Latent TuberculosisNCT05772065
Clinical Practice Guidelines Versus Decision-support for Latent Tuberculosis Infection (LTBI) Management
A study testing CDC/NTCA guidelines only and LTBI ASSIST and CDC/NTCA guidelines only in people with Latent Tuberculosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- CDC/NTCA guidelines only and LTBI ASSIST and CDC/NTCA guidelines only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 17 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Student at Johns Hopkins School of Medicine, or Medical trainee at Hopkins Hospital or Bayview Program
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- CDC/NTCA guidelines only, LTBI ASSIST and CDC/NTCA guidelines only
- Keywords
- Tuberculosis, Education
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDC/NTCA guidelines onlyBehavioural
The control group will have a link to US guidelines only.
LTBI ASSIST and CDC/NTCA guidelines onlyBehavioural
The intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: LTBI ASSIST and CDC/NTCA guidelines only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Time to LTBI care selection
The time required for each group to reach a correct answer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jun 2023
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maunank Shah, MD, PhD, Principal investigator, Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772065
- Sponsor's protocol ID
- IRB00376488
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38062221
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05772065
- Acronym / sponsor ID
- IRB00376488
- Conditions
- Latent Tuberculosis
- Keywords
- Tuberculosis, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDC/NTCA guidelines only | Active comparator | Behavioral: CDC/NTCA guidelines onlyThe control group will have a link to US guidelines only and use it as a resource to answer the case vignettes. |
| LTBI ASSIST and CDC/NTCA guidelines | Experimental | Behavioral: LTBI ASSIST and CDC/NTCA guidelines onlyThe intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool as resources to answer the case vignettes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Student at Johns Hopkins School of Medicine, or Medical trainee at Hopkins Hospital or Bayview Program
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDC/NTCA guidelines onlyThe control group will have a link to US guidelines only. | Behavioural | CDC/NTCA guidelines only |
| LTBI ASSIST and CDC/NTCA guidelines onlyThe intervention group will have a link to both US guidelines, and the LTBI-ASSIST tool. | Behavioural | LTBI ASSIST and CDC/NTCA guidelines |
Primary outcome
Reported confidence with LTBI management [using a Likert scale questionnaire developed by study team]
Time frame: 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.
2 secondary outcomes
Proportion of appropriate LTBI care selection
Time frame: 3 months
Time to LTBI care selection
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 38062221Starke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maunank Shah, MD, PhD principal investigator
Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDC/NTCA guidelines only and LTBI ASSIST and CDC/NTCA guidelines only in people with Latent Tuberculosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported confidence with LTBI management [using a Likert scale questionnaire developed by study team] (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05772065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.