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

ConditionsASCVDDiabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Permanente

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Active Kaiser Permanente Northern California (KPNC) membership

Diagnosis of atherosclerotic cardiovascular disease (ASCVD) or diabetes and inclusion in the Preventing Heart Attacks and Strokes Everyday (PHASE) Registry

No statin prescription fill within the prior 3 months

Disqualifiers

Documented allergic reaction or contraindication to statin therapy

Receiving hospice care

Medicare beneficiaries

Other exclusions applied per operational standard practice

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

22,000 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: SMS/SMSExperimental treatment 2 interventions
Group B: SMS/Secure Portal MessageExperimental treatment 2 interventions
Group C: SMS/Non-secure EmailExperimental treatment 2 interventions
Group D: SMS/Usual CareExperimental treatment 1 intervention
Group E: Secure Portal Message/Secure Portal MessageExperimental treatment 2 interventions
Group F: Secure Portal Message/SMSExperimental treatment 2 interventions
Group G: Secure Portal Message/Non-secure EmailExperimental treatment 2 interventions
Group H: Secure Portal Message/Usual CareExperimental treatment 1 intervention
Group I: Non-secure Email/Non-secure EmailExperimental treatment 2 interventions
Group J: Non-secure Email/SMSExperimental treatment 2 interventions
Group K: Non-secure Email/Secure Portal MessageExperimental treatment 2 interventions
Group L: Non-secure Email/Usual CareExperimental treatment 1 intervention
Group M: Usual Care/Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Statin refill after message delivery

Proportion of participants who refill a statin prescription following message delivery (first-stage intervention) or, among non-responders, following second-stage messaging. Refill status will be determined using pharmacy dispensing records.

Time frame
Within 14 days after each stage of message delivery

Secondary outcomes

1

Time to statin refill

Time from message delivery (first-stage or second-stage, as applicable) to statin refill, measured using pharmacy dispensing records. Participants who do not refill will be censored at disenrollment, death, or end

Time frame
Up to 30 days after each stage of message delivery
2

Statin refill

Proportion of participants who refill a statin prescription following message delivery (first-stage or second-stage, as applicable), based on pharmacy dispensing records.

Time frame
Within 30 days after message delivery
3

Statin persistence

Proportion of participants who remain persistent with statin therapy, defined as continuous statin use without a gap exceeding 60 days between prescription fills.

Time frame
At 6 months and 12 months post randomization.
4

Statin adherence (proportion of days covered)

Adherence to statin therapy measured as the proportion of days covered (PDC), defined as the number of days with statin supply available divided by the number of days in the observation period. Adherence will be assessed as both a continuous measure and as a binary indicator using a threshold of ≥80%.

Time frame
At 6 months and 12 months post randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaiser Permanente

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: