Impact of an Electronic Health Record based Interruptive Alert among Patients with Headaches seen in Primary Care: A Cluster Randomized Controlled Trial (Preprint)

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. Electronic health record-based alerts have been used in the past within primary care with varying degree of success to influence provider behaviors in multiple disease states except for headaches. OBJECTIVE The aim of this project was 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 healthcare delivery system in the United States. Clinics were stratified into six blocks based on region and patient-to-provider ratios and then 1:1 randomized within each block into either control or intervention. Providers practicing at intervention clinics received an interruptive alert in the electronic health record. The primary endpoint was a change in headache burden, measured using the Headache Impact Test 6 (HIT-6) scale, from baseline to six months. Secondary outcomes included change in headache frequency and intensity, access to care, and resource utilization. The analysis was performed to assess the difference in difference outcomes 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 HIT-6 scores (standard deviation) in each arm were not significantly different (Intervention – 63 (+- 6.9) vs. Control - 61.8 (+- 6.6), P= .21). We observed a significant reduction in the headache burden only in the intervention arm at follow-up (3.5-point, P= .009). The reduction in the headache burden was not statistically different between groups (difference-in-difference estimate: -1.89 (95% confidence interval -5.0, 1.31; P= .25). Similarly, secondary outcomes were not significantly different between groups. Only 11% of alerts were acted upon. CONCLUSIONS The use of an interruptive electronic alert did not significantly improve headache outcomes. Low use of alerts by providers prompts future alterations of the alert and exploration of alternative approaches. CLINICALTRIAL Registered at clinicaltrials.gov as registration number NCT05067725.