NCT00105664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

October 1, 2007

First QC Date

March 16, 2005

Last Update Submit

April 6, 2015

Conditions

Myocardial IschemiaAngina PectorisCoronary Disease

Keywords

Outcomes AssessmentPrimary Health CareGroup Process

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Marginal cost effectiveness during one-year study period

Study Arms (1)

Arm 1

OTHER
Procedure: Collaborative care modelProcedure: Group interventionsProcedure: Facilitated consultation

Interventions

Collaborative care modelPROCEDURE
Arm 1
Group interventionsPROCEDURE
Arm 1
Facilitated consultationPROCEDURE
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Providers:
  • Staff (MD, PA, NP) or resident (R1, R2)
  • at least 1 participating patient
  • Patients
  • assigned to participating provider
  • diagnosis consistent with IHD
  • visits in past year
  • frequent angina symptoms (SAQ freq. score less than 70)

You may not qualify if:

  • Providers:
  • \- No participating patients
  • Patients:
  • cognitive impairment (inability to complete questionnaires and phone interviews)
  • non-participating provider
  • life expectancy of less than 24 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (3)

  • 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.

    PMID: 22819429RESULT

  • 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.

    PMID: 21911632RESULT

  • 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.

    PMID: 20720400RESULT

MeSH Terms

Conditions

Myocardial IschemiaAngina PectorisCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephan D. Fihn, MD MPH

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2005

First Posted

March 17, 2005

Study Start

October 1, 2004

Study Completion

July 1, 2007

Last Updated

April 7, 2015

Record last verified: 2007-10

Locations

US(4)