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A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Completed
Phase 4

Conditions

Chronic Kidney Disease

Treatments

Other: Pharmacist based QI program
Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01290614
10088-H41

Details and patient eligibility

About

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.

Full description

Research Plan:

The experimental design is a prospective, randomized controlled trial evaluating the impact of a Chronic Care Model (CCM) based quality improvement program on CKD guideline adherence. The intervention will focus on three main goals: 1) reduction of BP to target levels, 2) appropriate monitoring of patients for metabolic complications of CKD, and 3) reduced use of dialysis catheters in patients initiating dialysis. The CKD CCM QI program will include a lecture on CKD guidelines and hypertension to all CBOC providers and a centrally located pharmacist with access to the CKD registry.

Methodology:

Veterans receive primary care at Community Based Outpatient Centers (CBOCs) throughout Northeast Ohio. Patients with CKD who receive their primary care at a Northeast Ohio CBOC will be eligible for the study. The hypothesis was formulated before data collection.

Enrollment

2,199 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2,199 participants in 2 patient groups

Pharmacist intervention
Experimental group
Treatment:
Other: Pharmacist based QI program
Control - usual care
Active Comparator group
Description:
Patients assigned to control will continue to receive care from their VA provider.
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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