Clinical Decision Support for Patient Migraine Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Decision Support for Patient Migraine Management

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: Clinical Decision Support Tool
* Behavioral: Headache Education


Participation Criteria
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Eligibility Criteria
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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 Are currently prescribed a triptan for acute migraine management Are stable on current preventive and acute treatment regimen for migraine Are between the ages of 18 and 65 Reads and understands English Has capacity to consent Completes 80% of diary recordings in the first 30 days of monitoring Exclusion Criteria: Probable or confirmed medication overuse headache A plan to change, or changing preventive or acute migraine medication during study participation Are pregnant or are planning to become pregnant during study involvement (as triptans are Category C medications) Psychiatric illness or cognitive difficulties that would interfere with participation in the study Participated in the pilot development of the intervention evaluated by this research protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Decision Support Tool<br>Tailored education provided via a smartphone application | Behavioral: Clinical Decision Support Tool<br>* Tailored education provided via a smartphone application.<br>|
| Active Comparator: Headache Education<br>Non-tailored education provided via a smartphone application. | Behavioral: Headache Education<br>* Non-tailored education provided via a smartphone application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Acute Migraine Management Strategies: Treat Early | 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. | Month 6 of the Treatment | 
| Adherence to Acute Migraine Management Strategies: Overuse | 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. | Month 6 of the Treatment | 
| Adherence to Preventive Behavioral Strategies | Number of adherent days/month | Month 6 of the Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to preventive medication | Number of adherent days/month | Month 6 of the Treatment | 
| Headache days | Number of headache days/month | Month 6 of the Treatment | 
| Average head pain | Average of daily head pain assessments/month | Month 6 of the Treatment | 
| Migraine-Related Disability | 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. | Month 6 of the Treatment | 
| Migraine-Specific Quality of Life | 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. | Month 6 of the Treatment | 
| Pain Interference | 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. | Month 6 of the Treatment |