- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02047448
Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model
28. april 2017 oppdatert av: Judith L. Kristeller, Wilkes University
The purpose of this pilot study is to determine if medication adherence is improved by a transitional care pharmacy practice model designed to integrate hospital and community pharmacists in the care and education of patients with heart failure or COPD who are discharged from a community hospital to home.
The hospital and community pharmacists will collaborate with each other, the patient, and other practitioners including the primary care physician, nurse, and case manager to prevent and correct medication-related problems and attempt to improve patient outcomes especially during the error-prone transition from hospital to home.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
180
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Scranton, Pennsylvania, Forente stater, 18510
- Moses Taylor Hospital
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- admitted to hospital with a primary or secondary diagnosis of heart failure or COPD
- anticipated eventual discharge to home
- agreeable to participate in monthly counseling sessions (if randomized to intervention group) from a participating community pharmacist
Exclusion Criteria:
- presence of cognitive impairment or dementia that would significantly prevent effective patient education and counseling
- non English-speaking
- anticipated discharge to a long-term care or skilled nursing facility on a permanent basis
- permanent long-term care facility residents
- surgical patients
- hospice patients
- patients who die within 30 days of initial study hospitalization
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Control Group
The control group will receive the current standard of care including medication reconciliation during hospitalization performed by a nurse or physician and education about discharge medications provided by the inpatient nurse.
There will not be a pharmacist discharge care plan developed for this group.
The patients will not be required to choose a participating community pharmacist and no counseling and education appointments will be scheduled.
Any medication-related problems identified by the pharmacists and will be communicated as appropriate and resolved as is the standard of care.
Any other interaction between the patient and their pharmacist will be according to the current standard of care.
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Eksperimentell: Pharmacist Counseling
The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems.
The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist.
The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge.
The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education.
The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.
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The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems.
The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist.
The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge.
The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education.
The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Medication Adherence
Tidsramme: 6 months
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The primary endpoint will be medication adherence as measured by the Proportion of Days Covered (PDC) calculation.
This is calculated by dividing the total days' supply dispensed by 180 days.
Medications considered in this calculation will include those used for the treatment of heart failure or COPD and known to improve outcomes.
The composite PDC will be an average of the individual PDC for each drug class.
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Medication related problems
Tidsramme: 6 months
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Actual or potential medication-related problems (MRP) that are identified by the hospital and participating community pharmacists will be categorized based on an MRP classification tool.
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6 months
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Patient Satisfaction
Tidsramme: 6 months
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The Care Transitions Measure (CTM-3) is a validated survey to assess the patient's satisfaction with the quality of transitional care during hospitalization and will be completed by the patient following hospital discharge.
The patient's satisfaction with the services provided by the community pharmacies will be assessed with the Consumer Experience with Pharmacy Services survey (© Pharmacy Quality Alliance).
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6 months
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Hospital readmissions or ED visits
Tidsramme: 6 months
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Hospital readmissions are defined as an unplanned and overnight admission to the hospital
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6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Judith Kristeller, PharmD, Wilkes University
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
1. januar 2014
Primær fullføring (Faktiske)
28. april 2017
Studiet fullført (Faktiske)
28. april 2017
Datoer for studieregistrering
Først innsendt
24. januar 2014
Først innsendt som oppfylte QC-kriteriene
27. januar 2014
Først lagt ut (Anslag)
28. januar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. april 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CPF
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