Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05531214 |
| Other study ID # |
NCR224155 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
George Washington University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
