- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in the proportion of patients prescribed potentially inappropriate medications (PIM) at discharge
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of prescribed drugs at admission and discharge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Stefano Bassetti, MD, University Hospital, Basel, Switzerland
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2013/039
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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