Using Artificially Intelligent Text Messaging Technology to Improve American Heart Association's Life's Essential 8 Health Behaviors: LE8 Bot + Backup
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- University of Colorado, Denver
- Enrollment
- 2100
- Locations
- 3
- Primary Endpoint
- Change in Life's Essential 8 risk score
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking.
This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes.
The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes.
The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center.
The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease.
Detailed Description
Our goal is to improve control of cardiovascular (CV) disease risk factors by engaging patients experiencing health disparities in an innovative technology-based self-management intervention with linkages to health system providers. The investigators will focus on the American Heart Association's Life's Essential 8 (LE8) lifestyle factors (blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking), that when uncontrolled lead to common co-existing chronic conditions (e.g., hypertension, diabetes), morbidity, health care costs and death. Patients disproportionately affected by these risk factors (e.g., Black, Hispanic/Latino), have worse disease control with greater adverse sequelae (e.g., heart attacks and death). Self-management is an individual's role in managing chronic disease and has strong evidence of benefit. It includes self-care, a healthy lifestyle (e.g., being physically active), taking medications as prescribed and managing exacerbations of chronic condition(s). Self-management for patients experiencing disparities is enhanced when programs recognize patient context and sociocultural factors that may modify healthy behavior. Self-management can be further enriched when patients are directly supported by their health care provider. Ample evidence shows text messaging can impact self-management behaviors, with the advantage of being universally available through mobile phones. Emerging technologies utilize artificially intelligent (AI) chatbots for the delivery of text messages have the promise of improving the impact of text messaging, particularly if they integrate evidence based communication strategies, including tailoring, behavioral nudges that support intuitive decision-making, and persuasive messaging. These strategies can optimize message content beyond generic, "one size fits all" communication. It is unknown if AI chatbot text messaging with linkages to providers can improve self-management support in large diverse patient populations. Using a patient level randomized pragmatic trial in 3 health systems caring for large patient populations experiencing health disparities, the investigators will test the comparative effectiveness of theory-based, tailored and socially contextualized communications for self-management support. Patients with CV disease risk factors will be randomized to 1 of 3 automated communication approaches: 1) generic text messages; 2) interactive AI chatbot text messaging leveraging evidenced-based communication strategies with attention to patient context and sociocultural factors influencing self-management; or 3) interactive AI chatbot text messaging plus proactive pharmacist management. Our goal is to increase patient self-management autonomy, competence, and relatedness to health systems, leading to improved and sustained health behaviors, better disease control and improved patient outcomes. The primary effectiveness outcome will be an improved LE8 health score. The investigators will partner with: 1) Salud Family Health Centers, a Federally Qualified Health Center (FQHC) with 13 clinics across Colorado, 2) Denver Health and Hospital Authority, a safety net health system with 9 FQHC clinics, and 3) STRIDE Community Health Center, a FQHC with18 locations surrounding Denver county. The investigators will enroll diverse patients including: Black, Hispanic/Latino, low-income, Spanish speaking-only and rural patients with at least one LE8 factor in the poor/intermediate health category and poor adherence to CV medications. Patients will be identified using demographic, clinical and pharmacy EHR data from each health system. In Year 1 (UG3 phase), applying the Health Equity in Implementation Framework, the investigators will partner with patients, providers, community advocates and health systems stakeholders to develop the AI chatbot infrastructure and message content relevant to the patient population using an intervention mapping approach; assess how best to integrate the intervention within each health system's existing CV prevention programs; and conduct a pilot study of the intervention. In Years 2-5 (UH3 phase), the investigators will conduct a pragmatic patient randomized trial. Aim 1 (UG3; Year 1): Iteratively update the infrastructure and expand content for the AI text message chatbot with attention to social determinants of health and sociocultural contextual relevant to the target population through stakeholder engaged N-of-1 and focus group interviews and nominal group sessions. Aim 2 (UG3; Year 1): Conduct a randomized pilot to demonstrate feasibility of intervention delivery and outcomes data collection to assess preliminary effects and to refine the intervention prior to widespread implementation Aim 3 (UH3; Years 2-5): Conduct a pragmatic patient-level randomized intervention of 3 text messaging delivery strategies for self-management support of CV risk factors. Primary outcome will be change in LE8 health score. Secondary effectiveness outcomes will include individual components of the LE8 lifestyle factors, Framingham risk score, self-efficacy, medication adherence, clinical outcomes (e.g., CV related hospitalizations), and healthcare utilization. Aim 4 (UH3; Years 2-5): Evaluate the intervention using PRISM and a mixed methods approach to evaluate pragmatic clinical and implementation outcomes (reach, effectiveness, adoption, implementation, and maintenance) with an emphasis on equity and representativeness, and systematically assess contextual influences to inform sustainment and future tailoring, adaptations, and dissemination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosis of one or more of the following CV risk factors (i.e., hypertension, diabetes or hyperlipidemia); and
- •the risk factor is at poor or intermediate health levels as defined by LE8 (e.g., BP\>140/90 mm Hg); and
- •the patient exhibits poor adherence to prescribed medication to treat the CV risk factor as defined by a delay in refilling the medication within the past 6 months.
Exclusion Criteria
- •patients who do not have cellphone; or
- •enrolled in hospice or palliative care; or
- •Non-English or Spanish speaking; or
- •enrolled in another clinical trial if denoted in the EHR.
Outcomes
Primary Outcomes
Change in Life's Essential 8 risk score
Time Frame: Baseline and 12 months after randomization
The primary outcome is change in Life's Essential 8 risk score from baseline and 12 months following randomization. The Life's Essential 8 (LE8) is a cardiovascular health score that uses a 0-100 scale. The score is calculated based on a participant's adherence to eight healthy lifestyle components: diet, physical activity, smoking habits, body mass index, total cholesterol, blood sugar, blood pressure, and sleep. Each component has scoring algorithm ranging from 0 to 100 points, allowing generation of a composite cardiovascular health score (the unweighted average of all components) that also varies from 0 to 100 points. 0 will indicate the lowest cardiovascular health scores and 100 will indicate the highest cardiovascular health scores.
Secondary Outcomes
- Self-Efficacy for Managing Chronic Diseases(Baseline and 12 months after randomization)
- Sleep (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Total cholesterol (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Blood pressure (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Blood sugar (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Smoking habits (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Health diet pattern (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Number of medication refill gaps (Medication adherence)(Baseline and 12 months after randomization)
- Clinic events(Baseline and 12 months after randomization)
- Body Mass Index (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Physical activity (Individual Life's Essential 8 components)(Baseline and 12 months after randomization)
- Cost(Baseline and 12 months after randomization)
- Length of refill gaps (Medication adherence)(Baseline and 12 months after randomization)
- Risk Score for Recurrent Coronary Heart Disease, Framingham Risk Score(Baseline and 12 months after randomization)
- Rate of routine clinical visits and/or other procedures associated with the clinical condition(Baseline and 12 months after randomization)
- Risk Score for Coronary Heart Disease (2-year risk) - First Event, Framingham Risk Score(Baseline and 12 months after randomization)