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

10 augusti 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

302

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Övrig: 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.

Övrig: Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
Övrig: 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.
Övrig: Personal Health Record
Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Korey Kennelty

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 mars 2014

Primärt slutförande (Faktisk)

1 november 2016

Avslutad studie (Faktisk)

1 april 2018

Studieregistreringsdatum

Först inskickad

28 oktober 2013

Först inskickad som uppfyllde QC-kriterierna

7 november 2013

Första postat (Uppskatta)

14 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 201308707

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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).

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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