in the two groups were nearly identical (59 vs. 56, 95% confidence interval [CI] for difference of 3 = )5 to 11), as was dissatisfaction with overall headache care (17% vs. 18%, 95% CI for difference of 1% = )22% to 24%). Patients randomized to the comprehensive intervention were more likely to be using triptans or migraine-specific therapy (43% vs. 0%, 95% CI for difference of 43% = 20 to 63%) 1 month later. Conclusions: A comprehensive migraine intervention, when compared to typical care, did not improve HIT-6 scores (a validated measure of the effect of migraine on one’s daily life) 1 month after ED discharge. Future work is needed to define a migraine intervention that is practical and useful in an ED, where many underserved patients, of necessity, present for care. ACADEMIC EMERGENCY MEDICINE 2012; 19:1151–1157 ª 2012 by the Society for Academic Emergency Medicine
From the Department of Emergency Medicine, Albert Einstein College of Medicine (BWF, JN, VA, CMC, DE, PEB, EJG), Bronx, NY; and the Pharmacy Department (CS) and the Department of Neurology and Montefiore Headache Center (SS, RBL), Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY. Received March 23, 2012; revision received April 13, 2012; accepted May 8, 2012. Some of this research was conducted with Dr. Friedman’s K23 Career Develoment Award from the National Institute of Neurological Disorders and Stroke 1K23NS051409. The authors have no relevant financial information or potential conflicts of interest to disclose. Supervising Editor: Steven B. Bird, MD. Address for correspondence and reprints: Benjamin W. Friedman, MD, MS; e-mail:
[email protected].
ª 2012 by the Society for Academic Emergency Medicine doi: 10.1111/j.1553-2712.2012.01458.x
ISSN 1069-6563 PII ISSN 1069-6563583
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igraine affects 12% of the general U.S. population.1 Work absenteeism and decreased productivity at work due to this illness result in $13 billion in annual costs to U.S. businesses.2 Migraine is underdiagnosed (only 56% of migraine patients have received this diagnosis) and undertreated (49% use only over-the-counter medications to treat their headaches). Few eligible patients use preventative medications.1 Remaining undiagnosed, and therefore inadequately treated, is associated with low socioeconomic status.3 Effective migraine treatment requires accurate diagnosis, patient education, and initiation of appropriate acute and preventive medications. Diagnosis and educational interventions can improve migraine disability scores as part of a comprehensive program of care.4 Medications have demonstrated efficacy at decreasing pain and functional disability. These include triptans, nonsteroidals, and dopamine receptor blockers such as metoclopramide.5,6 Various preventive medications decrease the number of headache days suffered by patients with frequent migraine.7 Incorporating these various components of care, while addressing comorbidities and excluding organic causes of headache, represents state-of-the-art migraine treatment. Patients who use the emergency department (ED) for treatment of severe migraine are socioeconomically depressed, have difficulty accessing primary care, and have more severe underlying disease than those who do not use the ED.8 As many as 50% of migraine patients who use the ED take no medication, not even acetaminophen, before presenting to the ED.9 Use of sumatriptan or other triptans is reported infrequently by patients who use the ED for treatment of acute migraine (B. W. Friedman, 2004 and 2006, unpublished data). However, it has been shown that prescribing sumatriptan can result in substantial improvements in overall health functioning scores, decreased absenteeism from work, and fewer health care visits.10 We conducted a randomized, controlled study to determine if a comprehensive ED-based migraine treatment protocol, which incorporated many of the features discussed above, could improve headache impact scores 1 month after an ED visit for acute headache. Our specific hypothesis was as follows: a protocol designed to diagnose, educate, treat, and refer underserved migraine patients at the time of their discharge from the ED would improve 1-month Headache Impact Test (HIT-6) scores (a validated measure of the effect of migraine on one’s daily life) significantly more than typical ED discharge care. METHODS Study Design This was a randomized controlled trial to test the hypothesis that a program of ED-based comprehensive migraine care could improve headache outcomes 1 month after ED discharge when compared to typical ED therapy. We registered the trial at http://clinicaltrials. gov (NCT01071317). The Montefiore Medical Center institutional review board approved the trial and provided ethics oversight.
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Study Setting and Population We performed this study in the ED of Montefiore Medical Center, an urban ED serving the communities in and around the Bronx, New York. The ED receives over 90,000 adult visits annually. The research staff of the Montefiore ED are salaried, trained, technician-level bilingual (English and Spanish) research associates, who execute research studies under the supervision of the principal investigators. These research associates staff the Montefiore ED around the clock. Patients with migraine were eligible for this study if they presented to the ED for treatment of acute headaches. Specific migraine subtypes eligible for enrollment included migraine with or without aura, as defined by the International Classification of Headache Disorders. To participate, patients were required to have baseline Migraine Disability Assessment (MIDAS) scores of 5 or more, signifying at least mild migraineassociated disability. To focus our intervention on underserved migraineurs, patients were excluded if they had current prescriptions for any triptan or migraine-preventive therapy or if they responded affirmatively to the question, ‘‘Do you have a doctor who helps you take care of your headaches?’’ We also excluded patients from participation for the following reasons: daily or near-daily headache or analgesic medication use, pregnant or breast-feeding, unavailable for 1-month follow-up, admitted to the hospital, previous enrollment in the study, or pain not currently severe enough to require parenteral medication, as determined by the clinical attending emergency physician (EP). After reviewing study eligibility criteria, research associates, supervised by the principal investigator, explained the study to eligible patients and then obtained their written consent to participate as research subjects. Study Protocol The intervention took place at two points: in person, at the time of discharge from the ED; and by telephone, 1 week after ED discharge (Figure 1). The intervention consisted of four components: reinforcement of diagnosis, migraine education, prescription of appropriate acute migraine medication, and referral to specialty care. Reinforcement of Diagnosis. Research personnel explained the following: ‘‘You have a migraine headache. Migraine is usually described as a one-sided [pointed to left or ride side of head] throbbing headache, with nausea, vomiting, and sensitivity to bright lights and loud noises. Migraine sometimes comes with an aura, which means changes in your vision like shapes, shadows, or lights, or odd sensations like tingling or numbness. The questions we asked you earlier allowed us to categorize your headache as a migraine.’’ Education. We used patient educational material provided online by the National Library of Medicine and National Institutes of Health. This information, part of the Medline Plus patient tutorials, is available at http:// medlineplus.gov/. Patients were given an opportunity to
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Acute treatment in the ED (This stage was prior to randomization. All patients receive this)
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Patients treated with IV medication at the discretion of the attending emergency physician. There were two options for initial treatment. 1) Metoclopramide with diphenhydramine was recommended as first-line treatment, with ketorolac recommended as second-line agent. 2) Alternatively, patients participated in an ongoing clinical trial in which they could have been randomized to metoclopramide, ketorolac, or valproic acid. Subjects in this latter clinical trial who had insufficient relief after 1 hour received metoclopramide with diphenhydramine as rescue therapy. Once subjects had experienced sufficient relief and were ready to be discharged, they proceded to randomization. Randomization
Intervention arm: comprehensive management
Control arm: typical care
Predischarge Reinforcement of diagnosis Educational presentation with take-home stage material Medications dispensed to patient: -Sumatriptan 100 mg -Naproxen 500 mg 1 week follow-up
4 week follow-up phone call
Intervention arm Patients instructed to combine dispensed medications if insufficent relief with individual medications Patient offered free appointment at the specialty headache clinic
Standard discharge instruction sheet
Clinical team instructed to address post-discharge care as appropriate Control arm Persistent headache encouraged to follow-up with primary physcian or return to ED
Intervention arm
Control arm HIT-6 assessment
Figure 1. Protocol outline. HIT-6 = Headache Impact Test.
review the online slide show presented at this website after their pain was relieved. Each patient received a printed copy of the tutorial to take home. Research associates then reviewed highlights of the tutorial with patients. Specific points stressed included: 1) awareness of migraine triggers, 2) the range of acute treatments available, 3) the availability and role of preventive medications, and 4) how to access specialist migraine care and migraine resources.
domized to typical care were informed that the patient was enrolled in a study examining outcomes after treatment of migraine in the ED and that they were to treat the patient as they saw fit.
Referral. Each patient was contacted by telephone 1 week after ED discharge and offered an expedited free appointment at the Montefiore headache clinic.
Randomization and Blinding of Outcome Assessment. Group assignment was determined by random allocation, using a random number generator (http:// sealedenvelope.com). After a patient consented to participate in the study, research associates logged into the website and received the patient’s assignment. Because of the nature of the intervention, it was not possible to blind patients randomized to the comprehensive intervention arm to allocation. However, the following efforts were made to blunt this limitation: 1) in the ED, all patients, regardless of assignment, received acute migraine therapy per protocol; 2) all patients received follow-up phone calls 1 week after ED discharge; and 3) most importantly, the 1-month outcome assessor was blinded to assignment.
Typical Care. Patients randomized to this group received standard ED discharge care, as determined by the attending EP, and were referred to a primary care provider. Health care providers caring for patients ran-
Outcome Measures The primary outcome for this trial was the HIT-6, a sixitem headache impact test that assesses the pain and functional effect of migraine on an individual’s daily
Medication. Six tablets of sumatriptan 100 mg and 14 tablets of naproxen 500 mg were distributed to each patient at the time of ED discharge. If a participant was allergic to or had a contraindication to one of these medications, metoclopramide 20 mg was substituted for that medication.
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life. This instrument closely tracks lengthier migraine and general health care-associated quality-of-life instruments and proves useful over the full range of migraine severity.11,12 Scores on this instrument range from 36 to 78, with higher scores indicating more substantial illness. The primary outcome assessment occurred 1 month after ED discharge. Scores were compared between the intervention group and the typical care group. Secondary outcomes included an assessment of health care resources utilized, including ED visits and medications taken, and an assessment of the patient’s satisfaction with the headache care they received (unsatisfied, mostly satisfied, completely satisfied). We also assessed the patients’ confidence in managing their migraines by having them describe themselves as uncomfortable, somewhat comfortable, or very comfortable with their ability to manage their headaches. We surveyed what medications the patients were currently using for their migraines and categorized the following as migraine-specific medication: triptans, dihydroergotamine, metoclopramide, topiramate, betablockers, and tricyclic antidepressants. Nonsteroidal anti-inflammatory drugs, opioids, and butalbitalcontaining compounds were not considered migrainespecific medication. Data Analysis We compared the HIT-6 scores between the intervention group versus the control group using the Student’s t-test. Statistical significance for between-group differences is reported with 95% confidence intervals (CIs). If the HIT-6 scores were not normally distributed, the Mann-Whitney U-test was to be used in place of the Student’s t-test. Secondary outcomes were compared statistically using the chi-square test and are also reported with 95% CI. The sample size calculation was based on a clinically relevant effect size identified in a study of patients with chronic daily headache: the change in the HIT-6 associated with patients feeling at least ‘‘somewhat better’’ over time was 2.5.13 Using standard deviations (SDs) reported in Coeytaux et al.,13 a two-sided alpha of 0.05, and 80% power, we determined the need for 23 subjects in each group. RESULTS Enrollment commenced in February of 2010 and continued for 19 months. Please see the CONSORT flow diagram (Figure 2). Baseline characteristics were comparable between the groups (Table 1). The HIT-6 scores 1 month after ED discharge were comparable (Table 2). Results did not change if the Mann-Whitney U-test was used in place of the Student’s t-test. Similarly, patients in both arms were comparably likely to return to an ED (Table 2). Patients randomized to the intervention were more likely to be using a migraine-specific medication 1 month (Table 2) and 1 week (Table 3) after ED discharge, but this did not translate into greater satisfaction with headache care, greater confidence in their own ability to manage headaches, or fewer days with headache.
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Patients with acute migraine approached: 351
Patients randomized: 51
Excluded: 300* MIDAS
