Web-Enhanced Guideline Implementation for Post MI CBOC Patients (VA MI Plus)
24 giugno 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
847
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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San Juan, Porto Rico, 00921-3201
- San Juan Vamc
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- VA Medical Center, Birmingham
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Arizona
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Phoenix, Arizona, Stati Uniti, 85012
- Carl T. Hayden VA Medical Center
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Arkansas
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Fayetteville, Arkansas, Stati Uniti, 72703
- Fayetteville, AR
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California
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Long Beach, California, Stati Uniti, 90822
- Long Beach
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San Francisco, California, Stati Uniti, 94121
- VA Medical Center
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Connecticut
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West Haven, Connecticut, Stati Uniti, 06516
- VA Connecticut Health Care System (West Haven)
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Florida
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Bay Pines, Florida, Stati Uniti, 33708
- Bay Pines VA Healthcare System, Pay Pines, FL
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Miami, Florida, Stati Uniti, 33125
- VA Medical Center, Miami
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Georgia
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Decatur, Georgia, Stati Uniti, 30033
- VA Medical Center, Decatur
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Jesse Brown VAMC (WestSide Division)
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Danville, Illinois, Stati Uniti, 61832
- VA Illiana Health Care System
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Iowa
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Iowa City, Iowa, Stati Uniti, 52246
- VA Medical Center Iowa City
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Kansas
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Topeka, Kansas, Stati Uniti, 66622
- VA Eastern Kansas Health Care System - Topeka
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Wichita, Kansas, Stati Uniti, 67218
- Robert J. Dole VAMC & ROC
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40206
- VA Medical Center, Louisville
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71101
- Overton Brooks VA Medical Center, Shreveport, LA
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Massachusetts
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Bedford, Massachusetts, Stati Uniti, 01730
- Edith Nourse Rogers Memorial Veterans Hospital
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Boston, Massachusetts, Stati Uniti, 02130
- VA Boston Health Care System, Jamaica Plain
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48105
- VA Ann Arbor Healthcare System
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Battle Creek, Michigan, Stati Uniti, 49015
- Battle Creek, MI
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Mississippi
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Biloxi, Mississippi, Stati Uniti, 39531
- VA Gulf Coast Veterans Health Care System
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Missouri
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Columbia, Missouri, Stati Uniti, 65201-5297
- Harry S. Truman Memorial VA Medical Center
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Kansas City, Missouri, Stati Uniti, 64128
- Kansas City VA Medical Center
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St Louis, Missouri, Stati Uniti, 63106
- VA Medical Center, St Louis
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New Jersey
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East Orange, New Jersey, Stati Uniti, 07018
- VA New Jersey Health Care System, East Orange
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New York
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Albany, New York, Stati Uniti, 12208
- Albany VA Medical Center: Samuel S. Stratton
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Albany, New York, Stati Uniti, 12208
- No Longer Valid, Use 528A8
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Montrose, New York, Stati Uniti, 10548
- Franklin Delano Roosevelt Campus of VAHVHCS
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New York, New York, Stati Uniti, 10010
- New York, NY
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45220
- VA Medical Center, Cincinnati
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Cleveland, Ohio, Stati Uniti, 44106-3800
- VA Medical Center, Cleveland
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Pennsylvania
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Coatesville, Pennsylvania, Stati Uniti, 19320
- Coatesville, PA
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Lebanon, Pennsylvania, Stati Uniti, 17042
- Lebanon, PA
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02908-4799
- VA Medical Center, Providence
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29401-5799
- Ralph H Johnson VA Medical Center, Charleston
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37212-2637
- VA Medical Center
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Utah
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Salt Lake City, Utah, Stati Uniti, 84148
- VA Salt Lake City Health Care System, Salt Lake City
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Vermont
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White River Junction, Vermont, Stati Uniti, 05009-0001
- VA Medical & Regional Office Center, White River
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53705
- William S. Middleton Memorial Veterans Hospital
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Milwaukee, Wisconsin, Stati Uniti, 53295-1000
- Clement J. Zablocki VAMC
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Braccio 1
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators
Lasso di tempo: 1/1/02 - 12/31/08
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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
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Thomas K Houston, MD MPH, Edith Nourse Rogers Memorial Veterans Hospital, Bedford
- Investigatore principale: Ellen Funkhouser, DrPH MS BS, VA Medical Center, Birmingham
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2003
Completamento primario (Effettivo)
1 giugno 2010
Completamento dello studio (Effettivo)
1 giugno 2010
Date di iscrizione allo studio
Primo inviato
2 agosto 2005
Primo inviato che soddisfa i criteri di controllo qualità
2 agosto 2005
Primo Inserito (Stima)
4 agosto 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
23 luglio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 giugno 2015
Ultimo verificato
1 giugno 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SDR 03-090
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .