Myocardial Infarction Clinical Trial
— VA MI PlusOfficial title:
MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
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 |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States, Puerto Rico,
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
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 |
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