The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.
Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),
Are in stage 2 CKM: the presence of metabolic risk factors (hypertension [stages 1 and 2], hypertriglyceridemia [≥135 mg/dL], diabetes, Metabolic Equivalents (MetS)*) and/or Chronic Kidney Disease (CKD) [moderate- to high-risk CKD which are stages 1-3 CKD]), and
Receive primary care at Johns Hopkins Community Physicians (JHCP).
Access to smart phone or tablet to use app.
Have diagnosis of CVD,
Stage 4-5 CKD, kidney failure, or on dialysis
Have a serious medical condition such as cancer;
On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;
Parallel
Team-based shared decision-making
Combination product1. Patients use the Healthy Heart Patient Decision Aid (PtDA) to prepare for the SDM and track progress: Patients will use the Healthy Heart to self-assess baseline LE8 scores, medication adherence, preferences, and Social Determinants of Health (SDOH) before meeting with pharmacist and primary care providers (PCPs). 2. Pharmacist-led telehealth SDM visits focus on medication management and lifestyle modifications. The baseline telehealth visit (30-45 minutes) will provide participants with SDM training and the use of Healthy Heart PtDA and assess patients' medications and lifestyle. Follow-up telehealth visits (30 minutes) will be conducted biweekly in the first 2 months and monthly in 3-6 months. Follow-ups will discuss available options, goals, and strategies tailored to the patient's needs and preferences based on the AHA's CKM management algorithm for stage 2 CKM.4 Pharmacist will engage patients in discussions about alternative medication options for metabolic risk factors.
Life's Essential 8 (LE8)
Change in mean LE8 scores from baseline to 6 months post-randomization compared to usual care. LE8 scores ranged from 0 to 100, with higher scores indicating better cardiovascular health.
Health-related quality of life as assessed by the Short Form Health Survey - 12
Patient-centered and patient-reported outcomes - health-related quality of life as measured by the 12-item Short Form Health Survey (SF-12). The SF-12 scores ranged from 0 to 100 and higher scores indicate better health.
Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18
The Patient Satisfaction Questionnaire (PSQ-18) Short Form. The PSQ-18 scores ranged from 18 to 90, and higher scores reflect better satisfaction with medical care.
Shared Decision-Making (SDM) level as assessed by the Collaborate survey
Shared Decision-Making (SDM) level will be measured by the CollaboRATE survey. The CollaboRATE scores ranged from 0-27, with higher scores indicating better SDM level.
Medication adherence as assessed by the Medication Adherence Report Scale -10
Mean scores of medication adherence assessed by the Medication Adherence Report Scale-10 (MARS-10). Scores range from 0 to 50, or 0 to 10 depending on the exact scoring format used. Higher scores consistently indicate a higher level of medication adherence.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
