Latent Tuberculosis
Conditions
Keywords
adherence, digital health intervention
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.
Interventions
OTHERLTBI video intervention
3-minute educational video about latent tuberculosis and importance of taking and completing treatment
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Completion | 1 year after treatment prescription | Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription |
Countries
United States
Participant flow
Recruitment details
Adults at Kaiser Permanente Southern California prescribed LTBI treatment were randomized to receive messages with the video link (intervention) or no intervention (control).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18-35 | 517 Participants |
| Age, Customized 36-49 | 586 Participants |
| Age, Customized 50-64 | 503 Participants |
| Age, Customized 65-74 | 217 Participants |
| Age, Customized >=75 | 71 Participants |
| Age, years (median) | 45 years |
| Country of birth Born in high TB incidence country | 191 Participants |
| Country of birth Missing | 402 Participants |
| Country of birth Not born in high TB incidence country | 570 Participants |
| Dialysis, ever | 16 Participants |
| Drug coverage at time of prescription | 1856 Participants |
| High-dose steroids in prior year | 3 Participants |
| HIV diagnosis, ever | 30 Participants |
| Immunosuppressants in prior year | 27 Participants |
| LTBI treatment prescribed Isoniazid | 115 Participants |
| LTBI treatment prescribed Isoniazid + rifampin | 46 Participants |
| LTBI treatment prescribed Isoniazid + rifapentine | 19 Participants |
| LTBI treatment prescribed Other | 15 Participants |
| LTBI treatment prescribed Rifampin | 340 Participants |
| Organ transplant, ever | 7 Participants |
| Race/Ethnicity, Customized Asian | 103 Participants |
| Race/Ethnicity, Customized Black | 40 Participants |
| Race/Ethnicity, Customized Hispanic | 768 Participants |
| Race/Ethnicity, Customized Other/unknown | 36 Participants |
| Race/Ethnicity, Customized White | 62 Participants |
| Sex: Female, Male Female | 291 Participants |
| Sex: Female, Male Male | 765 Participants |
| Weighted Charlson Comorbidity Index (mean) | 1.1 scores on a scale STANDARD_DEVIATION 1.9 |
| Weighted Charlson Comorbidity Index (median) | 0 scores on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed