TuberculosisEnTICNCT02073240
Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand
An observational study of Tuberculosis, run by Centers for Disease Control and Prevention at 22 sites in 2 countries.
Trial summary
Study Design: Stratified, matched, cluster-randomized, controlled trial Unit of Randomization: Healthcare facility Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Enhanced TB IC Package
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 17 Feb 2014to 18 Nov 2016
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will be conducted at 22 hospitals, 10 in Thailand and 12 in Vietnam. The study facilities will be hospitals that typically provide care to patients with confirmed or suspected TB, namely TB or general hospitals.
Who may be able to join
- General provincial or regional hospital of at least 300 beds OR
- TB or Respiratory hospitals of at least 100 beds
- Geographic location that allows for ground transport of blood specimens to a designated reference laboratory within 16 hours of blood draw
- Hospital director is willing to commit staff time to study participation, including designating personnel to oversee TB IC and EnTIC study activities, as evidenced by a letter of support for the study
Who cannot join
- Specialty hospitals (such as, pediatric, infectious diseases, maternity)
- Recent (within the past 3 years) or current participation in a TB IC initiative
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Vietnam12 sites
Binh Phuoc General Hospital
Bình Phước
Dong Nai TB Hospital
Đông Nãi
Dong Thap TB Hospial
Dong Thập
Hai Duong TB Hospital
Hải Dương, Hai Duong
Hoa Binh General Hospital
Hòa Bình
Hung Yen Provincial Hospital
Hung Yen
Long An General Hospital
Long An
Nam Dinh General Hospital
Nam Định
Quang Ninh TB Hospital
Quang Ninh
Tien Giang General Hospital
Tiền Giang
Vinh Long General Hosptial
Vĩnh Long
Vinh Phuc General Hospital
Vĩnh Phúc
Thailand10 sites
Banpong Hospital
Ban Pong, Changwat Ratchaburi, 70110
Praputtabat Hosptial
Changwat Sara Buri, Praputtabat
Buddhasothorn Hospital
Maruphong, Cha Cherng Sao
Chumponkhetudomsak Hospital
Mueang, Chumpon
Nakhon Nayok Hospital
Mueang Nakhonnayok, Changwat Nakhon Nayok, 26000
Chao Phraya Abhaibhubejhr Hosptial
Mueang Prachinburi, Changwat Prachin Buri, 25000
Singburi Hospital
Mueang Singburi, Changwat Sing Buri, 16000
Chaiyaphum Hosptial
Nai Mueang, Changwat Chaiyaphum, 36000
Pichit Hospital
Nai Mueang, Pichit, 66000
Nan Hospital
Nai Wiang, Mueang Nan, Changwat Nan, 55000
About this study
Study Design: Stratified, matched, cluster-randomized, controlled trial
Unit of Randomization: Healthcare facility
Read more
Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and disseminated.
Study Components: Assessment of institutional safety culture; observations/audits of Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices; documentation of time intervals for processing sputum smears and initiation of TB treatment; facility assessments; random allocation and implementation of enhanced Tuberculosis infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost evaluation of intervention.
Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per cluster with 50% LTBI prevalence at baseline).
Read the detailed description
TB remains a cause of substantial morbidity and mortality, affecting an estimated 13.7 million persons and resulting in 1.8 million deaths worldwide. TB transmission has been well-documented in a wide variety of healthcare settings. Moreover, the global expansion of HIV care programs may inadvertently increase TB transmission in healthcare settings by congregating highly susceptible individuals with those likely to have TB disease. The urgency of reducing TB transmission in healthcare facilities has been intensified by the emergence of drug-resistant TB strains, including extensively resistant TB strains, and the high mortality of these strains in people living with human immunodeficiency virus (HIV).
Healthcare workers are at higher risk of both TB infection and disease compared to the general population, with estimates that 63-94% of TB infection and up to 89% of TB disease in this population is due to occupational exposure.
The World Health Organization (WHO) has identified institutional TB IC as one of the core "3 I's" interventions required to reduce the burden of TB among people living with HIV. Although TB IC guidelines exist and a "package" of interventions has been shown to successfully interrupt TB outbreaks in U.S. hospitals, there is limited information on feasibility, impact or cost of TB IC programs in middle- and low-income countries where TB burdens are high and nosocomial TB transmission has been well-documented.
Currently recommended TB IC strategies are complex and multi-faceted and include: administrative controls (e.g., early identification, treatment, and isolation or cohorting of infectious TB patients); effective engineering/environmental controls (such as, general ventilation or ultraviolet germicidal irradiation); and appropriate use of respiratory protection (N-95 particulate respirators) to protect HCWs. Implementation of many of these recommended measures require administrative/managerial support and sustained behavior change of frontline staff; some require substantial healthcare expenditures. There is an urgent need for simple, evidence-based and cost-effective strategies to help guide implementation of TB IC programs and reduce institutional TB transmission in resource-limited settings where TB and HIV are endemic. A recent call to address gaps in the TB IC evidence base identified key priorities including operational research to investigate the efficacy and cost-effectiveness of TB IC measures, and behavioral research to develop effective strategies to inform, motivate and provide skills to HCWs to implement and sustain effective airborne IC procedures and practices. This study directly addresses these identified priorities.
At root, ensuring good implementation of all TB IC procedures is a challenge of HCW behavior change. Even appropriate use of simple environmental control measures, requires a substantial element of behavior change to ensure effectiveness; for example, keeping needed windows open, ensuring needed fans are on and directed appropriately, and ensuring performance of routine maintenance checks of equipment. In this evaluation, the proposed intervention package focuses on tools and techniques that support the development of an institutional culture of safety and HCW behavior change regarding TB IC practices.
The theoretical framework for this intervention package is based on evidence showing that certain interventions favorably impact HCWs' IC practices and related patient outcomes, specifically 1) audits and feedback of IC performance and outcome data, 2) participation in IC collaborative (including mentoring), and 3) use of standardized IC checklists. Audit and feedback of performance have been used for decades as a strategy to improve implementation and adherence to clinical practice guidelines. Performance feedback has similarly been shown to be an effective intervention for improving IC practices. Also, there is a growing body of evidence to support the use of simple, evidence-based checklists as an effective IC strategy. When studied, use of checklists has fostered adoption of best practices, resulting in significant and sustained reductions in the targeted healthcare-associated infections (such as, surgical site infections and catheter-related bloodstream infections). Checklists are intended to be practical, easy-to-use tools that are designed to improve recall, prompt providers to perform recommended infection prevention steps, and make clear minimum expectations for IC. While the checklist approach has been used widely in other aspects of hospital IC, it has not yet been used widely for airborne IC. Lastly, collaboratives have been used to address a variety of health care issues and when studied in randomized trials, their efficacy has ranged from -16% to 70%. In Thailand, IC collaboratives have been associated with lower rates of healthcare-associated infections and better IC practices. In this study, we propose to use a robust study design to implement a multi-faceted TB IC package and to assess the impact of its implementation on TB transmission in hospitals and clinics where care is provided to patients with TB or other potential airborne respiratory infections.
- Conditions
- Tuberculosis
- Being tested
- Enhanced TB IC Package
- Keywords
- Tuberculosis, Infection Control
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced TB IC PackageBehavioural
Facilities randomized to the intervention group will receive:
- Skills-based training addressing the hierarchy of TB IC measures, how to conduct a facility TB IC /risk assessment; and development, implementation, and monitoring of an operational TB IC plan for the facility
- Audits and Feedback of performance
- A TB IC collaborative membership
- A standardized unit-level daily checklist of critical IC activities
| Study group | Role | What they receive |
|---|---|---|
| Enhanced TB IC Package | Facilities randomized to the intervention group will receive the following:
1. Skills-based training for TB IC focal points
2. Audits and Feedback of performance data
3. TB IC collaborative (including mentoring)
4. Checklists Receives: Behavioral: Enhanced TB IC Package | |
| Usual Care Group | Usual Care group will receive available TB IC training/education alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prevalence and incidence of latent Tuberculosis infection in healthcare workers
Measured by an interferon gamma release assay, QuantiFERON-TB Gold In-Tube
Measured: 0 months, 12 months, 24 months
Secondary outcomes (2)
Change in institutional safety culture
Measured by the Hospital Survey on Patient Safety
Measured: 0 months and 24 months
Adherence to recommended TB Infection Control practices
Measured by observation of healthcare worker-patient encounters, turn-around-times, wait times, and time-to-treatment
Measured: 0 months, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study start17 Feb 2014
- Primary completion18 Nov 2016
- Study completion18 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- United States President's Emergency Plan for AIDS Relief
- Responsible party
- Sponsor
- Investigators
- Michele L Pearson, MD, Principal investigator, Centers for Disease Control and Prevention, Center for Global Health, Division of Global HIV and TBSara J Whitehead, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073240
- Sponsor's protocol ID
- CDC-DTBE-6498
- Acronym
- EnTIC
- Status last verified
- Dec 2020
- First submitted
- 18 Feb 2014
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand
- ClinicalTrials.gov ID
- NCT02073240
- Acronym / sponsor ID
- EnTIC / CDC-DTBE-6498
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Infection Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- United States President's Emergency Plan for AIDS Relief
- Study start
- 17 Feb 2014 (actual)
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 27 Feb 2014 (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.
Study Design: Stratified, matched, cluster-randomized, controlled trial
Unit of Randomization: Healthcare facility
Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and disseminated.
Study Components: Assessment of institutional safety culture; observations/audits of Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices; documentation of time intervals for processing sputum smears and initiation of TB treatment; facility assessments; random allocation and implementation of enhanced Tuberculosis infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost evaluation of intervention.
Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per cluster with 50% LTBI prevalence at baseline).
Detailed description
TB remains a cause of substantial morbidity and mortality, affecting an estimated 13.7 million persons and resulting in 1.8 million deaths worldwide. TB transmission has been well-documented in a wide variety of healthcare settings. Moreover, the global expansion of HIV care programs may inadvertently increase TB transmission in healthcare settings by congregating highly susceptible individuals with those likely to have TB disease. The urgency of reducing TB transmission in healthcare facilities has been intensified by the emergence of drug-resistant TB strains, including extensively resistant TB strains, and the high mortality of these strains in people living with human immunodeficiency virus (HIV).
Healthcare workers are at higher risk of both TB infection and disease compared to the general population, with estimates that 63-94% of TB infection and up to 89% of TB disease in this population is due to occupational exposure.
The World Health Organization (WHO) has identified institutional TB IC as one of the core "3 I's" interventions required to reduce the burden of TB among people living with HIV. Although TB IC guidelines exist and a "package" of interventions has been shown to successfully interrupt TB outbreaks in U.S. hospitals, there is limited information on feasibility, impact or cost of TB IC programs in middle- and low-income countries where TB burdens are high and nosocomial TB transmission has been well-documented.
Currently recommended TB IC strategies are complex and multi-faceted and include: administrative controls (e.g., early identification, treatment, and isolation or cohorting of infectious TB patients); effective engineering/environmental controls (such as, general ventilation or ultraviolet germicidal irradiation); and appropriate use of respiratory protection (N-95 particulate respirators) to protect HCWs. Implementation of many of these recommended measures require administrative/managerial support and sustained behavior change of frontline staff; some require substantial healthcare expenditures. There is an urgent need for simple, evidence-based and cost-effective strategies to help guide implementation of TB IC programs and reduce institutional TB transmission in resource-limited settings where TB and HIV are endemic. A recent call to address gaps in the TB IC evidence base identified key priorities including operational research to investigate the efficacy and cost-effectiveness of TB IC measures, and behavioral research to develop effective strategies to inform, motivate and provide skills to HCWs to implement and sustain effective airborne IC procedures and practices. This study directly addresses these identified priorities.
At root, ensuring good implementation of all TB IC procedures is a challenge of HCW behavior change. Even appropriate use of simple environmental control measures, requires a substantial element of behavior change to ensure effectiveness; for example, keeping needed windows open, ensuring needed fans are on and directed appropriately, and ensuring performance of routine maintenance checks of equipment. In this evaluation, the proposed intervention package focuses on tools and techniques that support the development of an institutional culture of safety and HCW behavior change regarding TB IC practices.
The theoretical framework for this intervention package is based on evidence showing that certain interventions favorably impact HCWs' IC practices and related patient outcomes, specifically 1) audits and feedback of IC performance and outcome data, 2) participation in IC collaborative (including mentoring), and 3) use of standardized IC checklists. Audit and feedback of performance have been used for decades as a strategy to improve implementation and adherence to clinical practice guidelines. Performance feedback has similarly been shown to be an effective intervention for improving IC practices. Also, there is a growing body of evidence to support the use of simple, evidence-based checklists as an effective IC strategy. When studied, use of checklists has fostered adoption of best practices, resulting in significant and sustained reductions in the targeted healthcare-associated infections (such as, surgical site infections and catheter-related bloodstream infections). Checklists are intended to be practical, easy-to-use tools that are designed to improve recall, prompt providers to perform recommended infection prevention steps, and make clear minimum expectations for IC. While the checklist approach has been used widely in other aspects of hospital IC, it has not yet been used widely for airborne IC. Lastly, collaboratives have been used to address a variety of health care issues and when studied in randomized trials, their efficacy has ranged from -16% to 70%. In Thailand, IC collaboratives have been associated with lower rates of healthcare-associated infections and better IC practices. In this study, we propose to use a robust study design to implement a multi-faceted TB IC package and to assess the impact of its implementation on TB transmission in hospitals and clinics where care is provided to patients with TB or other potential airborne respiratory infections.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced TB IC Package | – | Behavioral: Enhanced TB IC PackageFacilities randomized to the intervention group will receive the following: 1. Skills-based training for TB IC focal points 2. Audits and Feedback of performance data 3. TB IC collaborative (including mentoring) 4. Checklists |
| Usual Care Group | – | –Usual Care group will receive available TB IC training/education alone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will be conducted at 22 hospitals, 10 in Thailand and 12 in Vietnam. The study facilities will be hospitals that typically provide care to patients with confirmed or suspected TB, namely TB or general hospitals.
Key inclusion criteria (4 listed)
- General provincial or regional hospital of at least 300 beds OR
- TB or Respiratory hospitals of at least 100 beds
- Geographic location that allows for ground transport of blood specimens to a designated reference laboratory within 16 hours of blood draw
- Hospital director is willing to commit staff time to study participation, including designating personnel to oversee TB IC and EnTIC study activities, as evidenced by a letter of support for the study
Key exclusion criteria (2 listed)
- Specialty hospitals (such as, pediatric, infectious diseases, maternity)
- Recent (within the past 3 years) or current participation in a TB IC initiative
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 |
|---|---|---|
| Enhanced TB IC PackageFacilities randomized to the intervention group will receive: 1. Skills-based training addressing the hierarchy of TB IC measures, how to conduct a facility TB IC /risk assessment; and development, implementation, and monitoring of an operational TB IC plan for the facility 2. Audits and Feedback of performance 3. A TB IC collaborative membership 4. A standardized unit-level daily checklist of critical IC activities | Behavioural | Enhanced TB IC Package |
Primary outcome
Change in prevalence and incidence of latent Tuberculosis infection in healthcare workers
Time frame: 0 months, 12 months, 24 months
Measured by an interferon gamma release assay, QuantiFERON-TB Gold In-Tube
2 secondary outcomes
Change in institutional safety culture
Time frame: 0 months and 24 months
Adherence to recommended TB Infection Control practices
Time frame: 0 months, 6 months, 12 months, 18 months, 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 2 Feb 2021.
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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.
Michele L Pearson, MD principal investigator
Centers for Disease Control and Prevention, Center for Global Health, Division of Global HIV and TB
Sara J Whitehead, MD principal investigator
Centers for Disease Control and Prevention
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Centers for Disease Control and Prevention at 22 sites in 2 countries.
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 4 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Vietnam, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prevalence and incidence of latent Tuberculosis infection in healthcare workers (time frame: 0 months, 12 months, 24 months). 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 2 Feb 2021.