Clinical trial NCT05531214: Creating A Cardiorenal Multidisciplinary Team for Management HF and CKD Patients
Official title: A Comparative Effectiveness Study to Assess the Impact of a Multidisciplinary Cardiorenal Care Team to Assist Primary Care Clinicians in Managing Patients With Heart Failure and Chronic Kidney Disease vs Usual Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Chronic Kidney Diseases
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our pragmatic randomized controlled trial will firstly identify primary care clinicians (PCCs) currently working at the George Washington University Medical Faculty Associates (GW-MFA) who care for adult patients diagnosed with both heart failure with a reduced ejection fraction (HFrEF) and chronic kidney disease (CKD). 164 patients who meet our inclusion criteria will be first identified via their respective PCCs at the GW-MFA. These PCCs will be randomized to the control and intervention arms, and the intervention arm will be receiving recommendations from a multidisciplinary team of cardiologists and nephrologists.
Primary purpose: OTHER

Brief summary: Several drugs have been labeled as guideline-directed-medical therapies (GDMT) to improve overall health outcomes and slow the progression of disease in patients with heart failure (HF). Although scientific trials have deemed these drugs to be successful, many HF patients have been unable to either get started on the appropriate drug regimens or be optimized on the doses required to show substantial benefit, particularly in those who also suffer from chronic kidney disease (CKD). This is largely due to the current health care delivery model that requires a primary care clinician or general internist to refer patients to heart failure specialists and nephrologists. The specialty care itself then requires even more coordination resulting in patients getting lost to follow-up, physicians losing track of recommendations from different clinics, and too many separate electronic medical documentations to consolidate prior to deciding on what medication is appropriate at one thirty-minute outpatient visit. This study plans to create a new, virtual cardio-renal multidisciplinary team including a heart failure specialist and nephrologist to ease the coordination of care and consequently show a better implementation of GDMT in patients with HF and CKD when comparing those rates to the traditional referral-based way that these medications get prescribed.

Detailed description: Major advancements have occurred in guideline-directed medical therapies (GDMT) for heart failure (HF) over the last decade. Various classes of drugs including beta-adrenergic receptor blockers, renin-angiotensin system inhibitors, sodium-glucose co-transporter inhibitors, etc. have demonstrated significant improvement in the quality of life, prevention of recurrent hospitalizations for HF, and reduction in overall morbidity and mortality. However, despite the billions of healthcare dollars and additional clinical resources invested into developing these evidence-based treatment regimens, a substantial proportion of the affected patient populations remains undertreated worldwide rendering GDMT unrealistic to implement broadly, particularly in the subgroup of patients with concomitant chronic kidney disease (CKD).

Several deterrents contribute to the low implementation rates of GDMT in HF with CKD including clinicians' therapeutic inertia and fear of inducing harm, poor coordination of care between inpatient and outpatient titration of medications, fragmented healthcare models, inaccessibility to specialists' support, and high-cost burden deeming certain medications unaffordable. These factors also primarily affect minority communities, patients among the lower socioeconomic strata, and individuals with limited health literacy who are unequally affected by higher rates of HF with CKD. Although current research can both qualify and quantify the benefits of the medications, minimal treatment prototypes exist to ensure that patients have and maintain access to these therapies, the frequent follow-up visits, and the surveillance screenings required to monitor long-term symptoms and potential medication side-effects.

This study aims to compare the effects of a co-localized multidisciplinary cardiorenal team supporting a primary care clinician versus the traditional referral-based care model, on the implementation rates of GDMT in patients with specifically heart failure with reduced ejection fraction (HFrEF) and CKD. Investigators will conduct a single-center pragmatic randomized controlled trial that will compare the following approaches:

1. Co-localized care with a telemedicine-based cardiorenal multidisciplinary team (cardiologist, nephrologist, and research coordinators) providing guidance and recommendations to the primary care clinician 2. A control group of usual care with a primary care clinician making referrals to a cardiologist or nephrologist "for-cause" as determined by the primary care clinician, to ultimately assess the rates of improvement in the implementation of GDMT. The research coordinators will also play a crucial role in identifying financial barriers, circumventing insurance and prior authorization issues, as well as monitoring medication side-effect profiles and potential drug-to-drug interactions as they pertain to each individual patient involved in the study.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* History of HF with reduced ejection fraction (HFrEF) or ejection fraction (EF) \<50% and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \< 60cc/min/1.73m2

Exclusion Criteria:

* Patients \< 18 years of age
* Patients with a heart or kidney transplant
* Patients on dialysis at the time of enrollment
* Pregnant
* Non-English speaking
* Patients that are unable to understand the process of the study and consent

Primary outcomes:
measure: Difference in rate of sodium glucose co-transporter 2 inhibitors (SGLT2i)
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life of patients-Kidney Disease Questionnaire
timeFrame: 6 months
measure: Quality of life of patients-Cardiomyopathy Questionnaire
timeFrame: 6 months
measure: Heart failure hospitalizations
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: Fellowship program director for the Division of Nephrology, Director of the cardiorenal program
name: Janai Rangaswami, MD
role: PRINCIPAL_INVESTIGATOR
References: