SBIR-STTR Award

Impact of Dialysis Workflow Decision Support on Conformance to KDOQI Guidelines
Award last edited on: 7/20/10

Sponsored Program
SBIR
Awarding Agency
NIH : NIDDK
Total Award Amount
$1,670,074
Award Phase
2
Solicitation Topic Code
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Principal Investigator
John Hartman

Company Information

Visonex LLC

926 Willard Drive Suite 200
Green Bay, WI 54304
   (920) 496-0600
   jhartman@visonex.com
   www.visonex.com
Location: Single
Congr. District: 08
County: Brown

Phase I

Contract Number: 1R44DK079404-01A1
Start Date: 5/11/09    Completed: 4/30/11
Phase I year
2008
Phase I Amount
$337,402
KDOQI clinical practice guidelines (CPGs) improve dialysis patient care but their complexity makes them difficult to integrate into the dialysis clinic. Previous technological solutions {Electronic medical records, Clinical Decision Support Systems (CDS)} have failed because they were not integrated into the clinic workflow. Visonex LLC proposes to build and test (during Phases I and II) an innovative type of dialysis CDS that assists dialysis clinics to consistently conform to CPGs, provides workflow support and improves quality of care. In order to test the innovation, this project will focuses on a selected subset of KDOQI CPGs. Increased adherence to these CPGs is associated with decreased risk of cardiovascular and all-cause mortality. The software's workflow support will assist the clinic in responding faster and more accurately to CPG deviations and ensure completion of the tasks necessary to achieve conformance to CPG recommendations, improving the ability of the clinic to maintain mineral metabolism markers within their recommended ranges. The software will be built during Phase I and undergo functional testing. It will then be tested using de-identified retrospective data from dialysis clinics. The software's results will be compared to those of manual chart reviews of the same data by clinicians. Any differences between clinician and software will be examined and used to refine the software's functionality before phase II. In Phase II the software will be deployed and integrated into actual dialysis clinics in a stepwise manner. Further refinements will be made to increase the CDS's integration into clinic workflow based on information gathered during deployments. Phase II's overall aim is to increase the number of mineral metabolism markers maintained within the KDOQI recommended range for each patient. A supporting aim is to increase the number of CPG recommended tasks the clinic uses. All effects will be measured pre and post software deployment. The post deployment measures will occur after clinical acclimation to the CDS. While the study is not powered to look at mechanisms of improvement, a subset analysis will be performed with the intent of identifying trends, which could lead to future studies. The end of phase II will result in a dialysis CDS that is quickly assimilated into a clinic's workflow and assists in identifying and treating patients according to the recommendations of the CPGs, which are associated with improved health and decreased mortality. PUBLIC HEALTH RELEVANCE Chronic Kidney Disease (CKD) is a public health crisis and dialysis is the most expensive phase of CKD. The proposed project will result in an integrated expert system that assists dialysis clinics in consistently conforming to guidelines, improves control of mineral metabolism, and becomes a tool for improving the quality of care delivered to patients on dialysis. This system will enrich the data set being collected, providing a new and previously unobtainable insight into clinic operations that can be used for future research.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.

Phase II

Contract Number: 4R44DK079404-02
Start Date: 5/11/09    Completed: 4/30/11
Phase II year
2009
(last award dollars: 2010)
Phase II Amount
$1,332,672

KDOQI clinical practice guidelines (CPGs) improve dialysis patient care but their complexity makes them difficult to integrate into the dialysis clinic. Previous technological solutions {Electronic medical records, Clinical Decision Support Systems (CDS)} have failed because they were not integrated into the clinic workflow. Visonex LLC proposes to build and test (during Phases I and II) an innovative type of dialysis CDS that assists dialysis clinics to consistently conform to CPGs, provides workflow support and improves quality of care. In order to test the innovation, this project will focuses on a selected subset of KDOQI CPGs. Increased adherence to these CPGs is associated with decreased risk of cardiovascular and all-cause mortality. The software's workflow support will assist the clinic in responding faster and more accurately to CPG deviations and ensure completion of the tasks necessary to achieve conformance to CPG recommendations, improving the ability of the clinic to maintain mineral metabolism markers within their recommended ranges. The software will be built during Phase I and undergo functional testing. It will then be tested using de-identified retrospective data from dialysis clinics. The software's results will be compared to those of manual chart reviews of the same data by clinicians. Any differences between clinician and software will be examined and used to refine the software's functionality before phase II. In Phase II the software will be deployed and integrated into actual dialysis clinics in a stepwise manner. Further refinements will be made to increase the CDS's integration into clinic workflow based on information gathered during deployments. Phase II's overall aim is to increase the number of mineral metabolism markers maintained within the KDOQI recommended range for each patient. A supporting aim is to increase the number of CPG recommended tasks the clinic uses. All effects will be measured pre and post software deployment. The post deployment measures will occur after clinical acclimation to the CDS. While the study is not powered to look at mechanisms of improvement, a subset analysis will be performed with the intent of identifying trends, which could lead to future studies. The end of phase II will result in a dialysis CDS that is quickly assimilated into a clinic's workflow and assists in identifying and treating patients according to the recommendations of the CPGs, which are associated with improved health and decreased mortality. PUBLIC HEALTH RELEVANCE Chronic Kidney Disease (CKD) is a public health crisis and dialysis is the most expensive phase of CKD. The proposed project will result in an integrated expert system that assists dialysis clinics in consistently conforming to guidelines, improves control of mineral metabolism, and becomes a tool for improving the quality of care delivered to patients on dialysis. This system will enrich the data set being collected, providing a new and previously unobtainable insight into clinic operations that can be used for future research.

Project Terms:
Acclimation; Acclimatization; Adherence; Adherence (attribute); Administrator; Analysis, Data; Animal Welfare; Annual Reports; Bibliography; Blood; Blood Coagulation Factor IV; Ca++ element; Calcium; Cardiovascular; Cardiovascular Body System; Cardiovascular system; Cardiovascular system (all sites); Caring; Centers for Medicare and Medicaid Services; Centers for Medicare and Medicaid Services (U.S.); Chronic Kidney Failure; Chronic Renal Disease; Clin Spec; Clinic; Clinical; Clinical Data; Clinical Decision Support Systems; Clinical Nurse Specialists; Clinical Practice Guideline; Clinical Practice Guidelines; Coagulation Factor IV; Communication; Complex; Compliance behavior; Complication; Computer Programs; Computer software; Computerized Medical Record; Computers; Country; Data; Data Analyses; Data Banks; Data Bases; Data Element; Data Set; Databank, Electronic; Databanks; Database, Electronic; Databases; Dataset; Dialysis; Dialysis patients; Dialysis procedure; Disease Outcome; Doctor's Assistants; Drug usage; E-Mail; ESRD; Ecological impact; Electronic Mail; Electronic Medical Record; Email; End stage renal failure; End-Stage Kidney Disease; Ensure; Environment; Environmental Impact; Equipment; Ethics Committees, Research; Evaluation; Evidence based practice guidelines; Expert Systems; FLR; Factor IV; Failure (biologic function); Fax; Foundations; Future; Goals; Government; Guidelines; Health; Health Care Financing Administration; Health Care Financing Administration (U.S.); Health Care Team; Healthcare Team; Hour; Human Resources; IACUC; IRBs; IT Systems; Impact, Environmental; Individual; Information Systems; Information Technology; Information Technology Systems; Infrastructure; Institute of Medicine; Institute of Medicine (U.S.); Institutional Animal Care and Use Committee; Institutional Review Boards; Instruction; Intelligent systems; Intermediary Metabolism; International; Intervention; Intervention Strategies; Kidney; Kidney Diseases; Kidney Failure, Chronic; Lead; Link; METBL; Management Information Systems; Manpower; Manuals; Marketing; Measures; Medical; Medical Care Team; Medical Directors; Medical Record, Computerized; Metabolic Processes; Metabolism; Methods; Minerals; Mortality; Mortality Vital Statistics; NAS/IOM; Names; Nephropathy; Notification; Nurse Clinicians; Nurses; On-Line Systems; Online Systems; Organ System, Cardiovascular; P element; PROV; PTH (1-84); PTH protein, human; Parathyroid Hormone; Parathyroid Hormone (1-84); Parathyroid Hormones; Patient Care; Patient Care Delivery; Patient Compliance; Patient Cooperation; Patients; Pb element; Performance; Personnel, Nursing; Persons; Phase; Phosphorus; Phrases (PT); Phrases [Publication Type]; Physician Assistants; Physician Executives; Physicians' Extenders; Price; Principal Investigator; Programs (PT); Programs [Publication Type]; Provider; Public Health; QOC; Quality of Care; Recommendation; Relative Risks; Renal Disease; Renal Disease, End-Stage; Renal Failure, Chronic; Reporting; Research; Research Ethics Committees; Research Infrastructure; Research Resources; Resources; Reticuloendothelial System, Blood; Role; Sales; Sensitivity and Specificity; Services; Simulate; Site; Software; Solutions; Source; Specific qualifier value; Specified; Staging; System; System, LOINC Axis 4; Systems Analyses; Systems Analysis; Systems, Data; Technology; Telefacsimile; Telefax; Testing; Time; Treatment Compliance; United States Centers for Medicare and Medicaid Services; United States Health Care Financing Administration; Urinary System, Kidney; Vascular, Heart; Vertebrate Animals; Vertebrates; Work; abstracting; base; cardiovascular risk; cardiovascular risk factor; chronic kidney disease; circulatory system; clinical data repository; clinical data warehouse; commercial application; commercialization; compliance cooperation; computer program/software; cost; data repository; develop software; developing computer software; dialysis therapy; drug use; evidence based guidelines; evidence based recommendations; experience; expiration; failure; falls; hPTH(1-84); heavy metal Pb; heavy metal lead; human PTH protein; human subject; improved; information gathering; innovate; innovation; innovative; insight; interventional strategy; kidney disorder; meetings; member; online computer; parathormone; parathyroid hormone, human; patient adherence; personnel; phrases; pricing; primary outcome; programs; public health medicine (field); quality assurance; relational database; renal; renal disorder; response; social role; software development; task analysis; therapy compliance; therapy cooperation; tool; trend; vertebrata; web based