N/A N=1,596 Randomized Single-blind Treatment

Kidney Coordinated Health Management Partnership

Chronic Kidney Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03832595 ↗

Enrolled (actual)

1,596

Serious AEs

2.4%

Results posted

Apr 2024

Primary outcome: Primary: Renal Failure Event Defined as Greater Than or Equal to 40% Decline in Estimated Glomerular Filtration Rate (eGFR) or Occurrence of End Stage Renal Disease (ESRD) — 9.7; 10.9 percent — p=0.82

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EHR-based PHM (Other); Usual Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Renal Failure Event Defined as Greater Than or Equal to 40% Decline in Estimated Glomerular Filtration Rate (eGFR) or Occurrence of End Stage Renal Disease (ESRD)	9.7; 10.9	0.82
SECONDARY Hypertension (HTN) Control Outcome	0.011; 0.0005	—
SECONDARY Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year	196.8; 163.1	—
SECONDARY Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year	5.3; 6.7	—
SECONDARY Medication Safety: Glyburide Exposure Days Per Year	2.4; 2.0	—
SECONDARY Medication Safety: Metformin Exposure Days Per Year	17.8; 16.0	—
SECONDARY Medication Safety: Gemfibrozil Exposure Days	—	—

Summary

As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention that targets improvements in the delivery of evidence-based CKD care.

Eligibility Criteria

Inclusion criteria for PCPs: presence of an ambulatory continuity clinic in the University of Pittsburgh Medical Center (UPMC) community medicine practice.

Inclusion criteria for patients:

age greater than or equal to 18, and less than or equal to 85
most recent eGFR less than 60 ml/min/yr
established care with UPMC PCP
high risk CKD based on validated external and internal risk prediction models or severe reduction in eGFR, or substantial loss in eGFR in prior 18 months.

Exclusion Criteria for PCPs: none

Exclusion Criteria for patients:

history of kidney transplant
receiving maintenance dialysis
recent (within 12 months) outpatient nephrology visit
baseline eGFR less than 15ml/min
expected survival less than 6 months or hospice enrollee (e.g., stage IV heart failure, metastatic cancer, oxygen dependent Chronic Obstructive Pulmonary Disease)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03832595). 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.