Brief Educational Video for Patients Prescribed LTBI Treatment

Sponsor
Kaiser Permanente (Other)
Overall Status
Recruiting
CT.gov ID
NCT05412212
Collaborator
(none)
918
1
2
32.9
27.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: LTBI video intervention
N/A

Detailed Description

Please see the full protocol for details of the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
918 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Brief Educational Video for Patients Prescribed Latent Tuberculosis Treatment: A Randomized Trial in an Integrated Healthcare Organization in the United States
Actual Study Start Date :
Jun 3, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Treatment completion [1 year after treatment prescription]

    Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription

Secondary Outcome Measures

  1. Treatment initiation [1 year after treatment prescription]

    Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of treatment prescription

  2. Treatment initiation by treatment regimen [1 year after treatment prescription]

    Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of treatment prescription, by treatment regimen (if feasible)

  3. Treatment completion by treatment regimen [1 year after treatment prescription]

    Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription, by treatment regimen (if feasible)

  4. Video Watch Completion [1 year after treatment prescription]

    Proportion of patients randomized to the LTBI video who watch the full video

  5. Video Accessibility [1 year after treatment prescription]

    Proportion of patients who watch the video who report no difficulties watching the video

  6. Understanding of Treatment Importance [1 year after treatment prescription]

    Proportion of patients who watch the video who report understanding the importance of completing LTBI treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente Southern California Department of Research and Evaluation Pasadena California United States 91103

Sponsors and Collaborators

  • Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT05412212
Other Study ID Numbers:
  • 12324
First Posted:
Jun 9, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kaiser Permanente
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022