- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01897870
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
Status
Fullført
Intervensjon / Behandling
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
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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
|
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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.
Sponsor
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.
Generelle publikasjoner
- Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, Kachalia A, Horng M, Roy CL, McKean SC, Bates DW. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006 Mar 13;166(5):565-71. doi: 10.1001/archinte.166.5.565.
- Al-Rashed SA, Wright DJ, Roebuck N, Sunter W, Chrystyn H. The value of inpatient pharmaceutical counselling to elderly patients prior to discharge. Br J Clin Pharmacol. 2002 Dec;54(6):657-64. doi: 10.1046/j.1365-2125.2002.01707.x.
- Kwint HF, Faber A, Gussekloo J, Bouvy ML. The contribution of patient interviews to the identification of drug-related problems in home medication review. J Clin Pharm Ther. 2012 Dec;37(6):674-80. doi: 10.1111/j.1365-2710.2012.01370.x. Epub 2012 Aug 3.
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZGA-1
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