Tobacco Use CessationNCT01691105
Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
A study testing AD + Integrated Tobacco Order Set in people with Tobacco Use Cessation and Smoking Cessation, run by Yale University at 1 site in United States.
Trial summary
This study will implement and test the effectiveness and cost-effectiveness of a tobacco cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for adults admitted to the hospital. The intervention will begin during the hospital stay and continue after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Smoking Cessation, Smoking
- What is being tested?
- AD + Integrated Tobacco Order Set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,044 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years or older
- admitted to any medical ward, telemetry or cardiac care unit
- identified as a smoker by the nurse or physician in the admitting EMR
- treated by a study physician
- able to give written informed consent
Who cannot join
- inability to read or understand English or Spanish
- lacks capacity to give informed consent
- currently receiving formal tobacco dependence treatment
- current suicide or homicide risk
- current psychotic disorder or life-threatening or unstable medical or psychiatric condition within past 6 months
- unable to provide 2 telephone contact numbers
Show all 14Show fewer
- unwilling to follow up per study protocol, including release of information to assess treatment engagement at 30-days
- live outside of New Haven County
- leaving the hospital against medical advice
- history of clinically significant allergic reaction to nicotine replacement therapies, varenicline or bupropion
- use of an investigational drug within 30 days
- use of tobacco products other than cigarettes
- women of childbearing potential who are pregnant, nursing, or sexually active and not practicing effective contraception (oral injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide)
- do not have access to a phone with a CT area code (required to use the CT Tobacco Quitline)
Trial locations and contacts
1 site in 1 country.
About this study
This study will implement and test the effectiveness and cost-effectiveness of a tobacco cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for adults admitted to the hospital. The intervention will begin during the hospital stay and continue after discharge. The intervention will use resources easily available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL).
The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report and biochemical verification (exhaled carbon monoxide reading).
Read the detailed description
Cigarette smoking remains the leading cause of preventable death and illness in the United States. In 2008, 20.6% of all American adults smoked, and 435,000 died from smoking-related illnesses. Economic costs of smoking dependence are estimated at $193 billion/year and have far-reaching implications for the individual, workplace, society and the healthcare system. However, treatment is associated with significant individual and society benefits, and both counseling and pharmacotherapy have been demonstrated to be effective treatments. Along with poverty and low education, smoking causes a greater loss of quality-adjusted life years than race, uninsurance, overweight, or binge drinking.
Smokers are admitted to acute care hospital more than nonsmokers. Using estimates from a number of sources, we estimate that approximately 6.1-12.5 million hospitalizations occur annually among adult smokers. This represents 20-41% of the 29.8 million annual inpatient stays in US acute care hospitals among adults age 18 and older unrelated to pregnancy or childbirth. Put another way, the nation's 46 million smokers represent 20% of the adult population, but account for 20-40% of all hospitalizations unrelated to pregnancy. Given that US hospitals are now smoke-free (per Joint Commission regulations), and many of these admissions are for tobacco-related conditions, the hospital admission represents a profound opportunity-a "teachable moment"-for tobacco control.
Recent "core measure" regulations by the Joint Commission and the Centers for Medicare and Medicaid Services require hospitals to report publicly their tobacco screening for patients admitted with acute myocardial infarction, congestive heart failure, and pneumonia. Although many hospitals have improved their performance considerably on these smoking measures, sometimes this has resulted from "gaming," e.g. giving all discharged patients a preprinted instruction sheet that includes boilerplate text about smoking cessation. Thus, although most hospitals assess inpatients for tobacco use (either through a nursing assessment or the physician's initial history and physical examination), there are often no systems in place to initiate or sustain tobacco treatment for smokers. This gap in service delivery prevents millions of smokers from accessing the many effective, evidence-based treatments for tobacco dependence during a period in which they may be particularly receptive to an intervention.
Hence, the overarching goal of this project is to implement and study the effectiveness and cost-effectiveness of a tobacco intervention for hospitalized adults that begins during inpatient treatment and continues after discharge. To enhance dissemination, we will use resources currently available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses, and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL). In the final year, a toolkit will be disseminated by professional societies. We hypothesize that the proposed intervention is clinically effective, cost effective, sustainable, and generalizable. All interventions are evidence-based and consistent with the 2008 Public Health Service clinical practice guideline for tobacco dependence treatment.
The Specific Aims of the proposed project are to:
Primary Aims:
- Determine whether Academic Detailing (AD) and an Integrated Tobacco Order Set (ITOS) compared to AD alone improves biologically verified smoking cessation at 12 months post-quit in a cohort of 960 smokers age > 18 years admitted to Yale New Haven Hospital (YNHH). Secondary Aims:
- Study ITOS's ability to encourage smokers to use treatment services and reduce consumption.
- Study ITOS's ability to enhance provider delivery of tobacco screening and treatment.
- Conduct an incremental cost-effectiveness analysis of the intervention.
Our associated hypotheses are:
- Subjects treated by physicians in the AD+ITOS arm will have a higher rate of biochemically verified 7-day point prevalence smoking abstinence at 12 months post-quit than subjects treated by physicians in the AD arm, in a cohort of adult smokers admitted to the inpatient units of Yale-New Haven Hospital.
- Subjects treated by AD+ITOS physicians will have made more quit attempts, and experienced greater reduction in daily cigarette consumption, than smokers treated by AD physicians.
- A higher proportion of patients treated by AD+ITOS physicians will have tobacco treatment initiated in hospital than patients treated by AD physicians.
- Societal costs of AD+ITOS, per abstinent smoker, will be cost-effective relative to AD.
- Being tested
- AD + Integrated Tobacco Order Set
- Keywords
- Tobacco Use Cessation, Smoking Cessation, Nicotine Replacement Therapy, Hospitalized Smokers
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation, Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD + Integrated Tobacco Order SetOther
Physician will have access to:
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center
| Study group | Role | What they receive |
|---|---|---|
| Academic Detailing (AD) | No intervention | Standard of care for patients who are smokers and admitted to the hospital. |
| AD + Integrated Tobacco Order Set | Experimental | Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center Receives: Other: AD + Integrated Tobacco Order Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence
Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.
Measured: 12 months post enrollment
Secondary outcomes (7)
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months
Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
Measured: 12 months post enrollment
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months
Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
Measured: 6 months post enrollment
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month
Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
Measured: 1 month post enrollment
Number of Participants Self-Reporting Use of Cessation Medications - 1 Month
Nicotine replacement therapy (NRT) use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
Measured: 1 month post enrollment
Number of Participants Self-Reporting Use of Cessation Medications - 6 Months
NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 6 months post enrollment.
Measured: 6 months post enrollment
Number of Participants Self-Reporting Use of Cessation Medications - 12 Months
NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
Measured: 12 months post enrollment
Number of Participants Self-Reporting Treatment Engagement - 1 Month
Treatment engagement will be assessed by subject self-report during the 1 month follow-up interview. Subjects will be considered engaged in treatment if at 30 days after randomization the subject reports currently receiving care for the Quitline or another treatment program that addresses the subject's nicotine dependence.
Measured: 1 month post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startAug 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Steven L Bernstein, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691105
- Sponsor's protocol ID
- 1205010297
- Other IDs
- R18HL108788
- Status last verified
- Aug 2021
- First submitted
- 19 Sep 2012
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bernstein SL, Weiss J, DeWitt M, Tetrault JM, Hsiao AL, Dziura J, Sussman S, Miller T, Carpenter K, O'Connor P, Toll B. A randomized trial of decision support for tobacco dependence treatment in an inpatient electronic medical record: clinical results. Implement Sci. 2019 Jan 22;14(1):8. doi: 10.1186/s13012-019-0856-8.
PubMed 30670043Bernstein SL, Rosner J, DeWitt M, Tetrault J, Hsiao AL, Dziura J, Sussman S, O'Connor P, Toll B. Design and implementation of decision support for tobacco dependence treatment in an inpatient electronic medical record: a randomized trial. Transl Behav Med. 2017 Jun;7(2):185-195. doi: 10.1007/s13142-017-0470-8.
PubMed 28194729
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
- ClinicalTrials.gov ID
- NCT01691105
- Acronym / sponsor ID
- 1205010297
- Keywords
- Tobacco Use Cessation, Smoking Cessation, Nicotine Replacement Therapy, Hospitalized Smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,044 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will implement and test the effectiveness and cost-effectiveness of a tobacco cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for adults admitted to the hospital. The intervention will begin during the hospital stay and continue after discharge. The intervention will use resources easily available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL).
The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report and biochemical verification (exhaled carbon monoxide reading).
Detailed description
Cigarette smoking remains the leading cause of preventable death and illness in the United States. In 2008, 20.6% of all American adults smoked, and 435,000 died from smoking-related illnesses. Economic costs of smoking dependence are estimated at $193 billion/year and have far-reaching implications for the individual, workplace, society and the healthcare system. However, treatment is associated with significant individual and society benefits, and both counseling and pharmacotherapy have been demonstrated to be effective treatments. Along with poverty and low education, smoking causes a greater loss of quality-adjusted life years than race, uninsurance, overweight, or binge drinking.
Smokers are admitted to acute care hospital more than nonsmokers. Using estimates from a number of sources, we estimate that approximately 6.1-12.5 million hospitalizations occur annually among adult smokers. This represents 20-41% of the 29.8 million annual inpatient stays in US acute care hospitals among adults age 18 and older unrelated to pregnancy or childbirth. Put another way, the nation's 46 million smokers represent 20% of the adult population, but account for 20-40% of all hospitalizations unrelated to pregnancy. Given that US hospitals are now smoke-free (per Joint Commission regulations), and many of these admissions are for tobacco-related conditions, the hospital admission represents a profound opportunity-a "teachable moment"-for tobacco control.
Recent "core measure" regulations by the Joint Commission and the Centers for Medicare and Medicaid Services require hospitals to report publicly their tobacco screening for patients admitted with acute myocardial infarction, congestive heart failure, and pneumonia. Although many hospitals have improved their performance considerably on these smoking measures, sometimes this has resulted from "gaming," e.g. giving all discharged patients a preprinted instruction sheet that includes boilerplate text about smoking cessation. Thus, although most hospitals assess inpatients for tobacco use (either through a nursing assessment or the physician's initial history and physical examination), there are often no systems in place to initiate or sustain tobacco treatment for smokers. This gap in service delivery prevents millions of smokers from accessing the many effective, evidence-based treatments for tobacco dependence during a period in which they may be particularly receptive to an intervention.
Hence, the overarching goal of this project is to implement and study the effectiveness and cost-effectiveness of a tobacco intervention for hospitalized adults that begins during inpatient treatment and continues after discharge. To enhance dissemination, we will use resources currently available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses, and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL). In the final year, a toolkit will be disseminated by professional societies. We hypothesize that the proposed intervention is clinically effective, cost effective, sustainable, and generalizable. All interventions are evidence-based and consistent with the 2008 Public Health Service clinical practice guideline for tobacco dependence treatment.
The Specific Aims of the proposed project are to:
Primary Aims:
- Determine whether Academic Detailing (AD) and an Integrated Tobacco Order Set (ITOS) compared to AD alone improves biologically verified smoking cessation at 12 months post-quit in a cohort of 960 smokers age > 18 years admitted to Yale New Haven Hospital (YNHH). Secondary Aims:
- Study ITOS's ability to encourage smokers to use treatment services and reduce consumption.
- Study ITOS's ability to enhance provider delivery of tobacco screening and treatment.
- Conduct an incremental cost-effectiveness analysis of the intervention.
Our associated hypotheses are:
- Subjects treated by physicians in the AD+ITOS arm will have a higher rate of biochemically verified 7-day point prevalence smoking abstinence at 12 months post-quit than subjects treated by physicians in the AD arm, in a cohort of adult smokers admitted to the inpatient units of Yale-New Haven Hospital.
- Subjects treated by AD+ITOS physicians will have made more quit attempts, and experienced greater reduction in daily cigarette consumption, than smokers treated by AD physicians.
- A higher proportion of patients treated by AD+ITOS physicians will have tobacco treatment initiated in hospital than patients treated by AD physicians.
- Societal costs of AD+ITOS, per abstinent smoker, will be cost-effective relative to AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Academic Detailing (AD) | No intervention | –Standard of care for patients who are smokers and admitted to the hospital. |
| AD + Integrated Tobacco Order Set | Experimental | Other: AD + Integrated Tobacco Order SetAccess to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- admitted to any medical ward, telemetry or cardiac care unit
- identified as a smoker by the nurse or physician in the admitting EMR
- treated by a study physician
- able to give written informed consent
Key exclusion criteria (14 listed)
- inability to read or understand English or Spanish
- lacks capacity to give informed consent
- currently receiving formal tobacco dependence treatment
- current suicide or homicide risk
- current psychotic disorder or life-threatening or unstable medical or psychiatric condition within past 6 months
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 |
|---|---|---|
| AD + Integrated Tobacco Order SetPhysician will have access to: NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center | Other | AD + Integrated Tobacco Order Set |
Primary outcome
Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence
Time frame: 12 months post enrollment
Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.
7 secondary outcomes
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months
Time frame: 12 months post enrollment
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months
Time frame: 6 months post enrollment
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month
Time frame: 1 month post enrollment
Number of Participants Self-Reporting Use of Cessation Medications - 1 Month
Time frame: 1 month post enrollment
Number of Participants Self-Reporting Use of Cessation Medications - 6 Months
Time frame: 6 months post enrollment
Number of Participants Self-Reporting Use of Cessation Medications - 12 Months
Time frame: 12 months post enrollment
Number of Participants Self-Reporting Treatment Engagement - 1 Month
Time frame: 1 month post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30670043Bernstein SL, Weiss J, DeWitt M, Tetrault JM, Hsiao AL, Dziura J, Sussman S, Miller T, Carpenter K, O'Connor P, Toll B. A randomized trial of decision support for tobacco dependence treatment in an inpatient electronic medical record: clinical results. Implement Sci. 2019 Jan 22;14(1):8. doi: 10.1186/s13012-019-0856-8.
- Derived from this study: PubMed 28194729Bernstein SL, Rosner J, DeWitt M, Tetrault J, Hsiao AL, Dziura J, Sussman S, O'Connor P, Toll B. Design and implementation of decision support for tobacco dependence treatment in an inpatient electronic medical record: a randomized trial. Transl Behav Med. 2017 Jun;7(2):185-195. doi: 10.1007/s13142-017-0470-8.
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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.
Steven L Bernstein, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AD + Integrated Tobacco Order Set in people with Tobacco Use Cessation and Smoking Cessation, run by Yale University 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 5 inclusion and 14 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 5 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence (time frame: 12 months post enrollment). 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 NCT01691105, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.