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CompletedNCT05772065Updated Jan 3, 2024

Clinical Practice Guidelines Versus Decision-support for Latent Tuberculosis Infection (LTBI) Management

An interventional study of CDC/NTCA guidelines only and LTBI ASSIST and CDC/NTCA guidelines only in Latent Tuberculosis, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Latent Tuberculosis infection (LTBI) guidelines can be complex. LTBI-ASSIST is a web-based interactive tool to navigate US LTBI clinical practice guidelines in a patient-centered format that may guide clinical decision making around Latent TB care.

The research goal is to determine the difference in reported confidence among trainees that are not experts in LTBI care. The investigators further aim to assess if access to the LTBI-ASSIST tool improves clinical decision making in a series of simulated case scenarios containing guideline-derived, multiple choice items, as well as assess the efficiency in navigating the scenarios - measured by time to complete the survey.

The investigators proposed a randomized study design, in which an electronic survey/questionnaire with 4 case scenarios consisting of 14 multiple choice questions. Participants providing informed consent will be randomized to receiving access to either US Centers for Disease Control (CDC)/National Tuberculosis (TB) Controllers Association (NTCA) Guidelines or the LTBI-ASSIST online tool. Those in the experimental arm will further complete a 10 question System Usability Scale to assess usability of the LTBI-ASSIST tool.

All Johns Hopkins medical trainees and residents will be eligible to participate.

02

Conditions studied

  • Latent Tuberculosis

Keywords

  • Tuberculosis
  • Education
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 168 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Student at Johns Hopkins School of Medicine, or Medical trainee at Hopkins Hospital or Bayview Program

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Active comparator
    CDC/NTCA guidelines only

    The control group will have a link to US guidelines only and use it as a resource to answer the case vignettes.

    Behavioral: CDC/NTCA guidelines only

  • Experimental
    LTBI ASSIST and CDC/NTCA guidelines

    The intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool as resources to answer the case vignettes.

    Behavioral: LTBI ASSIST and CDC/NTCA guidelines only

Interventions

  • BehavioralCDC/NTCA guidelines only

    The control group will have a link to US guidelines only.

  • BehavioralLTBI ASSIST and CDC/NTCA guidelines only

    The intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool.

06

What researchers measure

Primary outcomes

  1. Reported confidence with LTBI management [using a Likert scale questionnaire developed by study team]

    The primary outcome will be the change in reported confidence with LTBI management, comparing between the control and intervention group. This outcome will be measured using a Likert Scale questionnaire administered pre- and post-intervention asking trainees to rate their confidence in performing critical LTBI care proficiencies.

    Time frame: 3 months

Secondary outcomes

  1. Proportion of appropriate LTBI care selection

    The number of multiple choice questions answered correctly in the case scenarios comparing between trainees and/or CDC/NTCA guidelines.

    Time frame: 3 months

  2. Time to LTBI care selection

    The time required for each group to reach a correct answer.

    Time frame: 3 months

07

Study locations

1 site
  • Johns Hopkins
    Baltimore, Maryland 21224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05772065
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Mar 16, 2023
Start date
Jun 1, 2023
Primary completion
Jul 17, 2023
Completion
Jul 17, 2023
Last update
Jan 3, 2024

Study contacts

Maunank Shah, MD, PhD
principal investigator · Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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