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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pharmacist intervention

Group Type EXPERIMENTAL

Pharmacist based QI program

Intervention Type OTHER

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.

Control - usual care

Patients assigned to control will continue to receive care from their VA provider.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

Interventions

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Pharmacist based QI program

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.

Intervention Type OTHER

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No