NCT02712268

Brief Summary

This study tested the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy in elderly adults admitted to an internal medicine unit.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

February 29, 2016

Last Update Submit

January 2, 2017

Conditions

Keywords

PolypharmacyClinical decision-making

Outcome Measures

Primary Outcomes (2)

  • Change in the proportion of patients prescribed potentially inappropriate medications (PIM) at discharge

    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

    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)

Secondary Outcomes (14)

  • Number of prescribed drugs at admission and 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)

  • Prevalence of polypharmacy at admission and 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)

  • Prevalence of hyperpolypharmacy at admission and 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)

  • Prevalence of potentially inappropriate prescribing omissions (PPO) at admission and 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)

  • Number of patients prescribed NSAID at admission and 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)

  • +9 more secondary outcomes

Study Arms (1)

After introduction of the checklist

OTHER

Review of medications of all consecutive admitted patients during the study period using a checklist

Other: Checklist

Interventions

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.

After introduction of the checklist

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Checklist

Intervention Hierarchy (Ancestors)

Data CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Stefano Bassetti, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 18, 2016

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data are available.