CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,199 enrolled
Drug / intervention
Pharmacist based QI program +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01290614
NCT01290614Phase 4Completed
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A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD

University of Minnesota·interventional·Posted Feb 7, 2011·Updated Jul 13, 2015

In Brief

A Phase 4 clinical trial evaluating Pharmacist based QI program and Usual Care for Chronic Kidney Disease. Completed, enrolled 2,199 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2011
Enrollment StartFeb 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.4 years ago

Interventions

Pharmacist based QI programother

Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.

Usual Careother

Patients in the control arm will continue to receive "usual care" from their VA providers.