Web-Enhanced Guideline Implementation for Post MI CBOC Patients (VA MI Plus)
24. juni 2015 opdateret af: US Department of Veterans Affairs
MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
847
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- VA Medical Center, Birmingham
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-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85012
- Carl T. Hayden VA Medical Center
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-
Arkansas
-
Fayetteville, Arkansas, Forenede Stater, 72703
- Fayetteville, AR
-
-
California
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Long Beach, California, Forenede Stater, 90822
- Long Beach
-
San Francisco, California, Forenede Stater, 94121
- VA Medical Center
-
-
Connecticut
-
West Haven, Connecticut, Forenede Stater, 06516
- VA Connecticut Health Care System (West Haven)
-
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Florida
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Bay Pines, Florida, Forenede Stater, 33708
- Bay Pines VA Healthcare System, Pay Pines, FL
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Miami, Florida, Forenede Stater, 33125
- VA Medical Center, Miami
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Georgia
-
Decatur, Georgia, Forenede Stater, 30033
- VA Medical Center, Decatur
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Jesse Brown VAMC (WestSide Division)
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Danville, Illinois, Forenede Stater, 61832
- VA Illiana Health Care System
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Iowa
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Iowa City, Iowa, Forenede Stater, 52246
- VA Medical Center Iowa City
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Kansas
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Topeka, Kansas, Forenede Stater, 66622
- VA Eastern Kansas Health Care System - Topeka
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Wichita, Kansas, Forenede Stater, 67218
- Robert J. Dole VAMC & ROC
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40206
- VA Medical Center, Louisville
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71101
- Overton Brooks VA Medical Center, Shreveport, LA
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Massachusetts
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Bedford, Massachusetts, Forenede Stater, 01730
- Edith Nourse Rogers Memorial Veterans Hospital
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Boston, Massachusetts, Forenede Stater, 02130
- VA Boston Health Care System, Jamaica Plain
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48105
- VA Ann Arbor Healthcare System
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Battle Creek, Michigan, Forenede Stater, 49015
- Battle Creek, MI
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39531
- VA Gulf Coast Veterans Health Care System
-
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Missouri
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Columbia, Missouri, Forenede Stater, 65201-5297
- Harry S. Truman Memorial VA Medical Center
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Kansas City, Missouri, Forenede Stater, 64128
- Kansas City VA Medical Center
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St Louis, Missouri, Forenede Stater, 63106
- VA Medical Center, St Louis
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New Jersey
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East Orange, New Jersey, Forenede Stater, 07018
- VA New Jersey Health Care System, East Orange
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New York
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Albany, New York, Forenede Stater, 12208
- Albany VA Medical Center: Samuel S. Stratton
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Albany, New York, Forenede Stater, 12208
- No Longer Valid, Use 528A8
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Montrose, New York, Forenede Stater, 10548
- Franklin Delano Roosevelt Campus of VAHVHCS
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New York, New York, Forenede Stater, 10010
- New York, NY
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220
- VA Medical Center, Cincinnati
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Cleveland, Ohio, Forenede Stater, 44106-3800
- VA Medical Center, Cleveland
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Pennsylvania
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Coatesville, Pennsylvania, Forenede Stater, 19320
- Coatesville, PA
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Lebanon, Pennsylvania, Forenede Stater, 17042
- Lebanon, PA
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02908-4799
- VA Medical Center, Providence
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29401-5799
- Ralph H Johnson VA Medical Center, Charleston
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37212-2637
- VA Medical Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84148
- VA Salt Lake City Health Care System, Salt Lake City
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Vermont
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White River Junction, Vermont, Forenede Stater, 05009-0001
- VA Medical & Regional Office Center, White River
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- William S. Middleton Memorial Veterans Hospital
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Milwaukee, Wisconsin, Forenede Stater, 53295-1000
- Clement J. Zablocki VAMC
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San Juan, Puerto Rico, 00921-3201
- San Juan Vamc
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Arm 1
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators
Tidsramme: 1/1/02 - 12/31/08
|
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%).
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1/1/02 - 12/31/08
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Thomas K Houston, MD MPH, Edith Nourse Rogers Memorial Veterans Hospital, Bedford
- Ledende efterforsker: Ellen Funkhouser, DrPH MS BS, VA Medical Center, Birmingham
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2003
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
2. august 2005
Først indsendt, der opfyldte QC-kriterier
2. august 2005
Først opslået (Skøn)
4. august 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SDR 03-090
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .