Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health

Early Phase 1Not Yet RecruitingNCT07662616

Johns Hopkins University94 enrolled

Overview

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.

The investigators proposed a novel team-based shared decision-making (SDM) program. The overall goal of this proposal is to conduct a pilot randomized controlled trial to evaluate the SDM intervention compared to usual care among 94 adult patients with cardiometabolic factors and cardiovascular-kidney-metabolic (CKM) syndrome at a primary care clinic in Maryland. Participants in the intervention group will receive the 6-month intervention and usual care, while those in the control group will receive usual care. Specific aims include: Aim 1: To evaluate the feasibility of the Team-Based SDM Program. Feasibility outcomes include recruitment, retention, intervention adherence, and fidelity. Aim 2: To assess the preliminary efficacy of the Team-Based SDM Program versus usual care in improving clinical, patient-reported, and patient-centered outcomes at 12 weeks post-intervention Aim 3: To examine the preliminary efficacy of the Team-Based SDM Program versus usual care in improving patients' life's essential 8 and medication adherence from baseline to 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Interventions

Team-based shared decision-makingCOMBINATION_PRODUCT

1. 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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Have cognitive impairment; * Are currently involved in other programs on improving LE8; or * Unwillingness to provide informed consent * Unable to speak, read, or communicate in English.

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.