Improving Drug Safety in Emergency Patients -a Randomized Controlled Trial
EPIMERR
1 other identifier
interventional
806
1 country
1
Brief Summary
Aim/Objective: Investigate the effect of implementing a working model for performing medication reconciliation (MR) and medication review (MRe) in the emergency department (ED), on readmissions, patient safety and efficiency of the stay in the ED and the hospital. Research design: randomized, controlled, non-blinded trial. Control group; standard care. Intervention group; MR and MRe performed at admission to the ED by a clinical pharmacist in the interdisciplinary team. The intervention is based on a working model for MR, developed in our initiation project, and it will be adapted to also include MRe. Key challenges in this research field: Currently no implemented systematic model ensuring that the patient's correct medication list is obtained and assessed at the point of admission. There is lack of studies investigating the clinically outcome of performing MR and MRe in the ED. Lack of knowledge on the extent of drug related hospital admissions in Norway. These challenges are also recognized and prioritized by the Norwegian authorities. Impact and utility: The results from this study will give important answers to the challenges listed above. The results could imply a huge impact on how to organize ED in Norway regarding drug safety. If the hypothesis of this study is confirmed, implementing the intervention described will increase patient safety, both the hospital and society can reduce health care expenses from readmissions, and also the readmission-burden can be reduced for the patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2022
CompletedFebruary 21, 2023
February 1, 2023
1.1 years
April 12, 2017
February 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients readmitted
Difference between intervention- and control group in proportion of patients readmitted
12 months from inclusion
Secondary Outcomes (12)
Proportion of patients readmitted
6 months from inclusion
Average number of admissions
12 months from inclusion
Time to next contact with a hospital
Time to next readmission, maximum 12 months from inclusion
Proportion of patients not hospitalized following admission to the emergency department (patients which condition is resolved in the emergency department)
During the relevant hospital admission (at inclusion)
Length of stay at the emergency department
During the relevant hospital admission (at inclusion)
- +7 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALPharmacist conducts medication reconciliation and medication review while the patient is admitted to the emergency Department. The pharmacist present results from medication reconciliation to physicians at the emergency Department before the Medical history is obtained. Further the pharmacist will discuss drug related problems obtained during the medication review with the physicians to customize and optimize the medication treatment for each patient.
Control group
NO INTERVENTIONStandard treatment without pharmacist intervention in the emergency department
Interventions
Pharmacist performed medication reconciliation and medication review
Eligibility Criteria
You may qualify if:
- Patients ≥ 18 years admitted to the emergency department
You may not qualify if:
- Patient have previously been included
- Terminal ill patients with short life expectancy
- Control group patients where physician at the emergency department request an assessment from a clinical pharmacist
- Control group patients where the project pharmacist reveal drug-related problems of major clinical relevance and has to intervene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diakonhjemmet Hospitallead
- Diakonhjemmet Hospital Pharmacycollaborator
- Diakonhjemmet Foundationcollaborator
- University of Oslocollaborator
Study Sites (1)
Diakonhjemmet Hospital
Oslo, Norway
Related Publications (1)
Nymoen LD, Flatebo TE, Moger TA, Oie E, Molden E, Viktil KK. Impact of systematic medication review in emergency department on patients' post-discharge outcomes-A randomized controlled clinical trial. PLoS One. 2022 Sep 19;17(9):e0274907. doi: 10.1371/journal.pone.0274907. eCollection 2022.
PMID: 36121830DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Erik H Øie, PhD, MD
Diakonhjemmet Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Not possible to mask the intervention
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.d. candidate and project pharmacist
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 21, 2017
Study Start
April 24, 2017
Primary Completion
May 16, 2018
Study Completion
September 4, 2022
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share