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

Evaluation of Clinical Practice Guidelines and Educational Decision-support Tools on Medical Trainees' Confidence With Latent Tuberculosis (LTBI) Testing and Treatment: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Latent Tuberculosis
• Intervention / Treatment: Behavioral: CDC/NTCA guidelines only; Behavioral: LTBI ASSIST and CDC/NTCA guidelines only

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maunank Shah, MD, PhD; Phone Number: 443-287-0401; Email: mshah28@jhmi.edu
• Study Contact Backup: Name: Samuel Starke, MD; Email: sstarke3@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The control group will have a link to US 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; The intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
Time to LTBI care selection	The time required for each group to reach a correct answer.	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Maunank Shah, MD, PhD, Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Tuberculosis; Education
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: IRB00376488

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No