Collaborative Cardiac Care Project (C3P)

Tracking Information
First Submitted Date ICMJE	March 16, 2005
First Posted Date ICMJE	March 17, 2005
Last Update Posted Date	April 7, 2015
Study Start Date ICMJE	October 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: August 10, 2005)	Symptom control, quality of life and satisfaction at one year; improved practitioner compliance with national clinical practice guidelines over the one-year intervention period
Original Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	Patient-reported changes in scores on the angina frequency, physical limitation, and quality of life scales of the SAQ
Change History	Complete list of historical versions of study NCT00105664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 10, 2005)	Marginal cost effectiveness during one-year study period
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Collaborative Cardiac Care Project
Official Title ICMJE	Collaborative Cardiac Care Project (C3P)
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Myocardial Ischemia; Angina Pectoris; Coronary Disease
Intervention ICMJE	Procedure: Collaborative care model; Procedure: Group interventions; Procedure: Facilitated consultation
Study Arms	Arm 1; Interventions: Procedure: Collaborative care model; Procedure: Group interventions; Procedure: Facilitated consultation
Publications *	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 11, 2007)	287
Original Enrollment ICMJE; (submitted: June 23, 2005)	4000
Actual Study Completion Date	July 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00105664
Other Study ID Numbers ICMJE	IHI 02-062
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	VA Office of Research and Development
Study Sponsor ICMJE	VA Office of Research and Development
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Stephan D. Fihn, MD MPH VA Puget Sound Health Care System Seattle Division, Seattle, WA
PRS Account	VA Office of Research and Development
Verification Date	October 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP