Clinical trial NCT00921687: Chronic Kidney Disease (CKD) Guideline Adherence - A Quality Improvement Study
Official title: Chronic Kidney Disease Guideline Adherence - a Cluster Randomized Controlled Quality Improvement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Insufficiency
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
First posted: 2009-06-16
Enrollment: 781
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: PTH (Parathyroid Hormone) Adherence
timeFrame: One year
Secondary outcomes:
measure: Last Clinic BP <130/80 mmHg
timeFrame: One year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes Cleveland Veterans Affairs Medical Center
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center
name: Paul E Drawz, MD, MHS, MS
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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.
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.
citation: 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. doi: 10.1001/jama.282.15.1458.
citation: 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.