Messaging Strategies for Cardiovascular Disease

(ADHERE-ASCVD Trial)

Overseen By Mirasol M Apostol-Largeteau, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Statins

Disqualifiers: Allergy to statins, Hospice, Medicare, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

Inclusion Criteria

6. Active kp.org account within the past 12 months

I have a valid email and a phone that can receive texts.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Outreach

Participants receive an initial outreach message encouraging statin refill, with a 14-day window to refill

2 weeks

Remote monitoring

Follow-up Outreach

Non-responders receive a second outreach message using the same or different communication method

2 weeks

Remote monitoring

Follow-up

Participants are monitored for statin refill and adherence outcomes over a longer term

6-12 months

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Secure Portal Message/Usual Care Experimental Treatment 1 Intervention

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).

Group II: Secure Portal Message/Secure Portal Message Experimental Treatment 2 Interventions

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.

Group III: Secure Portal Message/SMS Experimental Treatment 2 Interventions

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).

Group IV: Secure Portal Message/Non-secure Email Experimental Treatment 2 Interventions

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.

Group V: SMS/Usual Care Experimental Treatment 1 Intervention

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).

Group VI: SMS/Secure Portal Message Experimental Treatment 2 Interventions

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.

Group VII: SMS/SMS Experimental Treatment 2 Interventions

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.

Group VIII: SMS/Non-secure Email Experimental Treatment 2 Interventions

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.

Group IX: Non-secure Email/Usual Care Experimental Treatment 1 Intervention

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).

Group X: Non-secure Email/Secure Portal Message Experimental Treatment 2 Interventions

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.

Group XI: Non-secure Email/SMS Experimental Treatment 2 Interventions

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).

Group XII: Non-secure Email/Non-secure Email Experimental Treatment 2 Interventions

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.

Group XIII: Usual Care/Usual Care Active Control 1 Intervention

Participants in this arm will receive usual care with no proactive outreach during the study period.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+