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

Официальное название

Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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

Первичные конечные точки

• Life's Essential 8 (LE8) [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Health-related quality of life as assessed by the Short Form Health Survey - 12 [Срок оценки: 3 months and 6 months]
• Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18 [Срок оценки: 3 months and 6 months]
• Shared Decision-Making (SDM) level as assessed by the Collaborate survey [Срок оценки: 3 months and 6 months]
• Medication adherence as assessed by the Medication Adherence Report Scale -10 [Срок оценки: 3 months and 6 months]
• Patients' perceptions of involvement in SDM as assessed by the Patient SDM questionnaire - 9 [Срок оценки: 3 months and 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07662616 · IRB00556549 · 26RIRA1635044

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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