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
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
Scientific
Hanzeplein 1
Groningen
9713 GZ
Netherlands
0000-0002-0350-8948 | |
Phone | +31 653854652 |
r.n.rahman@umcg.nl |
Public
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Phone | +31 653854652 |
---|---|
r.n.rahman@umcg.nl |
Study information
Study design | Prospective multicenter non-randomized controlled intervention study |
---|---|
Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Hospital |
Study type | Other |
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 | 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. |
Secondary outcome measures | 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. |
Overall study start date | 14/06/2016 |
Completion date | 01/01/2018 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 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
Rotterdam
3015 GD
Netherlands
Amsterdam
1061 AE
Netherlands
Sponsor information
Hospital/treatment centre
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands
Phone | +31 010 704 0704 |
---|---|
secretariaatapotheek@erasmusmc.nl | |
Website | http://www.erasmusmc.nl/ |
https://ror.org/018906e22 |
Funders
Funder type
Industry
No information available
Results and Publications
Intention to publish date | 25/02/2021 |
---|---|
Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a peer-reviewed medical journal. |
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? |
---|---|---|---|---|---|
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
Editorial Notes
27/08/2024: Publication reference added.
22/05/2023: Publication reference added.
04/03/2022: Trial's existence confirmed by Erasmus MC.