Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge. (HomeCoMe)

22. februar 2016 oppdatert av: H.T. Ensing, PharmD, MSc

The Effect of a Home-based Community Pharmacist-led Medication Management Program (HomeCoMe-program) Complementary to an In-hospital Medication Reconciliation Program on Drug-related Problems Post-discharge: A Prospective Cohort Study.

the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.

Studieoversikt

Detaljert beskrivelse

Inaccuracy of medication histories and lack of knowledge on actual medication use results in confusion about medication regimens and medication mismanagement before- during - and after hospital admission. This phenomenon accounts for many readmissions, longer duration of admission and preventable and serious Adverse Drug Events (ADEs) as a result of Drug Related Problems (DRPs). Several studies show that discharge medication reconciliation (MR) and counseling by a pharmacy employee reduces the amount of discrepancies in the discharge prescription lists. Still, no unequivocal effect of MR on the occurrence of DRPs after discharge has been shown. This is due to a shift in underlying potential harmful discrepancies from mainly patient based (unintended nonadherence) to mainly system based (eg dispensing errors) and might be explained by (1) suboptimal transfer of information (2) an overload of information during a stressful situation and (3) difficulty to implement changes in medication at home. Therefore the reduction of DRPs, improvement of patients' medication knowledge and initial adherence can probably most effectively be addressed in a multifaceted integrated transmural intervention. Repetition of important information is the key to success. Moreover, the first weeks following hospital discharge are most crucial in preventing drug-related problems as patients could slip back in old medication schemes, or new problems may arise, such as emerging ADEs due to medication changes made during hospitalization.

Studietype

Intervensjonell

Registrering (Faktiske)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Flevoland
      • Almere, Flevoland, Nederland, 1315RA
        • Zorgapotheken Flevoland

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:

  • patient uses more than three prescribed systemic drugs intended for chronic use at admission and discharge
  • patient has an expected length of stay of 48 hours or longer

Exclusion Criteria:

  • Patients admitted for scheduled chemotherapy
  • Patients admitted for radiation therapy
  • Patients admitted for transplantation
  • Patients transferred from another hospital
  • Patients transferred from another non-eligible ward within the same hospital
  • No informed consent signed
  • A live expectancy less than 6 months
  • Inability to be counselled (e.g. cognitive dysfunction, language constraints who cannot be solved with an interpreter)
  • Discharge to a nursing home (presuming dependence on medication administration)
  • If patients' community pharmacy is not participating in this study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: HomeCoMe-program group
the arm receiving the pharmacist home visit
A home visit by patients own community pharmacist within seven days after hospital discharge. The community pharmacist will perform a semi-structured interview on (1) use of the prescribed medication, (2) ADEs, (3) adherence issues, by (A) assessing patient's needs and concerns around his pharmacotherapy, (B) identifying and solving obstacles for medicines intake, (C) checking on the need for a compliance aid, (D) collecting spare medication and finally (4) knowledge on medication use, when to take which medicine and why, and medication changes made during the hospitalisation.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge
Tidsramme: within 7 days post-discharge

The total number of assessed and solved ADEs post-discharge will be measured. Assessing and solving ADEs takes place during the pharmacist home visit.

Using START-STOPP criteria on patients medication records, ADEs will also be compared between the intervention and usual care group.

within 7 days post-discharge

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improvement of adherence to medication at hospital discharge
Tidsramme: up to 6 months after discharge
The "medication possession ratio" will be calculated retrospectively from pharmacy dispensing data after 6 months to investigate patient's adherence and compared between the intervention and control group.
up to 6 months after discharge
Patient assessment of medication knowledge at time of home visit
Tidsramme: within 7 days after discharge
At time of the home visit patients are asked about their knowledge (e.g. indication, dose regime, etc) regarding the medication they are taking. Knowledge is scored and lack of knowledge is solved by teaching the patient.
within 7 days after discharge
Types of interventions made at the pharmacist home visit
Tidsramme: within 7 days after discharge
The types of intervention the pharmacist works on during the 7 day follow-up home visit are assessed.
within 7 days after discharge
Patient satisfaction with the pharmacist home visit
Tidsramme: Immediately after receiving the home visit
The satisfaction survey consists of 13 interview questions, where the subject subjectively scores each question on a four-point scale, developed specifically for this study.
Immediately after receiving the home visit
Assessment of patient reported health rating
Tidsramme: at 14 days after discharge
Patient are asked by telephone to report their health on a scale from 1 (worst imaginable health) to 10 (best imaginable health). Number are compared between the intervention and control group.
at 14 days after discharge
General practitioners satisfaction with the pharmacist home visit
Tidsramme: Immediately after the home visit is executed
The satisfaction survey consists of 13 interview questions, where the subject subjectively scores each question on a four-point scale, developed specifically for this study.
Immediately after the home visit is executed
Assessment of patient reported health rating
Tidsramme: at 42 days after discharge
Patient are asked by telephone to report their health on a scale from 1 (worst imaginable health) to 10 (best imaginable health). Number are compared between the intervention and control group.
at 42 days after discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Marcel L Bouvy, Prof, PharmD, PhD, UIPS

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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. november 2013

Primær fullføring (Faktiske)

1. februar 2016

Studiet fullført (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først innsendt

2. juli 2013

Først innsendt som oppfylte QC-kriteriene

9. juli 2013

Først lagt ut (Anslag)

12. juli 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere