ResuscitationNCT03021122
Reducing Medication Errors and Time to Drugs Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter RCT
A study testing PedAMINES™ / Conventional Method and Conventional Method / PedAMINES™ in people with Resuscitation and Pediatrics, run by Pediatric Clinical Research Platform at 6 sites in Switzerland.
Trial summary
The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resuscitation, Pediatrics
- What is being tested?
- PedAMINES™ / Conventional Method and Conventional Method / PedAMINES™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 1 Mar 2017to 31 Dec 2017
- 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
- To be nurse certified
- To know how to prepare intravenous drugs injection.
- To have previously completed the 5-minute introductory course to the use of PedAMINES dispensed by the investigators of the study.
- Participation agreement
Who cannot join
- To have at any time undergone a previous experiment with a cognitive numeric device aimed to help vasoactive drugs preparation.
- To have not undergone the 5-minute introductory course to the use of PedAMINES.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Inselspital Bern
Bern, 3010
HFR Fribourg
Fribourg, 1752
Geneva Children's Hospital, Geneva University Hospitals
Geneva, 1205
Hôpital de l'Enfance (HEL)
Lausanne, Canton of Vaud, 1000
Hôpital Neuchâtelois
Neuchâtel, 2000
Hôpital du Valais
Sion, Valais, 1950
About this study
Official title: Reducing Medication Errors and Time to Vasoactive Drugs Preparation and Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized Controlled Trial
The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them step-by-step from order to delivery of these drugs.
- Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
- Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).
Read the detailed description
During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. It is well established that CPR duration is inversely correlated to survival, decreasing linearly by 2.1 % per minute, and to decreased risk of neurological sequelae [1].
In this study, the investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin (Laerdal SimJunior™). The scenario will take place in the shock room to increase realism.
According to randomization with a 1:1 allocation ratio, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™ (Pediatric Accurate Medication In Emergency Situations). PedAMINES™ is designed to support nurses step-by-step from order to delivery of a wide range of drugs, especially those requiring continuous infusion. PedAMINES™ has already been shown in a single-center simulation-based study to reduce time to vasoactive drug preparation, to delivery and the rate of medication errors [2].
On the day of participation, after obtaining nurse's written informed consent and randomization, nurses will receive a standardized 5-minute training session on how to use the app. Then, the nurses will be asked to perform a standardized 15-minute highly realistic CPR scenario, including post-return of spontaneous circulation (ROSC). After epinephrine-induced ROSC, nurses will be asked to first prepare a continuous infusion of dopamine, using either PedAMINES™ or a conventional method, and then a continuous infusion of norepinephrine by crossing the procedure. Moreover, 2 questionnaires will be given before and after the scenario to ask the nurses about their demographics data, perceived stress and degree of satisfaction.
- Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
- Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).
All the actions (i.e. primary and secondary outcomes) performed by the nurses during the scenario will be automatically recorded and stored by the responsive simulator detectors, the application and by several video cameras. To avoid assessment bias, two evaluators will then independently review these video recordings. In case of disagreement, a third independent evaluator will help reach a consensus.
We aim to determine whether the use of PedAMINES™ might improve the management of acute life-threatening conditions by quickly delivering expertise in vasoactive drugs administration in other hospitals in Switzerland, even in non-university hospitals where nurses (and physicians) are either little or not exposed to pediatric CPRs. We hypothesize that PedAMINES™ might primary reduce medication errors, and secondary reduce delays to drugs preparation and delivery independently of the existing conventional preparation methods or nurses' skills.
- Conditions
- Resuscitation, Pediatrics
- Being tested
- PedAMINES™ / Conventional Method, Conventional Method / PedAMINES™
- Keywords
- Medication errors, Resuscitation, Drugs, Pediatrics, Biomedical technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedAMINES™ / Conventional MethodDevice
Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:
- PedAMINES™ (Period 1) and then Conventional Method (Period 2)
Conventional Method / PedAMINES™Device
Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:
- Conventional Method (Period 1) and then PedAMINES™ (Period 2)
| Study group | Role | What they receive |
|---|---|---|
| Arm A (PedAMINES™ / Conventional Method) | Experimental | A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of PedAMINES™ first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of a Conventional Method. Receives: Device: PedAMINES™ / Conventional Method |
| Arm B (Conventional Method / PedAMINES™) | Active comparator | A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of a Conventional Method first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of PedAMINES™. Receives: Device: Conventional Method / PedAMINES™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication dosage errors
To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
Measured: On the day of study participation
Secondary outcomes (1)
Time to drug preparation (TDP) and time to drug delivery (TDD)
To measure in each allocation group the elapsed time in seconds between the oral prescription by the physician to drug preparation completion by the nurse (TDP) and to drug delivery (TDD) by the nurse.
Measured: On the day of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, University of Lausanne Hospitals, Insel Gruppe AG, University Hospital Bern, Neuchâtel Hospital, Neuchâtel, Switzerland, Fribourg Hospital, Fribourg, Switzerland, Sion Hospital, Sion, Switzerland
- Responsible party
- Principal investigator, Johan Siebert, University Hospital, Geneva
- Investigators
- Johan N Siebert, MD, Principal investigator, Geneva Children Hospital, Geneva University Hospitals, Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021122
- Sponsor's protocol ID
- SNSF_32003B_169348
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives (HDD) at the Geneva Children's Hospital. Data will be freely available to anyone upon request 1 year after study completion. Only deidentified/anonymized data will be shared.
Publications
Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.
PubMed 23339874Siebert JN, Ehrler F, Combescure C, Lacroix L, Haddad K, Sanchez O, Gervaix A, Lovis C, Manzano S. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 1;19(2):e31. doi: 10.2196/jmir.7005.
PubMed 28148473Siebert JN, Gosetto L, Sauvage M, Bloudeau L, Suppan L, Rodieux F, Haddad K, Hugon F, Gervaix A, Lovis C, Combescure C, Manzano S, Ehrler F; PedAMINES Trial Group; PedAMINES Prehospital Group. Usability Testing and Technology Acceptance of an mHealth App at the Point of Care During Simulated Pediatric In- and Out-of-Hospital Cardiopulmonary Resuscitations: Study Nested Within 2 Multicenter Randomized Controlled Trials. JMIR Hum Factors. 2022 Mar 1;9(1):e35399. doi: 10.2196/35399.
PubMed 35230243Siebert JN, Ehrler F, Combescure C, Lovis C, Haddad K, Hugon F, Luterbacher F, Lacroix L, Gervaix A, Manzano S; PedAMINES Trial Group. A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial. Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.
PubMed 30797722Siebert JN, Ehrler F, Lovis C, Combescure C, Haddad K, Gervaix A, Manzano S. A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial. JMIR Res Protoc. 2017 Aug 22;6(8):e167. doi: 10.2196/resprot.7901.
PubMed 28830854
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Medication Errors and Time to Vasoactive Drugs Preparation and Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03021122
- Acronym / sponsor ID
- SNSF_32003B_169348
- Conditions
- Resuscitation, Pediatrics
- Keywords
- Medication errors, Resuscitation, Drugs, Pediatrics, Biomedical technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, University of Lausanne Hospitals, Insel Gruppe AG, University Hospital Bern, Neuchâtel Hospital, Neuchâtel, Switzerland, Fribourg Hospital, Fribourg, Switzerland, Sion Hospital, Sion, Switzerland
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 13 Jan 2017 (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 investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them step-by-step from order to delivery of these drugs.
- Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
- Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).
Detailed description
During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. It is well established that CPR duration is inversely correlated to survival, decreasing linearly by 2.1 % per minute, and to decreased risk of neurological sequelae [1].
In this study, the investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin (Laerdal SimJunior™). The scenario will take place in the shock room to increase realism.
According to randomization with a 1:1 allocation ratio, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™ (Pediatric Accurate Medication In Emergency Situations). PedAMINES™ is designed to support nurses step-by-step from order to delivery of a wide range of drugs, especially those requiring continuous infusion. PedAMINES™ has already been shown in a single-center simulation-based study to reduce time to vasoactive drug preparation, to delivery and the rate of medication errors [2].
On the day of participation, after obtaining nurse's written informed consent and randomization, nurses will receive a standardized 5-minute training session on how to use the app. Then, the nurses will be asked to perform a standardized 15-minute highly realistic CPR scenario, including post-return of spontaneous circulation (ROSC). After epinephrine-induced ROSC, nurses will be asked to first prepare a continuous infusion of dopamine, using either PedAMINES™ or a conventional method, and then a continuous infusion of norepinephrine by crossing the procedure. Moreover, 2 questionnaires will be given before and after the scenario to ask the nurses about their demographics data, perceived stress and degree of satisfaction.
- Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
- Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).
All the actions (i.e. primary and secondary outcomes) performed by the nurses during the scenario will be automatically recorded and stored by the responsive simulator detectors, the application and by several video cameras. To avoid assessment bias, two evaluators will then independently review these video recordings. In case of disagreement, a third independent evaluator will help reach a consensus.
We aim to determine whether the use of PedAMINES™ might improve the management of acute life-threatening conditions by quickly delivering expertise in vasoactive drugs administration in other hospitals in Switzerland, even in non-university hospitals where nurses (and physicians) are either little or not exposed to pediatric CPRs. We hypothesize that PedAMINES™ might primary reduce medication errors, and secondary reduce delays to drugs preparation and delivery independently of the existing conventional preparation methods or nurses' skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (PedAMINES™ / Conventional Method) | Experimental | Device: PedAMINES™ / Conventional MethodA 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of PedAMINES™ first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of a Conventional Method. |
| Arm B (Conventional Method / PedAMINES™) | Active comparator | Device: Conventional Method / PedAMINES™A 2-period study where nurses will be randomized to a 15-minute CPR scenario to prepare and deliver Dopamine with the help of a Conventional Method first, then crossover (incl. washout period) to prepare and deliver Norepinephrine with the help of PedAMINES™. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be nurse certified
- To know how to prepare intravenous drugs injection.
- To have previously completed the 5-minute introductory course to the use of PedAMINES dispensed by the investigators of the study.
- Participation agreement
Key exclusion criteria (2 listed)
- To have at any time undergone a previous experiment with a cognitive numeric device aimed to help vasoactive drugs preparation.
- To have not undergone the 5-minute introductory course to the use of PedAMINES.
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 |
|---|---|---|
| PedAMINES™ / Conventional MethodEach nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • PedAMINES™ (Period 1) and then Conventional Method (Period 2) | Device | Arm A (PedAMINES™ / Conventional Method) |
| Conventional Method / PedAMINES™Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Conventional Method (Period 1) and then PedAMINES™ (Period 2) | Device | Arm B (Conventional Method / PedAMINES™) |
Primary outcome
Medication dosage errors
Time frame: On the day of study participation
To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.
1 secondary outcome
Time to drug preparation (TDP) and time to drug delivery (TDD)
Time frame: On the day of study participation
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 30 Jan 2018.
- Background: PubMed 23339874Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.
- Background: PubMed 28148473Siebert JN, Ehrler F, Combescure C, Lacroix L, Haddad K, Sanchez O, Gervaix A, Lovis C, Manzano S. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 1;19(2):e31. doi: 10.2196/jmir.7005.
- Derived from this study: PubMed 35230243Siebert JN, Gosetto L, Sauvage M, Bloudeau L, Suppan L, Rodieux F, Haddad K, Hugon F, Gervaix A, Lovis C, Combescure C, Manzano S, Ehrler F; PedAMINES Trial Group; PedAMINES Prehospital Group. Usability Testing and Technology Acceptance of an mHealth App at the Point of Care During Simulated Pediatric In- and Out-of-Hospital Cardiopulmonary Resuscitations: Study Nested Within 2 Multicenter Randomized Controlled Trials. JMIR Hum Factors. 2022 Mar 1;9(1):e35399. doi: 10.2196/35399.
- Derived from this study: PubMed 30797722Siebert JN, Ehrler F, Combescure C, Lovis C, Haddad K, Hugon F, Luterbacher F, Lacroix L, Gervaix A, Manzano S; PedAMINES Trial Group. A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial. Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.
- Derived from this study: PubMed 28830854Siebert JN, Ehrler F, Lovis C, Combescure C, Haddad K, Gervaix A, Manzano S. A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial. JMIR Res Protoc. 2017 Aug 22;6(8):e167. doi: 10.2196/resprot.7901.
- Individual participant dataSharing planned: Yes. IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives (HDD) at the Geneva Children's Hospital. Data will be freely available to anyone upon request 1 year after study completion. Only deidentified/anonymized data will be shared.
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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.
Johan N Siebert, MD principal investigator
Geneva Children Hospital, Geneva University Hospitals, Geneva, Switzerland
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PedAMINES™ / Conventional Method and Conventional Method / PedAMINES™ in people with Resuscitation and Pediatrics, run by Pediatric Clinical Research Platform at 6 sites in Switzerland.
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 4 inclusion and 2 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. 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?
Medication dosage errors (time frame: On the day of study participation). 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 NCT03021122, which also lists 5 linked publications.
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 30 Jan 2018.