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

22. februar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Holland
    • Flevoland
      • Almere, Flevoland, Holland, 1315RA
        • Zorgapotheken Flevoland

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HomeCoMe-program group
the arm receiving the pharmacist home visit
Adfærdsmæssigt: HomeCoMe-program
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

H.T. Ensing, PharmD, MSc

Samarbejdspartnere

Flevoziekenhuis
Zorggroep Almere

Efterforskere

  • Ledende efterforsker: Marcel L Bouvy, Prof, PharmD, PhD, UIPS

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

1. november 2013

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

2. juli 2013

Først indsendt, der opfyldte QC-kriterier

9. juli 2013

Først opslået (Skøn)

12. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZGA-1

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Kliniske forsøg med Bivirkningshændelse

Kliniske forsøg med HomeCoMe-program

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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