Web-Enhanced Guideline Implementation for Post MI CBOC Patients

Myocardial Infarction Clinical Trial

— VA MI Plus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126750
• Other study ID #: SDR 03-090
• Status: Completed
• Phase: N/A
• First received: August 2, 2005
• Last updated: June 24, 2015
• Start date: September 2003
• Est. completion date: June 2010

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Comorbidity
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Puerto Rico	San Juan VAMC	San Juan
United States	Albany VA Medical Center: Samuel S. Stratton	Albany	New York
United States	No Longer Valid, Use 528A8	Albany	New York
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Battle Creek, MI	Battle Creek	Michigan
United States	Bay Pines VA Healthcare System, Pay Pines, FL	Bay Pines	Florida
United States	Edith Nourse Rogers Memorial Veterans Hospital	Bedford	Massachusetts
United States	VA Gulf Coast Veterans Health Care System	Biloxi	Mississippi
United States	VA Medical Center, Birmingham	Birmingham	Alabama
United States	VA Boston Health Care System, Jamaica Plain	Boston	Massachusetts
United States	Ralph H Johnson VA Medical Center, Charleston	Charleston	South Carolina
United States	Jesse Brown VAMC (WestSide Division)	Chicago	Illinois
United States	VA Medical Center, Cincinnati	Cincinnati	Ohio
United States	VA Medical Center, Cleveland	Cleveland	Ohio
United States	Coatesville, PA	Coatesville	Pennsylvania
United States	Harry S. Truman Memorial VA Medical Center	Columbia	Missouri
United States	VA Illiana Health Care System	Danville	Illinois
United States	VA Medical Center, Decatur	Decatur	Georgia
United States	VA New Jersey Health Care System, East Orange	East Orange	New Jersey
United States	Fayetteville, AR	Fayetteville	Arkansas
United States	VA Medical Center Iowa City	Iowa City	Iowa
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Lebanon, PA	Lebanon	Pennsylvania
United States	Long Beach	Long Beach	California
United States	VA Medical Center, Louisville	Louisville	Kentucky
United States	William S. Middleton Memorial Veterans Hospital	Madison	Wisconsin
United States	VA Medical Center, Miami	Miami	Florida
United States	Clement J. Zablocki VAMC	Milwaukee	Wisconsin
United States	Franklin Delano Roosevelt Campus of VAHVHCS	Montrose	New York
United States	VA Medical Center	Nashville	Tennessee
United States	New York, NY	New York	New York
United States	Carl T. Hayden VA Medical Center	Phoenix	Arizona
United States	VA Medical Center, Providence	Providence	Rhode Island
United States	VA Salt Lake City Health Care System, Salt Lake City	Salt Lake City	Utah
United States	VA Medical Center	San Francisco	California
United States	Overton Brooks VA Medical Center, Shreveport, LA	Shreveport	Louisiana
United States	VA Medical Center, St Louis	St Louis	Missouri
United States	VA Eastern Kansas Health Care System - Topeka	Topeka	Kansas
United States	VA Connecticut Health Care System (West Haven)	West Haven	Connecticut
United States	VA Medical & Regional Office Center, White River	White River Junction	Vermont
United States	Robert J. Dole VAMC & ROC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (15)

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. — View 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. — View Citation

Basile J. The importance of prompt blood pressure control. J Clin Hypertens (Greenwich). 2008 Jan;10(1 Suppl 1):13-9. Review. — View Citation

Bloch MJ, Basile JN. Analysis of Recent Papers in Hypertension. J Clin Hypertens (Greenwich). 2009 May;11(5):292-95. — View 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 i — View Citation

Funkhouser E, Houston TK, Levine DA, Richman J, Allison JJ, Kiefe CI. Physician and patient influences on provider performance: ß-blockers in postmyocardial infarction management in the MI-Plus study. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):99-106. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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 clust — View 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 pharmaci — View 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):246-5 — View 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: 10.1177/106286 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%).	1/1/02 - 12/31/08	No