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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	MEC-2016-346
Sponsor	Erasmus MC
Funder	Innovation Fund of Dutch Healthcare Insurance Companies

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 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

Primary study design	Interventional
Study design	Prospective multicenter non-randomized controlled intervention study
Secondary study design	Non randomised study
Participant information sheet	41260 PIS control group.pdf
Scientific title	The 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 acronym	SHARM
Study objectives	Intervention 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) studied	Patients visiting the emergency department with an adverse drug event
Intervention	Intervention 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 type	Behavioural
Primary outcome measure(s)	The 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.
Key secondary outcome measure(s)	1. 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.
Completion date	01/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	200
Total final enrolment	216
Key inclusion criteria	Patients aged 18 years and older were eligible for inclusion if they were hospitalised for more than 24 hours after visiting the ED.
Key exclusion criteria	1. 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 enrolment	01/10/2016
Date of final enrolment	01/07/2017

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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The 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?
Results article		17/11/2022	22/05/2023	Yes	No
Results article	cost study	23/08/2024	27/08/2024	Yes	No
Participant information sheet	in Dutch		04/03/2022	No	Yes
Participant information sheet	in Dutch		04/03/2022	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.0	10/05/2016	04/03/2022	No	No

Additional files

41260 Protocol v1.0 10May2016.pdf: Protocol file
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.