BurnoutNCT06812234
Impact of Digital Ambient EXperience on Pediatric Subspecialist Documentation Burden
A study testing DAX Copilot in people with Burnout, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
This randomized quality improvement pilot project aims to assess whether the implementation of generative AI software for documentation, Microsoft Nuance's Digital Ambient eXperience (DAX) Copilot, enhances physician documentation efficiency and reduces burnout. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- DAX Copilot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Aug 2024
- 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
- Providers:
- Practices at Children's in a specialty supported by DAX Copilot product and with available documentation efficiency metrics from Epic's Signal product.
- >0.5 clinical full time equivalent (cFTE)
- 2 or more half days per week on average seeing outpatients as the primary provider (not overseeing trainees or APPs).
- Agrees to use the Children's EHR mobile application (Haiku) on their personal device.
- Agrees to offer use of the DAX Copilot generative AI software for all eligible patient visit encounters for the duration of the project period
Show all 11Show fewer
- Sufficient and stable EHR data on documentation efficiency from Epic's Signal product, defined as:
- Having populated data available for at least 40 of the last 52 weeks.
- Having stable metrics for pajama time and time in notes in the last 6 months as determined by two physician informaticists based on visual inspection.
- >75% of ambulatory documentation completed by the provider themselves (as opposed to taking over a note of a trainee or advanced practice provider).
- Visits: In person office visits in which interactions occur in English. For example, a visit with an interpreter present who translates verbally into English during the visit would be eligible. A visit in which all interactions occur in another language (i.e. the provider speaks the language the family uses as well) would not be eligible as the AI has not been developed yet for other languages.
Who cannot join
- Poor WiFi and cellular coverage in the clinic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
Official title: Evaluation of AI-Generated Documentation Software to Improve Pediatric Physician
This randomized quality improvement pilot project aims to assess whether the implementation of generative AI software for documentation, Microsoft Nuance's Digital Ambient eXperience (DAX) Copilot, enhances physician documentation efficiency and reduces burnout.
Read the detailed description
Background: While electronic health record (EHR) systems have contributed to advances in patient safety and quality of care, they have also been associated with a significant increase in documentation burden, contributing to burnout among clinicians [1]. This is particularly true for physicians with insufficient time for documentation. In some cases, it has resulted in a reduction in appointment slots to allow for additional documentation time, which in turn decreases patient access to care and physician productivity [2,3].
Microsoft Nuance© has recently announced general availability of a new generative artificial intelligence (AI) solution called Digital Ambient eXperience (DAX) DAX CoPilot [4], in which the visit is recorded with patient/parental consent, but a note is generated through the AI along with a visit transcript in near-real time that the provider can use and edit as they see fit. In addition, it allows providers to continue to use their documentation templates while adding the generative AI to "smart sections" within their note. This approach has the potential to substantially reduce documentation burden while maintaining documentation preferences of many providers.
This randomized quality improvement pilot project aims to assess whether the implementation of generative AI software for documentation, Microsoft Nuance's DAX Copilot, can enhance physician documentation efficiency and reduce burnout.
Objectives
Quality Improvement Global Aim: To increase provider documentation efficiency and reduce provider burnout related to documentation burden.
Children's Operational Goal: Determine if the cost of DAX Copilot or related vendor software is justified by reduction in proxies for physician burnout and/or could be offset by seeing more patients in the same time period to improve revenue and patient access.
Goals of the Proposed Work:
- Determine the influence of DAX Copilot on proxies for physician burnout including pajama time, time in notes, and subjective measures of EHR efficiency.
Methods: This is a randomized quality improvement project that will assess changes to proxies for provider documentation efficiency and burnout through a difference-in-differences design.
Project Participants
The project will recruit 20 providers who meet the following inclusion criteria:
- Practices at Children's in a specialty supported by DAX Copilot product and with available documentation efficiency metrics from Epic's Signal product.
- >0.5 clinical full time equivalent (cFTE)
- 2 or more half days per week on average seeing outpatients as the primary provider (not overseeing trainees or APPs).
- Agrees to use the Children's EHR mobile application (Haiku) on their personal device.
- Agrees to offer use of the DAX Copilot generative AI software for all patient visit encounters for the duration of the project period
- Sufficient and stable EHR data on documentation efficiency from Epic's Signal product, defined as:
- Having populated data available for at least 40 of the last 52 weeks.
- Having stable metrics for pajama time and time in notes in the last 6 months as determined by two physician informaticists based on visual inspection.
- >75% of ambulatory documentation completed by the provider themselves (as opposed to taking over a note of a trainee or advanced practice provider).
Participants will be identified based on characteristics such as specialty, cFTE, proportion and location of outpatient work, and Epic's Ambient Opportunity Index from Signal, which is based on normalized scores for proportion of same-day charts closed, pajama type, and characters manually typed.
Randomization will be conducted in blocks of two at the specialty level to ensure equal representation of specialties into one of the two following groups for a 3 month pilot:
- Use of DAX Copilot generative AI software (AI Group)
- Continuation of current documentation workflow (Control Group)
Outcomes
Our primary outcomes to be obtained through Epic's Signal product will be:
- "Pajama Time", defined as the average number of minutes per scheduled day spent in charting activities outside 7 AM to 5:30 PM on weekdays, time outside scheduled hours on weekends, and time on unscheduled holidays. This metric is associated with the exhaustion subscale of the Maslach Burnout Inventory [5].
- "Time in Notes per Appointment" in minutes Additional outcome metrics will include:
- Progress Note Length (characters)
- Note Contribution (written by provider vs. others)
- Time to Appointment Closure
- Proportion of notes completed using DAX Copilot generative AI software
- Average patient volume per week
- Pre- and post-project user responses on a modified KLAS EHR Efficiency and Satisfaction survey, a validated benchmarking tool.
- Pre- and post-project patient experience scores through routinely capture NRC surveys.
Data Collection
Data will be collected from Epic© Signal and through surveys. The data will include:
- Demographic information of project participants
- Data related to documentation efficiency as outlined in the quality metrics above
Statistical Analysis Our primary analysis will be a difference-in-differences analysis for each outcome. For example, the difference between the provider's average pajama time before and after the intervention period will be calculated for all participants. We will then determine how this average differs in the AI group and in the control group to assess the difference-in-differences.
Additional analyses will include adjusted or stratified difference-in-differences analyses based on provider characteristics listed above. We will also calculate descriptive statistics to compare the outcomes and covariates between the two groups. Depending on the nature of the data, we may use run charts, t-tests, ANOVA, or other appropriate statistical methods to assess the impact of generative AI documentation software.
References
- Budd, J. Burnout Related to Electronic Health Record Use in Primary Care. J Prim Care Community Health 14, 21501319231166921 (2023).
- Colicchio, T.K., Cimino, J.J. \& Del Fiol, G. Unintended Consequences of Nationwide Electronic Health Record Adoption: Challenges and Opportunities in the Post-Meaningful Use Era. J Med Internet Res 21, e13313 (2019).
- Gaffney, A., et al. Medical Documentation Burden Among US Office-Based Physicians in 2019: A National Study. JAMA Intern Med 182, 564-566 (2022).
- Microsoft+Nuance. Automatically document care with Dragon Ambient eXperience (DAX). https://www.nuance.com/asset/en_us/collateral/healthcare/data-sheet/ds-ambient-clinical-intelligence-en-us.pdf. (2023).
- Adler-Milstein, J. \& Wang, M.D. The impact of transitioning from availability of outside records within electronic health records to integration of local and outside records within electronic health records. J Am Med Inform Assoc 27, 606-612 (2020).
- Conditions
- Burnout
- Being tested
- DAX Copilot
- Keywords
- Documentation burden, Clinician Efficiency, Generative AI, Digital Ambient eXperience (DAX), Pediatric subspecialty care
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAX CopilotOther
- Enrolled in DAX Copilot program.
- Epic Haiku verified and adapted to record visits for DAX.
- Virtual training to add Patient List column to schedule for DAX Note Status, add appropriate smartlinks to note templates (AI-generated history of present illness, physical exam, and assessment and plan).
- In person at-the-elbow support from Children's Epic Support on Site team at initiation and up to 2 additional sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | * No change in documentation practice * Complete modified KLAS net EHR experience surveys |
| Intervention | Experimental | - Enrolled in DAX Copilot with appropriate training and asked to use for every eligible visit where the family does not decline use for 3 months. Receives: Other: DAX Copilot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pajama Time
Per Epic Signal: Average number of minutes per scheduled day spent in charting activities outside 7 AM to 5:30 PM on weekdays, time outside scheduled hours on weekends, and time on unscheduled holidays.
Numerator: Minutes spent in charting activities outside 7 AM to 5:30 PM on weekdays and outside scheduled hours on weekends.
Denominator: Scheduled days where time was spent in the system within the reporting period.
Measured: 12 months prior to study through end of study period.
Time in Notes per Appointment
Per Epic Signal: Time spent writing notes per appointment. Numerator: Minutes providers spent in a notes activity or navigator section within the reporting period.
Denominator: Appointments within the reporting period. Excludes data from days where the User Action Log data was not submitted.
Measured: 12 months prior to study through end of study period.
Secondary outcomes (7)
Progress Note Length (characters)
Per Epic Signal: Average number of characters in a Progress Note. Numerator: Characters, excluding white spaces, carriage returns, and tabs, in all Progress Notes providers wrote within the reporting period (IDN 34013).
Denominator: Progress Notes providers wrote within the reporting period (IDN 34013).
Measured: 12 months prior to study through end of study period.
Note Contribution
Per Epic Signal: Percentage of text written by the given source. Numerator: Characters written by the given source in all notes except letters and patient instructions. While you were affected by reportable issue 6823364, this excluded white space characters such as spaces, carriage returns, and tabs.
Denominator: Characters in all notes, except letters and patient instructions, signed within the reporting period. While you were affected by reportable issue 6823364, this excluded white space characters such as spaces, carriage returns, and tabs
Measured: 12 months prior to study through end of study period.
Time to Appointment Closure
Time from appointment date to appointment closure in the electronic health record.
Measured: 12 months prior to study through end of study period.
Proportion of notes completed using DAX copilot generative AI software
Numerator: Notes with at least 1 smartlink from DAX copilot used in the final signed note. Denominator: All progress notes signed for ambulatory patients for that provider during the study period.
Measured: 12 months prior to study through end of study period.
Patient Volume
Average patient volume per week
Measured: 12 months prior to study through end of study period.
Electronic Health Record satisfaction
Pre- and post-project user responses on a modified KLAS EHR Efficiency and Satisfaction survey, a validated benchmarking tool.
Measured: Pre-test within 2 months prior to study period and post-test within 2 months after study end.
Patient Experience
Patient experience overall score and sub-scores routinely obtained via NRC for patients seen by the provider.
Measured: 12 months prior to study through end of study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 May 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stella Shin, MD, Principal investigator, Children's Healthcare of AtlantaEvan Orenstein, MD, Study director, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812234
- Sponsor's protocol ID
- STUDY00001962
- Status last verified
- Jan 2025
- First submitted
- 28 May 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregate data will be published. De-identified individual participant data may be requested by other researchers and will be considered on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AI-Generated Documentation Software to Improve Pediatric Physician
- ClinicalTrials.gov ID
- NCT06812234
- Acronym / sponsor ID
- STUDY00001962
- Conditions
- Burnout
- Keywords
- Documentation burden, Clinician Efficiency, Generative AI, Digital Ambient eXperience (DAX), Pediatric subspecialty care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 Feb 2025 (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 randomized quality improvement pilot project aims to assess whether the implementation of generative AI software for documentation, Microsoft Nuance's Digital Ambient eXperience (DAX) Copilot, enhances physician documentation efficiency and reduces burnout.
Detailed description
Background: While electronic health record (EHR) systems have contributed to advances in patient safety and quality of care, they have also been associated with a significant increase in documentation burden, contributing to burnout among clinicians [1]. This is particularly true for physicians with insufficient time for documentation. In some cases, it has resulted in a reduction in appointment slots to allow for additional documentation time, which in turn decreases patient access to care and physician productivity [2,3].
Microsoft Nuance© has recently announced general availability of a new generative artificial intelligence (AI) solution called Digital Ambient eXperience (DAX) DAX CoPilot [4], in which the visit is recorded with patient/parental consent, but a note is generated through the AI along with a visit transcript in near-real time that the provider can use and edit as they see fit. In addition, it allows providers to continue to use their documentation templates while adding the generative AI to "smart sections" within their note. This approach has the potential to substantially reduce documentation burden while maintaining documentation preferences of many providers.
This randomized quality improvement pilot project aims to assess whether the implementation of generative AI software for documentation, Microsoft Nuance's DAX Copilot, can enhance physician documentation efficiency and reduce burnout.
Objectives
Quality Improvement Global Aim: To increase provider documentation efficiency and reduce provider burnout related to documentation burden.
Children's Operational Goal: Determine if the cost of DAX Copilot or related vendor software is justified by reduction in proxies for physician burnout and/or could be offset by seeing more patients in the same time period to improve revenue and patient access.
Goals of the Proposed Work:
- Determine the influence of DAX Copilot on proxies for physician burnout including pajama time, time in notes, and subjective measures of EHR efficiency.
Methods: This is a randomized quality improvement project that will assess changes to proxies for provider documentation efficiency and burnout through a difference-in-differences design.
Project Participants
The project will recruit 20 providers who meet the following inclusion criteria:
- Practices at Children's in a specialty supported by DAX Copilot product and with available documentation efficiency metrics from Epic's Signal product.
- >0.5 clinical full time equivalent (cFTE)
- 2 or more half days per week on average seeing outpatients as the primary provider (not overseeing trainees or APPs).
- Agrees to use the Children's EHR mobile application (Haiku) on their personal device.
- Agrees to offer use of the DAX Copilot generative AI software for all patient visit encounters for the duration of the project period
- Sufficient and stable EHR data on documentation efficiency from Epic's Signal product, defined as:
- Having populated data available for at least 40 of the last 52 weeks.
- Having stable metrics for pajama time and time in notes in the last 6 months as determined by two physician informaticists based on visual inspection.
- >75% of ambulatory documentation completed by the provider themselves (as opposed to taking over a note of a trainee or advanced practice provider).
Participants will be identified based on characteristics such as specialty, cFTE, proportion and location of outpatient work, and Epic's Ambient Opportunity Index from Signal, which is based on normalized scores for proportion of same-day charts closed, pajama type, and characters manually typed.
Randomization will be conducted in blocks of two at the specialty level to ensure equal representation of specialties into one of the two following groups for a 3 month pilot:
- Use of DAX Copilot generative AI software (AI Group)
- Continuation of current documentation workflow (Control Group)
Outcomes
Our primary outcomes to be obtained through Epic's Signal product will be:
- "Pajama Time", defined as the average number of minutes per scheduled day spent in charting activities outside 7 AM to 5:30 PM on weekdays, time outside scheduled hours on weekends, and time on unscheduled holidays. This metric is associated with the exhaustion subscale of the Maslach Burnout Inventory [5].
- "Time in Notes per Appointment" in minutes Additional outcome metrics will include:
- Progress Note Length (characters)
- Note Contribution (written by provider vs. others)
- Time to Appointment Closure
- Proportion of notes completed using DAX Copilot generative AI software
- Average patient volume per week
- Pre- and post-project user responses on a modified KLAS EHR Efficiency and Satisfaction survey, a validated benchmarking tool.
- Pre- and post-project patient experience scores through routinely capture NRC surveys.
Data Collection
Data will be collected from Epic© Signal and through surveys. The data will include:
- Demographic information of project participants
- Data related to documentation efficiency as outlined in the quality metrics above
Statistical Analysis Our primary analysis will be a difference-in-differences analysis for each outcome. For example, the difference between the provider's average pajama time before and after the intervention period will be calculated for all participants. We will then determine how this average differs in the AI group and in the control group to assess the difference-in-differences.
Additional analyses will include adjusted or stratified difference-in-differences analyses based on provider characteristics listed above. We will also calculate descriptive statistics to compare the outcomes and covariates between the two groups. Depending on the nature of the data, we may use run charts, t-tests, ANOVA, or other appropriate statistical methods to assess the impact of generative AI documentation software.
References
- Budd, J. Burnout Related to Electronic Health Record Use in Primary Care. J Prim Care Community Health 14, 21501319231166921 (2023).
- Colicchio, T.K., Cimino, J.J. \& Del Fiol, G. Unintended Consequences of Nationwide Electronic Health Record Adoption: Challenges and Opportunities in the Post-Meaningful Use Era. J Med Internet Res 21, e13313 (2019).
- Gaffney, A., et al. Medical Documentation Burden Among US Office-Based Physicians in 2019: A National Study. JAMA Intern Med 182, 564-566 (2022).
- Microsoft+Nuance. Automatically document care with Dragon Ambient eXperience (DAX). https://www.nuance.com/asset/en_us/collateral/healthcare/data-sheet/ds-ambient-clinical-intelligence-en-us.pdf. (2023).
- Adler-Milstein, J. \& Wang, M.D. The impact of transitioning from availability of outside records within electronic health records to integration of local and outside records within electronic health records. J Am Med Inform Assoc 27, 606-612 (2020).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –* No change in documentation practice * Complete modified KLAS net EHR experience surveys |
| Intervention | Experimental | Other: DAX Copilot- Enrolled in DAX Copilot with appropriate training and asked to use for every eligible visit where the family does not decline use for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Practices at Children's in a specialty supported by DAX Copilot product and with available documentation efficiency metrics from Epic's Signal product.
- >0.5 clinical full time equivalent (cFTE)
- 2 or more half days per week on average seeing outpatients as the primary provider (not overseeing trainees or APPs).
- Agrees to use the Children's EHR mobile application (Haiku) on their personal device.
- Agrees to offer use of the DAX Copilot generative AI software for all eligible patient visit encounters for the duration of the project period
Key exclusion criteria (1 listed)
- Poor WiFi and cellular coverage in the clinic.
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 |
|---|---|---|
| DAX Copilot* Enrolled in DAX Copilot program. * Epic Haiku verified and adapted to record visits for DAX. * Virtual training to add Patient List column to schedule for DAX Note Status, add appropriate smartlinks to note templates (AI-generated history of present illness, physical exam, and assessment and plan). * In person at-the-elbow support from Children's Epic Support on Site team at initiation and up to 2 additional sessions. | Other | Intervention |
Primary outcome
Pajama Time
Time frame: 12 months prior to study through end of study period.
Per Epic Signal: Average number of minutes per scheduled day spent in charting activities outside 7 AM to 5:30 PM on weekdays, time outside scheduled hours on weekends, and time on unscheduled holidays. Numerator: Minutes spent in charting activities outside 7 AM to 5:30 PM on weekdays and outside scheduled hours on weekends. Denominator: Scheduled days where time was spent in the system within the reporting period.
Time in Notes per Appointment
Time frame: 12 months prior to study through end of study period.
Per Epic Signal: Time spent writing notes per appointment. Numerator: Minutes providers spent in a notes activity or navigator section within the reporting period. Denominator: Appointments within the reporting period. Excludes data from days where the User Action Log data was not submitted.
7 secondary outcomes
Progress Note Length (characters)
Time frame: 12 months prior to study through end of study period.
Note Contribution
Time frame: 12 months prior to study through end of study period.
Time to Appointment Closure
Time frame: 12 months prior to study through end of study period.
Proportion of notes completed using DAX copilot generative AI software
Time frame: 12 months prior to study through end of study period.
Patient Volume
Time frame: 12 months prior to study through end of study period.
Electronic Health Record satisfaction
Time frame: Pre-test within 2 months prior to study period and post-test within 2 months after study end.
Patient Experience
Time frame: 12 months prior to study through end of study period.
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 6 Feb 2025.
- Individual participant dataSharing planned: Undecided. Aggregate data will be published. De-identified individual participant data may be requested by other researchers and will be considered on a case-by-case basis.
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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.
Stella Shin, MD principal investigator
Children's Healthcare of Atlanta
Evan Orenstein, MD study director
Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAX Copilot in people with Burnout, run by Children's Healthcare of Atlanta 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 11 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 6 Feb 2025. 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?
Pajama Time (time frame: 12 months prior to study through end of study period.). The study lists 2 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 6 Feb 2025.