Cardiovascular-kidney-metabolic (CKM), Diabetes (DM), Hyperlipidaemia, Hypertension (HTN), Kidney Disease, Obesity, Overweight
Conditions
Keywords
shared decision-making, Cardiovascular-kidney-metabolic, Behavioral counseling, Team-based care
Brief summary
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_PRODUCTTeam-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 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.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Life's Essential 8 (LE8) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life as assessed by the Short Form Health Survey - 12 | 3 months and 6 months | 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 | 3 months and 6 months | 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 | 3 months and 6 months | 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 | 3 months and 6 months | 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. |
| Patients' perceptions of involvement in SDM as assessed by the Patient SDM questionnaire - 9 | 3 months and 6 months | Mean scores of patients' perceptions of involvement in SDM assessed by the Patient SDM Questionnaire (SDM-Q-9). The scores ranged from 0 to 45, and higher scores indicate better involvement in SDM. |
Contacts
CONTACTYuling Chen, PhD
PRINCIPAL_INVESTIGATORCheryl Himmelfarb, PhD
Johns Hopkins University
Outcome results
None listed