The effect of emergency department pharmacists on drug overuse and drug underuse in patients with an adverse drug event (ADE)-related hospitalisation

ISRCTN ISRCTN12506329
DOI https://doi.org/10.1186/ISRCTN12506329
Secondary identifying numbers MEC-2016-346
Submission date
01/03/2022
Registration date
06/03/2022
Last edited
27/08/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Drug overuse or drug underuse are the most common causes of adverse drug events and can lead to hospital admissions. Using clinical pharmacists in the emergency department (ED) may improve patient safety as they are specialised in recognising adverse drug events (ADE) and tackling drug overuse and drug underuse. This study tested the effect of an emergency department pharmacist on the number of medication changes for drug overuse and drug underuse taking place in patients with an adverse drug event-related hospitalisation following an emergency department visit.

Who can participate?
Patients of 18 years and older visiting the ED and are hospitalised.

What does the study involve?
Intervention of ED pharmacist to detect potential ADEs as reason for admission, perform pharmacist-led medication review in those patients, feedback session with patients and transmission of medication changes to the next healthcare giver after hospital discharge.

What are the possible benefits and risks of participating?
Benefit: Pharmacist led medication review to reduce drug overuse and drug underuse to prevent the continuation of drug-related problems which can lead to hospitalisation.
No risks.

Where is the study run from?
The study is carried out in the Erasmus Medical center and the OLCG hospital, both based in The Netherlands.

When is the study starting and how long is it expected to run for?
June 2016 to January 2018

Who is funding the study?
Innovation Fund of Dutch Healthcare Insurance Companies (the Netherlands)

Who is the main contact?
Rehana Rahman, r.n.rahman@umcg.nl

Contact information

Ms Rehana Rahman
Scientific

Hanzeplein 1
Groningen
9713 GZ
Netherlands

ORCiD logoORCID ID 0000-0002-0350-8948
Phone +31 653854652
Email r.n.rahman@umcg.nl
Ms Rehana Rahman
Public

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone +31 653854652
Email r.n.rahman@umcg.nl

Study information

Study designProspective multicenter non-randomized controlled intervention study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet 41260 PIS control group.pdf
Scientific titleThe effect of a pharmacist-led medication review on reduction of drug overuse and drug underuse in patients with an ADE-related hospital admission after ED visit compared to regular care
Study acronymSHARM
Study objectivesIntervention of ED pharmacists can led to detection of adverse drug event-related admissions and reduce drug related problems such as drug overuse and drug underuse
Ethics approval(s)The Medical Ethics Committee (METC) Erasmus MC Rotterdam approved the study and decided that it was outside the scope of the Human Research Act. The approval of METC Erasmus MC Rotterdam is registered with number MEC-2016-346 on 14-06-2016.
Health condition(s) or problem(s) studiedPatients visiting the emergency department with an adverse drug event
InterventionIntervention group: regular care + the interdisciplinary intervention consists of a pharmacist-led medication review, patient counselling regarding medication, and information transmission to general practitioners and community pharmacies after discharge
Control group: regular care during hospitalization
Patients are followed up for six months.
Intervention typeBehavioural
Primary outcome measureThe number of medication changes for drug overuse and drug underuse that took place during hospital admission and persisted six months thereafter measured using medication overviews and estimate the difference between groups with poisson regression analysis.
Secondary outcome measures1. The number of all medication changes that took place during admission and persisted six months after discharge measured using medication overviews and estimate the difference between groups with poisson regression analysis.
2. The number of medication changes for drug overuse and drug underuse that took place
during admission and all medication changes during admission measured using medication discharge records and estimate the difference between both groups with poisson regression analysis.
3. The proportion of ADEs causing hospitalisations recognised by physicians in the ED measured using discharge letters from the ED of intervention patients at moment of ED visit.
4. The degree of patient satisfaction with the intervention of the ED pharmacist measured in the intervention group using a Visual Analogue Scale (VAS) at three months after admission.
5. The number of (ADE-related) hospitalisations within a period of six months before and after the index admission within the intervention group measured using medical records from general practitioners and the difference between periods will be estimated by a Wilcoxon signed rank test.
Overall study start date14/06/2016
Completion date01/01/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants200
Total final enrolment216
Key inclusion criteriaPatients aged 18 years and older were eligible for inclusion if they were hospitalised for more than 24 hours after visiting the ED.
Key exclusion criteria1. No communication possible due to condition or language barrier
2. Cognitive impairment; transfers to other hospital
3. No pre-admission medication; admission due to problems with cancer treatment
4. Alcohol intoxication and/or (self)poisoning related hospitalisation
5. Psychiatric hospitalisation
6. Intensive care unit (ICU) hospitalisation
7. Foreign tourist or homeless patient
8. Already included patient readmitted within the research period
9. Patients with no informed consent
Date of first enrolment01/10/2016
Date of final enrolment01/07/2017

Locations

Countries of recruitment

  • Netherlands

Study participating centres

Erasmus University Medical Center
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands
OLVG hospital
Jan Tooropstraat 164
Amsterdam
1061 AE
Netherlands

Sponsor information

Erasmus MC
Hospital/treatment centre

Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Phone +31 010 704 0704
Email secretariaatapotheek@erasmusmc.nl
Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Industry

Innovation Fund of Dutch Healthcare Insurance Companies

No information available

Results and Publications

Intention to publish date25/02/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed medical journal.
IPD sharing planThe datasets generated and analyzed during the current study are not publicly available because they contain information that could compromise the privacy of research participants, but are available from the corresponding author upon reasonable request.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet in Dutch 04/03/2022 No Yes
Participant information sheet in Dutch 04/03/2022 No Yes
Protocol file version 1.0 10/05/2016 04/03/2022 No No
Results article 17/11/2022 22/05/2023 Yes No
Results article cost study 23/08/2024 27/08/2024 Yes No

Additional files

41260 Protocol v1.0 10May2016.pdf
41260 PIS control group.pdf
in Dutch
41260 PIS intervention group.pdf
in Dutch

Editorial Notes

27/08/2024: Publication reference added.
22/05/2023: Publication reference added.
04/03/2022: Trial's existence confirmed by Erasmus MC.