Suicide RiskTIPSNCT04800029
Telehealth to Improve Prevention of Suicide (TIPS)
A study testing TIPS Program and TIPS Program + ED-SAFE in people with Suicide Risk, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Risk
- What is being tested?
- TIPS Program and TIPS Program + ED-SAFE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,406 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 30 Nov 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Adults presenting to ED who either screen positive on the universal suicide risk screener completed at triage or those who the ED treating team decides should have a mental health evaluation
- Research sample limited to those who live in Massachusetts
Who cannot join
- < 18 years of age
- Residing outside Massachusetts
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Telehealth to Improve Prevention of Suicide in EDs
The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal of RFA-MH-20-226. Notably, the study will surpass this primary requirement, because it will extend understanding of the relative added value of the ED-SAFE post-visit telephone intervention and will create knowledge about key factors related to implementation and sustainment.
Read the detailed description
Suicide is one of the most pressing public health problems facing the United States (US), ranking as the 10th leading cause of death, with incidence rates increasing year after year in the recent past. The National Action Alliance for Suicide Prevention (NAASP) has prioritized suicide prevention efforts in emergency departments (EDs) because of their well-established safety-net role in treating patients with suicide risk. However, there are serious problems with accessing timely, high-quality behavioral healthcare in many EDs, leading to unnecessary psychiatric hospitalizations, long waiting times, and substandard suicide-related care. As suggested by RFA-MH-20-226, telemental health service delivery has promise for not only improving timely access to behavioral health specialists, it also holds promise for improving adherence to best practice suicide prevention standards.
The study will evaluate whether telehealth can improve behavioral health specialist access and suicide-related care quality using a Type 2 hybrid effectiveness-implementation trial, titled Telehealth to Improve Prevention of Suicide (TIPS) in EDs. The study will involve ED patients with suicide risk from two Intervention EDs that do not currently have on-site behavioral health specialists and two Non-intervention control EDs. The study design will blend a three-phase interrupted time series design with a nested individual level randomized comparative effectiveness trial. Phase 1, Treatment as Usual (TAU), will comprise a historical control for the four EDs. It will use data spanning three years (October 2017 to September 2020) and will include all patients who screened positive on a universally administered, evidence-based screener, or who received a mental health evaluation in the participating EDs, which will allow the study team to establish a stable, representative control sample. Phase 2, Intervention, will involve implementing the TIPS telehealth protocol into routine clinical care for 24 months within the two Intervention EDs. Masters-level behavioral health specialists from an existing mental health center will perform a behavioral health evaluation using synchronous, two-way televideo software and hardware. In addition, for patients with a preliminary decision to be hospitalized, a telepsychiatrist will be consulted, with the goal of reducing hospitalization for those who can be adequately managed in a lower level of care. When needed, the telepsychiatrist will also complete his or her own televideo evaluation of the patient and collaterals. In addition to expanded behavioral health specialist access, the study team will improve the quality of suicide-related care. The study team will not only provide enhanced training for behavioral health specialists on best practice suicide risk assessment, safety planning, and care transition strategies, the study team will leverage fidelity review of recorded televideo evaluations and provide personalized feedback to improve adherence to performance standards.
In addition, during Phase 2, a 50% subset of patients who received the TIPS evaluation during their visit and who are discharged from the ED will be randomly assigned to the evidence-based Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) protocol after the visit (TIPS+EDSAFE). This will allow the Investigators to evaluate the added value of contact after the visit to further decrease suicidal behavior compared to the within-visit components alone (i.e., comparative effectiveness). Phase 3, Sustainment, will be the final phase during which the study team will remove grant financial subsidies for clinical services to definitively ascertain self-sustainability of the interventions. The investigators will collect the same system metrics and clinician behaviors on two Non-intervention EDs across the same time periods. These EDs will not implement the study interventions, and their data will help control for confounders, like macro-system or secular trends.
- Conditions
- Suicide Risk
- Being tested
- TIPS Program, TIPS Program + ED-SAFE
- Keywords
- suicide ideation, suicide attempt
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS ProgramOther
TIPS Program where a telehealth evaluation from a mental health clinician proficient in best practices was administered. The goal of which was to improve access and timeliness of evaluations through telehealth and the quality of management of suicidality in the ED. The main focus of TIPS was to replace the usual "call and arrive" or "transfer to a regional ED" models previously offered to a telehealth based evaluation. Components of the TIPS program included: (1) Telehealth evaluations with a masters-level mental health clinician; (2) Evidence informed-risk assessment with the Columbia Suicide Severity Rating Scale (CSSRS), Risk Assessment version; (3) Safety planning using the Stanley-Brown Safety Planning Intervention; (4) Care transitions using NAASP Best Practices in Care Transitions for Individuals with Suicide Risk; and (5) Telepsychiatry evaluation.
TIPS Program + ED-SAFEOther
TIPS+EDSAFE condition in which a random subset of discharged patients who received TIPS also received up to 3 follow-ups call over 3 three months after their initial presentation at the ED. The first call happened within a week, the second within a month and third within 3 months. It was one call to create a safety plan with the patient and 2 more calls to have a value discussion and life plan and check in on whether the safety plan needs to be updated and any barriers to getting outpatient treatment.
| Study group | Role | What they receive |
|---|---|---|
| Implementation (TIPS Program) | Experimental | The implementation phase took place over 24 months from the end of Covid TAU phase. The implementation phase established a TIPS condition reflecting only a telehealth evaluation from a mental health clinician proficient in best practices. Receives: Other: TIPS Program |
| Covid- TAU Phase | No intervention | The study design was submitted to NIMH for consideration prior to the COVID-19 pandemic. When COVID-19 happened, all four EDs implemented telehealth mental health evaluation procedures to address the care needs of patients. As a result, we added a COVID-19 TAU phase that represents when telehealth was used but the specific protocols or training to enhance suicide-related care or the post-visit ED-SAFE protocols were not implemented. |
| Treatment as Usual (TAU) | No intervention | This arm establishes a control condition reflecting baseline system metrics, clinician suicide-related care practices (intervention targets), and patient outcomes. |
| Sustainment | No intervention | The final phase of the interrupted time series design involved removing all Intervention related financial subsidies from supporting clinical and technical services. ED-SAFE follow-up is discontinued during this phase. This phase refers to 12 months following completion of the implementation phase. |
| Implementation (TIPS + ED SAFE) | Experimental | A TIPS+EDSAFE condition was also established during the same 24 months of intervention period, which reflected a randomized subset of discharged patients from the TIPS condition who also received 3 follow-up calls within 3 months after they were discharged. Receives: Other: TIPS Program + ED-SAFE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Stratified as High/Imminent Risk
The percentage of patients with final stratum of high risk or who are transferred to another hospital for evaluation among all patients with any risk on screener or evaluated by Behavioral Health
Measured: 24 months
Percentage of Patients Admitted to Inpatient Psychiatric Treatment
Percentage of Patients admitted to inpatient psychiatric treatment among all patients with any risk on screener or evaluated by Behavioral Health
Measured: 24 months
Emergency Department Psychiatric Boarding Hours for Admitted Patients
Average time from Behavioral Health evaluation in the Emergency Department to transfer to inpatient psychiatric hospital for admission.
Measured: 24 months
Secondary outcomes (13)
Intervention Targets - Behavioral Health Evaluations
This intervention target measures the total number of Behavioral Health Evaluations completed
Measured: 24 months
Intervention Targets - Suicide Risk Assessments
The intervention target measures the total number of evidence-based suicide risk assessments completed.
Measured: 24 months
Intervention Targets - Observations
The intervention target measures the number of one-on-one observations ordered.
Measured: 24 months
Intervention Targets - Safety Plans (Total Number)
The intervention target measures the number of safety plans created.
Measured: 24 months
Intervention Targets - Safety Plans (Overall Quality)
The intervention target measures the overall level of safety plan quality. The quality of the safety plan is measured using a standardized form known as the SPISA (Safety Plan Intervention Scoring Algorithm). Each line in the safety plan receives a score of 0-2 and then there is a total score that is the summation of the individual lines. Based on the final score, a final quality category will be assigned - Poor, Mediocre, Satisfactory, Good, or Excellent.
Measured: 24 months
Intervention Targets - Behavioral Health Appointments
The intervention target measures the number of scheduled Behavioral Health appointments prior to discharge.
Measured: 24 months
Intervention Targets - Post Visit Contacts
The intervention target measures the number of post-visit contacts the patient had.
Measured: 24 months
Door to Behavioral Health Evaluation Time
Total time from triage to Behavioral Health evaluation
Measured: 24 months
Total Length of Stay
Total time from registration to patient exiting the Emergency Department
Measured: 24 months
Transfer for psychiatric evaluation
The percentage of patients transferred out of Emergency Department to get Behavioral Health evaluation compared to all patients with any risk on screener or deemed to require a Behavioral Health evaluation
Measured: 24 months
Suicide composite outcome
Number of Emergency Department or inpatient visits with an International Classification of Disease (ICD) code or Natural Language Processing (NLP) algorithm indicating suicidal ideation or behavior or death due to intentional self-injury, as coded on death record
Measured: 24 months
In-situ intentional self-injury
Number of intentional self-harm observed during healthcare encounter
Measured: 24 months
Unintentional injury death
Number of deaths due to injuries not from intentional self-injury
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start12 Jul 2021
- Primary completion9 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multiphase interrupted time series design - 1. Treatment as usual (TAU) which is the historical period with no intervention implemented; 2. COVID- TAU which is part of historical control, but telehealth was introduced due to Covid but not as part of study implementation. No other intervention protocols were implemented at this time; 3. Experimental phase introducing intervention condition- TIPS program; 4. Experimental phase introducing intervention condition- TIPS + ED-SAFE; 5. Sustainment Phase with all intervention related subsidies removed and ED-SAFE discontinued.
- Masking
- None (open label)
- Enrolment
- 32,406 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Community HealthLink, Collective Medical, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Edwin Boudreaux, University of Massachusetts, Worcester
- Investigators
- Edwin Boudreaux, PhD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800029
- Sponsor's protocol ID
- H00021007
- Other IDs
- 1R01MH124685
- Acronym
- TIPS
- Status last verified
- Nov 2025
- First submitted
- 9 Mar 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be shared with the NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth to Improve Prevention of Suicide in EDs
- ClinicalTrials.gov ID
- NCT04800029
- Acronym / sponsor ID
- TIPS / H00021007
- Conditions
- Suicide Risk
- Keywords
- suicide ideation, suicide attempt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32,406 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Community HealthLink, Collective Medical, National Institute of Mental Health (NIMH)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 16 Mar 2021 (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.
The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal of RFA-MH-20-226. Notably, the study will surpass this primary requirement, because it will extend understanding of the relative added value of the ED-SAFE post-visit telephone intervention and will create knowledge about key factors related to implementation and sustainment.
Detailed description
Suicide is one of the most pressing public health problems facing the United States (US), ranking as the 10th leading cause of death, with incidence rates increasing year after year in the recent past. The National Action Alliance for Suicide Prevention (NAASP) has prioritized suicide prevention efforts in emergency departments (EDs) because of their well-established safety-net role in treating patients with suicide risk. However, there are serious problems with accessing timely, high-quality behavioral healthcare in many EDs, leading to unnecessary psychiatric hospitalizations, long waiting times, and substandard suicide-related care. As suggested by RFA-MH-20-226, telemental health service delivery has promise for not only improving timely access to behavioral health specialists, it also holds promise for improving adherence to best practice suicide prevention standards.
The study will evaluate whether telehealth can improve behavioral health specialist access and suicide-related care quality using a Type 2 hybrid effectiveness-implementation trial, titled Telehealth to Improve Prevention of Suicide (TIPS) in EDs. The study will involve ED patients with suicide risk from two Intervention EDs that do not currently have on-site behavioral health specialists and two Non-intervention control EDs. The study design will blend a three-phase interrupted time series design with a nested individual level randomized comparative effectiveness trial. Phase 1, Treatment as Usual (TAU), will comprise a historical control for the four EDs. It will use data spanning three years (October 2017 to September 2020) and will include all patients who screened positive on a universally administered, evidence-based screener, or who received a mental health evaluation in the participating EDs, which will allow the study team to establish a stable, representative control sample. Phase 2, Intervention, will involve implementing the TIPS telehealth protocol into routine clinical care for 24 months within the two Intervention EDs. Masters-level behavioral health specialists from an existing mental health center will perform a behavioral health evaluation using synchronous, two-way televideo software and hardware. In addition, for patients with a preliminary decision to be hospitalized, a telepsychiatrist will be consulted, with the goal of reducing hospitalization for those who can be adequately managed in a lower level of care. When needed, the telepsychiatrist will also complete his or her own televideo evaluation of the patient and collaterals. In addition to expanded behavioral health specialist access, the study team will improve the quality of suicide-related care. The study team will not only provide enhanced training for behavioral health specialists on best practice suicide risk assessment, safety planning, and care transition strategies, the study team will leverage fidelity review of recorded televideo evaluations and provide personalized feedback to improve adherence to performance standards.
In addition, during Phase 2, a 50% subset of patients who received the TIPS evaluation during their visit and who are discharged from the ED will be randomly assigned to the evidence-based Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) protocol after the visit (TIPS+EDSAFE). This will allow the Investigators to evaluate the added value of contact after the visit to further decrease suicidal behavior compared to the within-visit components alone (i.e., comparative effectiveness). Phase 3, Sustainment, will be the final phase during which the study team will remove grant financial subsidies for clinical services to definitively ascertain self-sustainability of the interventions. The investigators will collect the same system metrics and clinician behaviors on two Non-intervention EDs across the same time periods. These EDs will not implement the study interventions, and their data will help control for confounders, like macro-system or secular trends.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Multiphase interrupted time series design - 1. Treatment as usual (TAU) which is the historical period with no intervention implemented; 2. COVID- TAU which is part of historical control, but telehealth was introduced due to Covid but not as part of study implementation. No other intervention protocols were implemented at this time; 3. Experimental phase introducing intervention condition- TIPS program; 4. Experimental phase introducing intervention condition- TIPS + ED-SAFE; 5. Sustainment Phase with all intervention related subsidies removed and ED-SAFE discontinued.
| Arm | Type | Receives |
|---|---|---|
| Implementation (TIPS Program) | Experimental | Other: TIPS ProgramThe implementation phase took place over 24 months from the end of Covid TAU phase. The implementation phase established a TIPS condition reflecting only a telehealth evaluation from a mental health clinician proficient in best practices. |
| Covid- TAU Phase | No intervention | –The study design was submitted to NIMH for consideration prior to the COVID-19 pandemic. When COVID-19 happened, all four EDs implemented telehealth mental health evaluation procedures to address the care needs of patients. As a result, we added a COVID-19 TAU phase that represents when telehealth was used but the specific protocols or training to enhance suicide-related care or the post-visit ED-SAFE protocols were not implemented. |
| Treatment as Usual (TAU) | No intervention | –This arm establishes a control condition reflecting baseline system metrics, clinician suicide-related care practices (intervention targets), and patient outcomes. |
| Sustainment | No intervention | –The final phase of the interrupted time series design involved removing all Intervention related financial subsidies from supporting clinical and technical services. ED-SAFE follow-up is discontinued during this phase. This phase refers to 12 months following completion of the implementation phase. |
| Implementation (TIPS + ED SAFE) | Experimental | Other: TIPS Program + ED-SAFEA TIPS+EDSAFE condition was also established during the same 24 months of intervention period, which reflected a randomized subset of discharged patients from the TIPS condition who also received 3 follow-up calls within 3 months after they were discharged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Adults presenting to ED who either screen positive on the universal suicide risk screener completed at triage or those who the ED treating team decides should have a mental health evaluation
- Research sample limited to those who live in Massachusetts
Key exclusion criteria (2 listed)
- < 18 years of age
- Residing outside Massachusetts
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 |
|---|---|---|
| TIPS ProgramTIPS Program where a telehealth evaluation from a mental health clinician proficient in best practices was administered. The goal of which was to improve access and timeliness of evaluations through telehealth and the quality of management of suicidality in the ED. The main focus of TIPS was to replace the usual "call and arrive" or "transfer to a regional ED" models previously offered to a telehealth based evaluation. Components of the TIPS program included: (1) Telehealth evaluations with a masters-level mental health clinician; (2) Evidence informed-risk assessment with the Columbia Suicide Severity Rating Scale (CSSRS), Risk Assessment version; (3) Safety planning using the Stanley-Brown Safety Planning Intervention; (4) Care transitions using NAASP Best Practices in Care Transitions for Individuals with Suicide Risk; and (5) Telepsychiatry evaluation. | Other | Implementation (TIPS Program) |
| TIPS Program + ED-SAFETIPS+EDSAFE condition in which a random subset of discharged patients who received TIPS also received up to 3 follow-ups call over 3 three months after their initial presentation at the ED. The first call happened within a week, the second within a month and third within 3 months. It was one call to create a safety plan with the patient and 2 more calls to have a value discussion and life plan and check in on whether the safety plan needs to be updated and any barriers to getting outpatient treatment. | Other | Implementation (TIPS + ED SAFE) |
Primary outcome
Percentage of Patients Stratified as High/Imminent Risk
Time frame: 24 months
The percentage of patients with final stratum of high risk or who are transferred to another hospital for evaluation among all patients with any risk on screener or evaluated by Behavioral Health
Percentage of Patients Admitted to Inpatient Psychiatric Treatment
Time frame: 24 months
Percentage of Patients admitted to inpatient psychiatric treatment among all patients with any risk on screener or evaluated by Behavioral Health
Emergency Department Psychiatric Boarding Hours for Admitted Patients
Time frame: 24 months
Average time from Behavioral Health evaluation in the Emergency Department to transfer to inpatient psychiatric hospital for admission.
13 secondary outcomes
Intervention Targets - Behavioral Health Evaluations
Time frame: 24 months
Intervention Targets - Suicide Risk Assessments
Time frame: 24 months
Intervention Targets - Observations
Time frame: 24 months
Intervention Targets - Safety Plans (Total Number)
Time frame: 24 months
Intervention Targets - Safety Plans (Overall Quality)
Time frame: 24 months
Intervention Targets - Behavioral Health Appointments
Time frame: 24 months
Intervention Targets - Post Visit Contacts
Time frame: 24 months
Door to Behavioral Health Evaluation Time
Time frame: 24 months
Total Length of Stay
Time frame: 24 months
Transfer for psychiatric evaluation
Time frame: 24 months
Suicide composite outcome
Time frame: 24 months
In-situ intentional self-injury
Time frame: 24 months
Unintentional injury death
Time frame: 24 months
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 Jun 2026.
- Individual participant dataSharing planned: Yes. The dataset will be shared with the NIMH Data Archive
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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.
Edwin Boudreaux, PhD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS Program and TIPS Program + ED-SAFE in people with Suicide Risk, run by University of Massachusetts, Worcester 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 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 24 Jun 2026. 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?
Percentage of Patients Stratified as High/Imminent Risk (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.