- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105664
Collaborative Cardiac Care Project (C3P)
April 6, 2015 updated by: US Department of Veterans Affairs
Collaborative Cardiac Care Project (C3P)
Data from VA-funded studies and the broader literature indicate that chronic stable angina (CSA) is prevalent, under recognized, under treated and associated with reduced quality of life.
There are substantial opportunities for improving care of patients with this debilitating and potentially fatal problem.
Because primary care providers manage most patients with CSA, efforts to improve care must necessarily involve the primary care delivery system.
C3P is composed of a set of interventions employing a Collaborative Care Team model, which has been shown to be effective in managing other chronic illnesses in the primary care setting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objectives of the proposed project are to: 1) ascertain whether a collaborative approach to managing CSA in primary care results in better symptom control and quality of life than routine care; 2) assess whether the practice of providers assigned to the intervention group is more consistent with national clinical practice guidelines than that of control providers; 3) assess satisfaction of both patients and providers with this approach to management; and 4) assess marginal cost-effectiveness.
Study Type
Interventional
Enrollment (Actual)
287
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
-
-
California
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Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
-
-
Colorado
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Denver, Colorado, United States, 80220
- VA Eastern Colorado Health Care System, Denver, CO
-
-
Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System, Portland, OR
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-
Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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-
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:
Providers:
- Staff (MD, PA, NP) or resident (R1, R2)
- at least 1 participating patient
Patients
- assigned to participating provider
- diagnosis consistent with IHD
- 2 visits in past year
- frequent angina symptoms (SAQ freq. score less than 70)
Exclusion Criteria:
Providers:
- No participating patients
Patients:
- cognitive impairment (inability to complete questionnaires and phone interviews)
- non-participating provider
- life expectancy of less than 24 months
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Symptom control, quality of life and satisfaction at one year; improved practitioner compliance with national clinical practice guidelines over the one-year intervention period
|
Secondary Outcome Measures
Outcome Measure |
---|
Marginal cost effectiveness during one-year study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephan D. Fihn, MD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA
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.
General Publications
- Fan VS, Bridevaux PO, McDonell MB, Fihn SD, Besser LM, Au DH. Regional variation in health status among chronic obstructive pulmonary disease patients. Respiration. 2011;81(1):9-17. doi: 10.1159/000320115. Epub 2010 Aug 17.
- Wang L, Porter B, Maynard C, Bryson C, Sun H, Lowy E, McDonell M, Frisbee K, Nielson C, Fihn SD. Predicting risk of hospitalization or death among patients with heart failure in the veterans health administration. Am J Cardiol. 2012 Nov 1;110(9):1342-9. doi: 10.1016/j.amjcard.2012.06.038. Epub 2012 Jul 21.
- Fihn SD, Bucher JB, McDonell M, Diehr P, Rumsfeld JS, Doak M, Dougherty C, Gerrity M, Heidenreich P, Larsen G, Lee PI, Lucas L, McBryde C, Nelson K, Plomondon ME, Stadius M, Bryson C. Collaborative care intervention for stable ischemic heart disease. Arch Intern Med. 2011 Sep 12;171(16):1471-9. doi: 10.1001/archinternmed.2011.372.
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
October 1, 2004
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
March 16, 2005
First Submitted That Met QC Criteria
March 16, 2005
First Posted (Estimate)
March 17, 2005
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IHI 02-062
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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