Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease (ADHERE-ASCVD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22,000
- 试验地点
- 1
- 主要终点
- Statin refill after message delivery
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Documented allergic reaction or contraindication to statin therapy
- •Receiving hospice care
- •Medicare beneficiaries
- •Other exclusions applied per operational standard practice
研究组 & 干预措施
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.
干预措施: SMS (Initial Outreach) (Behavioral)
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.
干预措施: SMS (Initial Outreach) (Behavioral)
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.
干预措施: SMS (Follow-up for Non-responders) (Behavioral)
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.
干预措施: Secure Portal Message (Follow-up for Non-responders) (Behavioral)
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).
干预措施: SMS (Follow-up for Non-responders) (Behavioral)
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).
干预措施: Non-secure Email (Initial Outreach) (Behavioral)
Usual Care/Usual Care
Participants in this arm will receive usual care with no proactive outreach during the study period.
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.
干预措施: Non-secure Email (Follow-up for Non-responders) (Behavioral)
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).
干预措施: SMS (Follow-up for Non-responders) (Behavioral)
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.
干预措施: Non-secure Email (Initial Outreach) (Behavioral)
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.
干预措施: Non-secure Email (Initial Outreach) (Behavioral)
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.
干预措施: SMS (Initial Outreach) (Behavioral)
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.
干预措施: Non-secure Email (Follow-up for Non-responders) (Behavioral)
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).
干预措施: SMS (Initial Outreach) (Behavioral)
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.
干预措施: Secure Portal Message (Initial Outreach) (Behavioral)
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.
干预措施: Secure Portal Message (Follow-up for Non-responders) (Behavioral)
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).
干预措施: Secure Portal Message (Initial Outreach) (Behavioral)
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.
干预措施: Secure Portal Message (Initial Outreach) (Behavioral)
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).
干预措施: Secure Portal Message (Initial Outreach) (Behavioral)
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.
干预措施: Non-secure Email (Follow-up for Non-responders) (Behavioral)
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).
干预措施: Non-secure Email (Initial Outreach) (Behavioral)
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.
干预措施: Secure Portal Message (Follow-up for Non-responders) (Behavioral)
结局指标
主要结局
Statin refill after message delivery
时间窗: 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.
次要结局
- Time to statin refill(Up to 30 days after each stage of message delivery)
- Statin refill(Within 30 days after message delivery)
- Statin persistence(At 6 months and 12 months post randomization.)
- Statin adherence (proportion of days covered)(At 6 months and 12 months post randomization.)