Virtual Nephrologist for Chronic Kidney Disease

(vHCA Trial)

Recruiting at 1 trial location

Overseen By Adam Mussell, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Vulnerable populations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual healthcare agent, the Virtual Nephrologist, designed to educate patients with advanced chronic kidney disease about kidney transplants. The goal is to evaluate the effectiveness of this virtual tool in educating patients and their caregivers. Patients with advanced chronic kidney disease at Penn Medicine may be suitable candidates. English speakers who can consent to participate may qualify. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions and enhance patient education.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual healthcare agent is safe for patients with chronic kidney disease?

Research has shown that virtual kidney care, such as the Virtual Nephrologist, is generally safe. For example, one study on virtual kidney care found that 84% of patients had good results. Although specific data on the safety of virtual kidney consultations is limited, these early findings are encouraging. Since this study uses a virtual agent, the risks are likely lower than those of traditional medical treatments. Similar virtual healthcare settings have reported no major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Virtual Nephrologist is unique because it leverages telemedicine to provide specialized care for individuals with chronic kidney disease (CKD). Unlike traditional treatments that rely on in-person visits and consultations, this approach offers patients remote access to nephrology expertise, making it more convenient and potentially more frequent. Researchers are excited about this treatment because it could improve patient outcomes by offering timely interventions and personalized management plans without the need for constant hospital visits. Additionally, it may enhance access to care for those living in remote areas or facing mobility challenges, addressing a significant gap in the current healthcare system for CKD patients.

What evidence suggests that the Virtual Nephrologist is effective for educating patients with chronic kidney disease?

Research has shown that virtual care can help manage chronic kidney disease (CKD). In one study, 84% of patients using virtual care experienced early positive results. Another study found that telehealth improved blood pressure and quality of life for people with CKD. Virtual clinics also effectively monitor CKD patients. While these findings are encouraging, results can vary for each person. Participants in this trial will use the Virtual Nephrologist, an experimental approach being tested for its effectiveness in managing CKD. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent, speak English, are patients of Penn Medicine, and have advanced chronic kidney disease. It's not open to vulnerable populations.

Inclusion Criteria

English speaking

Patient of Penn Medicine

My kidneys are not working well and it's a severe condition.

Exclusion Criteria

Vulnerable populations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants interact with a virtual healthcare assistant to learn about kidney transplantation

1 year

Follow-up

Participants are monitored for changes in transplant intention and understanding

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Nephrologist

Trial Overview The study is testing a virtual healthcare agent designed to educate patients with advanced chronic kidney disease and their caregivers about the option of kidney transplantation.

How Is the Trial Designed?

Group I: Virtual Nephrologist Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

A survey of 175 French nephrologists revealed that while they are generally satisfied with telenephrology and actively use technology for communication and patient follow-up, significant barriers such as technical and administrative challenges still hinder its full implementation.

The study highlights the growing need for e-health solutions in nephrology, as the number of patients with chronic kidney diseases is increasing while the number of nephrologists remains static, indicating a potential gap in care that telenephrology could help address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[e-Health in nephrology: 1st French survey on telenephrology]. Citarda, S., Camarroque, AL., Seret, G., et al.[2020]

A pilot trial involving 52 patients with advanced chronic kidney disease (CKD) tested the feasibility of using online electronic patient-reported outcome measures (ePROMs) for real-time symptom monitoring, showing high retention (96%) and adherence (74% at 180 days).

The ePROM intervention was well-accepted by patients, indicating potential for improving patient engagement in managing CKD, although strategies are needed to maintain long-term participation beyond 270 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease. Kyte, D., Anderson, N., Bishop, J., et al.[2022]

Patients with stage 3 and 4 chronic kidney disease (CKD) are at high risk for adverse drug events (ADEs) due to the kidneys' role in medication clearance, highlighting the need for effective monitoring systems.

Interviews with clinics revealed significant differences in electronic decision support practices and organizational culture, which are crucial factors to consider when implementing electronic drug-disease alerts to reduce ADEs in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics. Lin, CP., Guirguis-Blake, J., Keppel, GA., et al.[2018]

In a study of 64 patients using live interactive telenephrology, 31.2% had their treatment plans changed compared to what their referring health provider suggested, indicating effective diagnosis and management of kidney diseases.

Patients reported significant improvements in their quality of life, with SF8 scores increasing from 33.1 to 45.0 after 2 months, alongside high satisfaction rates due to reduced waiting times and costs associated with teleconsultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telenephrology application in rural and remote areas of Jordan: benefits and impact on quality of life. AlAzab, R., Khader, Y.[2016]

Participation in the Cricket Health program significantly improved CKD knowledge among patients, with scores increasing from an average of 52% to 94% correct answers on a knowledge-based survey.

Patients in the program were more likely to start dialysis in an outpatient setting (80% of those who started dialysis) compared to controls (22%), suggesting the program may facilitate better planning for dialysis initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Multidisciplinary Care Program for Management of Advanced Chronic Kidney Disease: Matched Cohort Study. Kaiser, P., Pipitone, O., Franklin, A., et al.[2020]

Patients with chronic kidney disease (CKD) face increased risks of adverse safety events due to medication dosing errors and the use of nephrotoxic drugs, which can worsen kidney function.

Improving outcomes for CKD patients may involve better communication among healthcare providers and empowering patients to manage their condition with support from multidisciplinary care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse safety events in patients with Chronic Kidney Disease (CKD). Offurum, A., Wagner, LA., Gooden, T.[2017]

A retrospective study of 427 patients over 4 years showed that a virtual renal clinic can effectively manage early assessments for chronic kidney disease, leading to timely specialist care and better patient outcomes.

The virtual clinic approach resulted in a cost saving of £111.56 per patient compared to traditional outpatient services, demonstrating its efficiency in handling high patient volumes while maintaining quality care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the quality of care and financial impact of a virtual renal clinic compared with the traditional outpatient service model. Mark, DA., Fitzmaurice, GJ., Haughey, KA., et al.[2011]

A survey of 372 patients with chronic kidney disease revealed that 68% found telephone consultations comfortable and 73% considered them safer during the COVID-19 pandemic, highlighting a positive reception to this virtual care method.

Despite the advantages, participants noted drawbacks such as the inability to conduct physical examinations and reduced rapport with their nephrologists, indicating that while telephone consultations are effective, in-person visits may still be necessary for certain situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quantitative and Qualitative Study on Patient and Physician Perceptions of Nephrology Telephone Consultation During COVID-19. Heyck Lee, S., Ramondino, S., Gallo, K., et al.[2022]

The telenephrology system significantly reduced unnecessary in-person referrals, with only 13.9% of patients needing referral according to nephrologists compared to 35.3% as initially intended by family physicians.

The system was efficient, requiring less than 10 minutes per consultation and providing a quick response time of 1.6 days, indicating it can effectively support primary care physicians in managing chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial implementation of a web-based consultation process for patients with chronic kidney disease. Scherpbier-de Haan, ND., van Gelder, VA., Van Weel, C., et al.[2021]

Remote patient management (RPM) can enhance the confidence of both healthcare providers and patients with end-stage kidney disease in adopting home dialysis therapies, potentially leading to better clinical outcomes.

Despite promising results in other conditions like diabetes and heart disease, there is currently only observational data on RPM in dialysis patients, highlighting the need for randomized controlled trials to better understand its effectiveness and economic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Management for Home Dialysis Patients. Wallace, EL., Rosner, MH., Alscher, MD., et al.[2022]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

Patients with chronic kidney disease (CKD) are particularly vulnerable to adverse drug events during hospitalization, which can lead to significant harm.

The study emphasizes the need for new strategies to minimize medical errors and improve safety for CKD patients in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. Fink, JC., Chertow, GM.[2022]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6334099/

A virtual clinic to improve long-term outcomes in chronic ... The VC is a non-face-to-face results review of patients with CKD. We found that the VC was an effective monitoring system. None of the patients from the VC ...

2. mdpi.com mdpi.com/2077-0383/13/1/66

Virtual Care in Nephrology: An In-Depth Retrospective ... The data suggests that the Reset Kidney Health care model can be effective as 84% of the patients experienced early favorable outcomes, either ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949761224001111

The Effectiveness of Telehealth Intervention on Chronic ... The primary findings suggest that telehealth interventions effectively improve blood pressure, QoL scores, and dietary habits in patients with CKD. However, it ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2817606

Electronic Health Record Population Health Management ... Large gaps in clinical care in patients with chronic kidney disease (CKD) lead to poor outcomes. Objective To compare the effectiveness of ...

5. nature.com nature.com/articles/s41746-024-01296-1

The effects of a digital health intervention on patient ... There were no between-group differences found in the percentage of correct responses to the CKD-SMKT at 20 weeks (P = 0.945), but a significant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4291537/

Chronic kidney disease care in the US safety net - PMC An increased risk of progression to ESRD among the uninsured and publically insured individuals with CKD and an eGFR > 30 ml/min/1.73m2 compared to those with ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1548559514000822

Chronic Kidney Disease Care in the US Safety Net MDCD enrollees with CKD have been shown to have poorer outcomes and have higher rates of hospitalization [22]. Using performance characteristics from a PA ...

8. academic.oup.com academic.oup.com/ndt/article/38/Supplement_1/gfad063b_3281/7195267

#3281 SAFETY AND EFFICACY OF VIRTUAL OUTPATIENT ... Data establishing safety and effectiveness of virtual consultation in kidney care has been limited. ... Changes in wait time to see a nephrologist ...