CDST: Clinical Decision Support for Patient Migraine Management
Study Details
Study Description
Brief Summary
Little is known about who adheres to migraine management strategies, and circumstances that enhance adherence. This knowledge is required to develop patient-level interventions to improve adherence to migraine management strategies. The proposed project will pilot the first patient level intervention designed to improve adherence to preventive and acute migraine management strategies. The study will identify people most at risk for non-adherence to migraine management strategies. Participants will be randomly assigned to receive a tailored clinical decision support tool or education intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Participants with a diagnosis with migraine who currently meet criteria for episodic migraine (migraine with headaches that occur on fewer than 15 days per month) will be recruited from local providers. After an initial screening, eligible participants will complete 30 days of monitoring 3 times daily on an electronic headache diary (a smartphone app) to confirm study eligibility. Participants whose eligibility is confirmed will complete an additional 2 months (60 days) of monitoring headache activity and adherence to acute and preventive (medication and behavioral) strategies recommended for people with migraine. Participants who show suboptimal adherence during the first 3 months of monitoring (<50% of eligible days) will be eligible to continue to the intervention component of the study. Participants who choose to continue in the study will be randomized to receive a tailored clinical decision support tool or education intervention, both delivered through the smartphone app. Participants will continue to self-monitor, with the intervention components active, for 3 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Clinical Decision Support Tool Tailored education provided via a smartphone application |
Behavioral: Clinical Decision Support Tool
Tailored education provided via a smartphone application.
|
| Active Comparator: Headache Education Non-tailored education provided via a smartphone application. |
Behavioral: Headache Education
Non-tailored education provided via a smartphone application.
|
Outcome Measures
Primary Outcome Measures
- Adherence to Acute Migraine Management Strategies: Treat Early [Month 6 of the Treatment]
When participants record headache activity they are asked about the type of headache and the level of pain they were experiencing when they took their Migraine Specific Medication (MSM). A headache episode is coded as "Treat Early" if a participant took their MSM when the pain is mild (as opposed to moderate or severe). Number of Treat Early is reported.
- Adherence to Acute Migraine Management Strategies: Overuse [Month 6 of the Treatment]
Number of days per month that Migraine Specific Medication is used is taken directly from diary recordings. Overuse is considered taking MSM more than 10 times in a month. Total overuse is reported.
- Adherence to Preventive Behavioral Strategies [Month 6 of the Treatment]
Number of adherent days/month
Secondary Outcome Measures
- Adherence to preventive medication [Month 6 of the Treatment]
Number of adherent days/month
- Headache days [Month 6 of the Treatment]
Number of headache days/month
- Average head pain [Month 6 of the Treatment]
Average of daily head pain assessments/month
- Migraine-Related Disability [Month 6 of the Treatment]
Migraine Disability Assessment (MIDAS) measures migraine-related functional impairment. Total score ranges from 0 - 270, higher scores indicate higher degrees of impairment. Scores of 21 and above are considered "severe" levels of migraine-related disability.
- Migraine-Specific Quality of Life [Month 6 of the Treatment]
Migraine-Specific Quality of Life Questionnaire ( v2.1), measures migraine-related quality of life. Total score ranges from 14-84, higher scores indicate lower migraine-related quality of life.
- Pain Interference [Month 6 of the Treatment]
PROMIS (Patient-Reported Outcomes Measurement Information System) - Pain Interference measures the self-reported consequences of pain on relevant aspects of one's life. Total score ranges from 6 - 30, higher scores indicate more interference with activities.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have an International Classification of Headache Disorders - 3 beta diagnosis of migraine
-
Self-report and diary-confirmed 6 to 14 headache days per month
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Are currently prescribed a triptan for acute migraine management
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Are stable on current preventive and acute treatment regimen for migraine
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Are between the ages of 18 and 65
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Reads and understands English
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Has capacity to consent
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Completes 80% of diary recordings in the first 30 days of monitoring
Exclusion Criteria:
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Probable or confirmed medication overuse headache
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A plan to change, or changing preventive or acute migraine medication during study participation
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Are pregnant or are planning to become pregnant during study involvement (as triptans are Category C medications)
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Psychiatric illness or cognitive difficulties that would interfere with participation in the study
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Participated in the pilot development of the intervention evaluated by this research protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albert Einstein College of Medicine | Bronx | New York | United States | 10461 |
Sponsors and Collaborators
- Albert Einstein College of Medicine
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Elizabeth Seng, PhD, Albert Einstein College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-5743
- 1K23NS096107-01