- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02712268
Intervention to Improve Prescribing in Elderly Patients
Intervention to Improve Appropriate Prescribing and Reduce Polypharmacy in Elderly Patients Admitted to an Internal Medicine Unit
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Polypharmacy and inappropriate medication prescriptions are associated with increased morbidity and mortality. Most interventions proposed to improve appropriate prescribing are time and resource intensive and therefore hardly applicable in daily clinical practice.
Objective: To test the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy.
Design: single-center, interventional, quasi-experimental before-after study. Patients: Consecutive patients aged ≥65 years, hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).
Intervention: Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards.
Main Measures: The proportion of patients with prescription of potentially inappropriate medications (PIMs) at discharge, according to Screening tool of older people's prescriptions (STOPP) criteria, and the number of prescribed medications at discharge, before and after the introduction of the checklist. Secondary outcomes were the prevalence of polypharmacy (≥ 5 drugs) and hyperpolypharmacy (≥ 10 drugs), and the prevalence of potentially inappropriate prescribing omissions (PPOs) according to START criteria.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Consecutive patients aged ≥65 years,
- patients hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).
Exclusion Criteria:
- none
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: After introduction of the checklist
Review of medications of all consecutive admitted patients during the study period using a checklist
|
Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards to review and adapt the medications of the patient.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in the proportion of patients prescribed potentially inappropriate medications (PIM) at discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
The proportion of patients prescribed PIMs at discharge, according to STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) criteria, before and after the introduction of the checklist.
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Change in the number of prescribed medications at discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Number of prescribed medications at discharge, before and after the introduction of the checklist.
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of prescribed drugs at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
|
Prevalence of polypharmacy at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
concomitant use of more than 5 drugs
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Prevalence of hyperpolypharmacy at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
concomitant use of more than 10 drugs
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Prevalence of potentially inappropriate prescribing omissions (PPO) at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
according to START (Screening Tool of Alert doctors to the Right Treatment) criteria
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Number of patients prescribed NSAID at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Non-steroidal anti-inflammatory drugs (NSAID)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Rate (%) of inappropriate prescriptions of NSAID at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Non-steroidal anti-inflammatory drugs (NSAID)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Number of patients prescribed proton pump inhibitors at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
proton pump inhibitor (PPI)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Rate (%) of inappropriate prescriptions of proton pump inhibitors at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
proton pump inhibitor (PPI)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Number of patients prescribed systemic corticosteroids at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
|
Rate (%) of inappropriate prescriptions of systemic corticosteroids at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
|
Number of patients prescribed metamizole at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
|
Rate (%) of inappropriate prescriptions of metamizole at admission and discharge
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
|
In-Hospital mortality rate
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
|
All-cause re-hospitalization rate
Tidsramme: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
re-hospitalization rate 30 days after discharge
|
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Stefano Bassetti, MD, University Hospital, Basel, Switzerland
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2013/039
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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