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

NCT ID: NCT05772065

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Latent Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

CDC/NTCA guidelines only

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

LTBI ASSIST and CDC/NTCA guidelines only

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CDC/NTCA guidelines only

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

Intervention Type BEHAVIORAL

LTBI ASSIST and CDC/NTCA guidelines only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maunank Shah, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopkins University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38062221 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00376488

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.