Collaborative Cardiac Care Project (C3P)
Primary Purpose
Myocardial Ischemia, Angina Pectoris, Coronary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative care model
Group interventions
Facilitated consultation
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Outcomes Assessment, Primary Health Care, Group Process
Eligibility Criteria
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
Sites / Locations
- VA Palo Alto Health Care System, Palo Alto, CA
- VA Eastern Colorado Health Care System, Denver, CO
- VA Portland Health Care System, Portland, OR
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
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
Marginal cost effectiveness during one-year study period
Full Information
NCT ID
NCT00105664
First Posted
March 16, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00105664
Brief Title
Collaborative Cardiac Care Project
Acronym
C3P
Official Title
Collaborative Cardiac Care Project (C3P)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Angina Pectoris, Coronary Disease
Keywords
Outcomes Assessment, Primary Health Care, Group Process
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Collaborative care model
Intervention Type
Procedure
Intervention Name(s)
Group interventions
Intervention Type
Procedure
Intervention Name(s)
Facilitated consultation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Marginal cost effectiveness during one-year study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan D. Fihn, MD MPH
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
VA Eastern Colorado Health Care System, Denver, CO
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22819429
Citation
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.
Results Reference
result
PubMed Identifier
21911632
Citation
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.
Results Reference
result
PubMed Identifier
20720400
Citation
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.
Results Reference
result
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Collaborative Cardiac Care Project
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