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Completed

NCT Number: NCT00921687

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

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.

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Key information

Conditions

Chronic Renal Insufficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes Cleveland Veterans Affairs Medical Center

Cleveland, Ohio, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education only

Behavioral

The education will consist of a lecture and distribution of a CKD reference card.

Multifactorial intervention

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Louis Stokes VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2009
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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