Clinical trial NCT00126750: Web-Enhanced Guideline Implementation for Post MI CBOC Patients
Official title: MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Comorbidity
Keywords: Myocardial Infarction
Comorbidities
Guidelines
Computer Assisted Instruction
Physician Practice Instruction
Online Systems
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-04
Enrollment: 847
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators
timeFrame: 1/1/02 - 12/31/08
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: VA Medical Center, Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Carl T. Hayden VA Medical Center
state: Arizona
city: Fayetteville
country: United States
facility: Fayetteville, AR
state: Arkansas
city: Long Beach
country: United States
facility: Long Beach
state: California
city: San Francisco
country: United States
facility: VA Medical Center
state: California
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System, Pay Pines, FL
state: Florida
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
city: Decatur
country: United States
facility: VA Medical Center, Decatur
state: Georgia
city: Chicago
country: United States
facility: Jesse Brown VAMC (WestSide Division)
state: Illinois
city: Danville
country: United States
facility: VA Illiana Health Care System
state: Illinois
city: Iowa City
country: United States
facility: VA Medical Center Iowa City
state: Iowa
city: Topeka
country: United States
facility: VA Eastern Kansas Health Care System - Topeka
state: Kansas
city: Wichita
country: United States
facility: Robert J. Dole VAMC & ROC
state: Kansas
city: Louisville
country: United States
facility: VA Medical Center, Louisville
state: Kentucky
city: Shreveport
country: United States
facility: Overton Brooks VA Medical Center, Shreveport, LA
state: Louisiana
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital
state: Massachusetts
city: Boston
country: United States
facility: VA Boston Health Care System, Jamaica Plain
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Battle Creek
country: United States
facility: Battle Creek, MI
state: Michigan
city: Biloxi
country: United States
facility: VA Gulf Coast Veterans Health Care System
state: Mississippi
city: Columbia
country: United States
facility: Harry S. Truman Memorial VA Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: St Louis
country: United States
facility: VA Medical Center, St Louis
state: Missouri
city: East Orange
country: United States
facility: VA New Jersey Health Care System, East Orange
state: New Jersey
city: Albany
country: United States
facility: Albany VA Medical Center: Samuel S. Stratton
state: New York
city: Albany
country: United States
facility: No Longer Valid, Use 528A8
state: New York
city: Montrose
country: United States
facility: Franklin Delano Roosevelt Campus of VAHVHCS
state: New York
city: New York
country: United States
facility: New York, NY
state: New York
city: Cincinnati
country: United States
facility: VA Medical Center, Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Coatesville
country: United States
facility: Coatesville, PA
state: Pennsylvania
city: Lebanon
country: United States
facility: Lebanon, PA
state: Pennsylvania
city: Providence
country: United States
facility: VA Medical Center, Providence
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H Johnson VA Medical Center, Charleston
state: South Carolina
city: Nashville
country: United States
facility: VA Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City
state: Utah
city: White River Junction
country: United States
facility: VA Medical & Regional Office Center, White River
state: Vermont
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Clement J. Zablocki VAMC
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: San Juan VAMC
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford
name: Thomas K Houston, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Medical Center, Birmingham
name: Ellen Funkhouser, DrPH MS BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.