Patients in Highest Medication Error RiskNCT01819974
Effect of Medication Reviews Performed in High Risk Patients
A study testing Stratified medication review in people with Patients in Highest Medication Error Risk, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the study is to examine whether a stratified medication review performed in patients at highest risk of experiencing medication errors have impact on numbers of medication errrors during hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients in Highest Medication Error Risk
- What is being tested?
- Stratified medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to May 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acutely admitted
- >17 years
- Patients being treated with at least one drug at admission
Who cannot join
- Dying patients
- Suicidal patients
- Intoxicated patients
Trial locations and contacts
1 site in 1 country.
Lars P Nielsen, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Dorthe K Bonnerup, Msc
About this study
Official title: Effect of Medication Reviews in Hospitalized High-risk Patients - a Randomised Controlled Trial
The purpose of the study is to examine whether a stratified medication review performed in patients at highest risk of experiencing medication errors have impact on numbers of medication errrors during hospitalization.
Read the detailed description
Acutely admitted medical patients will be included after admission. After inclusion and randomization the patients will be risk stratified with an existing algorithm according to risk of medication error. The patients in the intervention group will receive a medication review performed by a clinical pharmacist if they are in high medication error risk. Patients in highest medication error risk will recieve a medication review performed by a clinical pharmacologist.
- Being tested
- Stratified medication review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratified medication reviewOther
A mediciation review will be performed in patients with high medication error rik. Patients in the highest risk will receive the medication review from a clinical pharmacologist whereas patients assessed in lesser risk will receive the medication review from a clinical pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The normal procedure at the ward |
| Stratified medication review | Active comparator | Medication review performed by either a clinical pharmacist or a clinical pharmacologist in patients with highest medication error risk Receives: Other: Stratified medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication errors
Medication errors are defined as errors in prescribing that has the potential to harm patients or actually harm patients. This will be assessed by checking the medical records. Two independent experts will do this.
Measured: During hospitalization ie. between 8 hours and approximately 20 days
Secondary outcomes (1)
hospital readmissions (all-cause)
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in Highest Medication Error RiskStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819974
- Sponsor's protocol ID
- MERIS2
- Status last verified
- Nov 2013
- First submitted
- 18 Mar 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medication Reviews in Hospitalized High-risk Patients - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01819974
- Acronym / sponsor ID
- MERIS2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 28 Mar 2013 (estimated)
- 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.
The purpose of the study is to examine whether a stratified medication review performed in patients at highest risk of experiencing medication errors have impact on numbers of medication errrors during hospitalization.
Detailed description
Acutely admitted medical patients will be included after admission. After inclusion and randomization the patients will be risk stratified with an existing algorithm according to risk of medication error. The patients in the intervention group will receive a medication review performed by a clinical pharmacist if they are in high medication error risk. Patients in highest medication error risk will recieve a medication review performed by a clinical pharmacologist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The normal procedure at the ward |
| Stratified medication review | Active comparator | Other: Stratified medication reviewMedication review performed by either a clinical pharmacist or a clinical pharmacologist in patients with highest medication error risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acutely admitted
- >17 years
- Patients being treated with at least one drug at admission
Key exclusion criteria (3 listed)
- Dying patients
- Suicidal patients
- Intoxicated patients
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 |
|---|---|---|
| Stratified medication reviewA mediciation review will be performed in patients with high medication error rik. Patients in the highest risk will receive the medication review from a clinical pharmacologist whereas patients assessed in lesser risk will receive the medication review from a clinical pharmacist. | Other | Stratified medication review |
Primary outcome
Medication errors
Time frame: During hospitalization ie. between 8 hours and approximately 20 days
Medication errors are defined as errors in prescribing that has the potential to harm patients or actually harm patients. This will be assessed by checking the medical records. Two independent experts will do this.
1 secondary outcome
hospital readmissions (all-cause)
Time frame: 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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.
Lars P Nielsen, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stratified medication review in people with Patients in Highest Medication Error Risk, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Nov 2013. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorthe K Bonnerup, Msc (+4560472921, dortbonn@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication errors (time frame: During hospitalization ie. between 8 hours and approximately 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2013.