Heart FailureNCT05531214
Creating A Cardiorenal Multidisciplinary Team for Management HF and CKD Patients
A study testing Multidisciplinary Care Coordination Team in people with Heart Failure and Chronic Kidney Diseases, run by George Washington University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Chronic Kidney Diseases
- What is being tested?
- Multidisciplinary Care Coordination Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
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.
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.
Read the 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:
- 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.
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Being tested
- Multidisciplinary Care Coordination Team
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Care Coordination TeamBehavioural
The intervention group will be patients whose primary care clinicians will be receiving guidance and recommendations from the multidisciplinary team consisting of cardiologists, nephrologists, and specialty pharmacists.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized based on their primary care clinician to a co-localized care with a telemedicine-based cardiorenal multidisciplinary team (cardiologist, nephrologist, and research coordinators) providing guidance and recommendations to the primary care clinician. Receives: Behavioral: Multidisciplinary Care Coordination Team |
| Control | No intervention | Patients randomized to the control group will proceed with 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in rate of sodium glucose co-transporter 2 inhibitors (SGLT2i)
Given that increased SGLT2i is likely to be the major driver of improved clinical outcomes in patients with heart failure and chronic kidney disease, the primary outcome of interest is the difference in rate of SGLT2i use between multidisciplinary care model versus usual care model at 3 months and 6 months.
Measured: 6 months
Secondary outcomes (3)
Quality of life of patients-Kidney Disease Questionnaire
Quality of life will be measured by a score at baseline, 3-months, and 6-months, using the Kidney Disease and Quality of Life survey (KDQOL-36).
Measured: 6 months
Quality of life of patients-Cardiomyopathy Questionnaire
Quality of life will be measured by a score at baseline, 3-months, and 6-months, using the Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12).
Measured: 6 months
Heart failure hospitalizations
Heart failure hospitalizations, ≥40% sustained decline in kidney function, need for maintenance dialysis or a kidney transplant.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jun 2022
- Primary completion30 Jan 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurusher Panjrath, George Washington University
- Investigators
- Janai Rangaswami, MD, Principal investigator, Fellowship program director for the Division of Nephrology, Director of the cardiorenal program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531214
- Sponsor's protocol ID
- NCR224155
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05531214
- Acronym / sponsor ID
- NCR224155
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multidisciplinary Care Coordination TeamPatients randomized based on their primary care clinician to a co-localized care with a telemedicine-based cardiorenal multidisciplinary team (cardiologist, nephrologist, and research coordinators) providing guidance and recommendations to the primary care clinician. |
| Control | No intervention | –Patients randomized to the control group will proceed with 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Patients < 18 years of age
- Patients with a heart or kidney transplant
- Patients on dialysis at the time of enrollment
- Pregnant
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Care Coordination TeamThe intervention group will be patients whose primary care clinicians will be receiving guidance and recommendations from the multidisciplinary team consisting of cardiologists, nephrologists, and specialty pharmacists. | Behavioural | Intervention |
Primary outcome
Difference in rate of sodium glucose co-transporter 2 inhibitors (SGLT2i)
Time frame: 6 months
Given that increased SGLT2i is likely to be the major driver of improved clinical outcomes in patients with heart failure and chronic kidney disease, the primary outcome of interest is the difference in rate of SGLT2i use between multidisciplinary care model versus usual care model at 3 months and 6 months.
3 secondary outcomes
Quality of life of patients-Kidney Disease Questionnaire
Time frame: 6 months
Quality of life of patients-Cardiomyopathy Questionnaire
Time frame: 6 months
Heart failure hospitalizations
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janai Rangaswami, MD principal investigator
Fellowship program director for the Division of Nephrology, Director of the cardiorenal program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Care Coordination Team in people with Heart Failure and Chronic Kidney Diseases, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in rate of sodium glucose co-transporter 2 inhibitors (SGLT2i) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.