Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Team-based shared decision-making.
- Who it may be relevant to
- Registry conditions: Hypertension (HTN), Diabetes (DM), Hyperlipidaemia, Kidney Disease. Basic parameters: 30 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health
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.
Detailed description
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.
Interventions
- Combination product Team-based shared decision-making
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
Primary outcome measures
- Life's Essential 8 (LE8) [Time frame: 6 months]
Secondary outcome measures (5)
- Health-related quality of life as assessed by the Short Form Health Survey - 12 [Time frame: 3 months and 6 months]
- Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18 [Time frame: 3 months and 6 months]
- Shared Decision-Making (SDM) level as assessed by the Collaborate survey [Time frame: 3 months and 6 months]
- Medication adherence as assessed by the Medication Adherence Report Scale -10 [Time frame: 3 months and 6 months]
- Patients' perceptions of involvement in SDM as assessed by the Patient SDM questionnaire - 9 [Time frame: 3 months and 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07662616 · IRB00556549 · 26RIRA1635044