Phase 4
N=2,199
A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01290614 ↗Enrolled (actual)
2,199
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Systolic Blood Pressure (SBP) — 135.1; 134.4 mmHg — p=0.57
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pharmacist based QI program (Other); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure (SBP) |
135.1; 134.4 | 0.57 |
| SECONDARY Number of Participants With PTH Measurement During the Study Period |
502; 182 | <0.001 sig |
Summary
The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.
Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.
Eligibility Criteria
Inclusion Criteria
- receipt of primary care at a VISN 10 Northeast Ohio CBOC
- GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and
- at least one primary care visit in the year prior to study initiation.
Exclusion Criteria
- ESRD as defined by chronic renal replacement therapy,
- receipt of a renal transplant,
- hospice care, and
- age greater than 85 years or less than 18 years at the time of study initiation.
Data sourced from ClinicalTrials.gov (NCT01290614). 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.