ASCVDADHERE-ASCVDNCT07522645
Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease
A study testing SMS (Initial Outreach), Secure Portal Message (Initial Outreach) and Non-secure Email (Initial Outreach) in people with ASCVD and Diabetes, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SMS (Initial Outreach), Secure Portal Message (Initial Outreach) and Non-secure Email (Initial Outreach)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Statin adherence <80% in the prior 12 months
- Active kp.org account within the past 12 months
- Valid email address and text-capable phone number on file
Who cannot join
- Documented allergic reaction or contraindication to statin therapy
- Receiving hospice care
- Medicare beneficiaries
- Other exclusions applied per operational standard practice
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permenante Northern California
Pleasant Hill, California, 94588
About this study
Official title: Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease (ADHERE-ASCVD)
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:
Read more
- Do different outreach methods (such as text messages, secure portal messages, or email) increase short-term statin refill compared to usual care?
- 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
Read the 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.
- Being tested
- SMS (Initial Outreach), Secure Portal Message (Initial Outreach), Non-secure Email (Initial Outreach), SMS (Follow-up for Non-responders), Secure Portal Message (Follow-up for Non-responders)
- Keywords
- ASCVD, ASCVD management, statin therapy, statin, SMART design, messaging strategies, patient outreach
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS (Initial Outreach)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| SMS/SMS | Experimental | 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. Receives: Behavioral: SMS (Initial Outreach); Behavioral: SMS (Follow-up for Non-responders) |
| SMS/Secure Portal Message | Experimental | 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. Receives: Behavioral: SMS (Initial Outreach); Behavioral: Secure Portal Message (Follow-up for Non-responders) |
| SMS/Non-secure Email | Experimental | 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. Receives: Behavioral: SMS (Initial Outreach); Behavioral: Non-secure Email (Follow-up for Non-responders) |
| SMS/Usual Care | Experimental | 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). Receives: Behavioral: SMS (Initial Outreach) |
| Secure Portal Message/Secure Portal Message | Experimental | 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. Receives: Behavioral: Secure Portal Message (Initial Outreach); Behavioral: Secure Portal Message (Follow-up for Non-responders) |
| Secure Portal Message/SMS | Experimental | 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). Receives: Behavioral: Secure Portal Message (Initial Outreach); Behavioral: SMS (Follow-up for Non-responders) |
| Secure Portal Message/Non-secure Email | Experimental | 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. Receives: Behavioral: Secure Portal Message (Initial Outreach); Behavioral: Non-secure Email (Follow-up for Non-responders) |
| Secure Portal Message/Usual Care | Experimental | 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). Receives: Behavioral: Secure Portal Message (Initial Outreach) |
| Non-secure Email/Non-secure Email | Experimental | 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. Receives: Behavioral: Non-secure Email (Initial Outreach); Behavioral: Non-secure Email (Follow-up for Non-responders) |
| Non-secure Email/SMS | Experimental | 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). Receives: Behavioral: Non-secure Email (Initial Outreach); Behavioral: SMS (Follow-up for Non-responders) |
| Non-secure Email/Secure Portal Message | Experimental | 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. Receives: Behavioral: Non-secure Email (Initial Outreach); Behavioral: Secure Portal Message (Follow-up for Non-responders) |
| Non-secure Email/Usual Care | Experimental | 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). Receives: Behavioral: Non-secure Email (Initial Outreach) |
| Usual Care/Usual Care | No intervention | Participants in this arm will receive usual care with no proactive outreach during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 14 days after each stage of message delivery
Secondary outcomes (4)
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
Measured: Up to 30 days after each stage of message delivery
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.
Measured: Within 30 days after message delivery
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.
Measured: At 6 months and 12 months post randomization.
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%.
Measured: At 6 months and 12 months post randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start14 Apr 2026
- Primary completion12 May 2026
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ASCVDStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Two-stage, sequential multiple assignment randomized trial (SMART)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 22,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522645
- Sponsor's protocol ID
- ADHERE-ASCVD
- Acronym
- ADHERE-ASCVD
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatt AS, Liu VX, Sun B, Apostol-Largeteau M, Marafino BJ, Amiri M, Tran DL, Ambrosy AP, Dinh HH, Finn L, Watt P, Au J, Nadella J, Jesani N, Digitale JC, Biering-Sorensen T, Claggett BL, Solomon SD, Vaduganathan M, Go AS, Ku IA, Manthripragada G, Yee K, Lee K, Khan M; ADHERE-ASCVD Investigators. Digital Outreach to Improve Statin Refills in Patients With Low Statin Adherence: The ADHERE-ASCVD Randomized Clinical Trial. JAMA. 2026 Aug 29. doi: 10.1001/jama.2026.16372. Online ahead of print.
PubMed 42667613
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease (ADHERE-ASCVD)
- ClinicalTrials.gov ID
- NCT07522645
- Acronym / sponsor ID
- ADHERE-ASCVD / ADHERE-ASCVD
- Keywords
- ASCVD, ASCVD management, statin therapy, statin, SMART design, messaging strategies, patient outreach
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do different outreach methods (such as text messages, secure portal messages, or email) increase short-term statin refill compared to usual care?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 13
- Model description
- Two-stage, sequential multiple assignment randomized trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| SMS/SMS | Experimental | Behavioral: SMS (Initial Outreach), Behavioral: SMS (Follow-up for Non-responders)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. |
| SMS/Secure Portal Message | Experimental | Behavioral: SMS (Initial Outreach), Behavioral: Secure Portal Message (Follow-up for Non-responders)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. |
| SMS/Non-secure Email | Experimental | Behavioral: SMS (Initial Outreach), Behavioral: Non-secure Email (Follow-up for Non-responders)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. |
| SMS/Usual Care | Experimental | Behavioral: SMS (Initial Outreach)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). |
| Secure Portal Message/Secure Portal Message | Experimental | Behavioral: Secure Portal Message (Initial Outreach), Behavioral: Secure Portal Message (Follow-up for Non-responders)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. |
| Secure Portal Message/SMS | Experimental | Behavioral: Secure Portal Message (Initial Outreach), Behavioral: SMS (Follow-up for Non-responders)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). |
| Secure Portal Message/Non-secure Email | Experimental | Behavioral: Secure Portal Message (Initial Outreach), Behavioral: Non-secure Email (Follow-up for Non-responders)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. |
| Secure Portal Message/Usual Care | Experimental | Behavioral: Secure Portal Message (Initial Outreach)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). |
| Non-secure Email/Non-secure Email | Experimental | Behavioral: Non-secure Email (Initial Outreach), Behavioral: Non-secure Email (Follow-up for Non-responders)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. |
| Non-secure Email/SMS | Experimental | Behavioral: Non-secure Email (Initial Outreach), Behavioral: SMS (Follow-up for Non-responders)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). |
| Non-secure Email/Secure Portal Message | Experimental | Behavioral: Non-secure Email (Initial Outreach), Behavioral: Secure Portal Message (Follow-up for Non-responders)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. |
| Non-secure Email/Usual Care | Experimental | Behavioral: Non-secure Email (Initial Outreach)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). |
| Usual Care/Usual Care | No intervention | –Participants in this arm will receive usual care with no proactive outreach during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Statin adherence <80% in the prior 12 months
Key exclusion criteria (4 listed)
- Documented allergic reaction or contraindication to statin therapy
- Receiving hospice care
- Medicare beneficiaries
- Other exclusions applied per operational standard practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | SMS/Non-secure Email, SMS/SMS, SMS/Secure Portal Message, SMS/Usual Care |
| 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. | Behavioural | Secure Portal Message/Non-secure Email, Secure Portal Message/SMS, Secure Portal Message/Secure Portal Message, Secure Portal Message/Usual Care |
| 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. | Behavioural | Non-secure Email/Non-secure Email, Non-secure Email/SMS, Non-secure Email/Secure Portal Message, Non-secure Email/Usual Care |
| 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. | Behavioural | Non-secure Email/SMS, SMS/SMS, Secure Portal Message/SMS |
| 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. | Behavioural | Non-secure Email/Secure Portal Message, SMS/Secure Portal Message, Secure Portal Message/Secure Portal Message |
| 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. | Behavioural | Non-secure Email/Non-secure Email, SMS/Non-secure Email, Secure Portal Message/Non-secure Email |
Primary outcome
Statin refill after message delivery
Time frame: Within 14 days after each stage of 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.
4 secondary outcomes
Time to statin refill
Time frame: Up to 30 days after each stage of message delivery
Statin refill
Time frame: Within 30 days after message delivery
Statin persistence
Time frame: At 6 months and 12 months post randomization.
Statin adherence (proportion of days covered)
Time frame: At 6 months and 12 months post randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 42667613Bhatt AS, Liu VX, Sun B, Apostol-Largeteau M, Marafino BJ, Amiri M, Tran DL, Ambrosy AP, Dinh HH, Finn L, Watt P, Au J, Nadella J, Jesani N, Digitale JC, Biering-Sorensen T, Claggett BL, Solomon SD, Vaduganathan M, Go AS, Ku IA, Manthripragada G, Yee K, Lee K, Khan M; ADHERE-ASCVD Investigators. Digital Outreach to Improve Statin Refills in Patients With Low Statin Adherence: The ADHERE-ASCVD Randomized Clinical Trial. JAMA. 2026 Aug 29. doi: 10.1001/jama.2026.16372. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS (Initial Outreach), Secure Portal Message (Initial Outreach) and Non-secure Email (Initial Outreach) in people with ASCVD and Diabetes, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statin refill after message delivery (time frame: Within 14 days after each stage of message delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.