NCT00921687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
781

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 23, 2013

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

June 15, 2009

Results QC Date

July 30, 2012

Last Update Submit

May 22, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (1)

  • Last Clinic BP <130/80 mmHg

    One year

Study Arms (2)

Multifactorial intervention

EXPERIMENTAL

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

Behavioral: Multifactorial intervention

Education only

ACTIVE COMPARATOR

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

Behavioral: Education only

Interventions

Education onlyBEHAVIORAL

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

Education only

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.

Multifactorial intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All primary care providers at the Wade Park Veterans Affairs Medical Center (VAMC) will be eligible for the study
  • Patients:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes Cleveland Veterans Affairs Medical Center

Cleveland, Ohio, United States

Location

Related Publications (5)

  • 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.

    PMID: 11904577BACKGROUND
  • 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.

    PMID: 17988187BACKGROUND
  • 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.

    PMID: 18175059BACKGROUND
  • 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.

    PMID: 10535437BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Paul Drawz, MD, MHS, MS
Organization
Louis Stokes Cleveland VA Medical Center

Study Officials

  • Paul E Drawz, MD, MHS, MS

    Louis Stokes VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 27, 2013

Results First Posted

May 23, 2013

Record last verified: 2013-05

Locations