A Risk Based Approach to Improving Chronic Kidney Disease Management

NCT01203813 | Completed Phase 3 DMC

• 1 other identifier: 5R18HS018226-02
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; Quality improvement; Self management support; Electronic health records; Clinical decision support; Electronic reminders; Patient outreach

Outcome Measures

Primary Outcomes (3)

• Annual Nephrology Evaluation

  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

  At 18 months

• Appropriate ACE/ARB Use

  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

  At 18 months

• Annual lab monitoring for CKD

  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

  At 18 months

Secondary Outcomes (2)

• Outcomes According to Primary Care Use

  At 18 months

• Outcomes According to Physician Attitudes

  At 18 months

Study Arms (2)

Physician Intervention

EXPERIMENTAL

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

Physician Control

NO INTERVENTION

Physicians randomized to the control arm will continue to manage their patients with chronic kidney disease according to routine primary care standards.

Interventions

Electronic Decision Support OTHER

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

Physician Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \> 85 years

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Vanguard Medical Associates: collaborator

Study Sites (1)

Harvard Vanguard Medical Associates

Newton, Massachusetts, 02466, United States

Location

Related Links

• Harvard Vanguard Medical Associates

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas D Sequist, MD, MPH

  Harvard Vanguard Medical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)