Patient SafetyFIQSNCT03202888
Family Input for Quality and Safety
A study testing Intervention in people with Patient Safety, run by University of California, San Francisco at 1 site in United States.
Trial summary
This project aims to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety
- What is being tested?
- Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 27 Apr 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient and caregiver participants will be recruited from admitted patients and their family members on the medical-surgical units at UCSF's Benioff Children's Hospital during the study period.
- Eligible providers will be the participating hospitalists during the study period.
- All nurse managers on the units and the patient safety and quality managers for the units will be eligible. All nurses will be eligible on the participating units.
Who cannot join
- Patients who are youth in the foster care system will not be eligible.
- Patients or parents/guardians who do not have smart phones will not be eligible.
- There are no provider or nurse or quality manager exclusions.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital
San Francisco, California, 94158
About this study
Official title: Novel IT to Create Patient-Integrated Hospital Quality Improvement and Improve Patient Safety
This project aims to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool. The investigators will conduct usability testing prior to study start, measure user (patients and providers) engagement over time, and gather feedback about the tool at study end. This will test the hypothesis that patient and caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and caregiver- observed processes of care to providers leads to changes over time. The investigators hypothesize that performance on structured items of interest will improve over time with rapidly available data presented to providers. Aim 3. Estimate tool implementation effect sizes, using a pre-post design, on medical errors.
Read the detailed description
More than a decade after the seminal Institute Of Medicine report, "To Err is Human", failure rates in patient safety remain stubbornly high in hospitals. Prior efforts to improve hospital quality have had relatively little impact, in part due to limited access to timely quality improvement data. The long-term goal of this application is to leverage existing technologies to give voice to hospitalized patients and their family members, leading to improvements in hospital safety and quality. The overall objective in this application is to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. The central hypothesis, based on the theory of co-production, is that observations from patients and families, gathered in a structured way, will provide actionable information regarding patient safety and quality. The rationale for doing this project is to test an innovative new approach to creating a rapidly available data stream to providers who are working on specific improvement efforts, and a mechanism for creating a quality improvement approach that is inherently patient-centered. The investigators plan to test the central hypothesis and thereby accomplish the objective of this application by focusing on the following areas of research for Health IT: Use, Implementation, and Impact on Outcomes, under the study type "Pilot and feasibility", pursuing three specific aims: Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool (Use and Implementation). The investigators will conduct usability testing prior to study start, measure user (patients and providers) engagement over time, and gather feedback about the tool at study end. The investigators hypothesize that patient and caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and caregiver- observed processes of care to providers leads to changes over time (Implementation). The investigators hypothesize that performance on structured items of interest will improve over time with rapidly available data presented to providers. Aim 3. Estimate tool implementation effect sizes, using a pre-post design, on medical errors (Impact on outcomes). The proposed research is innovative, in the investigators' opinion, based on a paradigm-shifting conceptual model of patient-engaged quality improvement, and because it leverages technology to gather and present data in an unprecedented manner. The expected contribution of the proposed research will be an adapted tool that will gather meaningful and important data on patient safety and present it in an actionable way to providers and hospital leaders, resulting in a powerful data stream to fuel rapid improvements in patient safety. Pilot data from this proposal will inform the design of a future cluster-randomized trial of the new tool across multiple hospital systems. This contribution will be significant because it represents key steps towards a new approach to improving patient safety in the hospital.
- Conditions
- Patient Safety
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
QuesGen-created mobile responsive website tool, Family Input for Quality and Safety.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | After completing enrollment surveys, including measures of patient activation and medical knowledge, participants will be invited to use the novel IT. The technology is a mobile responsive website for survey data collection made by our technology vendor, QuesGen. Patients and family members will be able to access the website from any personal device with internet access: laptop, tablet, or smart phone. QuesGen will send a text message reminder to participants with a link to specific questionnaires at scheduled time intervals. Frequency of text messaging will likely be daily, but will ultimately reflect family and patient feedback in Aim 1. In addition to text reminders, participants will be able to answer questionnaires at-will by accessing the mobile responsive website. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of preventable medical errors or adverse events per 100 admissions
This is a hospital unit-level outcome measure, assessing unit-level rate of adverse events and preventable medical errors in a time period before the intervention, and the unit-level rate at the end of the intervention. The investigators will apply standard definitions of medical errors as preventable failures in processes of care and adverse events as preventable and non-preventable unintended consequences of medical care that lead to patient harm. This is a composite measure and will be measured as total count of medical errors plus total count of adverse events per 100 admissions. The investigators will not track this measure across the same group of patients in the before and after periods. Participants will be included for the duration of their admission, which may vary. The rate will be measured cross-sectionally in both time periods.
Measured: Measured cross-sectionally in the hospital unit at baseline for three months, and again for three months at the end of the intervention (months 10,11,12 of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start26 Jun 2017
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Bardach, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202888
- Sponsor's protocol ID
- FIQS
- Acronym
- FIQS
- Status last verified
- Oct 2018
- First submitted
- 20 Jun 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.
PubMed 23860193Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, Whittington JC, Frankel A, Seger A, James BC. 'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011 Apr;30(4):581-9. doi: 10.1377/hlthaff.2011.0190.
PubMed 21471476Shekelle PG, Pronovost PJ, Wachter RM, Taylor SL, Dy SM, Foy R, Hempel S, McDonald KM, Ovretveit J, Rubenstein LV, Adams AS, Angood PB, Bates DW, Bickman L, Carayon P, Donaldson L, Duan N, Farley DO, Greenhalgh T, Haughom J, Lake ET, Lilford R, Lohr KN, Meyer GS, Miller MR, Neuhauser DV, Ryan G, Saint S, Shojania KG, Shortell SM, Stevens DP, Walshe K. Advancing the science of patient safety. Ann Intern Med. 2011 May 17;154(10):693-6. doi: 10.7326/0003-4819-154-10-201105170-00011.
PubMed 21576538Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010 Nov 25;363(22):2124-34. doi: 10.1056/NEJMsa1004404.
PubMed 21105794Chassin MR. Improving the quality of health care: what's taking so long? Health Aff (Millwood). 2013 Oct;32(10):1761-5. doi: 10.1377/hlthaff.2013.0809.
PubMed 24101066Erasmus V, Daha TJ, Brug H, Richardus JH, Behrendt MD, Vos MC, van Beeck EF. Systematic review of studies on compliance with hand hygiene guidelines in hospital care. Infect Control Hosp Epidemiol. 2010 Mar;31(3):283-94. doi: 10.1086/650451.
PubMed 20088678Conway PH, Mostashari F, Clancy C. The future of quality measurement for improvement and accountability. JAMA. 2013 Jun 5;309(21):2215-6. doi: 10.1001/jama.2013.4929. No abstract available.
PubMed 23736730Blumenthal D, McGinnis JM. Measuring Vital Signs: an IOM report on core metrics for health and health care progress. JAMA. 2015 May 19;313(19):1901-2. doi: 10.1001/jama.2015.4862. No abstract available.
PubMed 25919301Rossi P, Lipsey M, Freeman H. Evaluation: A Systematic Approach. 7th Edition ed: SAGE Publications, Inc; 2003.
Bardach NS, Asteria-Penaloza R, Boscardin WJ, Dudley RA. The relationship between commercial website ratings and traditional hospital performance measures in the USA. BMJ Qual Saf. 2013 Mar;22(3):194-202. doi: 10.1136/bmjqs-2012-001360. Epub 2012 Nov 23.
PubMed 23178860Greaves F, Pape UJ, King D, Darzi A, Majeed A, Wachter RM, Millett C. Associations between Web-based patient ratings and objective measures of hospital quality. Arch Intern Med. 2012 Mar 12;172(5):435-6. doi: 10.1001/archinternmed.2011.1675. Epub 2012 Feb 13. No abstract available.
PubMed 22331980Greaves F, Pape UJ, King D, Darzi A, Majeed A, Wachter RM, Millett C. Associations between Internet-based patient ratings and conventional surveys of patient experience in the English NHS: an observational study. BMJ Qual Saf. 2012 Jul;21(7):600-5. doi: 10.1136/bmjqs-2012-000906. Epub 2012 Apr 20.
PubMed 22523318Han E, Hudson Scholle S, Morton S, Bechtel C, Kessler R. Survey shows that fewer than a third of patient-centered medical home practices engage patients in quality improvement. Health Aff (Millwood). 2013 Feb;32(2):368-75. doi: 10.1377/hlthaff.2012.1183.
PubMed 23381530Clancy CM. Patient Safety: One Decade after To Err Is Human. 2009; http://www.psqh.com/septemberoctober-2009/234-september-october-2009-ahrq.html. Accessed October 29, 2013.
Guide to Patient and Family Engagement: Environmental Scan Report. October 2014; http://www.ahrq.gov/research/findings/final-reports/ptfamilyscan/ptfamilysum.html. Accessed June 10, 2015.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel IT to Create Patient-Integrated Hospital Quality Improvement and Improve Patient Safety
- ClinicalTrials.gov ID
- NCT03202888
- Acronym / sponsor ID
- FIQS / FIQS
- Conditions
- Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 29 Jun 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.
This project aims to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool. The investigators will conduct usability testing prior to study start, measure user (patients and providers) engagement over time, and gather feedback about the tool at study end. This will test the hypothesis that patient and caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and caregiver- observed processes of care to providers leads to changes over time. The investigators hypothesize that performance on structured items of interest will improve over time with rapidly available data presented to providers. Aim 3. Estimate tool implementation effect sizes, using a pre-post design, on medical errors.
Detailed description
More than a decade after the seminal Institute Of Medicine report, "To Err is Human", failure rates in patient safety remain stubbornly high in hospitals. Prior efforts to improve hospital quality have had relatively little impact, in part due to limited access to timely quality improvement data. The long-term goal of this application is to leverage existing technologies to give voice to hospitalized patients and their family members, leading to improvements in hospital safety and quality. The overall objective in this application is to create and evaluate a tool that gathers patient and family member feedback and makes it rapidly available to providers, enabling nimble and responsive safety and quality improvement efforts. The central hypothesis, based on the theory of co-production, is that observations from patients and families, gathered in a structured way, will provide actionable information regarding patient safety and quality. The rationale for doing this project is to test an innovative new approach to creating a rapidly available data stream to providers who are working on specific improvement efforts, and a mechanism for creating a quality improvement approach that is inherently patient-centered. The investigators plan to test the central hypothesis and thereby accomplish the objective of this application by focusing on the following areas of research for Health IT: Use, Implementation, and Impact on Outcomes, under the study type "Pilot and feasibility", pursuing three specific aims: Aim 1. Determine feasibility and acceptability of the patient data collection and provider dashboard tool (Use and Implementation). The investigators will conduct usability testing prior to study start, measure user (patients and providers) engagement over time, and gather feedback about the tool at study end. The investigators hypothesize that patient and caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and caregiver- observed processes of care to providers leads to changes over time (Implementation). The investigators hypothesize that performance on structured items of interest will improve over time with rapidly available data presented to providers. Aim 3. Estimate tool implementation effect sizes, using a pre-post design, on medical errors (Impact on outcomes). The proposed research is innovative, in the investigators' opinion, based on a paradigm-shifting conceptual model of patient-engaged quality improvement, and because it leverages technology to gather and present data in an unprecedented manner. The expected contribution of the proposed research will be an adapted tool that will gather meaningful and important data on patient safety and present it in an actionable way to providers and hospital leaders, resulting in a powerful data stream to fuel rapid improvements in patient safety. Pilot data from this proposal will inform the design of a future cluster-randomized trial of the new tool across multiple hospital systems. This contribution will be significant because it represents key steps towards a new approach to improving patient safety in the hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionAfter completing enrollment surveys, including measures of patient activation and medical knowledge, participants will be invited to use the novel IT. The technology is a mobile responsive website for survey data collection made by our technology vendor, QuesGen. Patients and family members will be able to access the website from any personal device with internet access: laptop, tablet, or smart phone. QuesGen will send a text message reminder to participants with a link to specific questionnaires at scheduled time intervals. Frequency of text messaging will likely be daily, but will ultimately reflect family and patient feedback in Aim 1. In addition to text reminders, participants will be able to answer questionnaires at-will by accessing the mobile responsive website. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient and caregiver participants will be recruited from admitted patients and their family members on the medical-surgical units at UCSF's Benioff Children's Hospital during the study period.
- Eligible providers will be the participating hospitalists during the study period.
- All nurse managers on the units and the patient safety and quality managers for the units will be eligible. All nurses will be eligible on the participating units.
Key exclusion criteria (3 listed)
- Patients who are youth in the foster care system will not be eligible.
- Patients or parents/guardians who do not have smart phones will not be eligible.
- There are no provider or nurse or quality manager exclusions.
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 |
|---|---|---|
| InterventionQuesGen-created mobile responsive website tool, Family Input for Quality and Safety. | Behavioural | Intervention |
Primary outcome
Change in rate of preventable medical errors or adverse events per 100 admissions
Time frame: Measured cross-sectionally in the hospital unit at baseline for three months, and again for three months at the end of the intervention (months 10,11,12 of the intervention).
This is a hospital unit-level outcome measure, assessing unit-level rate of adverse events and preventable medical errors in a time period before the intervention, and the unit-level rate at the end of the intervention. The investigators will apply standard definitions of medical errors as preventable failures in processes of care and adverse events as preventable and non-preventable unintended consequences of medical care that lead to patient harm. This is a composite measure and will be measured as total count of medical errors plus total count of adverse events per 100 admissions. The investigators will not track this measure across the same group of patients in the before and after periods. Participants will be included for the duration of their admission, which may vary. The rate will be measured cross-sectionally in both time periods.
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 26 Oct 2018.
- Background: PubMed 23860193James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.
- Background: PubMed 21471476Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, Whittington JC, Frankel A, Seger A, James BC. 'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011 Apr;30(4):581-9. doi: 10.1377/hlthaff.2011.0190.
- Background: PubMed 21576538Shekelle PG, Pronovost PJ, Wachter RM, Taylor SL, Dy SM, Foy R, Hempel S, McDonald KM, Ovretveit J, Rubenstein LV, Adams AS, Angood PB, Bates DW, Bickman L, Carayon P, Donaldson L, Duan N, Farley DO, Greenhalgh T, Haughom J, Lake ET, Lilford R, Lohr KN, Meyer GS, Miller MR, Neuhauser DV, Ryan G, Saint S, Shojania KG, Shortell SM, Stevens DP, Walshe K. Advancing the science of patient safety. Ann Intern Med. 2011 May 17;154(10):693-6. doi: 10.7326/0003-4819-154-10-201105170-00011.
- Background: PubMed 21105794Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010 Nov 25;363(22):2124-34. doi: 10.1056/NEJMsa1004404.
- Background: PubMed 24101066Chassin MR. Improving the quality of health care: what's taking so long? Health Aff (Millwood). 2013 Oct;32(10):1761-5. doi: 10.1377/hlthaff.2013.0809.
- Background: PubMed 20088678Erasmus V, Daha TJ, Brug H, Richardus JH, Behrendt MD, Vos MC, van Beeck EF. Systematic review of studies on compliance with hand hygiene guidelines in hospital care. Infect Control Hosp Epidemiol. 2010 Mar;31(3):283-94. doi: 10.1086/650451.
- Background: PubMed 23736730Conway PH, Mostashari F, Clancy C. The future of quality measurement for improvement and accountability. JAMA. 2013 Jun 5;309(21):2215-6. doi: 10.1001/jama.2013.4929. No abstract available.
- Background: PubMed 25919301Blumenthal D, McGinnis JM. Measuring Vital Signs: an IOM report on core metrics for health and health care progress. JAMA. 2015 May 19;313(19):1901-2. doi: 10.1001/jama.2015.4862. No abstract available.
- BackgroundRossi P, Lipsey M, Freeman H. Evaluation: A Systematic Approach. 7th Edition ed: SAGE Publications, Inc; 2003.
- Background: PubMed 23178860Bardach NS, Asteria-Penaloza R, Boscardin WJ, Dudley RA. The relationship between commercial website ratings and traditional hospital performance measures in the USA. BMJ Qual Saf. 2013 Mar;22(3):194-202. doi: 10.1136/bmjqs-2012-001360. Epub 2012 Nov 23.
- Background: PubMed 22331980Greaves F, Pape UJ, King D, Darzi A, Majeed A, Wachter RM, Millett C. Associations between Web-based patient ratings and objective measures of hospital quality. Arch Intern Med. 2012 Mar 12;172(5):435-6. doi: 10.1001/archinternmed.2011.1675. Epub 2012 Feb 13. No abstract available.
- Background: PubMed 22523318Greaves F, Pape UJ, King D, Darzi A, Majeed A, Wachter RM, Millett C. Associations between Internet-based patient ratings and conventional surveys of patient experience in the English NHS: an observational study. BMJ Qual Saf. 2012 Jul;21(7):600-5. doi: 10.1136/bmjqs-2012-000906. Epub 2012 Apr 20.
- 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.
Naomi Bardach, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Patient Safety, run by University of California, San Francisco 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 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: finished, as of the sponsor's last update on 26 Oct 2018. 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?
Change in rate of preventable medical errors or adverse events per 100 admissions (time frame: Measured cross-sectionally in the hospital unit at baseline for three months, and again for three months at the end of the intervention (months 10,11,12 of the intervention).). 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 NCT03202888, which also lists 15 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 26 Oct 2018.