Skip to main content
OpenTrials
Completed

NCT Number: NCT02073240

Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Buddhasothorn Hospital, Maruphong, Cha Cherng Sao, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Specialty hospitals (such as, pediatric, infectious diseases, maternity)
  • Recent (within the past 3 years) or current participation in a TB IC initiative

Treatment and study plan

Enhanced TB IC Package

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in institutional safety culture

    Time frame: 0 months and 24 months

    Measured by the Hospital Survey on Patient Safety

  2. Adherence to recommended TB Infection Control practices

    Time frame: 0 months, 6 months, 12 months, 18 months, 24 months

    Measured by observation of healthcare worker-patient encounters, turn-around-times, wait times, and time-to-treatment

Other outcomes

  1. Cost data

    Time frame: 0 months, 6 months, 12 months, 18 months, 24 months

    Measured by collecting costs associated with infection control

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • United States President's Emergency Plan for AIDS Relief

Registry information

Acronym: EnTIC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2014
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.