- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01897870
The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge. (HomeCoMe)
22 februari 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
150
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Flevoland
-
Almere, Flevoland, Nederländerna, 1315RA
- Zorgapotheken Flevoland
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement of adherence to medication at hospital discharge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Marcel L Bouvy, Prof, PharmD, PhD, UIPS
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2013
Primärt slutförande (Faktisk)
1 februari 2016
Avslutad studie (Faktisk)
1 februari 2016
Studieregistreringsdatum
Först inskickad
2 juli 2013
Först inskickad som uppfyllde QC-kriterierna
9 juli 2013
Första postat (Uppskatta)
12 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 februari 2016
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ZGA-1
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