N/A
N=6,295
Chronic Kidney Disease Clinical Decision Support
Chronic Kidney Diseases · Hypertension · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03890588 ↗Enrolled (actual)
6,295
Serious AEs
17.2%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants With CKD Diagnosis — 417; 389 Participants — p=.21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CKD enhanced clinical decision support (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With CKD Diagnosis |
417; 389 | .21 |
| PRIMARY Number of Patients With Orders for Angiotensin-converting Enzyme Inhibitors (ACEI) or Angiotension II Reception Blockers (ARB) |
151; 192 | .61 |
| PRIMARY Number of Patients With Optimal Blood Pressure Control |
334; 388 | .84 |
| PRIMARY Number of Patients With Optimal Glucose Control |
141; 159 | .99 |
| PRIMARY Number of Patients With Referral to Nephrology |
92; 95 | .86 |
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.
Eligibility Criteria
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 estimated glomerular filtration rate (eGFR) values =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 albumin to creatinine ratio (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.
Data sourced from ClinicalTrials.gov (NCT03890588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.