Chronic Kidney Disease Clinical Decision Support (CKD-CDS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03890588 |
Recruitment Status :
Completed
First Posted : March 26, 2019
Last Update Posted : September 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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Chronic Kidney Diseases Hypertension Diabetes | Other: CKD enhanced clinical decision support | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7221 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Clinic level cluster randomized study |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | A Technology-Driven Intervention to Improve Identification and Management of Chronic Kidney Disease in Primary Care |
Actual Study Start Date : | April 17, 2019 |
Actual Primary Completion Date : | August 18, 2021 |
Actual Study Completion Date : | August 18, 2021 |

Arm | Intervention/treatment |
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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.
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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.
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- Impact of the intervention on rates of provider-diagnosed CKD for patients with antecedent estimated glomerular filtration rate (eGFR) evidence of stage 3-4 CKD [ Time Frame: 12-month period after an index usual care clinic visit ]We will assess achievement of higher rates of provider-diagnosed CKD for patients with antecedent eGFR evidence of stage 3-4 CKD
- Impact of the intervention on rates of ACEI/ARB use for patients with antecedent eGFR evidence of stage 3-4 CKD [ Time Frame: 12-month period after an index usual care clinic visit ]We will assess achievement of higher rates of ACEI/ARB use for patients with antecedent eGFR evidence of stage 3-4 CKD
- Impact of the intervention on rates of recommended BP control for patients with antecedent eGFR evidence of stage 3-4 CKD [ Time Frame: 12-month period after an index usual care clinic visit ]We will assess achievement of higher rates of recommended BP control for patients with antecedent eGFR evidence of stage 3-4 CKD
- Impact of the intervention on rates of recommended blood glucose control for patients with antecedent eGFR evidence of stage 3-4 CKD [ Time Frame: 12-month period after an index usual care clinic visit ]We will assess achievement of higher rates of recommended blood glucose control for patients with antecedent eGFR evidence of stage 3-4 CKD
- Impact of the intervention on rates of consultation with nephrology for patients with eGFR laboratory evidence of stage 3b CKD and Albumin Creatine Ratio (ACR) >30 mg/g or patients with stage 4 CKD [ Time Frame: 12-month period after an index usual care clinic visit ]We will assess achievement of higher rates of consultation with nephrology for patients with eGFR laboratory evidence of stage 3b CKD and ACR >30 mg/g or patients with stage 4 CKD

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 to 75 years, inclusive. The evidence-based guidelines on which the CDS intervention is based are not applicable outside this age range.
- Have confirmed CKD based on 2 or more eGFR values <60 cc/min/1.73m2, including the most recent eGFR value and a previous eGFR at least one week prior
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Have a CKD care component suboptimally managed as defined by one or more of the following:
- Have two or more BP values from separate encounter dates of >=130/80 including the most recent BP to the index visit
- 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
- Have most recent eGFR 30-59 with hypertension identified or ACR > 30 mg/g and not on an ACEI or ARB
- Have non-steroidal anti-inflammatory drug (NSAID) other than aspirin on the active medication list
- 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:
- Patients enrolled in hospice,
- Patients with active cancer or undergoing chemotherapy
- Patients with pregnancy in the last year
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890588
United States, Minnesota | |
HealthPartners Care System | |
Bloomington, Minnesota, United States, 55425 |
Principal Investigator: | JoAnn M Sperl-Hillen, MD | Senior Investigator, HealthPartners Institute |
Responsible Party: | HealthPartners Institute |
ClinicalTrials.gov Identifier: | NCT03890588 |
Other Study ID Numbers: |
A17-353 1R18DK118463-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 26, 2019 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Kidney Disease CKD Clinical Decision Support Diabetes Hypertension |
Kidney Diseases Renal Insufficiency, Chronic Hypertension Vascular Diseases |
Cardiovascular Diseases Urologic Diseases Renal Insufficiency |