NCT00126750

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
847

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
2 countries

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2015

Completed
Last Updated

July 23, 2015

Status Verified

June 1, 2015

Enrollment Period

6.8 years

First QC Date

August 2, 2005

Results QC Date

January 27, 2015

Last Update Submit

June 24, 2015

Conditions

Keywords

Myocardial InfarctionComorbiditiesGuidelinesComputer Assisted InstructionPhysician Practice InstructionOnline Systems

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Arm 1

OTHER
Behavioral: VA MI Plus Interactive

Interventions

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.

Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

Carl T. Hayden VA Medical Center

Phoenix, Arizona, 85012, United States

Location

Fayetteville, AR

Fayetteville, Arkansas, 72703, United States

Location

Long Beach

Long Beach, California, 90822, United States

Location

VA Medical Center

San Francisco, California, 94121, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, 33708, United States

Location

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

VA Medical Center, Decatur

Decatur, Georgia, 30033, United States

Location

Jesse Brown VAMC (WestSide Division)

Chicago, Illinois, 60612, United States

Location

VA Illiana Health Care System

Danville, Illinois, 61832, United States

Location

VA Medical Center Iowa City

Iowa City, Iowa, 52246, United States

Location

VA Eastern Kansas Health Care System - Topeka

Topeka, Kansas, 66622, United States

Location

Robert J. Dole VAMC & ROC

Wichita, Kansas, 67218, United States

Location

VA Medical Center, Louisville

Louisville, Kentucky, 40206, United States

Location

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, 71101, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital

Bedford, Massachusetts, 01730, United States

Location

VA Boston Health Care System, Jamaica Plain

Boston, Massachusetts, 02130, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

Battle Creek, MI

Battle Creek, Michigan, 49015, United States

Location

VA Gulf Coast Veterans Health Care System

Biloxi, Mississippi, 39531, United States

Location

Harry S. Truman Memorial VA Medical Center

Columbia, Missouri, 65201-5297, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

VA Medical Center, St Louis

St Louis, Missouri, 63106, United States

Location

VA New Jersey Health Care System, East Orange

East Orange, New Jersey, 07018, United States

Location

Albany VA Medical Center: Samuel S. Stratton

Albany, New York, 12208, United States

Location

No Longer Valid, Use 528A8

Albany, New York, 12208, United States

Location

Franklin Delano Roosevelt Campus of VAHVHCS

Montrose, New York, 10548, United States

Location

New York, NY

New York, New York, 10010, United States

Location

VA Medical Center, Cincinnati

Cincinnati, Ohio, 45220, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106-3800, United States

Location

Coatesville, PA

Coatesville, Pennsylvania, 19320, United States

Location

Lebanon, PA

Lebanon, Pennsylvania, 17042, United States

Location

VA Medical Center, Providence

Providence, Rhode Island, 02908-4799, United States

Location

Ralph H Johnson VA Medical Center, Charleston

Charleston, South Carolina, 29401-5799, United States

Location

VA Medical Center

Nashville, Tennessee, 37212-2637, United States

Location

VA Salt Lake City Health Care System, Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

VA Medical & Regional Office Center, White River

White River Junction, Vermont, 05009-0001, United States

Location

William S. Middleton Memorial Veterans Hospital

Madison, Wisconsin, 53705, United States

Location

Clement J. Zablocki VAMC

Milwaukee, Wisconsin, 53295-1000, United States

Location

San Juan VAMC

San Juan, 00921-3201, Puerto Rico

Location

Related Publications (15)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Results Point of Contact

Title
Dr. Thomas Houston II
Organization
VA Bedford CHOIR

Study Officials

  • Thomas K Houston, MD MPH

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford

    PRINCIPAL INVESTIGATOR
  • Ellen Funkhouser, DrPH MS BS

    VA Medical Center, Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

September 1, 2003

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 23, 2015

Results First Posted

July 23, 2015

Record last verified: 2015-06

Locations