Cardiovascular DiseasesNCT00508014
Assessing the Effectiveness of Concurrent Peer Review for Patients With Cardiovascular Disease and Diabetes
A study testing Concurrent Peer Review visit in people with Cardiovascular Diseases, run by University of Rochester at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Concurrent Peer Review visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 727 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Westside Health Services, Inc
Rochester, New York, 14611
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Usual Care, Concurrent Peer Review visit
- Keywords
- Cardiovascular disease, Diabetes, Quality improvement, Peer review
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Usual Care with primary care provider during time period
Concurrent Peer Review visitBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | usual care Receives: Other: Usual Care |
| Concurrent Peer Review Visit | Experimental | See description of interventioin Receives: Behavioral: Concurrent Peer Review visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in blood pressure, glycated hemoglobin, and LDL-cholesterol between baseline and follow-up
Measured: 7 months
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 727 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Kevin Fiscella, University of Rochester
- Investigators
- Kevin Fiscella, MD, MPH, Study director, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508014
- Sponsor's protocol ID
- 59768
- Status last verified
- Oct 2013
- First submitted
- 25 Jul 2007
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Peer Review Visits to Reduce Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00508014
- Acronym / sponsor ID
- 59768
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular disease, Diabetes, Quality improvement, Peer review
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 727 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Dec 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Usual Careusual care |
| Concurrent Peer Review Visit | Experimental | Behavioral: Concurrent Peer Review visitSee description of interventioin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareUsual Care with primary care provider during time period | Other | Control |
| Concurrent Peer Review visitParticipants 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 | Behavioural | Concurrent Peer Review Visit |
Primary outcome
Mean change in blood pressure, glycated hemoglobin, and LDL-cholesterol between baseline and follow-up
Time frame: 7 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
- Robert Wood Johnson Foundation Website on GranteesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Fiscella, MD, MPH study director
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Peer Review visit in people with Cardiovascular Diseases, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in blood pressure, glycated hemoglobin, and LDL-cholesterol between baseline and follow-up (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.