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

22 februari 2016 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Improvement of adherence to medication at hospital discharge
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2013

Primaire voltooiing (Werkelijk)

1 februari 2016

Studie voltooiing (Werkelijk)

1 februari 2016

Studieregistratiedata

Eerst ingediend

2 juli 2013

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2013

Eerst geplaatst (Schatting)

12 juli 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

23 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

22 februari 2016

Laatst geverifieerd

1 februari 2016

Meer informatie

Termen gerelateerd aan deze studie

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