Brief Educational Video for Patients Prescribed LTBI Treatment

A Brief Educational Video for Patients Prescribed Latent Tuberculosis Treatment: A Randomized Trial in an Integrated Healthcare Organization in the United States

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Latent Tuberculosis
• Intervention / Treatment: Other: LTBI video intervention

Detailed Description

Please see the full protocol for details of the study.

• Study Type: Interventional
• Enrollment (Actual): 1902
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91103
      • Kaiser Permanente Southern California Department of Research and Evaluation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Active KSPC member
• Age ≥18 years

• Receipt of an LTBI treatment prescription order (medication ID codes listed below)

  • Isoniazid: 12199066, 1214000023, 1216000272, 12022505, 12035328, 12035329, 12035330, 12035331, 12035332, 12035333, 12035334, 12035335, 12035336, 12035337, 12015833, 12032230, 12035338, 12035339, 12035340, 12035341, 12035342, 12035343, 12035344, 12035345, 12024985, 12035346, 12181973
  • Rifampin: 12199042, 121103412, 1214000029, 1214000030, 1214000340, 1214000565, 1215200240, 1206096, 12017860, 1209060, 12011205, 12015920, 190716, 1902899, 190207268, 190210700, 12189972, 12189977, 12189987
  • Isoniazid (see codes above) + Rifampin (see codes above), also: 12032976, 12199041, 12029484, 12189973, 12168828
  • Isoniazid (see codes above) + Rifapentine (121100982, 1206442, 12025808, 12188784, 12189978)
• LTBI ICD-10 diagnosis code prior to prescription order: R76.11, R76.12, Z22.7

Exclusion Criteria:

• Active TB ICD-10 diagnosis code prior to prescription order: A15, A17, A18, A19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LTBI video intervention; Patients randomized to the intervention group will be sent an invitation with a link to watch a brief (~3 minute video) about the importance of taking and completing LTBI treatment.	Other: LTBI video intervention; 3-minute educational video about latent tuberculosis and importance of taking and completing treatment
No Intervention: Standard care; Patients who are randomized to receive standard of care will not receive any messages or have any contact with the research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment completion	Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription	1 year after treatment prescription

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment initiation	Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of treatment prescription	1 year after treatment prescription
Treatment initiation by treatment regimen	Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of treatment prescription, by treatment regimen (if feasible)	1 year after treatment prescription
Treatment completion by treatment regimen	Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription, by treatment regimen (if feasible)	1 year after treatment prescription
Video Watch Completion	Proportion of patients randomized to the LTBI video who watch the full video	1 year after treatment prescription
Video Accessibility	Proportion of patients who watch the video who report no difficulties watching the video	1 year after treatment prescription
Understanding of Treatment Importance	Proportion of patients who watch the video who report understanding the importance of completing LTBI treatment	1 year after treatment prescription

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: adherence; digital health intervention
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: 12324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No