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

10 augustus 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

302

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PHCVRS intervention
Each participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Ander: 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.

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Korey Kennelty

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 maart 2014

Primaire voltooiing (Werkelijk)

1 november 2016

Studie voltooiing (Werkelijk)

1 april 2018

Studieregistratiedata

Eerst ingediend

28 oktober 2013

Eerst ingediend dat voldeed aan de QC-criteria

7 november 2013

Eerst geplaatst (Schatting)

14 november 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 augustus 2019

Laatste update ingediend die voldeed aan QC-criteria

10 augustus 2019

Laatst geverifieerd

1 augustus 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 201308707

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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