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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00508014
Other study ID # 59768
Secondary ID
Status Completed
Phase N/A
First received July 25, 2007
Last updated October 10, 2013
Start date December 2006
Est. completion date June 2010

Study information

Verified date October 2013
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 727
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Usual Care
Usual Care with primary care provider during time period
Behavioral:
Concurrent Peer Review visit
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

Locations

Country Name City State
United States Westside Health Services, Inc Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in blood pressure, glycated hemoglobin, and LDL-cholesterol between baseline and follow-up 7 months No
Secondary 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 one year No
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