Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand
Condition: Tuberculosis
MeSH terms: Infections; Tuberculosis; Latent Tuberculosis
Study type: Observational

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 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.
    

Intervention name(s): Enhanced TB IC Package
Intervention type(s): Behavioral
Intervention description(s): 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
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
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.
      
Keywords: Tuberculosis; Infection Control