Collaborative Cardiac Care Project (C3P)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00105664

First received: March 16, 2005

Last updated: April 6, 2015

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

March 16, 2005

Last Updated Date

April 6, 2015

Start Date ^ICMJE

October 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

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

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 Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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 *

* 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

Enrollment ^ICMJE

287

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

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

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