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Team Management of High Blood Pressure

26. marts 2014 opdateret af: University of Iowa

Collaborative Management of Hypertension

The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

BACKGROUND:

The Healthy People 2010 target calls for controlled BP in 50% of the 50 million Americans with hypertension. BP is currently controlled in only 27% of the population. These population figures are in contrast to data from clinical trials (efficacy) in which BP has been controlled in 70 to 80% of study participants. Poor BP control exists in spite of six sets of guidelines generated over the last 30 years in the United States. While there are many causes for poor control, several studies have found that physicians are frequently satisfied with uncontrolled BPs. Numerous strategies exist to assist physicians with achieving better BP control, but a consistent, effective approach to solving the problem has not been found.

DESIGN NARRATIVE:

The objective of this study is to test whether BP control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams. The rationale for this proposal is generated from studies demonstrating that physician knowledge, quality of prescribing, and attainment of treatment goals can be improved when physicians collaborate with clinical pharmacists. Previous studies have suffered from insufficient sample size and controls and did not include a structured intervention. This study will address these gaps in knowledge by conducting a randomized, prospective study in 5 clinics (2 intervention and 3 control) with 27 physicians who care for 180 patients with uncontrolled BP. The structured intervention will involve clinical pharmacists who evaluate BP therapy and treatment strategies and make specific recommendations to the physician. Patients will be seen at baseline and at 2, 4, 6, 8, and 9 months, at which time random zero BP measurements will be performed. The specific aims of this study are (1) to determine if better BP control can be achieved by the use of physician/pharmacist teams that utilize physician education and feedback when compared to usual care, (2) to determine if improvements in BP control are related to an increase in physician knowledge of and adherence to BP guidelines when they are involved in physician/pharmacist teams, and (3) to determine if changes in BP control are associated with the level and scope of the physician/pharmacist relationships. This model utilizes an innovative system approach to improve BP control. This intervention has the potential to achieve marked improvements in BP control. This model could become one additional strategy to help achieve the BP goals for Healthy People 2010.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

179

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa

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

21 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Males or females, age 21-85
  • Taking 0-3 antihypertensive medications with no changes in regimen or dose within the past 4 weeks
  • Non-diabetic with clinic BP 145-179 / 95-109 or diabetic with BP greater than 135/85

Exclusion Criteria:

  • Previous 24 hour BP monitoring consult service within the past 6 months
  • Stage 3 hypertension greater than 180/110
  • Recent MI or stroke within the past 6 months
  • Class III or IV congestive heart failure
  • Unstable angina
  • Uncontrolled atrial fibrillation
  • Serious renal disease (serum creatinine greater than 3.5)
  • Serious hepatic disease (total bilirubin greater than 3.0)
  • Pregnancy
  • Poor prognosis with less than a 3 year life expectancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Intervention patients receive care from a clinical pharmacist to improve blood pressure.
The patient's physician collaborates with a clinical pharmacist to improve management of hypertension
Ingen indgriben: Control
Control patients receive usual care and do not have a clinical pharmacist included in their care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Blood pressure control
Tidsramme: Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months
Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months

Sekundære resultatmål

Resultatmål
Tidsramme
Mean number of antihypertensives
Tidsramme: Measured when each patient completed the study.
Measured when each patient completed the study.
Side effect score
Tidsramme: Measured when each patient completed the study.
Measured when each patient completed the study.
Physician knowledge
Tidsramme: Measured at the beginning and at the end of the study.
Measured at the beginning and at the end of the study.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Barry L. Carter, University of Iowa

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.

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. juli 2003

Studieafslutning (Faktiske)

1. oktober 2006

Datoer for studieregistrering

Først indsendt

12. september 2005

Først indsendt, der opfyldte QC-kriterier

12. september 2005

Først opslået (Skøn)

20. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2014

Sidst verificeret

1. december 2007

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 271
  • R01HL069801 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med Physician/Pharmacist Collaborative Teams

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