Chronic Kidney Disease, Type II Diabetes
Conditions
Keywords
Cardiovascular-kidney-metabolic, Multidisciplinary Care Model, Guideline Directed Medical Therapies
Brief summary
Our overarching goal of this study is to provide rigorous evidence for using an accelerated risk-based approach to implementing guideline directed medical therapies (GDMT) using a multidisciplinary care model (MCM) versus a usual care model (UCM) to improve a composite GDMT score, reduce kidney disease and heart failure (HF) events, hospitalizations, and total healthcare costs for patients with type 2 diabetes (T2D) and CKD with high- to very-high Kidney Disease: Improving Global Outcomes (KDIGO) risk.
Detailed description
The study is designed to provide evidence for MCM versus UCM to improve a composite GDMT score, reduce major kidney and cardiovascular risks, reduce hospitalizations (and thereby healthcare costs), and improve QoL, for patients with T2D and high and very high KDIGO CKD risk. These Specific Aims address critical gaps including lack of patient access to subspecialists, PCC and patient inertia, and inadequate infrastructure to optimize nutrition. The MCM is designed to increase GDMT uptake across the health system, PCC, and patient domains. Outside the US, MCMs in patients with CKD and T2D have shown promise by reducing CKM risk factors, healthcare costs, subspecialty clinic visits, and hospitalizations. Given lack of patient access to subspecialists in the US,32 especially nephrologists, a specialist-dominant model for GDMT uptake and optimization may not be feasible in many health systems. Notably, PCCs are also in shortage by workforce capacity, and they have large patient panels, severe time constraints, and competing priorities. Therefore, maintaining vital PCC and patient relationships, while bringing a primary-care-based CKM pharmacist onboard with consulting subspecialists, is a way forward. HOLISTIC will answer a call for research on team-based primary care to alleviate physician shortages for under-served health needs such as T2D and CKD. This approach can also capitalize on successes pioneered by telehealth during the COVID-19 pandemic for complex chronic conditions by assisting PCCs through pharmacist led CMM. Finally, it allows a strategic re-purposing of existing resources (pharmacist clinicians) who can support PCCs and lead CMM and GDMT deployment in a risk-appropriate and timely fashion, to demonstrate value to this alternate model across optimal care delivery, clinical outcomes, cost savings/return on investment.
Interventions
OTHERThe intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
Sponsors
Baim Institute for Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The proposed study uses an intervention that requires clinic-level randomization, which minimizes contamination between patients cared for within the same clinic. Therefore, we propose to conduct a cluster randomized, two-group trial of a MCM versus UCM. Each of the 6 health systems will have 6 clinics, with each clinic representing a cluster as the unit of randomization. Block randomization will be completed using a computer-generated algorithm to allocate clinics within the site randomly at a 1:1 ratio to MCM or UCM. The analysis of the primary outcome will be stratified by study site. Study outcomes pertain to the individual participant rather than the clinic.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent 2. Adults ≥18 years of age with T2D and CKD at high or very high KDIGO risk (Figure A1): eGFR 45-59 mL/min/1.73 m2 and UACR \>300 mg/g OR eGFR 30-44 mL/min/1.73 m2 and UACR \>30 mg/g OR any eGFR \<30 mL/min/1.73 m2.
Exclusion criteria
1. Advanced HF on inotrope support or requiring left ventricular assist device support. 2. Chronic hemodialysis or peritoneal dialysis or kidney transplant 3. Life expectancy of \<1-year, and vulnerable populations such as pregnant women, incarcerated individuals, or those with active psychiatric illness. 4. Unreliable or non-compliant, including patients with known history of alcoholism, drug abuse, or serious psychiatric disorder; as well as patients unwilling to abide by the requirements of the protocol 5. Any condition that would interfere with the patient's ability to comply with study instructions, might confound the interpretation of the study, or put the patient at risk 6. Personnel, or any relative of personnel, of the Sponsor, the CRO, or the investigative site(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Guideline-Directed Medical Therapy (GDMT) Score | Baseline to 12 months | Composite GDMT calculated from baseline to Month 12 across five pre-defined medication classes (RAS inhibitors, SGLT2 inhibitors, GLP-1 receptor antagonists, non-steroidal mineralocorticoid receptor antagonists, and statins). The score is the sum of baseline use and changes during follow-up (+1 for initiation of a medication class and -1 for discontinuation). This represents a single composite outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with all-cause mortality | 12 Months | Number of participants who die from any cause during the 12-month follow-up. |
| Outcome Measure: Number of Participants with Worsening Kidney Disease | 12 Months | Number of participants experiencing worsening kidney disease, defined according to the study protocol as ≥40% decline in estimated glomerular filtration rate (eGFR) from enrollment, eGFR \<10 mL/min/1.73 m², initiation of dialysis, or kidney transplantation. |
| Outcome Measure: Number of Participants with Worsening Heart Failure Events | 12 Months | Number of participants experiencing worsening heart failure, including heart failure hospitalization or urgent heart failure visit. |
| Outcome Measure: Major Adverse Cardiovascular Events (MACE) | 12 Months | Number of participants experiencing major adverse cardiovascular events, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke |
| Outcome Measure: Change from Baseline in Kidney Disease Quality of Life (KDQOL-36) Summary Score | Baseline and 12 Months | Mean change from baseline to Month 12 in the Kidney Disease Quality of Life (KDQOL-36) summary score. Unit of Measure: Points |
| Change in PREVENT-CVD Predicted Cardiovascular Risk Score | 12 Months | Change from baseline to 12 months in predicted cardiovascular risk estimated using the PREVENT-CVD risk calculator among participants without established cardiovascular disease at baseline. Unit of Measure: Percentage points (%) |
| eGFR Total Slope | 12 Months | Annualized rate of change in estimated glomerular filtration rate (eGFR) from baseline through 12 months. Unit of Measure: mL/min/1.73 m²/year |
Contacts
CONTACTC. Michael Gibson, MS, MD Chief Executive Officer, MS, MD
CONTACTPatricia Wedge M Chief Operating Officer, RN, BSN, CCRC
Outcome results
None listed