An Electronic Health Record–Integrated Application for Standardizing Care and Monitoring Patients With Autosomal Dominant Polycystic Kidney Disease Enrolled in a Tolvaptan Clinic: Design and Implementation Study

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Abstract

Background

Tolvaptan is the only US Food and Drug Administration–approved drug to slow the progression of autosomal dominant polycystic kidney disease (ADPKD), but it requires strict clinical monitoring due to potential serious adverse events.

Objective

We aimed to share our experience in developing and implementing an electronic health record (EHR)–based application to monitor patients with ADPKD who were initiated on tolvaptan.

Methods

The application was developed in collaboration with clinical informatics professionals based on our clinical protocol with frequent laboratory test monitoring to detect early drug-related toxicity. The application streamlined the clinical workflow and enabled our nursing team to take appropriate actions in real time to prevent drug-related serious adverse events. We retrospectively analyzed the characteristics of the enrolled patients.

Results

As of September 2022, a total of 214 patients were enrolled in the tolvaptan program across all Mayo Clinic sites. Of these, 126 were enrolled in the Tolvaptan Monitoring Registry application and 88 in the Past Tolvaptan Patients application. The mean age at enrollment was 43.1 (SD 9.9) years. A total of 20 (9.3%) patients developed liver toxicity, but only 5 (2.3%) had to discontinue the drug. The 2 EHR-based applications allowed consolidation of all necessary patient information and real-time data management at the individual or population level. This approach facilitated efficient staff workflow, monitoring of drug-related adverse events, and timely prescription renewal.

Conclusions

Our study highlights the feasibility of integrating digital applications into the EHR workflow to facilitate efficient and safe care delivery for patients enrolled in a tolvaptan program. This workflow needs further validation but could be extended to other health care systems managing chronic diseases requiring drug monitoring.

Related collections

Most cited references 37

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Systematic review: impact of health information technology on quality, efficiency, and costs of medical care.

Basit Chaudhry, Jerome K Wang, Shinyi Wu … (2006)

Experts consider health information technology key to improving efficiency and quality of health care. To systematically review evidence on the effect of health information technology on quality, efficiency, and costs of health care. The authors systematically searched the English-language literature indexed in MEDLINE (1995 to January 2004), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Abstracts of Reviews of Effects, and the Periodical Abstracts Database. We also added studies identified by experts up to April 2005. Descriptive and comparative studies and systematic reviews of health information technology. Two reviewers independently extracted information on system capabilities, design, effects on quality, system acquisition, implementation context, and costs. 257 studies met the inclusion criteria. Most studies addressed decision support systems or electronic health records. Approximately 25% of the studies were from 4 academic institutions that implemented internally developed systems; only 9 studies evaluated multifunctional, commercially developed systems. Three major benefits on quality were demonstrated: increased adherence to guideline-based care, enhanced surveillance and monitoring, and decreased medication errors. The primary domain of improvement was preventive health. The major efficiency benefit shown was decreased utilization of care. Data on another efficiency measure, time utilization, were mixed. Empirical cost data were limited. Available quantitative research was limited and was done by a small number of institutions. Systems were heterogeneous and sometimes incompletely described. Available financial and contextual data were limited. Four benchmark institutions have demonstrated the efficacy of health information technologies in improving quality and efficiency. Whether and how other institutions can achieve similar benefits, and at what costs, are unclear.

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Tolvaptan in patients with autosomal dominant polycystic kidney disease.

Vicente Torres, Arlene Chapman, Olivier Devuyst … (2012)

The course of autosomal dominant polycystic kidney disease (ADPKD) is often associated with pain, hypertension, and kidney failure. Preclinical studies indicated that vasopressin V(2)-receptor antagonists inhibit cyst growth and slow the decline of kidney function. In this phase 3, multicenter, double-blind, placebo-controlled, 3-year trial, we randomly assigned 1445 patients, 18 to 50 years of age, who had ADPKD with a total kidney volume of 750 ml or more and an estimated creatinine clearance of 60 ml per minute or more, in a 2:1 ratio to receive tolvaptan, a V(2)-receptor antagonist, at the highest of three twice-daily dose regimens that the patient found tolerable, or placebo. The primary outcome was the annual rate of change in the total kidney volume. Sequential secondary end points included a composite of time to clinical progression (defined as worsening kidney function, kidney pain, hypertension, and albuminuria) and rate of kidney-function decline. Over a 3-year period, the increase in total kidney volume in the tolvaptan group was 2.8% per year (95% confidence interval [CI], 2.5 to 3.1), versus 5.5% per year in the placebo group (95% CI, 5.1 to 6.0; P<0.001). The composite end point favored tolvaptan over placebo (44 vs. 50 events per 100 follow-up-years, P=0.01), with lower rates of worsening kidney function (2 vs. 5 events per 100 person-years of follow-up, P<0.001) and kidney pain (5 vs. 7 events per 100 person-years of follow-up, P=0.007). Tolvaptan was associated with a slower decline in kidney function (reciprocal of the serum creatinine level, -2.61 [mg per milliliter](-1) per year vs. -3.81 [mg per milliliter](-1) per year; P<0.001). There were fewer ADPKD-related adverse events in the tolvaptan group but more events related to aquaresis (excretion of electrolyte-free water) and hepatic adverse events unrelated to ADPKD, contributing to a higher discontinuation rate (23%, vs. 14% in the placebo group). Tolvaptan, as compared with placebo, slowed the increase in total kidney volume and the decline in kidney function over a 3-year period in patients with ADPKD but was associated with a higher discontinuation rate, owing to adverse events. (Funded by Otsuka Pharmaceuticals and Otsuka Pharmaceutical Development and Commercialization; TEMPO 3:4 ClinicalTrials.gov number, NCT00428948.).

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Tethered to the EHR: Primary Care Physician Workload Assessment Using EHR Event Log Data and Time-Motion Observations

Brian Arndt, John W Beasley, Michelle Watkinson … (2017)

PURPOSE Primary care physicians spend nearly 2 hours on electronic health record (EHR) tasks per hour of direct patient care. Demand for non–face-to-face care, such as communication through a patient portal and administrative tasks, is increasing and contributing to burnout. The goal of this study was to assess time allocated by primary care physicians within the EHR as indicated by EHR user-event log data, both during clinic hours (defined as 8:00 am to 6:00 pm Monday through Friday) and outside clinic hours. METHODS We conducted a retrospective cohort study of 142 family medicine physicians in a single system in southern Wisconsin. All Epic (Epic Systems Corporation) EHR interactions were captured from “event logging” records over a 3-year period for both direct patient care and non–face-to-face activities, and were validated by direct observation. EHR events were assigned to 1 of 15 EHR task categories and allocated to either during or after clinic hours. RESULTS Clinicians spent 355 minutes (5.9 hours) of an 11.4-hour workday in the EHR per weekday per 1.0 clinical full-time equivalent: 269 minutes (4.5 hours) during clinic hours and 86 minutes (1.4 hours) after clinic hours. Clerical and administrative tasks including documentation, order entry, billing and coding, and system security accounted for nearly one-half of the total EHR time (157 minutes, 44.2%). Inbox management accounted for another 85 minutes (23.7%). CONCLUSIONS Primary care physicians spend more than one-half of their workday, nearly 6 hours, interacting with the EHR during and after clinic hours. EHR event logs can identify areas of EHR-related work that could be delegated, thus reducing workload, improving professional satisfaction, and decreasing burnout. Direct time-motion observations validated EHR-event log data as a reliable source of information regarding clinician time allocation.

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Author and article information

Contributors

Maroun Chedid:

ORCID: http://orcid.org/0009-0001-2604-1121

Fouad T Chebib:

ORCID: http://orcid.org/0000-0002-3949-5720

Erin Dahlen:

ORCID: http://orcid.org/0009-0004-3072-2773

Theodore Mueller:

ORCID: http://orcid.org/0009-0000-0238-4202

Theresa Schnell

Melissa Gay:

ORCID: http://orcid.org/0009-0002-3749-3980

Musab Hommos:

ORCID: http://orcid.org/0000-0003-2697-4463

Sundararaman Swaminathan:

ORCID: http://orcid.org/0000-0003-4773-141X

Arvind Garg:

ORCID: http://orcid.org/0000-0003-4759-1576

Michael Mao:

ORCID: http://orcid.org/0000-0003-1814-7003

Brigid Amberg:

ORCID: http://orcid.org/0009-0004-0184-5803

Kirk Balderes:

ORCID: http://orcid.org/0009-0004-6755-7046

Karen F Johnson:

ORCID: http://orcid.org/0009-0001-5260-272X

Alyssa Bishop:

ORCID: http://orcid.org/0009-0000-0580-4110

Jackqueline Kay Vaughn:

ORCID: http://orcid.org/0009-0008-2535-4119

Marie Hogan:

ORCID: http://orcid.org/0000-0003-3031-8522

Vicente Torres:

ORCID: http://orcid.org/0000-0003-2008-1576

Rajeev Chaudhry:

ORCID: http://orcid.org/0000-0003-1249-5656

Ziad Zoghby:

ORCID: http://orcid.org/0000-0002-8734-9699

Journal

Journal ID (nlm-ta): JMIR Med Inform

Journal ID (iso-abbrev): JMIR Med Inform

Journal ID (hwp): JMI

Journal ID (publisher-id): medinform

Journal ID (index): 7

Title: JMIR Medical Informatics

Publisher: JMIR Medical Informatics

ISSN (Electronic): 2291-9694

Publication date Collection: 2024

Publication date (Electronic): 1 May 2024

Volume: 12

Electronic Location Identifier: 50164

Affiliations

[1 ]Hennepin Healthcare , Minneapolis, MN, United States

[2 ]departmentDivision of Nephrology and Hypertension, Department of Medicine , Mayo Clinic , Jacksonville, FL, United States

[3 ]departmentDivision of Nephrology and Hypertension, Department of Medicine , Mayo Clinic , Rochester, MN, United States

[4 ]departmentDivision of Nephrology and Hypertension, Department of Medicine , Mayo Clinic , Scottsdale, AZ, United States

[5 ]departmentDivision of Nephrology and Hypertension, Department of Medicine , Mayo Clinic , LaCrosse, WI, United States

[6 ]departmentDivision of Information Technology , Mayo Clinic , Rochester, MN, United States

[7 ]departmentDivision of Community Internal Medicine, Department of Medicine , Mayo Clinic , Rochester, MN, United States

Author notes

ZiadZoghbyMBA, MD, Division of Nephrology and Hypertension, Department of Medicine, Mayo Clinic, 200 First St SW, Rochester, 55905, MN, United States, 1 5072661046; zoghby.ziad@ 123456mayo.edu

ZZ serves as a member of the Epic nephrology steering board committee. MH has received consulting fees from Otsuka in the past for work unrelated to this study. All other authors report no conflicts of interest.

Author information

Maroun Chedid http://orcid.org/0009-0001-2604-1121

Fouad T Chebib http://orcid.org/0000-0002-3949-5720

Erin Dahlen http://orcid.org/0009-0004-3072-2773

Theodore Mueller http://orcid.org/0009-0000-0238-4202

Melissa Gay http://orcid.org/0009-0002-3749-3980

Musab Hommos http://orcid.org/0000-0003-2697-4463

Sundararaman Swaminathan http://orcid.org/0000-0003-4773-141X

Arvind Garg http://orcid.org/0000-0003-4759-1576

Michael Mao http://orcid.org/0000-0003-1814-7003

Brigid Amberg http://orcid.org/0009-0004-0184-5803

Kirk Balderes http://orcid.org/0009-0004-6755-7046

Karen F Johnson http://orcid.org/0009-0001-5260-272X

Alyssa Bishop http://orcid.org/0009-0000-0580-4110

Jackqueline Kay Vaughn http://orcid.org/0009-0008-2535-4119

Marie Hogan http://orcid.org/0000-0003-3031-8522

Vicente Torres http://orcid.org/0000-0003-2008-1576

Rajeev Chaudhry http://orcid.org/0000-0003-1249-5656

Ziad Zoghby http://orcid.org/0000-0002-8734-9699

Article

Publisher ID: 50164

DOI: 10.2196/50164

PMC ID: 11085039

PubMed ID: 38717378

SO-VID: 9083991e-1bf3-4bbe-926a-eccd85a21709

Copyright © Copyright © Maroun Chedid, Fouad T Chebib, Erin Dahlen, Theodore Mueller, Theresa Schnell, Melissa Gay, Musab Hommos, Sundararaman Swaminathan, Arvind Garg, Michael Mao, Brigid Amberg, Kirk Balderes, Karen F Johnson, Alyssa Bishop, Jackqueline Kay Vaughn, Marie Hogan, Vicente Torres, Rajeev Chaudhry, Ziad Zoghby. Originally published in JMIR Medical Informatics (https://medinform.jmir.org)

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Medical Informatics, is properly cited. The complete bibliographic information, a link to the original publication on https://medinform.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 21 June 2023

Date revision received : 06 March 2024

Date accepted : 25 March 2024

Custom metadata

Corresponding author for proofs 342147

ccc-integration-status Success

Assigned PE Cassandra

Language Non-ESL

Table Complexity Low

CE Triage Complete Yes

Planned CE Assignee Tim Hilts

pap 2024-05-01 12:48:35

Keywords: adpkd, autosomal dominant polycystic kidney disease,polycystic kidney disease,tolvaptan,ehr,electronic health record,digital health solutions,monitoring,kidney disease,drug-related toxicity,digital application,management,chronic disease

Data availability:

Keywords: adpkd, autosomal dominant polycystic kidney disease, polycystic kidney disease, tolvaptan, ehr, electronic health record, digital health solutions, monitoring, kidney disease, drug-related toxicity, digital application, management, chronic disease

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