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

Primary Purpose

Latent Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CDC/NTCA guidelines only
LTBI ASSIST and CDC/NTCA guidelines only
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Latent Tuberculosis focused on measuring Tuberculosis, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Student at Johns Hopkins School of Medicine, or Medical trainee at Hopkins Hospital or Bayview Program Exclusion Criteria: None

Sites / Locations

  • Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CDC/NTCA guidelines only

LTBI ASSIST and CDC/NTCA guidelines

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2023
Last Updated
August 9, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05772065
Brief Title
Clinical Practice Guidelines Versus Decision-support for Latent Tuberculosis Infection (LTBI) Management
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
July 17, 2023 (Actual)
Study Completion Date
July 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
Tuberculosis, Education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDC/NTCA guidelines only
Arm Type
Active Comparator
Arm Description
The control group will have a link to US guidelines only and use it as a resource to answer the case vignettes.
Arm Title
LTBI ASSIST and CDC/NTCA guidelines
Arm Type
Experimental
Arm Description
The intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool as resources to answer the case vignettes.
Intervention Type
Behavioral
Intervention Name(s)
CDC/NTCA guidelines only
Intervention Description
The control group will have a link to US guidelines only.
Intervention Type
Behavioral
Intervention Name(s)
LTBI ASSIST and CDC/NTCA guidelines only
Intervention Description
The intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool.
Primary Outcome Measure Information:
Title
Reported confidence with LTBI management [using a Likert scale questionnaire developed by study team]
Description
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 Outcome Measure Information:
Title
Proportion of appropriate LTBI care selection
Description
The number of multiple choice questions answered correctly in the case scenarios comparing between trainees and/or CDC/NTCA guidelines.
Time Frame
3 months
Title
Time to LTBI care selection
Description
The time required for each group to reach a correct answer.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Student at Johns Hopkins School of Medicine, or Medical trainee at Hopkins Hospital or Bayview Program Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maunank Shah, MD, PhD
Organizational Affiliation
Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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

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