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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921687
First Posted: June 16, 2009
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul Drawz, Louis Stokes VA Medical Center
  Purpose
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 Intervention
Chronic Renal Insufficiency Behavioral: Education only Behavioral: Multifactorial intervention

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Paul Drawz, Louis Stokes VA Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 781
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921687


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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Drawz, Senior Instructor, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier: NCT00921687     History of Changes
Other Study ID Numbers: LSCVAMCCKD1
First Submitted: June 15, 2009
First Posted: June 16, 2009
Results First Submitted: July 30, 2012
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