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

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05772065

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Latent Tuberculosis	Behavioral: CDC/NTCA guidelines only Behavioral: LTBI ASSIST and CDC/NTCA guidelines only	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Reported confidence with LTBI management [using a Likert scale questionnaire developed by study team] [3 months]
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.

Secondary Outcome Measures

Proportion of appropriate LTBI care selection [3 months]
The number of multiple choice questions answered correctly in the case scenarios comparing between trainees and/or CDC/NTCA guidelines.
Time to LTBI care selection [3 months]
The time required for each group to reach a correct answer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Maunank Shah, MD, PhD, Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT05772065

Other Study ID Numbers:

IRB00376488

First Posted:

Mar 16, 2023

Last Update Posted:

Mar 16, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Johns Hopkins University

Tuberculosis

Education

Additional relevant MeSH terms:

Tuberculosis

Latent Tuberculosis

Study Results

No Results Posted as of Mar 16, 2023