Elderly Internal Medicine PatientsNCT02712268

Intervention to Improve Prescribing in Elderly Patients

A study testing Checklist in people with Elderly Internal Medicine Patients, run by University Hospital, Basel, Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Elderly Internal Medicine Patients
What is being tested?: Checklist
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: No sites listed yet
Study dates: Sep 2013to Dec 2013
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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).

Who cannot join

none

About this study

Official title: Intervention to Improve Appropriate Prescribing and Reduce Polypharmacy in Elderly Patients Admitted to an Internal Medicine Unit

Read the detailed description

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.

Conditions: Elderly Internal Medicine Patients
Being tested: Checklist
Keywords: Polypharmacy, Clinical decision-making

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChecklistOther
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.

Study groups in NCT02712268
Study group	Role	What they receive
After introduction of the checklist	Other	Review of medications of all consecutive admitted patients during the study period using a checklist Receives: Other: Checklist

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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
concomitant use of more than 5 drugs
Measured: 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
concomitant use of more than 10 drugs
Measured: 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
according to START (Screening Tool of Alert doctors to the Right Treatment) criteria
Measured: 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
Non-steroidal anti-inflammatory drugs (NSAID)
Measured: 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
Non-steroidal anti-inflammatory drugs (NSAID)
Measured: 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
proton pump inhibitor (PPI)
Measured: 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
proton pump inhibitor (PPI)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
re-hospitalization rate 30 days after discharge
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Dec 2013

First posted18 Mar 2016 (estimated)
Study startSep 2013
Primary completionNov 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Elderly Internal Medicine PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02712268
Sponsor's protocol ID: 2013/039
Status last verified: Jan 2017
First submitted: 29 Feb 2016
Last updated: 4 Jan 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data are available.