- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00508014
Assessing the Effectiveness of Concurrent Peer Review for Patients With Cardiovascular Disease and Diabetes
October 10, 2013 updated by: Kevin Fiscella, University of Rochester
Concurrent Peer Review Visits to Reduce Cardiovascular Risk Factors
We will assess the impact of concurrent peer review vists on blood pressure, cholesterol and diabetes control.
Concurrent peer review (CPR) visits refer to special offic visits by patients to a clinician (physician, nurse practitioner, or physician assistant) other than than their primary care provider that are specifically designed to improve care for diabetes and cardiovascular disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project aims to reduce racial and ethnic disparities in health care by improving cardiovascular and diabetes management among poor and minority patients.
We propose to implement and evaluate an innovative, but practical intervention: CPR visits.
CPR visits are designed to minimize competing demands for clinicians and reduce clinical inertia by focusing clinician and patient attention on optimizing cardiovascular and/or diabetes management and disease control and through use of clinician prompts and decision support at the point of care.
Following training of clinician staff, CPR visits will be implemented within two sites of a single community health center (Westside Health Services, Inc).
Patients will be randomly assigned one CPR visit with a clinician other than their primary care clinician or to usual care.
The primary study outcome will include control of hypertension, diabetes, and lipids.
Secondary outcomes will include process measures for cardiovascular and diabetes care.
Both personnel and data collection infrastructure will build on the existing Health Disparities Collaborative at Westside.
A research team from the University of Rochester will assist in the implementation of study design.
This team will lead both the quantitative and qualitative evaluation of the project including outcome and process measures.
Project findings offer promise for improving care to underserved populations through dissemination and implementation of a feasible strategy among practices caring for the underserved.
Findings will be disseminated nationally in conjunction with the Robert Wood Johnson Foundation, the National Association of Community Health Centers, and the National Health Disparities Collaborative and through publication in the peer reviewed literature and presentation at national conferences.
Study Type
Interventional
Enrollment (Actual)
727
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14611
- Westside Health Services, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Active patient at Westside Health Services.
- Currently enrolled in the Health Disparities Collaborative at WHS.
- At least one visit to primary care provider in past year.
- Any of the following documented during the preceding three months:
- BP not at goal e,g. (BP 140/80 or greater unless has DM, CAD or CRI then BP greater than 130/80), LDL-C not at goal (level dependent on absolute ATP III CVD risk) or glycated hemoglogin 7 percent or higher
Exclusion Criteria:
- Less than 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
usual care
|
Usual Care with primary care provider during time period
|
|
Experimental: Concurrent Peer Review Visit
See description of interventioin
|
Participants are offered an office visit with a peer of their clinician primary clinician.
This office visit is structured and focused on blood pressure, diabetic, and/or lipid control with decision support available at point of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean change in blood pressure, glycated hemoglobin, and LDL-cholesterol between baseline and follow-up
Time Frame: 7 months
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Use of aspirin, ACE inhibiters/ARBs (diabetic patients), pneumonia vaccine updated, diabetic foot exam, diabetic microalbumuria check, retinal exam, smoking cessation counseling, dental visit, and self management goal
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Kevin Fiscella, MD, MPH, University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
July 25, 2007
First Submitted That Met QC Criteria
July 26, 2007
First Posted (Estimate)
July 27, 2007
Study Record Updates
Last Update Posted (Estimate)
October 14, 2013
Last Update Submitted That Met QC Criteria
October 10, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59768
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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