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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive care | Experimental | Reinforcement of diagnosis, education, medications, and referral |
|
| Typical care | Active Comparator | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Naproxen 500mg PO bid prn headache |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comprehensive Care | Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria |
| FG001 | Typical Care | Usual care Typical care: Care to be determined by attending physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who enrolled and were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Comprehensive Care | Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through NIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 2 patients in each group were lost-to-followup | Posted | Mean | 95% Confidence Interval | units on a scale | 1 month after study enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comprehensive Care | Reinforcement of diagnosis, education, medications, and referral Naproxen: Naproxen 500mg PO bid prn headache Sumatriptan: 100mg po q day prn headache Migraine education: Educational program available through HIH/ national library of medicine/ X-plain Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin W. Friedman, MD | Montefiore Health | 718-920-6626 | befriedm@montefiore.org |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Sumatriptan |
| Drug |
100mg po q day prn headache |
|
| Migraine education | Behavioral | Educational program available through NIH/ national library of medicine/ X-plain |
|
| Reenforcement of diagnosis | Behavioral | Patient advised has migraine headache and how the headache meets migraine criteria |
|
| Typical care | Other | Care to be determined by attending physician |
|
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 |
| BG001 | Typical Care | Usual care Typical care: Care to be determined by attending physician |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-existing migraine-related functional impairment as measured by the MIDAS scale | The Migraine Disability Assessment (MIDAS) Test is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. It is a 5-question instrument used to determine the severity of the underlying migraine disorder. Each question is scored from 0 to 90; the total minimum and total maximum scores are 0 and 450 respectively. A total score of 0 indicates no impairment. A total score greater than 20 indicates severe migraine related functional impairment. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Typical Care | Usual care Typical care: Care to be determined by attending physician |
|
|
| Secondary | 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. | 2 patients in each group were lost to followup. One patient in the Typical Care group did not answer the question | Posted | Count of Participants | Participants | 1 month after study enrollment |
|
|
|
| Secondary | 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 | Two patients in each arm were lost-to-follow-up. One patient in Typical Care did not answer this question. | Posted | Count of Participants | Participants | 1 month after study enrollment |
|
|
|
| Secondary | 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 | Two patients in each arm were lost to followup. | Posted | Count of Participants | Participants | 1 month after study enrollment |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Typical Care | Usual care Typical care: Care to be determined by attending physician | 0 | 25 | 0 | 25 |
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| D009422 | Nervous System Diseases |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |