A Risk Based Approach to Improving Chronic Kidney Disease Management

This study has been completed.
Sponsor:
Collaborator:
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
Thomas Dean Sequist, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01203813
First received: September 15, 2010
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be substantially improved over 18 months by:

  • Point of care electronic alerts to primary care physicians recommending risk-appropriate care, and
  • Quarterly mailings to patients providing self management support materials, including tailored recommendations based on personalized data from an electronic disease registry

Aim 2: To assess the relationship between utilization of the intervention components and primary care physician attitudes towards both chronic kidney disease management and electronic reminder systems.


Condition Intervention Phase
Chronic Kidney Disease
Other: Electronic Decision Support
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Risk Based Approach to Improving Chronic Kidney Disease Management

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Annual Nephrology Evaluation [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Patients with high risk chronic kidney disease (eGFR 30 to 45; or eGFR 45 to 60 with concurrent diabetes or proteinuria) should receive a nephrology office evaluation within the prior 12 months

  • Appropriate ACE/ARB Use [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Patients with chronic kidney disease (eGFR 30 to 60) with concurrent diabetes, proteinuria, or hypertension should receive a prescription for ACE/ARB within the prior 12 months

  • Annual lab monitoring for CKD [ Time Frame: At 18 months ] [ Designated as safety issue: No ]

    Patients with chronic kidney disease (eGFR 30 to 60) should have the following labs checked within the prior 12 months:

    1. eGFR/ creatinine
    2. Lipid profile
    3. Calcium
    4. Vitamin D
    5. Parathyroid hormone
    6. Phosphorous
    7. Hemoglobin
    8. Urine microalbumin


Secondary Outcome Measures:
  • Outcomes According to Primary Care Use [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    We will assess all three primary study outcomes according to the number of patient visits with their primary care physician during the 18 month period (0 visits, 1-2 visits, ≥ 3 visits).

  • Outcomes According to Physician Attitudes [ Time Frame: At 18 months ] [ Designated as safety issue: No ]

    We will assess all three primary care study outcomes according to physician attitudes as expressed in the post-intervention clinician survey. The three attitudes of interest include:

    1. Attitudes towards electronic decision support tools
    2. Attitudes towards patient self management support
    3. Self-assessed preparedness for managing chronic kidney disease


Enrollment: 10000
Study Start Date: May 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physician Intervention

Physicians randomized to the intervention will receive:

  1. Electronic alerts during office visits for patients with chronic kidney disease
  2. Opportunity to enroll their patients with chronic kidney disease in a self management support outreach program
Other: Electronic Decision Support

Physicians randomized to the intervention will receive:

  1. Electronic alerts during office visits for patients with chronic kidney disease
  2. Opportunity to enroll their patients with chronic kidney disease in a self management support outreach program
No Intervention: Physician Control
Physicians randomized to the control arm will continue to manage their patients with chronic kidney disease according to routine primary care standards.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 3 chronic kidney disease based on at least 2 eGFR 30-60 (separated by 90 days) within the prior 5 years
  • Must be at least 18 years of age
  • Must have a primary care visit at one of 15 of the HVMA health centers within the last 18 months

Exclusion Criteria:

  • Age > 85 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203813

Locations
United States, Massachusetts
Harvard Vanguard Medical Associates
Newton, Massachusetts, United States, 02466
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Vanguard Medical Associates
Investigators
Principal Investigator: Thomas D Sequist, MD, MPH Harvard Vanguard Medical Associates
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Dean Sequist, MD, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01203813     History of Changes
Other Study ID Numbers: 5R18 HS018226-02
Study First Received: September 15, 2010
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Chronic kidney disease
Quality improvement
Self management support
Electronic health records
Clinical decision support
Electronic reminders
Patient outreach

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2014