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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.
Please see the full protocol for details of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTBI video intervention | Experimental | 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. |
|
| Standard care | No Intervention | Patients who are randomized to receive standard of care will not receive any messages or have any contact with the research team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTBI video intervention | Other | 3-minute educational video about latent tuberculosis and importance of taking and completing treatment |
|
| 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 |
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Inclusion criteria:
Active KSPC member
Age ≥18 years
Receipt of an LTBI treatment prescription order (medication ID codes listed below)
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California Department of Research and Evaluation | Pasadena | California | 91103 | United States |
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Adults at Kaiser Permanente Southern California prescribed LTBI treatment were randomized to receive messages with the video link (intervention) or no intervention (control).
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| ID | Title | Description |
|---|---|---|
| FG000 | LTBI Video Intervention | Patients randomized to the intervention group were sent an invitation with a link to watch a brief (~3 minute video) about the importance of initiating and completing LTBI treatment. |
| FG001 | Standard Care | Patients randomized to receive standard of care did not receive any messages or have any contact with the research team. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LTBI Video Intervention | Patients randomized to the intervention group were sent an invitation with a link to watch a brief (~3 minute video) about the importance of initiating and completing LTBI treatment. |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Completion | Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription | Posted | Count of Participants | Participants | 1 year after treatment prescription |
|
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We did not collect information on adverse events as part of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LTBI Video Intervention | Patients randomized to the intervention group were sent an invitation with a link to watch a brief (~3 minute video) about the importance of initiating and completing LTBI treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katia Bruxvoort | University of Alabama - Birmingham | N/A | kbruxvoort@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2022 | May 8, 2026 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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Patients randomized to receive standard of care did not receive any messages or have any contact with the research team.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Age, years (median) | Median | Inter-Quartile Range | years |
|
| Country of birth | Count of Participants | Participants |
|
| Weighted Charlson Comorbidity Index (mean) | The Charlson Comorbidity Index predicts the mortality for a patient who may have a range of comorbidities such as heart disease, AIDS, or cancer. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Total possible scores can range from 0-29 with higher scores indicating higher predicted mortality. | Mean | Standard Deviation | scores on a scale |
|
| Weighted Charlson Comorbidity Index (median) | The Charlson Comorbidity Index predicts the mortality for a patient who may have a range of comorbidities such as heart disease, AIDS, or cancer. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Total possible scores can range from 0-29 with higher scores indicating higher predicted mortality. | Median | Inter-Quartile Range | scores on a scale |
|
| Immunosuppressants in prior year | Count of Participants | Participants |
|
| High-dose steroids in prior year | Count of Participants | Participants |
|
| Organ transplant, ever | Count of Participants | Participants |
|
| Dialysis, ever | Count of Participants | Participants |
|
| HIV diagnosis, ever | Count of Participants | Participants |
|
| LTBI treatment prescribed | Count of Participants | Participants |
|
| Drug coverage at time of prescription | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Care | Patients randomized to receive standard of care did not receive any messages or have any contact with the research team. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |