Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of Pharmacists Treating Diabetes in a FQHC

14. november 2018 opdateret af: Mary Louise Wagner, Rutgers, The State University of New Jersey

Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center

This study is a randomized controlled cross-over trial, in the form of a proof of concept study that is designed to evaluate the health outcomes resulting from incorporating a licensed clinical pharmacist in a health care team to provide case management for diabetic patients at the Henry J Austin Health Clinic. The study uses a control group design and will feature both an experimental group and a control group. The control group, of 80 patients, will receive the standard treatment at the clinic. The experimental group, of 80 patients, will receive the standard treatment as well as Medication Therapy Management and counseling from a pharmacist. After one year the patients in the control group can cross-over to the intervention group and receive care from the pharmacist.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We will put all patients into one of two groups by chance (like flipping a coin). One group of 80 patients will get the regular care at the clinic (control group). The other group of 80 patients will get their regular care at the clinic plus care by a pharmacist. The pharmacist and the regular provider will work as a team to manage the patient's drug therapy (Intervention group).

We will test the status of the patient's diabetes at each visit. Tests may include:

  1. Measuring weight, heart rate, and blood pressure
  2. Finger stick with a small needle to check lipid (fat) concentrations, fasting blood sugar or HbA1c
  3. Examining feet, skin, and eyes
  4. Reviewing the patient's diary of blood sugars, diet, and exercise history
  5. Filling out a survey that measures quality of life and problems that make it hard to control your diabetes
  6. Referral to other specialists such as a podiatrist (foot doctor), optometrist (eye doctor), nutritionist, and dentist

Patients will have appointments with their current provider and possibly with the pharmacist at least every 3 months. However, the total number of appointments is based on the patient's health needs. The first appointment with the pharmacist will take about one hour. Additional appointments will take about 30 minutes.

The group without the pharmacist will have regular appointment times. After 12 months in the study if the patients glucose is not well controlled they can be treated by the pharmacist for 6 months.

Final measures will be made after 12 mont

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

239

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New Jersey
      • Trenton, New Jersey, Forenede Stater, 08618
        • Henry J Austin Health Clinic

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 18 and 74
  2. Medicaid insurance
  3. HbA1c of 8% or greater

Exclusion Criteria:

  1. HbA1C greater than 15% because the finger stick device can not accurately read values greater than this unless the HbA1C can be confirmed with a value drawn in the laboratory.
  2. Age < 18 years old or age ≥ 75 years old

  3. HbA1c < 8.5% PLUS presence of one or more of the following regardless of age:

    1. Limited life expectancy
    2. History of severe hypoglycemia

  4. HbA1c < 8.5% PLUS presence of one or more of the following if age ≥ 65 years old:

    1. Residency in a long-term care facility (e.g. nursing home, adult family home, etc.)
    2. ≥ 3 co-existing chronic illnesses c
    3. Impairments in ability to perform two or more instrumental activities of daily living d
    4. Mild, moderate, or severe cognitive impairment as determined by the patient's provider and Mini-Cog test

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: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: No intervention
The no intervention group will serve as control group. This group will receive standard care and will be an active comparator. At the end of the study they may join the intervention group
Andet: Intervention group
The intervention group will be seen by a pharmacist iin addition to their normal provider. The pharmacist will provide medication therapy review of the patient's therapy. The pharmacist will make recommendations to make revisions in the patient's therapy.
Andet: Pharmacist review of therapy
Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hemoglobin A1C
Tidsramme: every 3 months for one year
Plasma glucose control
every 3 months for one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Preventative care
Tidsramme: Baseline 6 months and 12 months
How frequent does the patient see a dentist, podiatris, optomitrist,
Baseline 6 months and 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Rutgers, The State University of New Jersey

Efterforskere

  • Studiestol: Caitlin McCarthy, PharmD, Rutgers, Earnest Mario School of Pharmacy

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.

Generelle publikationer

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 (Faktiske)

1. august 2015

Primær færdiggørelse (Faktiske)

1. november 2018

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

26. april 2017

Først indsendt, der opfyldte QC-kriterier

27. april 2017

Først opslået (Faktiske)

28. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14-805

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

In addition, the pharacists at the clinic who are treating the have access to the patient data

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Diabetes mellitus, type 2

Kliniske forsøg med Pharmacist review of therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Panama

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner