Myocardial IschemiaC3PNCT00105664
Collaborative Cardiac Care Project
A study testing Collaborative care model, Group interventions and Facilitated consultation in people with Myocardial Ischemia and Angina Pectoris, run by US Department of Veterans Affairs at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Angina Pectoris, Coronary Disease
- What is being tested?
- Collaborative care model, Group interventions and Facilitated consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2004to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Providers:
- No participating patients
- Patients:
- cognitive impairment (inability to complete questionnaires and phone interviews)
- non-participating provider
- life expectancy of less than 24 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Ischemia, Angina Pectoris, Coronary Disease
- Being tested
- Collaborative care model, Group interventions, Facilitated consultation
- Keywords
- Outcomes Assessment, Primary Health Care, Group Process
- Medical subject headings
- Myocardial Ischemia, Angina Pectoris, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative care modelProcedure or surgery
Group interventionsProcedure or surgery
Facilitated consultationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: Collaborative care model; Procedure: Group interventions; Procedure: Facilitated consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startOct 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephan D. Fihn, MD MPH, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105664
- Sponsor's protocol ID
- IHI 02-062
- Acronym
- C3P
- Status last verified
- Oct 2007
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22819429Fihn 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.
PubMed 21911632Fan 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.
PubMed 20720400
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Cardiac Care Project (C3P)
- ClinicalTrials.gov ID
- NCT00105664
- Acronym / sponsor ID
- C3P / IHI 02-062
- Conditions
- Myocardial Ischemia, Angina Pectoris, Coronary Disease
- Keywords
- Outcomes Assessment, Primary Health Care, Group Process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Collaborative care model, Procedure: Group interventions, Procedure: Facilitated consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Staff (MD, PA, NP) or resident (R1, R2)
- at least 1 participating patient
- Patients
- assigned to participating provider
- diagnosis consistent with IHD
Key exclusion criteria (6 listed)
- No participating patients
- cognitive impairment (inability to complete questionnaires and phone interviews)
- non-participating provider
- life expectancy of less than 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative care model | Procedure or surgery | Arm 1 |
| Group interventions | Procedure or surgery | Arm 1 |
| Facilitated consultation | Procedure or surgery | Arm 1 |
Primary outcome
Symptom control, quality of life and satisfaction at one year; improved practitioner compliance with national clinical practice guidelines over the one-year intervention period
1 secondary outcome
Marginal cost effectiveness during one-year study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 22819429Wang 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 publication: PubMed 21911632Fihn 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 publication: PubMed 20720400Fan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan D. Fihn, MD MPH principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care model, Group interventions and Facilitated consultation in people with Myocardial Ischemia and Angina Pectoris, run by US Department of Veterans Affairs at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105664, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.