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

Part of paid clinical trials in Pleasant Hill, California.

Sponsor
Kaiser Permanente
Study ID
NCT07522645
Status
Not Yet Recruiting

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Conditions

  • ASCVD
  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SMS (Initial Outreach) — BEHAVIORAL
    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.
  • Secure Portal Message (Initial Outreach) — BEHAVIORAL
    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.
  • Non-secure Email (Initial Outreach) — BEHAVIORAL
    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.
  • SMS (Follow-up for Non-responders) — BEHAVIORAL
    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.
  • Secure Portal Message (Follow-up for Non-responders) — BEHAVIORAL
    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.
  • Non-secure Email (Follow-up for Non-responders) — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Apr 14, 2026
Status verified
Apr 2026
Primary completion
May 30, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
22,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: SMS/SMS
    Participants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a second SMS.
  • Experimental: SMS/Secure Portal Message
    Participants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a secure portal message.
  • Experimental: SMS/Non-secure Email
    Participants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a non-secure email.
  • Experimental: SMS/Usual Care
    Participants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive no additional outreach (usual care).
  • Experimental: Secure Portal Message/Secure Portal Message
    Participants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a second secure portal message.
  • Experimental: Secure Portal Message/SMS
    Participants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive an SMS (text message).
  • Experimental: Secure Portal Message/Non-secure Email
    Participants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a non-secure email.
  • Experimental: Secure Portal Message/Usual Care
    Participants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive no additional outreach (usual care).
  • Experimental: Non-secure Email/Non-secure Email
    Participants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a second non-secure email.
  • Experimental: Non-secure Email/SMS
    Participants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive an SMS (text message).
  • Experimental: Non-secure Email/Secure Portal Message
    Participants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a secure portal message.
  • Experimental: Non-secure Email/Usual Care
    Participants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive no additional outreach (usual care).
  • No Intervention: Usual Care/Usual Care
    Participants in this arm will receive usual care with no proactive outreach during the study period.

Primary Outcome Measure

Statin refill after message delivery [ Time Frame: Within 14 days after each stage of message delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permenante Northern CaliforniaPleasant HillCalifornia94588
Ankeet Bhatt, MD, MBA, ScM
[email protected]
4154706571

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