Brief Educational Video for Patients Prescribed LTBI Treatment

Latent Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05412212
• Other study ID #: 12324
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please see the full protocol for details of the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1902
• Est. completion date: February 28, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Other:
• LTBI video intervention
3-minute educational video about latent tuberculosis and importance of taking and completing treatment

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California Department of Research and Evaluation	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment completion	Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription	1 year after treatment prescription
Secondary	Treatment initiation	Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of treatment prescription	1 year after treatment prescription
Secondary	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
Secondary	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
Secondary	Video Watch Completion	Proportion of patients randomized to the LTBI video who watch the full video	1 year after treatment prescription
Secondary	Video Accessibility	Proportion of patients who watch the video who report no difficulties watching the video	1 year after treatment prescription
Secondary	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