Drug-Related Side Effects and Adverse Reactions Clinical Trial
— EPIMERROfficial title:
Improving Drug Safety in Emergency Patients -a Randomized Controlled Trial
Verified date | February 2023 |
Source | Diakonhjemmet Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 806 |
Est. completion date | September 4, 2022 |
Est. primary completion date | May 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients = 18 years admitted to the emergency department - Able and willing to provide written consent (see Inclusion and randomization procedures and 6.Ethics) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Diakonhjemmet Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Diakonhjemmet Hospital | Diakonhjemmet Foundation, Diakonhjemmet Hospital Pharmacy, University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients readmitted | Difference between intervention- and control group in proportion of patients readmitted | 12 months from inclusion | |
Secondary | Proportion of patients readmitted | Difference between intervention- and control group in proportion of patients readmitted | 6 months from inclusion | |
Secondary | Average number of admissions | Difference between intervention- and control group in average number of admissions | 12 months from inclusion | |
Secondary | Time to next contact with a hospital | Difference between intervention- and control group in time to next contact with a hospital | Time to next readmission, maximum 12 months from inclusion | |
Secondary | Proportion of patients not hospitalized following admission to the emergency department (patients which condition is resolved in the emergency department) | Difference between intervention- and control group in proportion of patients not hospitalized following admission to the emergency department | During the relevant hospital admission (at inclusion) | |
Secondary | Length of stay at the emergency department | Difference between intervention- and control group in length of stay at the emergency department | During the relevant hospital admission (at inclusion) | |
Secondary | Overall length of hospital stay | Difference between intervention- and control group in overall length of hospital stay | During the relevant hospital admission (at inclusion) | |
Secondary | Investigate the efficiency of the new working model (for conducting medication reconciliation and medication review) | Use a semi structural questionnaire to investigate the efficiency of the new working model | During inclusion period | |
Secondary | Identify risk factors correlated to medication related admissions and drug related problems | Identify risk factors correlated to medication related admissions and drug related problems and use binary regression to build a prioritizing model, evaluate and test the model | Retrospective, 18 months after inclusion start (24. April 2017) | |
Secondary | High risk patients | Compare high risk patients for medication related admissions and drug related problems to high risk patients for clinical relevant medication discrepancies | Retrospective, 18 months after inclusion start (24. April 2017) | |
Secondary | Drug related admission | Describe the frequency of drug related admissions in the intervention group, and describe consequences, out-come and follow-up for these patients. | By pharmacist during the relevant hospital admission (at inclusion), by physicians and multidisciplinary team; retrospective, 18 months after inclusion start (24. April 2017) | |
Secondary | Patients point of view | To reveal the patients point of view for adjustment of the intervention: Describe patients view on medication regimen, believes and concerns about medication, medication lists and drug-related admissions using results from group interview and survey amongst a randomized sample of patients. 10% of the included patient will retrospectively be invited to participate in the group interview and 25% of the included patient will retrospectively be invited to fill out a survey | 2 years after inclusion start (24. April 2017) | |
Secondary | Retrospectively testing the two prioritizing models | To investigate the effect our two prioritizing models can have on patient safety we will retrospectively investigate the proportion of high risk patients for clinical relevant medication discrepancies and high risk patients for medication related admissions, for those readmitted in the control group and the intervention group. | Retrospective, 2 years after inclusion start (24. April 2017) |
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