LTBI video intervention for Latent Tuberculosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kaiser Permanente Southern California Department of Research and Evaluation, Pasadena, CA
Latent Tuberculosis+1 More
LTBI video intervention - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Many patients who are prescribed treatment for latent tuberculosis (LTBI) do not complete treatment. Effective interventions that are low-cost and feasible for large-scale implementation are needed to support efforts to eliminate TB. The investigators hypothesize that a 3-minute educational LTBI video intervention will improve treatment completion compared to standard care (no intervention). A randomized trial will be conducted at Kaiser Permanente Southern California, including adults who are prescribed treatment for LTBI, identified using an electronic health record algorithm. At the time of treatment prescription, patients will be randomized to receive the LTBI video intervention or standard care at a ratio of 2 to 1. Those in the intervention group will be sent a secure text message or e-mail with a link to the video. Individuals who watch the LTBI video will be invited to respond to 4 short questions about their perceptions of the video accessibility and content. The primary outcome is LTBI treatment completion (dispensation of the required number of doses) in the year following prescription order. Secondary outcomes are LTBI treatment initiation (at least one dispensation) in the year following prescription order; initiation and completion within the year following prescription order stratified by LTBI treatment regimen (if feasible); the proportion of individuals randomized to the intervention group who watched the LTBI video; and the perceptions of those who watched the video. The primary analysis will be based on intention-to-treat. Characteristics of individuals in the intervention and standard care groups will be described, and rates of LTBI treatment completion will be calculated. To assess the effect of the intervention, Poisson regression with robust standard errors will be used to estimate unadjusted and adjusted rate ratios and 95% confidence intervals. Per-protocol analyses will also be conducted, comparing those in the intervention group who watched the LTBI video to those in the standard care group. Similar methods will be used for secondary analyses. Assuming the completion rate in the standard care group is 0.5 (based on recent KPSC data), approximately 918 patients will be needed to achieve 80% power with type one error 0.05 to detect an intervention effect of 0.10 in the completion rate between groups. This sample size will be feasible to achieve over the 1 year trial duration.

Eligible Conditions

  • Latent Tuberculosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Latent Tuberculosis

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 1 year after treatment prescription

Year 1
Treatment completion
Treatment completion by treatment regimen
Treatment initiation
Treatment initiation by treatment regimen
Understanding of Treatment Importance
Video Accessibility
Video Watch Completion

Trial Safety

Safety Progress

1 of 3

Other trials for Latent Tuberculosis

Trial Design

2 Treatment Groups

Standard care
1 of 2
LTBI video intervention
1 of 2
Active Control
Experimental Treatment

918 Total Participants · 2 Treatment Groups

Primary Treatment: LTBI video intervention · No Placebo Group · N/A

LTBI video intervention
Other
Experimental Group · 1 Intervention: LTBI video intervention · Intervention Types: Other
Standard careNoIntervention Group · 1 Intervention: Standard care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year after treatment prescription
Closest Location: Kaiser Permanente Southern California Department of Research and Evaluation · Pasadena, CA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Latent Tuberculosis
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a member of the KSPC.
You have received an LTBI treatment prescription order (medication ID codes listed below) in the last 12 months.
You have a positive tuberculin skin test (TST) prior to prescription of isoniazid.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.