Chronic Kidney Disease (CKD) Guideline Adherence - A Quality Improvement Study

Chronic Renal Insufficiency Clinical Trial

Official title:

Chronic Kidney Disease Guideline Adherence - a Cluster Randomized Controlled Quality Improvement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921687
• Other study ID #: LSCVAMCCKD1
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: May 22, 2013
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2013
• Source: Louis Stokes VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Chronic kidney disease (CKD) is defined as kidney damage for greater than 3 months or a glomerular filtration rate less than 60 mL/min per 1.73m2 for greater than 3 months. Patients with CKD are at high risk for development of cardiovascular disease and metabolic complications. Guidelines for the care of patients with CKD have been developed by the National Kidney Foundation. Despite the wide availability of these guidelines, adherence is low. The goal of the current study is to evaluate whether a multifactorial intervention, including a CKD registry, will improve CKD guideline adherence. The hypothesis is that providers exposed to a multifactorial clinical intervention including education, academic detailing, and a CKD registry will be more likely to adhere to CKD guidelines than those only exposed to education.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 781
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Providers:

Inclusion Criteria:

• All primary care providers at the Wade Park Veterans Affairs Medical Center (VAMC) will be eligible for the study

Patients:

Inclusion Criteria:

• Receive primary care from a provider at the Wade Park VAMC

• Have:

• CKD as defined by an estimated glomerular filtration rate (eGFR) less than 60 on two separate occasions 90 to 730 days apart,

• diabetes, OR

• hypertension

Exclusion Criteria:

• End-stage renal disease

• Renal transplant recipients

• Less than 18 years of age on July 1, 2009

• No primary care visit between Jan 1, 2008 and July 1, 2009

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Education only
The education will consist of a lecture and distribution of a CKD reference card.
• Multifactorial intervention
Providers in the intervention group will receive a lecture on CKD, a CKD reference card, academic detailing (residents only), and access to the CKD registry.

Locations

Country	Name	City	State
United States	Louis Stokes Cleveland Veterans Affairs Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. Review. — View Citation

Hoy T, Fisher M, Barber B, Borker R, Stolshek B, Goodman W. Adherence to K/DOQI practice guidelines for bone metabolism and disease. Am J Manag Care. 2007 Nov;13(11):620-5. — View Citation

National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. — View Citation

Philipneri MD, Rocca Rey LA, Schnitzler MA, Abbott KC, Brennan DC, Takemoto SK, Buchanan PM, Burroughs TE, Willoughby LM, Lentine KL. Delivery patterns of recommended chronic kidney disease care in clinical practice: administrative claims-based analysis and systematic literature review. Clin Exp Nephrol. 2008 Feb;12(1):41-52. doi: 10.1007/s10157-007-0016-3. Epub 2008 Jan 5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTH (Parathyroid Hormone) Adherence	Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.	One year	No
Secondary	Last Clinic BP <130/80 mmHg	Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.	One year	No

External Links

•   abstract - BMC Medical Informatics and Decision Making