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Chronic Kidney Disease Clinical Decision Support
NA trial testing CKD enhanced clinical decision support in Chronic Kidney Diseases in 6,295 participants. Completed in 29 September 2021.
| Lead sponsor | HealthPartners Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 6,295 |
| Start date | 17 April 2019 |
| Primary completion | 29 September 2021 |
| Estimated completion | 29 September 2021 |
| Sites | 1 location across United States |
HealthPartners Institute
Adults 18 to 75, any sex, with Chronic Kidney Diseases or Hypertension. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients who had a CKD diagnosis document in the 18 months post index.
| Group | Value | 95% CI |
|---|---|---|
| CKD Enhanced Clinical Decision Support (CKD-CDS Intervention) | 417 | |
| Usual Care | 389 |
Number of patients who had an Angiotensin-converting enzyme inhibitors (ACEI) or Angiotension II reception blockers (ARB) order in the 18 months post index.
| Group | Value | 95% CI |
|---|---|---|
| CKD Enhanced Clinical Decision Support (CKD-CDS Intervention) | 151 | |
| Usual Care | 192 |
Number of patients for whom the average of the two most recent blood pressures prior to 18 months post index was \<130/80.
| Group | Value | 95% CI |
|---|---|---|
| CKD Enhanced Clinical Decision Support (CKD-CDS Intervention) | 334 | |
| Usual Care | 388 |
Number of patients whose last A1c was \<7% in the 1-18 months post index.
| Group | Value | 95% CI |
|---|---|---|
| CKD Enhanced Clinical Decision Support (CKD-CDS Intervention) | 141 | |
| Usual Care | 159 |
Number of patients who have a referral to nephrology in the 18 months post index.
| Group | Value | 95% CI |
|---|---|---|
| CKD Enhanced Clinical Decision Support (CKD-CDS Intervention) | 92 | |
| Usual Care | 95 |
Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CKD Enhanced Clinical Deci… | Usual Care |
|---|---|---|---|
| hospitalizations | General disorders | — | — |
| Reaction | System | CKD Enhanced Clinical Deci… | Usual Care |
|---|---|---|---|
| Emergency Room Visits | General disorders | — | — |
| hypokalemia | Metabolism and nutrition disorders | — | — |
| hyperkalemia | Metabolism and nutrition disorders | — | — |
| hypotension | Vascular disorders | — | — |
| hypoglycemia | Endocrine disorders | — | — |
Most-reported serious reactions: hospitalizations.
Data from ClinicalTrials.gov NCT03890588 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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