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Web-Enhanced Guideline Implementation for Post MI CBOC Patients (VA MI Plus)

Primary Purpose

Myocardial Infarction, Comorbidity

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VA MI Plus Interactive
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myocardial Infarction focused on measuring Myocardial Infarction, Comorbidities, Guidelines, Computer Assisted Instruction, Physician Practice Instruction, Online Systems

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Medical Center, Birmingham
  • Carl T. Hayden VA Medical Center
  • Fayetteville, AR
  • Long Beach
  • VA Medical Center
  • VA Connecticut Health Care System (West Haven)
  • Bay Pines VA Healthcare System, Pay Pines, FL
  • VA Medical Center, Miami
  • VA Medical Center, Decatur
  • Jesse Brown VAMC (WestSide Division)
  • VA Illiana Health Care System
  • VA Medical Center Iowa City
  • VA Eastern Kansas Health Care System - Topeka
  • Robert J. Dole VAMC & ROC
  • VA Medical Center, Louisville
  • Overton Brooks VA Medical Center, Shreveport, LA
  • Edith Nourse Rogers Memorial Veterans Hospital
  • VA Boston Health Care System, Jamaica Plain
  • VA Ann Arbor Healthcare System
  • Battle Creek, MI
  • VA Gulf Coast Veterans Health Care System
  • Harry S. Truman Memorial VA Medical Center
  • Kansas City VA Medical Center
  • VA Medical Center, St Louis
  • VA New Jersey Health Care System, East Orange
  • Albany VA Medical Center: Samuel S. Stratton
  • No Longer Valid, Use 528A8
  • Franklin Delano Roosevelt Campus of VAHVHCS
  • New York, NY
  • VA Medical Center, Cincinnati
  • VA Medical Center, Cleveland
  • Coatesville, PA
  • Lebanon, PA
  • VA Medical Center, Providence
  • Ralph H Johnson VA Medical Center, Charleston
  • VA Medical Center
  • VA Salt Lake City Health Care System, Salt Lake City
  • VA Medical & Regional Office Center, White River
  • William S. Middleton Memorial Veterans Hospital
  • Clement J. Zablocki VAMC
  • San Juan VAMC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

Full Information

First Posted
August 2, 2005
Last Updated
June 24, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00126750
Brief Title
Web-Enhanced Guideline Implementation for Post MI CBOC Patients
Acronym
VA MI Plus
Official Title
MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Comorbidity
Keywords
Myocardial Infarction, Comorbidities, Guidelines, Computer Assisted Instruction, Physician Practice Instruction, Online Systems

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
847 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
VA MI Plus Interactive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators
Description
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%).
Time Frame
1/1/02 - 12/31/08

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas K Houston, MD MPH
Organizational Affiliation
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Funkhouser, DrPH MS BS
Organizational Affiliation
VA Medical Center, Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Carl T. Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Fayetteville, AR
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
VA Connecticut Health Care System (West Haven)
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Bay Pines VA Healthcare System, Pay Pines, FL
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
VA Medical Center, Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
VA Medical Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Jesse Brown VAMC (WestSide Division)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
VA Illiana Health Care System
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
VA Medical Center Iowa City
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
Facility Name
VA Eastern Kansas Health Care System - Topeka
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66622
Country
United States
Facility Name
Robert J. Dole VAMC & ROC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
VA Medical Center, Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Overton Brooks VA Medical Center, Shreveport, LA
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Edith Nourse Rogers Memorial Veterans Hospital
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Facility Name
VA Boston Health Care System, Jamaica Plain
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Battle Creek, MI
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49015
Country
United States
Facility Name
VA Gulf Coast Veterans Health Care System
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Harry S. Truman Memorial VA Medical Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201-5297
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
VA Medical Center, St Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
VA New Jersey Health Care System, East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Albany VA Medical Center: Samuel S. Stratton
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
No Longer Valid, Use 528A8
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Franklin Delano Roosevelt Campus of VAHVHCS
City
Montrose
State/Province
New York
ZIP/Postal Code
10548
Country
United States
Facility Name
New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
VA Medical Center, Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-3800
Country
United States
Facility Name
Coatesville, PA
City
Coatesville
State/Province
Pennsylvania
ZIP/Postal Code
19320
Country
United States
Facility Name
Lebanon, PA
City
Lebanon
State/Province
Pennsylvania
ZIP/Postal Code
17042
Country
United States
Facility Name
VA Medical Center, Providence
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4799
Country
United States
Facility Name
Ralph H Johnson VA Medical Center, Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
VA Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
VA Medical & Regional Office Center, White River
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009-0001
Country
United States
Facility Name
William S. Middleton Memorial Veterans Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Clement J. Zablocki VAMC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-1000
Country
United States
Facility Name
San Juan VAMC
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
21139090
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.
Results Reference
result
PubMed Identifier
19998447
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.
Results Reference
result
PubMed Identifier
22123798
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.
Results Reference
result
PubMed Identifier
21906278
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.
Results Reference
result
PubMed Identifier
21521591
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.
Results Reference
result
PubMed Identifier
17911944
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.
Results Reference
result
PubMed Identifier
19534038
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.
Results Reference
result
PubMed Identifier
18174777
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.
Results Reference
result
PubMed Identifier
18174779
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.
Results Reference
result
PubMed Identifier
18174783
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.
Results Reference
result
PubMed Identifier
19090876
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.
Results Reference
result
PubMed Identifier
19502568
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.
Results Reference
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PubMed Identifier
19537217
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.
Results Reference
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PubMed Identifier
18984559
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.
Results Reference
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PubMed Identifier
20574879
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.
Results Reference
result

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Web-Enhanced Guideline Implementation for Post MI CBOC Patients

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