Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Kidney Disease Clinical Decision Support (CKD-CDS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890588
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Hypertension Diabetes Other: CKD enhanced clinical decision support Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6100 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
Estimated Primary Completion Date : April 16, 2021
Estimated Study Completion Date : April 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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.


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Lilian N Chumba, MD 9529675279 lilian.n.chumba@healthpartners.com
Contact: JoAnn M Sperl-Hillen, MD 9529675009 joann.m.sperlhillen@healthpartners.com

Locations
Layout table for location information
United States, Minnesota
HealthPartners Care System Recruiting
Bloomington, Minnesota, United States, 55425
Contact: Lilian N Chumba, MD    952-976-5279    lilian.n.chumba@healthpartners.com   
Contact: JoAnn M Sperl-Hillen, MD    9529675009    joann.m.sperlhillen@healthpartners.com   
Principal Investigator: JoAnn Sperl-Hillen, MD         
Sub-Investigator: Patrick O'Connor, MD         
Sub-Investigator: Jay Desai, PhD         
Sub-Investigator: Kris Kopski, MD         
Sub-Investigator: Pritika Kumar, PhD         
Sub-Investigator: Malini DeSilva, MD         
Sub-Investigator: Lauren Crain, PhD         
Sponsors and Collaborators
HealthPartners Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: JoAnn M Sperl-Hillen, MD Senior Investigator, HealthPartners Institute

Publications:
Sperl-Hillen JM, O'Connor PJ, Averbeck BM, et al. Outpatient EHR-based diabetes clinical decision support that works: lessons learned from implementing Diabetes Wizard. Diabetes Spectrum. 2010;23(3):150-154

Layout table for additonal information
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03890588     History of Changes
Other Study ID Numbers: A17-353
1R18DK118463-01 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
Chronic Kidney Disease
CKD
Clinical Decision Support
Diabetes
Hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency