Medication ComplianceEPIMERRNCT03123640
Improving Drug Safety in Emergency Patients -a Randomized Controlled Trial
A study testing Medication reconciliation and medication review in people with Medication Compliance and Drug-Related Side Effects and Adverse Reactions, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Compliance, Drug-Related Side Effects and Adverse Reactions, Remission
- What is being tested?
- Medication reconciliation and medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 1 siteNorway
- Study dates
- 24 Apr 2017to 4 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years admitted to the emergency department
- Able and willing to provide written consent (see Inclusion and randomization procedures and 6.Ethics)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Inclusion and randomization procedures
Staff at the emergency department, including physicians and nurses will be informed about the project. At admission, the project pharmacist will describe the project to each potential participant and/or their next of kin, then provide written information about the project and answer potential questions. If patients temporary are unable to consent when asked to participate (e.g. delirium) their next of kin will be asked to supply a preliminary consent in the patients place. If the patient later refuses to participate he/she will be excluded from the trial, and any registered data for this patient will be deleted. Patients will periodically be included at day shift and evening shift and by different clinical pharmacists to reduce potential bias. We will randomize the patients into two study groups. The randomization process will be conducted by Department of Biostatistics and Epidemiology at Oslo University Hospital. This department will deliver randomization lists, and the project pharmacist will follow randomization procedure.
Data registration
Patient data will be registered on paper forms, which will be de-identified after the patient data is transferred de-identified to the password protected project database on the hospital research server. Only a code list will connect the patient to his or her data. Paper forms will at all times be kept accessible only to authorized project personnel, and eventually the forms will be maculated. De-identified patient information will not be brought out of the hospital. The code list connecting the patients to their data will at the latest be deleted 3 years after start of data collection. When results are published it will not be possible to identify individual patients.
Customized Standard Operating Procedures addressing inclusion and randomization operations, registry operations and how to perform the intervention is developed.
Sample size calculation
Available information about readmission frequency at Diakonhjemmet Hospital is based on 30 days follow-up, and therefore cannot be used to calculate proportion of patients readmitted after 12 months. However, numbers from Oslo University Hospital estimate a readmission proportion of 50% after 12 months in a comparable patient population. Therefore this estimate is used as the expected readmission rate in the control group of this project. In a previous Swedish study conducted by Ulrika Gillespie who is member of the reference group of this project, a 16% reduction in hospital revisits within 12 months was found amongst older patients (>80 years) following a comparable intervention as described in this project. On this basis, it will be necessary to include at least 146 patients in each group to show a significant effect on the primary endpoint (significance level of 5%, study power of 80%). However, the elderly patients included in the Swedish study had more comorbidity and therefore more use of health care resources. In this project we will include all patients 18 years and older and thereby the difference between the control group and intervention group probably will be smaller. A more realistic difference between the groups is 10%; thereby 385 patients would have to be included in each group to show a significant effect on the primary endpoint. To compensate for dropout the aim is to include 400 patients in each project group, thus a total of 800 patients. Based on statistics from Diakonhjemmet Hospital, inclusion of this amount of patients from the Emergency Department would require an inclusion period of 12 months.
Statistics and analysis
Statistical analyses will be conducted in IBM (International Business Machines)SPSS Statistics (Statistical Package for the Social Sciences). Data will be assessed for normality and analyzed according to appropriate statistical tests. The baseline demographic and clinical characteristics will be summarized using proportions, means and standard deviations, or median and interquartile range, as appropriate. Baseline comparisons: Characteristics of project participants in the two project groups will be compared using the chi-square test for categorical variables and the Student's t-test or non-parametric equivalent (e.g. the Mann-Whitney U test) for continuous variables. Multivariable analysis (logistic regression) will be used to compare endpoints between project groups while adjusting for prognostic variables and potential confounders. All statistical tests will be interpreted with a significance level of 5% (two-tailed). For building the model for prioritizing patients at increased risk of drug-related admissions and drug-related problems at admission to the emergency department binary regression analysis will be used. Data will be analyzed according to intention-to-treat (ITT) principles. In addition to ITT analysis, per protocol analysis will also be performed.
Approval
The project is approved by the Regional committee for medical and health research ethics (REC) and the research committee at Diakonhjemmet Hospital.
- Conditions
- Medication Compliance, Drug-Related Side Effects and Adverse Reactions, Remission, Medicinal Substance; Adverse Effect, Drug Interaction Potentiation
- Being tested
- Medication reconciliation and medication review
- Keywords
- Medication reconciliation, Medication review, Drug related admission
- Medical subject headings
- Medication Adherence, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reconciliation and medication reviewOther
Pharmacist performed medication reconciliation and medication review
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Pharmacist 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. Receives: Other: Medication reconciliation and medication review |
| Control group | No intervention | Standard treatment without pharmacist intervention in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients readmitted
Difference between intervention- and control group in proportion of patients readmitted
Measured: 12 months from inclusion
Secondary outcomes (12)
Proportion of patients readmitted
Difference between intervention- and control group in proportion of patients readmitted
Measured: 6 months from inclusion
Average number of admissions
Difference between intervention- and control group in average number of admissions
Measured: 12 months from inclusion
Time to next contact with a hospital
Difference between intervention- and control group in time to next contact with a hospital
Measured: 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)
Difference between intervention- and control group in proportion of patients not hospitalized following admission to the emergency department
Measured: During the relevant hospital admission (at inclusion)
Length of stay at the emergency department
Difference between intervention- and control group in length of stay at the emergency department
Measured: During the relevant hospital admission (at inclusion)
Overall length of hospital stay
Difference between intervention- and control group in overall length of hospital stay
Measured: During the relevant hospital admission (at inclusion)
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
Measured: During inclusion period
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
Measured: Retrospective, 18 months after inclusion start (24. April 2017)
High risk patients
Compare high risk patients for medication related admissions and drug related problems to high risk patients for clinical relevant medication discrepancies
Measured: Retrospective, 18 months after inclusion start (24. April 2017)
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.
Measured: By pharmacist during the relevant hospital admission (at inclusion), by physicians and multidisciplinary team; retrospective, 18 months after inclusion start (24. April 2017)
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
Measured: 2 years after inclusion start (24. April 2017)
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.
Measured: Retrospective, 2 years after inclusion start (24. April 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start24 Apr 2017
- Primary completion16 May 2018
- Study completion4 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial With intervention Group and Control group
- Masking
- None (open label)
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonhjemmet Hospital Pharmacy, Diakonhjemmet Foundation, University of Oslo
- Responsible party
- Principal investigator, Lisbeth Damlien Nymoen, Diakonhjemmet Hospital
- Investigators
- Erik H Øie, PhD, MD, Study chair, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123640
- Sponsor's protocol ID
- EPIMERR -2015/1356/REK sør-øst
- Acronym
- EPIMERR
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2017
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36121830
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Drug Safety in Emergency Patients -a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03123640
- Acronym / sponsor ID
- EPIMERR / EPIMERR -2015/1356/REK sør-øst
- Conditions
- Medication Compliance, Drug-Related Side Effects and Adverse Reactions, Remission, Medicinal Substance; Adverse Effect, Drug Interaction Potentiation
- Keywords
- Medication reconciliation, Medication review, Drug related admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Diakonhjemmet Hospital Pharmacy, Diakonhjemmet Foundation, University of Oslo
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion and randomization procedures
Staff at the emergency department, including physicians and nurses will be informed about the project. At admission, the project pharmacist will describe the project to each potential participant and/or their next of kin, then provide written information about the project and answer potential questions. If patients temporary are unable to consent when asked to participate (e.g. delirium) their next of kin will be asked to supply a preliminary consent in the patients place. If the patient later refuses to participate he/she will be excluded from the trial, and any registered data for this patient will be deleted. Patients will periodically be included at day shift and evening shift and by different clinical pharmacists to reduce potential bias. We will randomize the patients into two study groups. The randomization process will be conducted by Department of Biostatistics and Epidemiology at Oslo University Hospital. This department will deliver randomization lists, and the project pharmacist will follow randomization procedure.
Data registration
Patient data will be registered on paper forms, which will be de-identified after the patient data is transferred de-identified to the password protected project database on the hospital research server. Only a code list will connect the patient to his or her data. Paper forms will at all times be kept accessible only to authorized project personnel, and eventually the forms will be maculated. De-identified patient information will not be brought out of the hospital. The code list connecting the patients to their data will at the latest be deleted 3 years after start of data collection. When results are published it will not be possible to identify individual patients.
Customized Standard Operating Procedures addressing inclusion and randomization operations, registry operations and how to perform the intervention is developed.
Sample size calculation
Available information about readmission frequency at Diakonhjemmet Hospital is based on 30 days follow-up, and therefore cannot be used to calculate proportion of patients readmitted after 12 months. However, numbers from Oslo University Hospital estimate a readmission proportion of 50% after 12 months in a comparable patient population. Therefore this estimate is used as the expected readmission rate in the control group of this project. In a previous Swedish study conducted by Ulrika Gillespie who is member of the reference group of this project, a 16% reduction in hospital revisits within 12 months was found amongst older patients (>80 years) following a comparable intervention as described in this project. On this basis, it will be necessary to include at least 146 patients in each group to show a significant effect on the primary endpoint (significance level of 5%, study power of 80%). However, the elderly patients included in the Swedish study had more comorbidity and therefore more use of health care resources. In this project we will include all patients 18 years and older and thereby the difference between the control group and intervention group probably will be smaller. A more realistic difference between the groups is 10%; thereby 385 patients would have to be included in each group to show a significant effect on the primary endpoint. To compensate for dropout the aim is to include 400 patients in each project group, thus a total of 800 patients. Based on statistics from Diakonhjemmet Hospital, inclusion of this amount of patients from the Emergency Department would require an inclusion period of 12 months.
Statistics and analysis
Statistical analyses will be conducted in IBM (International Business Machines)SPSS Statistics (Statistical Package for the Social Sciences). Data will be assessed for normality and analyzed according to appropriate statistical tests. The baseline demographic and clinical characteristics will be summarized using proportions, means and standard deviations, or median and interquartile range, as appropriate. Baseline comparisons: Characteristics of project participants in the two project groups will be compared using the chi-square test for categorical variables and the Student's t-test or non-parametric equivalent (e.g. the Mann-Whitney U test) for continuous variables. Multivariable analysis (logistic regression) will be used to compare endpoints between project groups while adjusting for prognostic variables and potential confounders. All statistical tests will be interpreted with a significance level of 5% (two-tailed). For building the model for prioritizing patients at increased risk of drug-related admissions and drug-related problems at admission to the emergency department binary regression analysis will be used. Data will be analyzed according to intention-to-treat (ITT) principles. In addition to ITT analysis, per protocol analysis will also be performed.
Approval
The project is approved by the Regional committee for medical and health research ethics (REC) and the research committee at Diakonhjemmet Hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial With intervention Group and Control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Medication reconciliation and medication reviewPharmacist 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 intervention | –Standard treatment without pharmacist intervention in the emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 years admitted to the emergency department
- Able and willing to provide written consent (see Inclusion and randomization procedures and 6.Ethics)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication reconciliation and medication reviewPharmacist performed medication reconciliation and medication review | Other | Intervention group |
Primary outcome
Proportion of patients readmitted
Time frame: 12 months from inclusion
Difference between intervention- and control group in proportion of patients readmitted
12 secondary outcomes
Proportion of patients readmitted
Time frame: 6 months from inclusion
Average number of admissions
Time frame: 12 months from inclusion
Time to next contact with a hospital
Time frame: 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)
Time frame: During the relevant hospital admission (at inclusion)
Length of stay at the emergency department
Time frame: During the relevant hospital admission (at inclusion)
Overall length of hospital stay
Time frame: During the relevant hospital admission (at inclusion)
Investigate the efficiency of the new working model (for conducting medication reconciliation and medication review)
Time frame: During inclusion period
Identify risk factors correlated to medication related admissions and drug related problems
Time frame: Retrospective, 18 months after inclusion start (24. April 2017)
High risk patients
Time frame: Retrospective, 18 months after inclusion start (24. April 2017)
Drug related admission
Time frame: By pharmacist during the relevant hospital admission (at inclusion), by physicians and multidisciplinary team; retrospective, 18 months after inclusion start (24. April 2017)
Patients point of view
Time frame: 2 years after inclusion start (24. April 2017)
Retrospectively testing the two prioritizing models
Time frame: Retrospective, 2 years after inclusion start (24. April 2017)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 36121830Nymoen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik H Øie, PhD, MD study chair
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication reconciliation and medication review in people with Medication Compliance and Drug-Related Side Effects and Adverse Reactions, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients readmitted (time frame: 12 months from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.