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

NCT05772065 | Completed

• 1 other identifier: IRB00376488
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Latent Tuberculosis

Keywords

Tuberculosis; Education

Outcome Measures

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.

  3 months

Secondary Outcomes (2)

• Proportion of appropriate LTBI care selection

  3 months

• Time to LTBI care selection

  3 months

Study Arms (2)

CDC/NTCA guidelines only

ACTIVE COMPARATOR

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

LTBI ASSIST and CDC/NTCA guidelines

EXPERIMENTAL

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

CDC/NTCA guidelines only BEHAVIORAL

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

CDC/NTCA guidelines only

LTBI ASSIST and CDC/NTCA guidelines only BEHAVIORAL

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

LTBI ASSIST and CDC/NTCA guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Starke SJ, Martinez Rivera MB, Krishnan S, Shah M. Randomized Controlled Trial of Clinical Guidelines Versus Interactive Decision-Support for Improving Medical Trainees' Confidence with Latent Tuberculosis Care. J Gen Intern Med. 2024 May;39(6):951-959. doi: 10.1007/s11606-023-08551-3. Epub 2023 Dec 7.

  PMID: 38062221 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Maunank Shah, MD, PhD

  Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 16, 2023
• Study Start: June 1, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

US (1)