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

Chronic Kidney Disease Clinical Trial

Official title:

A Chronic Care Model Based QI Program to Improve the Care of Patients With CKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290614
• Other study ID #: 10088-H41
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2011
• Last updated: June 16, 2015
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2199
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• 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.
• Usual Care
Patients in the control arm will continue to receive "usual care" from their VA providers.

Locations

Country	Name	City	State
United States	LSCDVAMC	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cooney D, Moon H, Liu Y, Miller RT, Perzynski A, Watts B, Drawz PE. A pharmacist based intervention to improve the care of patients with CKD: a pragmatic, randomized, controlled trial. BMC Nephrol. 2015 Apr 16;16:56. doi: 10.1186/s12882-015-0052-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure (SBP)	Average SBP for those with a baseline BP > 130/80	one year	No
Secondary	Number of Participants With PTH Measurement During the Study Period	The primary process outcome was measurement of PTH during the study period.	one year	No

External Links

•   Open Access version of manuscript