AzTrials
AzTrials

Myocardial InfarctionVA MI PlusNCT00126750

Web-Enhanced Guideline Implementation for Post MI CBOC Patients

A study testing VA MI Plus Interactive in people with Myocardial Infarction and Comorbidity, run by US Department of Veterans Affairs at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in managing complex patients by providing a single, interactive, and personalized source of information regarding applicable guidelines for post-MI patients. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Myocardial Infarction, Comorbidity
What is being tested?
VA MI Plus Interactive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
847 participants
Where
41 sitesin 2 countries
Study dates
Sep 2003to Jun 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Potential subjects are defined as any VA-employed physician, PA, or CRNP who is a CBOC provider. All such providers will be offered the opportunity to participate and will have the option to agree to participate or not. Performance measure data from records of post-MI patients of the above providers will be extracted to test the experimental intervention. (Note: No individually identifying patient information will be extracted.) All VA-employed CBOC providers (physicians, PAs, CRNPs) will be offered the opportunity to participate in this study. Any subject may refuse to participate or to discontinue participation at will at any point in the study without consequence.

Who cannot join

  • Potential subjects must be VA-employed physician, PA, or CRNP who is a CBOC provider. No such healthcare providers will be excluded from the study.

Trial locations and contacts

41 sites in 2 countries.

41 sites in 2 countries

United States40 sites
  • Albany VA Medical Center: Samuel S. Stratton

    Albany, New York, 12208

  • No Longer Valid, Use 528A8

    Albany, New York, 12208

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

  • Battle Creek, MI

    Battle Creek, Michigan, 49015

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33708

  • Edith Nourse Rogers Memorial Veterans Hospital

    Bedford, Massachusetts, 01730

  • VA Gulf Coast Veterans Health Care System

    Biloxi, Mississippi, 39531

  • VA Medical Center, Birmingham

    Birmingham, Alabama, 35233

  • VA Boston Health Care System, Jamaica Plain

    Boston, Massachusetts, 02130

  • Ralph H Johnson VA Medical Center, Charleston

    Charleston, South Carolina, 29401-5799

  • Jesse Brown VAMC (WestSide Division)

    Chicago, Illinois, 60612

  • VA Medical Center, Cincinnati

    Cincinnati, Ohio, 45220

  • VA Medical Center, Cleveland

    Cleveland, Ohio, 44106-3800

  • Coatesville, PA

    Coatesville, Pennsylvania, 19320

  • Harry S. Truman Memorial VA Medical Center

    Columbia, Missouri, 65201-5297

  • VA Illiana Health Care System

    Danville, Illinois, 61832

  • VA Medical Center, Decatur

    Decatur, Georgia, 30033

  • VA New Jersey Health Care System, East Orange

    East Orange, New Jersey, 07018

  • Fayetteville, AR

    Fayetteville, Arkansas, 72703

  • VA Medical Center Iowa City

    Iowa City, Iowa, 52246

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • Lebanon, PA

    Lebanon, Pennsylvania, 17042

  • Long Beach

    Long Beach, California, 90822

  • VA Medical Center, Louisville

    Louisville, Kentucky, 40206

  • William S. Middleton Memorial Veterans Hospital

    Madison, Wisconsin, 53705

  • VA Medical Center, Miami

    Miami, Florida, 33125

  • Clement J. Zablocki VAMC

    Milwaukee, Wisconsin, 53295-1000

  • Franklin Delano Roosevelt Campus of VAHVHCS

    Montrose, New York, 10548

  • VA Medical Center

    Nashville, Tennessee, 37212-2637

  • New York, NY

    New York, New York, 10010

  • Carl T. Hayden VA Medical Center

    Phoenix, Arizona, 85012

  • VA Medical Center, Providence

    Providence, Rhode Island, 02908-4799

  • VA Salt Lake City Health Care System, Salt Lake City

    Salt Lake City, Utah, 84148

  • VA Medical Center

    San Francisco, California, 94121

  • Overton Brooks VA Medical Center, Shreveport, LA

    Shreveport, Louisiana, 71101

  • VA Medical Center, St Louis

    St Louis, Missouri, 63106

  • VA Eastern Kansas Health Care System - Topeka

    Topeka, Kansas, 66622

  • VA Connecticut Health Care System (West Haven)

    West Haven, Connecticut, 06516

  • VA Medical & Regional Office Center, White River

    White River Junction, Vermont, 05009-0001

  • Robert J. Dole VAMC & ROC

    Wichita, Kansas, 67218

Other trials in United States

Puerto Rico1 site
  • San Juan VAMC

    San Juan, 00921-3201

Other trials in Puerto Rico

About this study

Official title: MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients

To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in managing complex patients by providing a single, interactive, and personalized source of information regarding applicable guidelines for post-MI patients. Specifically, 1) the investigators will identify barriers to provider adherence to guidelines within VHA clinics; 2) Apply guideline-based performance measures to electronic medical records (CPRS) and associated administrative data; 3) Implement the interactive Internet intervention developed by the NHLBI study, after inclusion of VA-specific components, including performance feedback for CBOC clinicians; and 4) Test hypotheses on the intervention's effectiveness, sustainability, and cost-effectiveness in both the VA and Medicare populations. This will include a randomized controlled trial with the CBOC as a unit of randomization.

Read the detailed description

Some 7.1 million Americans and an estimated 250,000 Veterans actively using VHA are Myocardial Infarction (MI) survivors. To date, most guideline interventions focus on a single patient condition, but ambulatory post-MI patients are frequently more complex, multiple comorbidities, and conflicting guidelines applicable to them. For example, whereas JNC-6 guidelines for the treatment of hypertension suggest pharmacological treatment at blood pressures above 140/80 mm Hg, to be initiated with diuretics or beta-blockers as first line agents, other guidance suggests that for post-MI patients with diabetes, treatment cut-offs should be lower and ACE-inhibitors may be considered as optimal first-line agents. On October 1, 2002, the University of Alabama at Birmingham (UAB) began a study funded by the National Heart, Lung, and Blood institute (NHLBI) as an RO1 (Kiefe, PI (25%), Weissman, co-PI (20%)) to conduct a randomized trial, MI-plus to increase provider adherence to guidelines for post-MI patients. That NHLBI-funded study targets Medicare beneficiaries and their primary care providers in Alabama. Its primary goal is to develop and test with a randomized controlled trial, an Internet-based multimodal guideline implementation strategy. The investigators propose, herewith, to extend and adapt this study to a nationwide sample of VA post-MI patients and their primary care providers in the VA.

Being tested
VA MI Plus Interactive
Keywords
Myocardial Infarction, Comorbidities, Guidelines, Computer Assisted Instruction, Physician Practice Instruction, Online Systems
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VA MI Plus InteractiveBehavioural

    The experimental intervention, customized to the individual clinician in real-time consists of Internet learning modules integrating case-based education with audit, feedback, and benchmarking of practice profiles.

Study groups in NCT00126750
Study groupRoleWhat they receive
Arm 1OtherNot described
Receives: Behavioral: VA MI Plus Interactive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators

    The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level < previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level < previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (<8%).

    Measured: 1/1/02 - 12/31/08

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2005 (estimated)
  2. Study startSep 2003
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
847 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00126750
Sponsor's protocol ID
SDR 03-090
Acronym
VA MI Plus
Status last verified
Jun 2015
First submitted
2 Aug 2005
Last updated
23 Jul 2015
Data monitoring committee
No

Publications

  • Funkhouser E, Houston TK, Levine DA, Richman J, Allison JJ, Kiefe CI. Physician and patient influences on provider performance: beta-blockers in postmyocardial infarction management in the MI-Plus study. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):99-106. doi: 10.1161/CIRCOUTCOMES.110.942318. Epub 2010 Dec 7.

    PubMed 21139090
  • Schoen MJ, Tipton EF, Houston TK, Funkhouser E, Levine DA, Estrada CA, Allison JJ, Williams OD, Kiefe CI. Characteristics that predict physician participation in a Web-based CME activity: the MI-Plus study. J Contin Educ Health Prof. 2009 Fall;29(4):246-53. doi: 10.1002/chp.20043.

    PubMed 19998447
  • Levine DA, Funkhouser EM, Houston TK, Gerald JK, Johnson-Roe N, Allison JJ, Richman J, Kiefe CI. Improving care after myocardial infarction using a 2-year internet-delivered intervention: the Department of Veterans Affairs myocardial infarction-plus cluster-randomized trial. Arch Intern Med. 2011 Nov 28;171(21):1910-7. doi: 10.1001/archinternmed.2011.498.

    PubMed 22123798
  • Funkhouser E, Levine DA, Gerald JK, Houston TK, Johnson NK, Allison JJ, Kiefe CI. Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study. Implement Sci. 2011 Sep 9;6:105. doi: 10.1186/1748-5908-6-105.

    PubMed 21906278
  • Ahern DK, Woods SS, Lightowler MC, Finley SW, Houston TK. Promise of and potential for patient-facing technologies to enable meaningful use. Am J Prev Med. 2011 May;40(5 Suppl 2):S162-72. doi: 10.1016/j.amepre.2011.01.005.

    PubMed 21521591
  • Houston TK, Funkhouser E, Allison JJ, Levine DA, Williams OD, Kiefe CI. Multiple measures of provider participation in Internet delivered interventions. Stud Health Technol Inform. 2007;129(Pt 2):1401-5.

    PubMed 17911944
  • Bloch MJ, Basile JN. Analysis of Recent Papers in Hypertension. J Clin Hypertens (Greenwich). 2009 May;11(5):292-95. doi: 10.1111/j.1751-7176.2009.00115.x. No abstract available.

    PubMed 19534038
  • Basile J. Shifting paradigms in defining and treating hypertension: addressing global risk with combination therapy. J Clin Hypertens (Greenwich). 2008 Jan;10(1 Suppl 1):2-3. doi: 10.1111/j.1524-6175.2007.08026.x. No abstract available.

    PubMed 18174777
  • Basile J. The importance of prompt blood pressure control. J Clin Hypertens (Greenwich). 2008 Jan;10(1 Suppl 1):13-9. doi: 10.1111/j.1524-6175.2007.08027.x.

    PubMed 18174779
  • Jamerson KA, Basile J. Prompt, aggressive BP lowering in high-risk patients. J Clin Hypertens (Greenwich). 2008 Jan;10(1 Suppl 1):40-8. doi: 10.1111/j.1524-6175.2007.08145.x.

    PubMed 18174783
  • Cushman WC, Ford CE, Einhorn PT, Wright JT Jr, Preston RA, Davis BR, Basile JN, Whelton PK, Weiss RJ, Bastien A, Courtney DL, Hamilton BP, Kirchner K, Louis GT, Retta TM, Vidt DG; ALLHAT Collaborative Research Group. Blood pressure control by drug group in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2008 Oct;10(10):751-60. doi: 10.1111/j.1751-7176.2008.00015.x.

    PubMed 19090876
  • Yu FB, Menachemi N, Berner ES, Allison JJ, Weissman NW, Houston TK. Full implementation of computerized physician order entry and medication-related quality outcomes: a study of 3364 hospitals. Am J Med Qual. 2009 Jul-Aug;24(4):278-86. doi: 10.1177/1062860609333626. Epub 2009 Jun 5.

    PubMed 19502568
  • Levine DA, Allison JJ, Cherrington A, Richman J, Scarinci IC, Houston TK. Disparities in self-monitoring of blood glucose among low-income ethnic minority populations with diabetes, United States. Ethn Dis. 2009 Spring;19(2):97-103.

    PubMed 19537217
  • Houston TK, Richman JS, Ray MN, Allison JJ, Gilbert GH, Shewchuk RM, Kohler CL, Kiefe CI; DPBRN Collaborative Group. Internet delivered support for tobacco control in dental practice: randomized controlled trial. J Med Internet Res. 2008 Nov 4;10(5):e38. doi: 10.2196/jmir.1095.

    PubMed 18984559
  • Miller MJ, Allison JJ, Schmitt MR, Ray MN, Funkhouser EM, Cobaugh DJ, Saag KG, LaCivita C. Using single-item health literacy screening questions to identify patients who read written nonsteroidal anti-inflammatory medicine information provided at pharmacies. J Health Commun. 2010 Jun;15(4):413-27. doi: 10.1080/10810731003753091.

    PubMed 20574879

Questions about this trial

What is this clinical trial studying?

A study testing VA MI Plus Interactive in people with Myocardial Infarction and Comorbidity, run by US Department of Veterans Affairs at 41 sites in 2 countries.

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 1 inclusion and 1 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators (time frame: 1/1/02 - 12/31/08). 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 NCT00126750, which also lists 15 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 23 Jul 2015.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
VA MI Plus Clinical Trial NCT00126750 | AzTrials