Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 3439 for:    Facility

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073240
Recruitment Status : Unknown
Verified May 2014 by Centers for Disease Control and Prevention.
Recruitment status was:  Active, not recruiting
First Posted : February 27, 2014
Last Update Posted : August 24, 2015
Sponsor:
Collaborator:
United States President's Emergency Plan for AIDS Relief
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief 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).


Condition or disease Intervention/treatment
Tuberculosis Behavioral: Enhanced TB IC Package

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 22 participants
Time Perspective: Prospective
Official Title: Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand
Study Start Date : February 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Behavioral: Enhanced TB IC Package

Facilities 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

Usual Care Group
Usual Care group will receive available TB IC training/education alone.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Cost data [ Time Frame: 0 months, 6 months, 12 months, 18 months, 24 months ]
    Measured by collecting costs associated with infection control



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073240


Locations
Layout table for location information
Thailand
Banpong Hospital
Ratchaburi, Banpong, Thailand
Buddhasothorn Hospital
Muang, Cha Cherng Sao, Thailand
Chaiyaphum Hosptial
Muang, Chaiyaphum, Thailand
Chumponkhetudomsak Hospital
Muang, Chumpon, Thailand
Nakhon Nayok Hospital
Muang, Nakhonnayok, Thailand
Nan Hospital
Muang, Nan, Thailand
Pichit Hospital
Muang, Pichit, Thailand
Chao Phraya Abhaibhubejhr Hosptial
Muang, Prachinburi, Thailand
Praputtabat Hosptial
Saraburi, Praputtabat, Thailand
Singburi Hospital
Muang, Singburi, Thailand
Vietnam
Binh Phuoc General Hospital
Binh Phuoc, Vietnam
Dong Nai TB Hospital
Dong Nai, Vietnam
Dong Thap TB Hospial
Dong Thap, Vietnam
Hai Duong TB Hospital
Hai Duong, Vietnam
Hoa Binh General Hospital
Hoa Binh, Vietnam
Hung Yen Provincial Hospital
Hung Yen, Vietnam
Long An General Hospital
Long An, Vietnam
Nam Dinh General Hospital
Nam Dinh, Vietnam
Quang Ninh TB Hospital
Quang Ninh, Vietnam
Tien Giang General Hospital
Tien Giang, Vietnam
Vinh Long General Hosptial
Vinh Long, Vietnam
Vinh Phuc General Hospital
Vinh Phuc, Vietnam
Sponsors and Collaborators
Centers for Disease Control and Prevention
United States President's Emergency Plan for AIDS Relief
Investigators
Layout table for investigator information
Principal Investigator: Michele L Pearson, MD Centers for Disease Control and Prevention, Center for Global Health, Division of Global HIV and TB
Principal Investigator: Sara J Whitehead, MD Centers for Disease Control and Prevention

Layout table for additonal information
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02073240     History of Changes
Other Study ID Numbers: CDC-DTBE-6498
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: May 2014
Keywords provided by Centers for Disease Control and Prevention:
Tuberculosis
Infection Control
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections