Virtual Nephrologist for Chronic Kidney Disease

(vHCA Trial)

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

Trial Summary

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 data supports the effectiveness of the treatment Virtual Nephrologist for Chronic Kidney Disease?

Research suggests that virtual clinics can help patients with chronic kidney disease get early access to specialist care, which can lead to better health outcomes. Additionally, virtual care programs have shown potential in improving patients' understanding of their disease and increasing interest in home dialysis, which can lead to more planned and less emergency dialysis starts. ^{1 2 3 4 5}

Is the Virtual Nephrologist treatment generally safe for humans?

The research highlights that patients with chronic kidney disease (CKD) are at high risk for adverse safety events due to complex care needs and impaired kidney function. Telemedicine, like the Virtual Nephrologist, offers a way to improve safety by allowing patients to communicate safety-related issues to their healthcare providers, although some patients may face challenges using such technology. ^{6 7 8 9 10}

How is the Virtual Nephrologist treatment different from other treatments for chronic kidney disease?

The Virtual Nephrologist treatment is unique because it uses virtual clinics to provide early and efficient access to specialist care for chronic kidney disease, which can improve patient outcomes and reduce the need for in-person visits. This approach leverages technology to manage high patient volumes cost-effectively while maintaining high standards of care. ^{1 2 11 12 13}

What is the purpose of this trial?

To develop, pilot, and refine a virtual healthcare agent that will educate patients with advanced chronic kidney disease and their caregivers about kidney transplantation.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

1. India 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. [2011]

2. Canada pubmed.ncbi.nlm.nih.gov

A Virtual Multidisciplinary Care Program for Management of Advanced Chronic Kidney Disease: Matched Cohort Study. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Telenephrology application in rural and remote areas of Jordan: benefits and impact on quality of life. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Remote Patient Management for Home Dialysis Patients. [2022]

5. England 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. [2022]

6. United States 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. [2022]

7. England 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. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adverse safety events in patients with Chronic Kidney Disease (CKD). [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

11. France pubmed.ncbi.nlm.nih.gov

[e-Health in nephrology: 1st French survey on telenephrology]. [2020]

12. England pubmed.ncbi.nlm.nih.gov

A Quantitative and Qualitative Study on Patient and Physician Perceptions of Nephrology Telephone Consultation During COVID-19. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Initial implementation of a web-based consultation process for patients with chronic kidney disease. [2021]