Web-Enhanced Guideline Implementation for Post MI CBOC Patients

NCT ID: NCT00126750

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 847 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2010-06-30

Brief 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. 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.

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.

Conditions

Myocardial Infarction; Comorbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Group Type: OTHER

VA MI Plus Interactive

Intervention Type: BEHAVIORAL

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.

Interventions

VA MI Plus Interactive

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas K Houston, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Edith Nourse Rogers Memorial Veterans Hospital, Bedford

Ellen Funkhouser, DrPH MS BS

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Birmingham

Locations

VA Medical Center, Birmingham

Birmingham, Alabama, United States

Carl T. Hayden VA Medical Center

Phoenix, Arizona, United States

Fayetteville, AR

Fayetteville, Arkansas, United States

Long Beach

Long Beach, California, United States

VA Medical Center

San Francisco, California, United States

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, United States

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, United States

VA Medical Center, Miami

Miami, Florida, United States

VA Medical Center, Decatur

Decatur, Georgia, United States

Jesse Brown VAMC (WestSide Division)

Chicago, Illinois, United States

VA Illiana Health Care System

Danville, Illinois, United States

VA Medical Center Iowa City

Iowa City, Iowa, United States

VA Eastern Kansas Health Care System - Topeka

Topeka, Kansas, United States

Robert J. Dole VAMC & ROC

Wichita, Kansas, United States

VA Medical Center, Louisville

Louisville, Kentucky, United States

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, United States

Edith Nourse Rogers Memorial Veterans Hospital

Bedford, Massachusetts, United States

VA Boston Health Care System, Jamaica Plain

Boston, Massachusetts, United States

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Battle Creek, MI

Battle Creek, Michigan, United States

VA Gulf Coast Veterans Health Care System

Biloxi, Mississippi, United States

Harry S. Truman Memorial VA Medical Center

Columbia, Missouri, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

VA Medical Center, St Louis

St Louis, Missouri, United States

VA New Jersey Health Care System, East Orange

East Orange, New Jersey, United States

Albany VA Medical Center: Samuel S. Stratton

Albany, New York, United States

No Longer Valid, Use 528A8

Albany, New York, United States

Franklin Delano Roosevelt Campus of VAHVHCS

Montrose, New York, United States

New York, NY

New York, New York, United States

VA Medical Center, Cincinnati

Cincinnati, Ohio, United States

VA Medical Center, Cleveland

Cleveland, Ohio, United States

Coatesville, PA

Coatesville, Pennsylvania, United States

Lebanon, PA

Lebanon, Pennsylvania, United States

VA Medical Center, Providence

Providence, Rhode Island, United States

Ralph H Johnson VA Medical Center, Charleston

Charleston, South Carolina, United States

VA Medical Center

Nashville, Tennessee, United States

VA Salt Lake City Health Care System, Salt Lake City

Salt Lake City, Utah, United States

VA Medical & Regional Office Center, White River

White River Junction, Vermont, United States

William S. Middleton Memorial Veterans Hospital

Madison, Wisconsin, United States

Clement J. Zablocki VAMC

Milwaukee, Wisconsin, United States

San Juan VAMC

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

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.

Reference Type: RESULT

PMID: 21139090 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19998447 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22123798 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21906278 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21521591 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17911944 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19534038 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18174777 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18174779 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18174783 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19090876 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19502568 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19537217 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18984559 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20574879 (View on PubMed)

Other Identifiers

SDR 03-090

Identifier Type: -

Identifier Source: org_study_id