Chronic Kidney Disease Clinical Decision Support (CKD-CDS)

November 7, 2022 updated by: HealthPartners Institute

A Technology-Driven Intervention to Improve Identification and Management of Chronic Kidney Disease in Primary Care

To prevent serious chronic kidney disease (CKD) complications such as end-stage renal disease and cardiovascular events, better strategies are needed to identify, treat, and refer CKD patients seen in primary care clinics. This project expands an existing and successful Web-based clinical decision support (CDS) system to include key elements of CKD care and rigorously assesses the impact of this intervention on quality of CKD care for patients seen in primary care settings, including better recognition of CKD, better management of blood pressure and glucose, and more timely referral to nephrologists when appropriate. This low-cost and highly scalable intervention has high potential to improve CKD care and translate massive public and private sector investments in health informatics into tangible health benefits for large numbers of patients with CKD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinics are randomly allocated 1:1 through a computer-generated program to either control or intervention.

Control Clinics. All control clinics will continue to use the basic Electronic Medical Record (EMR)-linked CDS for cardiovascular (CV) risk factor management. This CDS includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. The basic CDS does not include information specific to CKD care.

Intervention Clinics. The CKD-CDS intervention provides updated clinical recommendations at any primary care visit for patients meeting inclusion and exclusion criteria. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CKD-CDS intervention is rooted in a series of antecedent studies that developed more limited but successful forms of CDS. From an operational point of view, implementing CKD-CDS at intervention clinics requires a series of 4 distinct steps that occur at every encounter:

Step 1: Data exchange and evaluation: The EMR securely exchanges data with the Web Service at every encounter of patients aged 18-75 triggered by BP entry.

Step 2: Recognition of CKD and presence of care deficits: Patients with stage 3-4 CKD are automatically identified by the Web Service and evaluated using algorithms maintained in the Web service for identification of CKD and for the 5 emphasized care gaps (identification of CKD, BP control, glucose control, Angiotensin converting enzyme inhibitor (ACEI)/Angiotensin receptor blocker (ARB) use if appropriate, and nephrology consultation if appropriate). If the patient has a care gap, the rooming staff receives an immediate best practice advisory (BPA) prompt to print CDS materials for the patient and the provider to review and use for shared decision making. Using a sequence of steps successfully implemented in previous studies, the rooming staff will print the materials and give the lay version to the patient to review while waiting for the provider. A professional version is left on the door for the provider to review before entering the exam room. This approach has been well-liked by our providers to help them be prepared and to engage patients in their care needs before the clinician-patient interaction. PCPs can also optionally view an electronic version of the CDS materials. The CDS can be viewed in real time for any patient by clicking on a button programmed in the EMR encounter display.

Step 3: Use of CKD-CDS recommendations as shared decision-making tools: The participating providers and all rooming staff in the intervention clinics will be trained in the use of the PCP (professional) and patient (low-literacy) versions of the CKD-CDS. For this study, the CDS tool will be adapted to emphasize CKD and, for each identified deficit in CKD care, the CKD-CDS will display patient-specific recommendations consistent with then-current national CKD clinical guidelines; for example: (a) recognize CKD and ask the PCP to enter a CKD diagnosis on the problem list if indicated, and/or (b) specific considerations for how to modify BP control, glucose control, or ACEI/ARB therapy, and/or (c) refer certain patients to nephrology when referral criteria are met. The PCP assesses patient preference for any of the CKD-related treatment options. If the patient wants to act on 1 or more, the PCP can address it then or schedule a subsequent visit for that purpose. If the patient is not interested in any option, no further action is needed at that day's visit. The decision support provided to the PCP is very specific and, if pharmacotherapy is indicated, decision support specifies either initiation or titration of specific drugs based on the drugs/doses the patient is currently taking, distance from goal, and other clinical considerations outlined above. The patient version of the CKD-CDS uses symbols to provide easy patient recognition of priority clinical areas and then suggests potential treatment options they can discuss with their provider. Presenting key CKD care recommendations when indicated (all of which are evidence based and capable of improving CKD care) allows the patient freedom to select his or her preferred treatment option from among several potentially beneficial treatment options. Because patient readiness to take health-related actions varies across specific actions, offering several options improves the chance that a given patient may be interested in addressing at least 1 of the evidence-based options presented. Moreover, patient readiness to act is a key predictor of subsequent adherence and success of treatment, as we have previously shown in this patient population. It is important to realize that the printed page the patient receives frames the discussion to a set of prioritized evidence-based treatment options with likely benefit to the patient.

Step 4. Take action based on the decisions made: After discussing with the patient, the provider can then go ahead and order the recommendations suggested by the CDS such as labs, medication, e-consults with nephrology, and referrals to specialists. All actions taken are also based on the provider's clinical judgement.

Study Type

Interventional

Enrollment (Actual)

6295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • HealthPartners Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 75 years, inclusive. The evidence-based guidelines on which the CDS intervention is based are not applicable outside this age range.
  2. Have confirmed CKD based on 2 or more estimated glomerular filtration rate (eGFR) values <60 cc/min/1.73m2, including the most recent eGFR value and a previous eGFR at least one week prior

  3. Have a CKD care component suboptimally managed as defined by one or more of the following:

    1. Have two or more BP values from separate encounter dates of >=130/80 including the most recent BP to the index visit
    2. Have an individualized A1C over goal as determined by CDS algorithm criteria of most recent glycated hemoglobin (A1C) > 7% OR > 8% if any of the following conditions are identified: cardiovascular disease (CVD) or calculated 10-yr atherosclerotic cardiovascular disease (ASCVD) risk >30%, cancer, hypoglycemia, cognitive impairment, on 2 or more glycemia medications with insulin, or on 3 or more non-insulin glycemia medications
    3. Have most recent eGFR 30-59 with hypertension identified or albumin to creatinine ratio (ACR) > 30 mg/g and not on an ACEI or ARB
    4. Have non-steroidal anti-inflammatory drug (NSAID) other than aspirin on the active medication list
    5. Have a eGFR 15-29 or ACR > 300 mg/g without a nephrology visit in the last 12 months

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from receiving the

CKD-CDS:

  1. Patients enrolled in hospice,
  2. Patients with active cancer or undergoing chemotherapy
  3. Patients with pregnancy in the last year
  4. Patients with end stage renal disease

Individuals who meet all inclusion and exclusion criteria at an index visit and have at least one post-index visit in the following 12 months will be included in the primary analyses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CKD enhanced clinical decision support (CKD-CDS Intervention)
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
Other: CKD enhanced clinical decision support
The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
No Intervention: Usual Care
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With CKD Diagnosis
Time Frame: 18-month period post index
Number of patients who had a CKD diagnosis document in the 18 months post index.
18-month period post index
Number of Patients With Orders for Angiotensin-converting Enzyme Inhibitors (ACEI) or Angiotension II Reception Blockers (ARB)
Time Frame: 18-month period post index
Number of patients who had an Angiotensin-converting enzyme inhibitors (ACEI) or Angiotension II reception blockers (ARB) order in the 18 months post index.
18-month period post index
Number of Patients With Optimal Blood Pressure Control
Time Frame: 18-month period post index
Number of patients for whom the average of the two most recent blood pressures prior to 18 months post index was <130/80.
18-month period post index
Number of Patients With Optimal Glucose Control
Time Frame: 1 to 18-month period post index
Number of patients whose last A1c was <7% in the 1-18 months post index.
1 to 18-month period post index
Number of Patients With Referral to Nephrology
Time Frame: 18-month period post index
Number of patients who have a referral to nephrology in the 18 months post index.
18-month period post index

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: JoAnn M Sperl-Hillen, MD, Senior Investigator, HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Actual)

September 29, 2021

Study Completion (Actual)

September 29, 2021

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A17-353
  • 1R18DK118463-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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