- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00469365
Pharmacy Interventions to Improve Chronic Disease Medication Refill
25. november 2008 opdateret af: Medical University of South Carolina
A Randomized Controlled Trial of Two Pharmacy Interventions to Improve Refill Adherence for Chronic Disease Medications
Compare the effectiveness of 3 strategies by pharmacists to decrease the time to refill of prescriptions for common chronic diseases (diabetes, hypertension, hyperlipidemia, heart failure, depression, psychoses).
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
The design was a multi-site 8-month randomized, controlled clinical trial with the patient as the unit of randomization.
The Institutional Review Board at the Medical University of South Carolina approved the study.
The setting included 9 pharmacies within a medium-sized grocery store chain in South Carolina.
The 9 pharmacies were selected to ensure an adequate sample size and sufficient representation by patients with respect to geographic region (urban, suburban, and rural), race/ethnicity, and socioeconomic background.
Individual pharmacy staff were informed by their district manager (P.P.) that they were required to participate in the project.
Beginning January 16, 2006 and continuing through August 29, 2006, all patients who were at least 7 days overdue for a qualified prescription were identified on a weekly basis (i.e.
every Monday morning) using the centralized computer database.
Patients identified as being overdue for a qualified medication were assigned a unique study identification number and randomized using a simple randomization technique operationalized within a Microsoft® Access® database.
The randomization was based on a permuted block design with a block size of 3, with each patient thus having a one-third chance of being placed in any one of the 3 treatment arms.After eligible patients were identified and randomized each week, there were 3 different protocols followed, depending on the assigned treatment arm.
The 3 treatment arms included 1) pharmacist contact with the patient via telephone, 2) pharmacist contact with the prescribing physician via facsimile, and 3) usual care.There were a total of 3,048 patients into arms 1 (n=1018), 2 (n=1016), and 3 (n= 1014).
The study was designed to detect relatively small differences in the outcomes of interest.
Baseline comparisons across treatment arms in the characteristics of patients and medications were made using t-tests and chi-square tests, as appropriate.
For the analyses of study outcomes, an intent-to-treat approach was used.
Statistical models were constructed to compare outcomes among the 3 treatment arms, after first examining whether significant interaction between treatment arm and medication disease classification was present.
For the analyses of secondary outcomes, all of which were binary in nature, multivariable logistic regression models were used, with treatment arm as the key independent variable of interest, adjusting for the same covariates used in the primary analyses.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
3048
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All patients who were at least 7 days overdue for a qualified prescription were identified on a weekly basis (i.e. every Monday morning) using the centralized computer database. A qualified prescription was defined as having at least 2 refills remaining, a duration of at least a 30 days' supply, and having been written for any one of a number of chronic disease medications identified by a clinical pharmacist (A.M.W.). The medications of interest were those indicated for chronic treatment of diabetes mellitus, hypertension, hyperlipidemia, heart failure, depression, and psychoses. Medications that treat any combination of the specified diseases were allowed.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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The primary outcome was the number of days from the index date until the next date on which the patient filled a prescription for any qualified medication, or until the end of the study follow-up period.
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Sekundære resultatmål
Resultatmål |
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Secondary outcomes included indicators for whether the patient filled any medication within 30 days for their chronic disease, and whether the patient filled any medication within 30 days.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Paul J Nietert, PhD, Medical University of South Carolina
- Studieleder: Barbara C Tilley, PhD, Medical University of South Carolina
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. januar 2006
Studieafslutning (Faktiske)
1. august 2006
Datoer for studieregistrering
Først indsendt
3. maj 2007
Først indsendt, der opfyldte QC-kriterier
3. maj 2007
Først opslået (Skøn)
4. maj 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. november 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. november 2008
Sidst verificeret
1. maj 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P01HS010871 (U.S.A. AHRQ 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 .
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