NCT07522645

Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease

Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease (ADHERE-ASCVD)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22,000 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the ADHERE-ASCVD study is to evaluate and optimize patient-facing messaging strategies to improve statin refill and adherence among adults with atherosclerotic cardiovascular disease (ASCVD) or diabetes. The main questions it aims to answer are: 1. Do different outreach methods (such as text messages, secure portal messages, or email) increase short-term statin refill compared to usual care? 2. Among patients who do not initially refill their prescription, does changing the outreach method improve refill rates? The team with operational partners will evaluate the comparitive effectivessness of multiple messaging strategies delivered through existing health system communication channels, including SMS (text messaging), secure patient portal messages, non-secure email, and usual care (no additional outreach). Participants * Receive an initial outreach message encouraging statin refill (or usual care) Be monitored for statin refill within 14 days * Potentially receive a second outreach message using the same or a different communication method if they do not initially refill their prescription * Have their medication refill patterns tracked over time, including longer-term adherence outcomes

Detailed description

Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death worldwide. Statins can reduce ASCVD events by 25%, yet nearly half of high-risk adults remain untreated, and adherence is poor. Since statin adherence impacts quality metrics like Medicare Stars ratings, even small gains in refill rates can boost health plan performance. However, no data driven approaches exist to optimize statin adherence. The ADHERE-ASCVD study is a pragmatic, Prospective Randomized Open-label Blinded End-point (PROBE) randomized clinical trial designed to evaluate and optimize patient-facing messaging strategies to improve statin refill and adherence. The project leverages a two-stage Sequential Multiple Assignment Randomized Trial (SMART) design to evaluate both initial outreach strategies and adaptive follow-up approaches among patients with suboptimal statin adherence. In the first stage, eligible participants will be randomized to one of four outreach strategies: secure portal message, SMS (text message), non-secure email, or usual care (no proactive outreach). The primary response window is 14 days following message delivery, during which statin refill will be ascertained using pharmacy dispensing records. Participants who refill within this window will be classified as responders and will not receive further study intervention. Participants who do not refill within 14 days will be classified as non-responders and re-randomized in a second stage to receive one of three follow-up strategies: (1) continued outreach using the same communication modality ("stay"), (2) outreach using an alternative modality ("switch"), or (3) usual care with no additional outreach. For the initial implementation phase, message content will remain consistent across stages within each modality, and the intervention focuses on evaluating modality and sequencing rather than content optimization. The primary estimands correspond to (1) first-stage effects comparing outreach modalities, (2) conditional second-stage effects among non-responders comparing stay, switch, and usual care strategies, and (3) dynamic treatment regime (DTR) effects comparing embedded adaptive sequences of interventions. DTR effects will be estimated using inverse-probability-weighted estimators that account for sequential randomization. In addition to estimating average treatment effects, the study will develop predictive models to characterize treatment effect heterogeneity across patient subgroups. The modeling framework focuses on estimating differences in response across messaging strategies conditional on baseline patient characteristics. Model evaluation will emphasize calibration of predicted treatment contrasts and the identification of clinically meaningful differences between strategies that can inform targeted outreach. This study is designed to generate actionable evidence within a learning health system by identifying optimal messaging strategies and sequences for improving statin refill and adherence, and enabling future deployment of targeted, data-driven outreach approaches.

Conditions

• ASCVD
• Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	SMS (Initial Outreach)	Participants will receive an initial SMS (text message) encouraging statin refill. Messages may include reminder prompts and interactive features implemented through automated keyword-triggered responses that provide refill instructions or educational information.
BEHAVIORAL	Secure Portal Message (Initial Outreach)	Participants will receive an initial secure message through the kp.org patient portal encouraging statin refill. Messages are delivered within the secure portal environment and may include informational and reminder content.
BEHAVIORAL	Non-secure Email (Initial Outreach)	Participants will receive an initial non-secure email encouraging statin refill. Emails may include informational content and reminders but are delivered outside of the secure patient portal.
BEHAVIORAL	SMS (Follow-up for Non-responders)	Participants who do not refill their prescription within 14 days of the initial outreach will receive a follow-up SMS (text message) encouraging statin refill. Messages may include reminder prompts and interactive features implemented through automated keyword-triggered responses that provide refill instructions or educational information.
BEHAVIORAL	Secure Portal Message (Follow-up for Non-responders)	Participants who do not refill their prescription within 14 days of the initial outreach will receive a follow-up secure portal message through the kp.org patient portal encouraging statin refill. Messages are delivered within the secure portal environment and may include informational and reminder content.
BEHAVIORAL	Non-secure Email (Follow-up for Non-responders)	Participants who do not refill their prescription within 14 days of the initial outreach will receive a follow-up non-secure email encouraging statin refill. Emails may include informational content and reminders but are delivered outside of the secure patient portal.

Timeline

• Start date: 2026-04-14
• Primary completion: 2026-05-30
• Completion: 2028-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States