A Risk Based Approach to Improving Chronic Kidney Disease Management
This study has been completed.
Sponsor:
Brigham and Women's Hospital
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
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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:
- eGFR/ creatinine
- Lipid profile
- Calcium
- Vitamin D
- Parathyroid hormone
- Phosphorous
- Hemoglobin
- 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:
- Attitudes towards electronic decision support tools
- Attitudes towards patient self management support
- 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:
|
Other: Electronic Decision Support
Physicians randomized to the intervention will receive:
|
|
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
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 May 23, 2013