Medication Administered in ErrorNCT02359734
A National Study of Intravenous Medication Errors
An observational study of Medication Administered in Error, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
To identify the key issues around use of computerized patient infusion devices (called "smart pumps"). To develop strategies that will improve the prevention of intravenous errors that will be broadly applicable. The investigators will conduct a national study using the general methodology developed by Husch et al. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Medication Administered in Error
- What is being tested?
- Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
- Type of treatment
- Injection or infusion
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2015
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Any patients who are hospitalized in Medical ICU, surgical ICU, medicine unit and surgical unit on the day of data collection
Who may be able to join
- Patients if they receive any IV fluid or medication on the day of observation in the study units.
Who cannot join
- patients who are under 21 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: A National Study of Intravenous Medication Errors: Understanding How to Improve Intravenous Safety With Smart Pumps
To identify the key issues around use of computerized patient infusion devices (called "smart pumps").
To develop strategies that will improve the prevention of intravenous errors that will be broadly applicable.
Read more
The investigators will conduct a national study using the general methodology developed by Husch et al. to allow a rapid assessment of the frequency and types of medication errors at an institution.
The key questions the investigators will address are:
- What are the frequency and types of intravenous medication errors?
- How much variability is there by frequency and type among settings?
- After review of the initial data, what strategies appear to have the greatest potential for reducing intravenous medication error frequency?
- How effective is an intervention including a bundle of these strategies at multiple sites?
Read the detailed description
Overall Study Design: This is a multi-hospital study to investigate medication errors using smart pumps. The proposed study will be conducted over three phases for a total of 36 months phases. In Year 1, an observational study will be conducted by investigators at ten multiple hospital sites. The investigators will prospectively compare the medication, dose, and infusion rate on the IV pump with the prescribed medication, doses, and rate in the medical record. Preventability with smart pump technology will be retrospectively determined based on a rigorous definition of currently available technology. The investigators will also make comparisons across sites by overall rate and degree of variability among sites.
Then, in Year 2, these results will be evaluated, and a consensus process including a face-to-face meeting will take place to evaluate the types of events and to develop an intervention which will be implemented at multiple sites. After a run-in period, the intervention will be tested in Year 3 at the sites, and the data will be analyzed, and the investigators will produce a report and a set of recommendations.
- Conditions
- Medication Administered in Error
- Being tested
- Smart pump safety Intervention bundle for improving IV medication administration process with smart pump
- Keywords
- Patient safety, Medication errors, Smart infusion pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpOther
Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies
| Study group | Role | What they receive |
|---|---|---|
| Brigham and Women's Hospital. | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Brigham and Women's Hospital. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Johns Hopkins University Hospital | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Johns Hopkins University Hospital. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Winchester Medical Center | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Winchester Medical Center. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Central DuPage Hospital | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Central DuPage Hospital. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Vanderbilt University | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Vanderbilt University Medical Center. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Massachusetts General Hospital | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Massachusetts General Hospital. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| University of California, San Diego | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at University of California, San Diego. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Maricopa Integrated Health System | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Maricopa Integrated Health System. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Danbury Hospital | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Danbury Hospital. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump | |
| Candler Hospital | Patients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Candler Hospital. In these unit, the intervention bundle was implemented. Receives: Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident rates of wrong dose
The same medication but the dose is different from the prescribed order.
Measured: Two years
Incident rates of wrong rate
A different rate is displayed on the pump from that prescribed in the medical record. Also refers to weight based doses calculated incorrectly including using a wrong weight.
Measured: Two years
Incident rates of wrong concentration
An amount of a medication in a unit of solution that is different from the prescribed order.
Measured: Two years
Incident rates of wrong IV fluids/medications
A different fluid/medication as documented on the IV bag label is being infused compared with the order in the medical record.
Measured: Two years
Incident rates of delay of medication administration
An order to start or change medication or rate not carried out within 4 hours of the written order or intended start time per institution policy.
Measured: Two years
Incident rates of omission of IV fluids/medications
The medication ordered was not administered to a patient or administered anytime after 4 hours of the intended start time.
Measured: Two years
Incident rates of unauthorized medication
Fluids/medications are administered to the patient but no order is present in medical record. This includes failure to document a verbal order.
Measured: Two years
Incident rates of patient identification (ID) error (wrong patient)
Patient either has no ID band on or information on the ID band or label is incorrect.
Measured: Two years
Incident rates of smart pump or drug library not used
Smart pump is not used (bypassing smart pump) or smart pump was used but the drug library was not selected, rather manual entry mode was used (bypassing drug library)
Measured: Two years
Incident rates of oversight allergy
Medication is administered to a patient with a known allergy to the drug or class.
Measured: Two years
Incident rates of pump setting error
Setting programmed into the pump is different from the prescribed order.
Measured: Two years
Compliance rate of label not complete according to policy
Documented information on the medication label is different from required information per institution policy.
Measured: Two years
Compliance rate of IV tubing not tagged according to policy
IV tubing change label is not tagged per institution policy.
Measured: Two years
Incident rates of expired drug
The expiration date or time of the fluids/medications has passed.
Measured: Two years
Overall medication errors
Total number of all observed medication errors(including outcome 1-14)
Measured: Two years
Higher-severity medication errors
All medication errors with an NCC MERP severity rating of C or greater (excluding violation of hospital policy errors;outcome 12 and 13).
Measured: Two years
Secondary outcomes (3)
Compliance rate of using smart pump use
Compliance rate of using smart pump
Measured: Two years
Compliance rate of using drug library use
Compliance rate of using drug library
Measured: Two years
Potential adverse drug events
Medication errors with potential for harm categorized as D (errors that would have required increased monitoring to preclude harm) or higher by NCC MERP Index
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication Administered in ErrorStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Winchester Medical Center, Central DuPage Hospital, Vanderbilt University, Massachusetts General Hospital, University of California, San Diego, Valleywise Health, Danbury Hospital, Association for the Advancement of Medical Instrumentation, CareFusion foundation, Candler Hospital
- Responsible party
- Principal investigator, David W. Bates, MD, MSc, Brigham and Women's Hospital
- Investigators
- David W Bates, MD, MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359734
- Sponsor's protocol ID
- 2012P000709
- Status last verified
- Aug 2016
- First submitted
- 5 Jan 2015
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schnock KO, Dykes PC, Albert J, Ariosto D, Call R, Cameron C, Carroll DL, Drucker AG, Fang L, Garcia-Palm CA, Husch MM, Maddox RR, McDonald N, McGuire J, Rafie S, Robertson E, Saine D, Sawyer MD, Smith LP, Stinger KD, Vanderveen TW, Wade E, Yoon CS, Lipsitz S, Bates DW. The frequency of intravenous medication administration errors related to smart infusion pumps: a multihospital observational study. BMJ Qual Saf. 2017 Feb;26(2):131-140. doi: 10.1136/bmjqs-2015-004465. Epub 2016 Feb 23.
PubMed 26908900Schnock KO, Dykes PC, Albert J, Ariosto D, Cameron C, Carroll DL, Donahue M, Drucker AG, Duncan R, Fang L, Husch M, McDonald N, Maddox RR, McGuire J, Rafie S, Robertson E, Sawyer M, Wade E, Yoon CS, Lipsitz S, Bates DW. A Multi-hospital Before-After Observational Study Using a Point-Prevalence Approach with an Infusion Safety Intervention Bundle to Reduce Intravenous Medication Administration Errors. Drug Saf. 2018 Jun;41(6):591-602. doi: 10.1007/s40264-018-0637-3.
PubMed 29411338
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Study of Intravenous Medication Errors: Understanding How to Improve Intravenous Safety With Smart Pumps
- ClinicalTrials.gov ID
- NCT02359734
- Acronym / sponsor ID
- 2012P000709
- Conditions
- Medication Administered in Error
- Keywords
- Patient safety, Medication errors, Smart infusion pump
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Winchester Medical Center, Central DuPage Hospital, Vanderbilt University, Massachusetts General Hospital, University of California, San Diego, Valleywise Health, Danbury Hospital, Association for the Advancement of Medical Instrumentation, CareFusion foundation, Candler Hospital
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Feb 2015 (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.
To identify the key issues around use of computerized patient infusion devices (called "smart pumps").
To develop strategies that will improve the prevention of intravenous errors that will be broadly applicable.
The investigators will conduct a national study using the general methodology developed by Husch et al. to allow a rapid assessment of the frequency and types of medication errors at an institution.
The key questions the investigators will address are:
- What are the frequency and types of intravenous medication errors?
- How much variability is there by frequency and type among settings?
- After review of the initial data, what strategies appear to have the greatest potential for reducing intravenous medication error frequency?
- How effective is an intervention including a bundle of these strategies at multiple sites?
Detailed description
Overall Study Design: This is a multi-hospital study to investigate medication errors using smart pumps. The proposed study will be conducted over three phases for a total of 36 months phases. In Year 1, an observational study will be conducted by investigators at ten multiple hospital sites. The investigators will prospectively compare the medication, dose, and infusion rate on the IV pump with the prescribed medication, doses, and rate in the medical record. Preventability with smart pump technology will be retrospectively determined based on a rigorous definition of currently available technology. The investigators will also make comparisons across sites by overall rate and degree of variability among sites.
Then, in Year 2, these results will be evaluated, and a consensus process including a face-to-face meeting will take place to evaluate the types of events and to develop an intervention which will be implemented at multiple sites. After a run-in period, the intervention will be tested in Year 3 at the sites, and the data will be analyzed, and the investigators will produce a report and a set of recommendations.
Study design
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Brigham and Women's Hospital. | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Brigham and Women's Hospital. In these unit, the intervention bundle was implemented. |
| Johns Hopkins University Hospital | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Johns Hopkins University Hospital. In these unit, the intervention bundle was implemented. |
| Winchester Medical Center | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Winchester Medical Center. In these unit, the intervention bundle was implemented. |
| Central DuPage Hospital | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Central DuPage Hospital. In these unit, the intervention bundle was implemented. |
| Vanderbilt University | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Vanderbilt University Medical Center. In these unit, the intervention bundle was implemented. |
| Massachusetts General Hospital | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Massachusetts General Hospital. In these unit, the intervention bundle was implemented. |
| University of California, San Diego | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at University of California, San Diego. In these unit, the intervention bundle was implemented. |
| Maricopa Integrated Health System | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Maricopa Integrated Health System. In these unit, the intervention bundle was implemented. |
| Danbury Hospital | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Danbury Hospital. In these unit, the intervention bundle was implemented. |
| Candler Hospital | – | Other: Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpPatients who had IV medications with smart pumps in one surgical unit, one medical unit, one Medical ICU, and one surgical ICU at Candler Hospital. In these unit, the intervention bundle was implemented. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Any patients who are hospitalized in Medical ICU, surgical ICU, medicine unit and surgical unit on the day of data collection
Key inclusion criteria (1 listed)
- Patients if they receive any IV fluid or medication on the day of observation in the study units.
Key exclusion criteria (1 listed)
- patients who are under 21 years old.
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 |
|---|---|---|
| Smart pump safety Intervention bundle for improving IV medication administration process with smart pumpSmart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies | Other | Brigham and Women's Hospital., Candler Hospital, Central DuPage Hospital, Danbury Hospital, Johns Hopkins University Hospital, Maricopa Integrated Health System, Massachusetts General Hospital, University of California, San Diego, Vanderbilt University, Winchester Medical Center |
Primary outcome
Incident rates of wrong dose
Time frame: Two years
The same medication but the dose is different from the prescribed order.
Incident rates of wrong rate
Time frame: Two years
A different rate is displayed on the pump from that prescribed in the medical record. Also refers to weight based doses calculated incorrectly including using a wrong weight.
Incident rates of wrong concentration
Time frame: Two years
An amount of a medication in a unit of solution that is different from the prescribed order.
Incident rates of wrong IV fluids/medications
Time frame: Two years
A different fluid/medication as documented on the IV bag label is being infused compared with the order in the medical record.
Incident rates of delay of medication administration
Time frame: Two years
An order to start or change medication or rate not carried out within 4 hours of the written order or intended start time per institution policy.
Incident rates of omission of IV fluids/medications
Time frame: Two years
The medication ordered was not administered to a patient or administered anytime after 4 hours of the intended start time.
Incident rates of unauthorized medication
Time frame: Two years
Fluids/medications are administered to the patient but no order is present in medical record. This includes failure to document a verbal order.
Incident rates of patient identification (ID) error (wrong patient)
Time frame: Two years
Patient either has no ID band on or information on the ID band or label is incorrect.
Incident rates of smart pump or drug library not used
Time frame: Two years
Smart pump is not used (bypassing smart pump) or smart pump was used but the drug library was not selected, rather manual entry mode was used (bypassing drug library)
Incident rates of oversight allergy
Time frame: Two years
Medication is administered to a patient with a known allergy to the drug or class.
Incident rates of pump setting error
Time frame: Two years
Setting programmed into the pump is different from the prescribed order.
Compliance rate of label not complete according to policy
Time frame: Two years
Documented information on the medication label is different from required information per institution policy.
Compliance rate of IV tubing not tagged according to policy
Time frame: Two years
IV tubing change label is not tagged per institution policy.
Incident rates of expired drug
Time frame: Two years
The expiration date or time of the fluids/medications has passed.
Overall medication errors
Time frame: Two years
Total number of all observed medication errors(including outcome 1-14)
Higher-severity medication errors
Time frame: Two years
All medication errors with an NCC MERP severity rating of C or greater (excluding violation of hospital policy errors;outcome 12 and 13).
3 secondary outcomes
Compliance rate of using smart pump use
Time frame: Two years
Compliance rate of using drug library use
Time frame: Two years
Potential adverse drug events
Time frame: Two years
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 24 Aug 2016.
- Results publication: PubMed 26908900Schnock KO, Dykes PC, Albert J, Ariosto D, Call R, Cameron C, Carroll DL, Drucker AG, Fang L, Garcia-Palm CA, Husch MM, Maddox RR, McDonald N, McGuire J, Rafie S, Robertson E, Saine D, Sawyer MD, Smith LP, Stinger KD, Vanderveen TW, Wade E, Yoon CS, Lipsitz S, Bates DW. The frequency of intravenous medication administration errors related to smart infusion pumps: a multihospital observational study. BMJ Qual Saf. 2017 Feb;26(2):131-140. doi: 10.1136/bmjqs-2015-004465. Epub 2016 Feb 23.
- Derived from this study: PubMed 29411338Schnock KO, Dykes PC, Albert J, Ariosto D, Cameron C, Carroll DL, Donahue M, Drucker AG, Duncan R, Fang L, Husch M, McDonald N, Maddox RR, McGuire J, Rafie S, Robertson E, Sawyer M, Wade E, Yoon CS, Lipsitz S, Bates DW. A Multi-hospital Before-After Observational Study Using a Point-Prevalence Approach with an Infusion Safety Intervention Bundle to Reduce Intravenous Medication Administration Errors. Drug Saf. 2018 Jun;41(6):591-602. doi: 10.1007/s40264-018-0637-3.
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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.
David W Bates, MD, MSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Administered in Error, run by Brigham and Women's Hospital at 1 site in United States.
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 1 inclusion and 1 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 24 Aug 2016. 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 United States. 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?
Incident rates of wrong dose (time frame: Two years). The study lists 16 primary outcomes in all. 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 NCT02359734, which also lists 2 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 24 Aug 2016.