Impact of an Electronic Health Record-Based InterruptiveAlert Among Patients With Headaches Seen in Primary Care:Cluster Randomized Controlled Trial

Background: Headaches, including migraines, are one of the most common causes of disability and account for nearly20%-30% of referrals from primary care to neurology. In primary care, electronic health record-based alerts offer a mechanismto influence health care provider behaviors, manage neurology referrals, and optimize headache care. Objective: This project aimed to evaluate the impact of an electronic alert implemented in primary care on patients' overallheadache management. Methods: We conducted a stratified cluster-randomized study across 38 primary care clinic sites between December 2021to December 2022 at a large integrated health care delivery system in the United States. Clinics were stratified into 6 blocksbased on region and patient-to-health care provider ratios and then 1:1 randomized within each block into either the controlor intervention. Health care providers practicing at intervention clinics received an interruptive alert in the electronic healthrecord. The primary end point was a change in headache burden, measured using the Headache Impact Test 6 scale, frombaseline to 6 months. Secondary outcomes included changes in headache frequency and intensity, access to care, and resourceuse. We analyzed the difference-in-differences between the arms at follow-up at the individual patient level. Results: We enrolled 203 adult patients with a confirmed headache diagnosis. At baseline, the average Headache Impact Test6 scores in each arm were not significantly different (intervention: mean 63, SD 6.9; control: mean 61.8, SD 6.6; P=.21).We observed a significant reduction in the headache burden only in the intervention arm at follow-up (3.5 points; P=.009).The reduction in the headache burden was not statistically different between groups (difference-in-differences estimate -1.89,95% CI -5 to 1.31; P=.25). Similarly, secondary outcomes were not significantly different between groups. Only 11.32%(303/2677) of alerts were acted upon. Conclusions: The use of an interruptive electronic alert did not significantly improve headache outcomes. Low use of alertsby health care providers prompts future alterations of the alert and exploration of alternative approaches. Trial Registration: ClinicalTrials.gov NCT05067725; https://clinicaltrials.gov/study/NCT05067725