Impact of an Electronic Health Record-Based Interruptive Alert 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 nearly 20%-30% of referrals from primary care to neurology. In primary care, electronic health record-based alerts offer a mechanism to 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' overall headache management. Methods: We conducted a stratified cluster-randomized study across 38 primary care clinic sites between December 2021 to December 2022 at a large integrated health care delivery system in the United States. Clinics were stratified into 6 blocks based on region and patient-to-health care provider ratios and then 1:1 randomized within each block into either the control or intervention. Health care providers practicing at intervention clinics received an interruptive alert in the electronic health record. The primary end point was a change in headache burden, measured using the Headache Impact Test 6 scale, from baseline to 6 months. Secondary outcomes included changes in headache frequency and intensity, access to care, and resource use. 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 Test 6 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 alerts by health care providers prompts future alterations of the alert and exploration of alternative approaches.