Intervention ComplianceCSDM PilotNCT02955563
CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool
A study testing CSDM Web-Based Tool Intervention in people with Intervention Compliance and Usability, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal is to develop a pragmatic, scalable intervention to overcome problems with surrogate decision making in ICUs. The aim is to conduct a pilot study among surrogates and clinicians of 50 incapacitated patients at high risk of death to assess the feasibility of deploying the web-based tool as well as to examine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention Compliance, Usability, Acceptability
- What is being tested?
- CSDM Web-Based Tool Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 16 May 2019
- 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
- Surrogate decision maker for ICU patient that lacks decisional capacity
- Permission from Patient's ICU Primary Attending Physician
Who cannot join
- Non-English Speaking
- Inability to read or write
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15216
About this study
The goal is to develop a pragmatic, scalable intervention to overcome problems with surrogate decision making in ICUs.
The aim is to conduct a pilot study among surrogates and clinicians of 50 incapacitated patients at high risk of death to assess the feasibility of deploying the web-based tool as well as to examine the tools impact on the patient and family outcome measures summarized in the hypotheses below.
Read the detailed description
Roughly 600,000 Americans annually die in or shortly after an ICU admission, generally after decisions by surrogates to forego life support. Several decades of research indicate:
- Family members in ICUs often struggle in the role of surrogate and experience high rates of lasting psychological sequelae (e.g. depression, anxiety, PTSD). For example, a systematic review found that one third of surrogates have long term feelings of guilt and doubt about the decisions they made.
- Patients often receive treatment that is inconsistent with their values and preferences. For example, in the SUPPORT trial, physicians were frequently unaware of patients' wishes regarding end-of-life care, and patients often died receiving more invasive treatment than they preferred.
- Intensive care near the end of life is a significant contributor to health care costs. For example, medical care in the last year of life accounts for 25% of Medicare costs, and ICU care contributes substantially.
Breakdowns in clinician-family communication in ICUs are common and an important target for interventions. Using quantitative analysis of audiorecorded goals of care discussions in ICUs, we found that in more than 50% of conversations clinicians did not inquire about the patient's values and treatment preferences, and in a similar proportion failed to explicitly offer alternatives to indefinite life-prolonging treatment, such as time-limited trials or comfort-focused treatment. We have also documented frequent omissions of important prognostic information during such conversations and other researchers have documented that surrogates often hold unduly optimistic estimates of patients' prognosis. These data highlight the importance of improving the quality of collaborative decision making in ICUs.
This proposal is responsive to national research priorities: The proposed research addresses priority areas for national action from the Institute of Medicine and NIH: improving clinician-family communication and end-of-life care for patients with advanced organ system failure. It is responsive to calls by the Institute on Aging to promote patient-centered decision making for elderly patients.
A critical barrier to addressing these problems is the absence of a scalable intervention. No empirically validated decision support tools exist for the range of critical illnesses confronted in ICUs. Prior interventions to address these problems (e.g., proactive palliative care consultation or adding a family support counselor to the ICU team) face major barriers to dissemination due to projected palliative care workforce shortages and the high cost of adding more personnel to ICU care teams.
A pragmatic, scalable intervention to overcome these problems has been developed. This pilot study among surrogates and clinicians of 50 incapacitated patients will assess the feasibility of deploying the web-based tool as well as to examine the tools impact on measures of communication and decision quality.
- Conditions
- Intervention Compliance, Usability, Acceptability
- Being tested
- CSDM Web-Based Tool Intervention
- Keywords
- decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, Palliative Care, End of Life, Quality of Communication, Anxiety, Depression
- Medical subject headings
- Death, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSDM Web-Based Tool InterventionOther
The web and tablet-based tool is designed to help family members become familiar with ICU environment, routines, and clinicians, prepare for family meetings, and learn how to make values-based decisions for their loved one. The tool contains short videos, interactive exercises, and links to other resources. Family members work through the tool shortly after admission to the ICU, before each family meeting, and any other time they wish to during the ICU admission.
| Study group | Role | What they receive |
|---|---|---|
| CSDM Tool | Experimental | Surrogate will complete educational sessions on CSDM tool prior to each family meeting with clinical team. Receives: Other: CSDM Web-Based Tool Intervention |
| Control | No intervention | Surrogates will receive augmented usual care. The augmentation is that there will be 2 family meetings scheduled during the first 10 days of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention compliance
Data tracking analytics will be employed to determine the extent to which the tool is used as per protocol.
Measured: Duration of ICU stay, an expected average of 4 weeks
Secondary outcomes (5)
Participants' ratings of usability of the tool
Usability of the tool will be measured with the System Usability Scale
Measured: Duration of hospital stay, an expected average of 4 weeks
Participants' ratings of acceptability of the tool
Acceptability will be measured with the user Acceptability Assessment
Measured: Duration of hospital stay, an expected average of 4 weeks
Participants' ratings of perceived usefulness of the tool
Usefulness will be measured with the Usefulness Assessment
Measured: Duration of hospital stay, an expected average of 4 weeks
Feasibility of enrolling family members in a critical care setting
Measured by meeting target enrollment
Measured: Through study completion, estimate one year past primary start date
Feasibility of retaining family members in a critical care setting in a trial
The number of subjects that complete the long term follow up
Measured: Three months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start1 May 2017
- Primary completion16 May 2019
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Intervention ComplianceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas White, University of Pittsburgh
- Investigators
- Douglas B White, MD, MAS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955563
- Sponsor's protocol ID
- PRO16050247
- Acronym
- CSDM Pilot
- Status last verified
- Jun 2019
- First submitted
- 2 Nov 2016
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available.
Publications
Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
PubMed 10966293Lynn J, Teno JM, Phillips RS, Wu AW, Desbiens N, Harrold J, Claessens MT, Wenger N, Kreling B, Connors AF Jr. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997 Jan 15;126(2):97-106. doi: 10.7326/0003-4819-126-2-199701150-00001.
PubMed 9005760Schenker Y, Tiver GA, Hong SY, White DB. Association between physicians' beliefs and the option of comfort care for critically ill patients. Intensive Care Med. 2012 Oct;38(10):1607-15. doi: 10.1007/s00134-012-2671-4. Epub 2012 Aug 11.
PubMed 22885651Schenker Y, Tiver GA, Hong SY, White DB. Discussion of treatment trials in intensive care. J Crit Care. 2013 Oct;28(5):862-9. doi: 10.1016/j.jcrc.2013.04.015. Epub 2013 Jun 13.
PubMed 23768446A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
PubMed 7474243White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
PubMed 17353493White DB, Engelberg RA, Wenrich MD, Lo B, Curtis JR. Prognostication during physician-family discussions about limiting life support in intensive care units. Crit Care Med. 2007 Feb;35(2):442-8. doi: 10.1097/01.CCM.0000254723.28270.14.
PubMed 17205000Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
PubMed 15665319Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011 Mar 1;154(5):336-46. doi: 10.7326/0003-4819-154-5-201103010-00008.
PubMed 21357911Riley GF, Lubitz JD. Long-term trends in Medicare payments in the last year of life. Health Serv Res. 2010 Apr;45(2):565-76. doi: 10.1111/j.1475-6773.2010.01082.x. Epub 2010 Feb 9.
PubMed 20148984Hogan C, Lunney J, Gabel J, Lynn J. Medicare beneficiaries' costs of care in the last year of life. Health Aff (Millwood). 2001 Jul-Aug;20(4):188-95. doi: 10.1377/hlthaff.20.4.188.
PubMed 11463076Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.
PubMed 15090940Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.
PubMed 9769276Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002 Apr 4;346(14):1061-6. doi: 10.1056/NEJMsa012528.
PubMed 11932474Sudore RL, Fried TR. Redefining the "planning" in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010 Aug 17;153(4):256-61. doi: 10.7326/0003-4819-153-4-201008170-00008.
PubMed 20713793
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool
- ClinicalTrials.gov ID
- NCT02955563
- Acronym / sponsor ID
- CSDM Pilot / PRO16050247
- Conditions
- Intervention Compliance, Usability, Acceptability
- Keywords
- decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, Palliative Care, End of Life, Quality of Communication, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 4 Nov 2016 (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 goal is to develop a pragmatic, scalable intervention to overcome problems with surrogate decision making in ICUs.
The aim is to conduct a pilot study among surrogates and clinicians of 50 incapacitated patients at high risk of death to assess the feasibility of deploying the web-based tool as well as to examine the tools impact on the patient and family outcome measures summarized in the hypotheses below.
Detailed description
Roughly 600,000 Americans annually die in or shortly after an ICU admission, generally after decisions by surrogates to forego life support. Several decades of research indicate:
- Family members in ICUs often struggle in the role of surrogate and experience high rates of lasting psychological sequelae (e.g. depression, anxiety, PTSD). For example, a systematic review found that one third of surrogates have long term feelings of guilt and doubt about the decisions they made.
- Patients often receive treatment that is inconsistent with their values and preferences. For example, in the SUPPORT trial, physicians were frequently unaware of patients' wishes regarding end-of-life care, and patients often died receiving more invasive treatment than they preferred.
- Intensive care near the end of life is a significant contributor to health care costs. For example, medical care in the last year of life accounts for 25% of Medicare costs, and ICU care contributes substantially.
Breakdowns in clinician-family communication in ICUs are common and an important target for interventions. Using quantitative analysis of audiorecorded goals of care discussions in ICUs, we found that in more than 50% of conversations clinicians did not inquire about the patient's values and treatment preferences, and in a similar proportion failed to explicitly offer alternatives to indefinite life-prolonging treatment, such as time-limited trials or comfort-focused treatment. We have also documented frequent omissions of important prognostic information during such conversations and other researchers have documented that surrogates often hold unduly optimistic estimates of patients' prognosis. These data highlight the importance of improving the quality of collaborative decision making in ICUs.
This proposal is responsive to national research priorities: The proposed research addresses priority areas for national action from the Institute of Medicine and NIH: improving clinician-family communication and end-of-life care for patients with advanced organ system failure. It is responsive to calls by the Institute on Aging to promote patient-centered decision making for elderly patients.
A critical barrier to addressing these problems is the absence of a scalable intervention. No empirically validated decision support tools exist for the range of critical illnesses confronted in ICUs. Prior interventions to address these problems (e.g., proactive palliative care consultation or adding a family support counselor to the ICU team) face major barriers to dissemination due to projected palliative care workforce shortages and the high cost of adding more personnel to ICU care teams.
A pragmatic, scalable intervention to overcome these problems has been developed. This pilot study among surrogates and clinicians of 50 incapacitated patients will assess the feasibility of deploying the web-based tool as well as to examine the tools impact on measures of communication and decision quality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSDM Tool | Experimental | Other: CSDM Web-Based Tool InterventionSurrogate will complete educational sessions on CSDM tool prior to each family meeting with clinical team. |
| Control | No intervention | –Surrogates will receive augmented usual care. The augmentation is that there will be 2 family meetings scheduled during the first 10 days of enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surrogate decision maker for ICU patient that lacks decisional capacity
- Permission from Patient's ICU Primary Attending Physician
Key exclusion criteria (2 listed)
- Non-English Speaking
- Inability to read or write
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 |
|---|---|---|
| CSDM Web-Based Tool InterventionThe web and tablet-based tool is designed to help family members become familiar with ICU environment, routines, and clinicians, prepare for family meetings, and learn how to make values-based decisions for their loved one. The tool contains short videos, interactive exercises, and links to other resources. Family members work through the tool shortly after admission to the ICU, before each family meeting, and any other time they wish to during the ICU admission. | Other | CSDM Tool |
Primary outcome
Intervention compliance
Time frame: Duration of ICU stay, an expected average of 4 weeks
Data tracking analytics will be employed to determine the extent to which the tool is used as per protocol.
5 secondary outcomes
Participants' ratings of usability of the tool
Time frame: Duration of hospital stay, an expected average of 4 weeks
Participants' ratings of acceptability of the tool
Time frame: Duration of hospital stay, an expected average of 4 weeks
Participants' ratings of perceived usefulness of the tool
Time frame: Duration of hospital stay, an expected average of 4 weeks
Feasibility of enrolling family members in a critical care setting
Time frame: Through study completion, estimate one year past primary start date
Feasibility of retaining family members in a critical care setting in a trial
Time frame: Three months post-discharge
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 11 Jun 2019.
- Background: PubMed 10966293Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
- Background: PubMed 9005760Lynn J, Teno JM, Phillips RS, Wu AW, Desbiens N, Harrold J, Claessens MT, Wenger N, Kreling B, Connors AF Jr. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997 Jan 15;126(2):97-106. doi: 10.7326/0003-4819-126-2-199701150-00001.
- Background: PubMed 22885651Schenker Y, Tiver GA, Hong SY, White DB. Association between physicians' beliefs and the option of comfort care for critically ill patients. Intensive Care Med. 2012 Oct;38(10):1607-15. doi: 10.1007/s00134-012-2671-4. Epub 2012 Aug 11.
- Background: PubMed 23768446Schenker Y, Tiver GA, Hong SY, White DB. Discussion of treatment trials in intensive care. J Crit Care. 2013 Oct;28(5):862-9. doi: 10.1016/j.jcrc.2013.04.015. Epub 2013 Jun 13.
- Background: PubMed 7474243A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
- Background: PubMed 17353493White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
- Background: PubMed 17205000White DB, Engelberg RA, Wenrich MD, Lo B, Curtis JR. Prognostication during physician-family discussions about limiting life support in intensive care units. Crit Care Med. 2007 Feb;35(2):442-8. doi: 10.1097/01.CCM.0000254723.28270.14.
- Background: PubMed 15665319Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
- Background: PubMed 21357911Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011 Mar 1;154(5):336-46. doi: 10.7326/0003-4819-154-5-201103010-00008.
- Background: PubMed 20148984Riley GF, Lubitz JD. Long-term trends in Medicare payments in the last year of life. Health Serv Res. 2010 Apr;45(2):565-76. doi: 10.1111/j.1475-6773.2010.01082.x. Epub 2010 Feb 9.
- Background: PubMed 11463076Hogan C, Lunney J, Gabel J, Lynn J. Medicare beneficiaries' costs of care in the last year of life. Health Aff (Millwood). 2001 Jul-Aug;20(4):188-95. doi: 10.1377/hlthaff.20.4.188.
- Background: PubMed 15090940Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.
- Individual participant dataSharing planned: No. Individual participant data will not be made available.
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Quality of Life
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.
Douglas B White, MD, MAS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSDM Web-Based Tool Intervention in people with Intervention Compliance and Usability, run by University of Pittsburgh 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 2 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 11 Jun 2019. 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?
Intervention compliance (time frame: Duration of ICU stay, an expected average of 4 weeks). 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 NCT02955563, which also lists 20 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 11 Jun 2019.