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

Primary Purpose

Chronic Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education only
Multifactorial intervention
Sponsored by
Louis Stokes VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Renal Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Louis Stokes Cleveland Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multifactorial intervention

Education only

Arm Description

The multifactorial intervention will consist of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.

Providers in the education only arm will receive a CKD lecture and be given a CKD reference card.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 15, 2009
Last Updated
May 22, 2013
Sponsor
Louis Stokes VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00921687
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louis Stokes VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
781 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifactorial intervention
Arm Type
Experimental
Arm Description
The multifactorial intervention will consist of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
Arm Title
Education only
Arm Type
Active Comparator
Arm Description
Providers in the education only arm will receive a CKD lecture and be given a CKD reference card.
Intervention Type
Behavioral
Intervention Name(s)
Education only
Intervention Description
The education will consist of a lecture and distribution of a CKD reference card.
Intervention Type
Behavioral
Intervention Name(s)
Multifactorial intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTH (Parathyroid Hormone) Adherence
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Last Clinic BP <130/80 mmHg
Description
Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Drawz, MD, MHS, MS
Organizational Affiliation
Louis Stokes VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes Cleveland Veterans Affairs Medical Center
City
Cleveland
State/Province
Ohio
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11904577
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.
Results Reference
background
PubMed Identifier
17988187
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.
Results Reference
background
PubMed Identifier
18175059
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.
Results Reference
background
PubMed Identifier
10535437
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.
Results Reference
background
PubMed Identifier
22765882
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.
Results Reference
derived
Links:
URL
http://www.biomedcentral.com/1472-6947/12/62/abstract
Description
abstract - BMC Medical Informatics and Decision Making

Learn more about this trial

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

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