Brief Educational Video for Patients Prescribed LTBI Treatment
Primary Purpose
Latent Tuberculosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LTBI video intervention
Sponsored by
About this trial
This is an interventional other trial for Latent Tuberculosis focused on measuring adherence, digital health intervention
Eligibility Criteria
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
Sites / Locations
- Kaiser Permanente Southern California Department of Research and EvaluationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LTBI video intervention
Standard care
Arm Description
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.
Patients who are randomized to receive standard of care will not receive any messages or have any contact with the research team.
Outcomes
Primary Outcome Measures
Treatment completion
Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription
Secondary Outcome Measures
Treatment initiation
Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of 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)
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)
Video Watch Completion
Proportion of patients randomized to the LTBI video who watch the full video
Video Accessibility
Proportion of patients who watch the video who report no difficulties watching the video
Understanding of Treatment Importance
Proportion of patients who watch the video who report understanding the importance of completing LTBI treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05412212
Brief Title
Brief Educational Video for Patients Prescribed LTBI Treatment
Official Title
A Brief Educational Video for Patients Prescribed Latent Tuberculosis Treatment: A Randomized Trial in an Integrated Healthcare Organization in the United States
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
Please see the full protocol for details of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
adherence, digital health intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
918 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LTBI video intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients who are randomized to receive standard of care will not receive any messages or have any contact with the research team.
Intervention Type
Other
Intervention Name(s)
LTBI video intervention
Intervention Description
3-minute educational video about latent tuberculosis and importance of taking and completing treatment
Primary Outcome Measure Information:
Title
Treatment completion
Description
Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription
Time Frame
1 year after treatment prescription
Secondary Outcome Measure Information:
Title
Treatment initiation
Description
Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of treatment prescription
Time Frame
1 year after treatment prescription
Title
Treatment initiation by treatment regimen
Description
Proportion of patients prescribed LTBI treatment who initiate the treatment within one year of treatment prescription, by treatment regimen (if feasible)
Time Frame
1 year after treatment prescription
Title
Treatment completion by treatment regimen
Description
Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription, by treatment regimen (if feasible)
Time Frame
1 year after treatment prescription
Title
Video Watch Completion
Description
Proportion of patients randomized to the LTBI video who watch the full video
Time Frame
1 year after treatment prescription
Title
Video Accessibility
Description
Proportion of patients who watch the video who report no difficulties watching the video
Time Frame
1 year after treatment prescription
Title
Understanding of Treatment Importance
Description
Proportion of patients who watch the video who report understanding the importance of completing LTBI treatment
Time Frame
1 year after treatment prescription
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katia J Bruxvoort, PhD
Phone
626-564-3053
Email
kbruxvoort@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte Spence, MPH
Phone
626-564-3053
Email
brigitte.x.spence@kp.org
Facility Information:
Facility Name
Kaiser Permanente Southern California Department of Research and Evaluation
City
Pasadena
State/Province
California
ZIP/Postal Code
91103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte C Spence, MPH
Phone
626-564-3053
Email
brigitte.x.spence@kp.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Brief Educational Video for Patients Prescribed LTBI Treatment
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