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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Renal Insufficiency	Behavioral: Education only; Behavioral: Multifactorial intervention	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	781 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	Chronic Kidney Disease Guideline Adherence - a Cluster Randomized Controlled Quality Improvement Study
Study Start Date :	July 2009
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	June 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Multifactorial intervention; The multifactorial intervention will consist of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.	Behavioral: 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.
Active Comparator: Education only; Providers in the education only arm will receive a CKD lecture and be given a CKD reference card.	Behavioral: Education only; The education will consist of a lecture and distribution of a CKD reference card.

Outcome Measures

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Primary Outcome Measures :

1. PTH (Parathyroid Hormone) Adherence [ Time Frame: One year ]
   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.

Secondary Outcome Measures :

1. Last Clinic BP <130/80 mmHg [ Time Frame: One year ]
   Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Ohio
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States

Sponsors and Collaborators

Louis Stokes VA Medical Center

Investigators

Principal Investigator:	Paul E Drawz, MD, MHS, MS	Louis Stokes VA Medical Center

More Information

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Additional Information:

abstract - BMC Medical Informatics and Decision Making 

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Drawz PE, Miller RT, Singh S, Watts B, Kern E. Impact of a chronic kidney disease registry and provider education on guideline adherence--a cluster randomized controlled trial. BMC Med Inform Decis Mak. 2012 Jul 5;12:62. doi: 10.1186/1472-6947-12-62.

Responsible Party:	Paul Drawz, Senior Instructor, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier:	NCT00921687 History of Changes
Other Study ID Numbers:	LSCVAMCCKD1
First Posted:	June 16, 2009
Results First Posted:	May 23, 2013
Last Update Posted:	May 27, 2013
Last Verified:	May 2013

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases