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Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE)

10. august 2019 oppdatert av: Korey Kennelty
The trial will examine whether a centralized Prevention Health & Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.

This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects.

Studietype

Intervensjonell

Registrering (Faktiske)

302

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Iowa
      • Akron, Iowa, Forente stater, 51001-0200
        • Akron Mercy Medical Clinic
      • Belmond, Iowa, Forente stater, 50421
        • Iowa Specialty Hospitals - Belmond Clinic
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Employee Health Clinic, Mercy Cedar Rapids
      • Clarion, Iowa, Forente stater, 50525
        • Iowa Speciality Hospitals - Clarion Clinic
      • Davenport, Iowa, Forente stater, 52897
        • Great River Medical Group
      • Des Moines, Iowa, Forente stater, 50312
        • Des Moines University Family Medicine Clinic
      • Grinnell, Iowa, Forente stater, 50112-1833
        • Grinnell Regional Family Practice
      • Knoxville, Iowa, Forente stater, 50138
        • Knoxville Hospital Clinic
      • Newton, Iowa, Forente stater, 50208-3137
        • Newton Clinic, P.C.
      • Riverside, Iowa, Forente stater, 52327
        • UI Health Care-River Crossing
      • Sioux City, Iowa, Forente stater, 511105
        • Siouxland Community Health Center
      • West Burlington, Iowa, Forente stater, 52655-1645
        • Burlington Area Family Practice Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

INCLUSION CRITERIA

Section A: Demographic Criteria

  1. Patient was seen in your clinic or practice at least once in the past 24 months
  2. English-speaking male or female

  3. Age is 50 or older at medical record screening

    Section B: Risk Factors - Must have at least one of the following conditions

  4. Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
  5. Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140 otherwise

  6. Elevated blood pressure with:

    • Systolic BP >= 140 or Diastolic BP >=90 in persons with diabetes or chronic kidney disease OR
    • Systolic BP >= 150 in persons with uncomplicated hypertension

    Section C: Cardiovascular Conditions - total number of risk factors in Section B (above) plus number of conditions Section C (below) must be THREE OR MORE

  7. History of coronary artery disease
  8. Previous Heart Attack
  9. History of Stroke
  10. History of Transient Ischemic Attack
  11. History of Atrial fibrillation
  12. History of Peripheral Vascular Disease / claudication
  13. History of carotid artery disease
  14. Current smoker

  15. Obesity with BMI > 30

    EXCLUSION CRITERIA

    Section D: Exclusion Criteria - has NONE of the following:

  16. Inability to give informed consent
  17. Pregnant
  18. Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
  19. Cancer diagnosis with a life expectancy estimated less than 2 years
  20. Residence in a nursing home or diagnosis of dementia
  21. No telephone or a hearing impairment not allowing them to use a phone
  22. Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM
  23. Patient has plans to move from the area or transfer care to a different clinic in the next 12 months
  24. Omron blood pressure cuff cannot be used on patient's arm for any reason

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Annen: PHCVRS Intervention

A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including:

  1. Contact via email, phone or text every 2-4 weeks
  2. Assessment and counseling for medication adherence, side effects, and lifestyle modifications to decrease risk of cardiovascular disease.
  3. Collaborative communication with the participant's physician to address gaps in screening or therapy, update medication list, and recommend medication changes.

Each participant in this arm will also have access to an online Personal Health Record that can be used to track medications, diagnosed conditions and laboratory values related to cardiovascular disease risk.

Annen: Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Annen: Usual care/Personal Health Record
Will receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions.
Annen: Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
Tidsramme: 12 months for each participant
The primary outcome measure was adherence to the GA criteria as a surrogate for quality of care because each subject had varying gaps in guideline-concordant care, depending on their specific cardiovascular conditions and preventative care needs.
12 months for each participant

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
Tidsramme: 12 months for each participant
Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline.
12 months for each participant

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Korey Kennelty

Etterforskere

  • Hovedetterforsker: Barry L. Carter, Pharm.D., University of Iowa
  • Hovedetterforsker: Barcey T. Levy, M.D., Ph.D., University of Iowa

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. mars 2014

Primær fullføring (Faktiske)

1. november 2016

Studiet fullført (Faktiske)

1. april 2018

Datoer for studieregistrering

Først innsendt

28. oktober 2013

Først innsendt som oppfylte QC-kriteriene

7. november 2013

Først lagt ut (Anslag)

14. november 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 201308707

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual, de-identified data will be shared with the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BIOLINCC).

Data and supporting materials will include:

  • The analytic data set used in the main outcomes paper
  • Source data sets used to create the analytic data set (for baseline and 12 month follow up data collection points)
  • Informed consent document
  • Study protocol and manuals
  • Subject brochure and subject handout
  • Case report forms (baseline and 12 month follow up)
  • Summary of data redactions
  • Summary of protocol changes over time

All dates will be converted to days or months from a reference event; no text will be included (e.g., comments).

IPD-delingstidsramme

Data and documentation will be provided to BIOLINCC in early 2019 and will be made available to researchers after BIOLINCC staff processes the data and documentation.

Tilgangskriterier for IPD-deling

All reviews for data are coordinated by BioLINCC and are performed by the NHLBI Data Repository Program Officer. The review includes:

  • Appropriateness of the proposed research for the dataset(s) being requested
  • Completion of the IRB requirements to obtain the datasets.

Requests that include datasets must have IRB approval (waiver, expedited review, convened review). Some datasets require that the researcher's IRB provide an expedited (Chairman) or convened review for the proposed project. In these cases, an IRB approval is needed because although obvious identifiers have been redacted, the wealth of individual level data that remain (demographic, anthropometric, medical history, personal history, outcomes) means that the possibility of direct identification of a study subject cannot be eliminated.

Consult the BIOLINCC website (https://biolincc.nhlbi.nih.gov/home/) or access the handbook at https://biolincc.nhlbi.nih.gov/media/guidelines/handbook.pdf for more information.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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