A Promising HIP Intervention — Electronic Directly Observed Therapy for Active TB Disease

Summary

TB is the leading cause of infectious disease death worldwide. The bacterium that causes TB, Mycobacterium tuberculosis, is spread when a person with TB disease of the lungs or throat coughs. In 2020, a total of 7,174 persons received a diagnosis for TB disease in the United States.¹ The majority of persons with TB disease can be treated by taking certain medications for ≥6 months. Effective case management supports patients’ adherence to medication and treatment completion.

Directly observed therapy (DOT) is a key element of TB case management. Endorsed by the World Health Organization and CDC, DOT entails a trained observer watching as the patient swallows the anti-TB medications. As the percentage of the population that owns a mobile phone, computer, or tablet with video capability has increased, potential for having the trained observer use an electronic device to enable DOT also has increase.^2,3 One form of electronic DOT, or eDOT, allows a member of the health care team to watch the patient swallow the anti-TB medications by using live or real-time video, or recorded video that is submitted for later review.  Multiple pilot studies have documented that eDOT is acceptable to patients and feasible to implement; these studies also identified potential cost savings from reduced staff time and travel expenditures for either patients or medical staff.^4-15 These studies have also shown adherence to attending scheduled sessions and treatment completion with eDOT has been comparable with in-person DOT. For example, in a study based in New York City, 61 (16%) patients were on eDOT, and 329 (84%) were on in-person DOT. Adherence to scheduled eDOT sessions was 95%, compared with 91% for in-person DOT, and treatment completion was similar between the 2 groups (96% versus 97%, respectively). Among pilot studies that collected cost data, the amount of money saved by using eDOT ranged from $1,811 (2016 US$)/patient^10,16 to $14,355 (2016US$)/patient.^14,16 These studies selected participants for eDOT based on patients having demonstrated good adherence to initial doses of medication and that their TB cases were uncomplicated. Additional evaluations with large patient samples in different situations will add useful information about eDOT’s feasibility, effectiveness, and cost.

Selected Pilots and Small Case Studies with Cost Data Regarding eDOT

Recent Studies of eDOT

More recent studies have validated the findings of the initial pilot and case studies of eDOT.  A randomized controlled trial to evaluate in-person DOT and eDOT for TB, funded by CDC in collaboration with the New York City (NYC) Department of Health and Mental Hygiene and Columbia University, demonstrated that when implemented by a program with a history of successfully providing in-person DOT, eDOT is noninferior to in-person DOT across multiple modes of statistical analysis.  The study, which observed patients from July 2017 through October 2019, found that:

• The percentage of completed doses with in-person DOT was 87.2% vs 89.8% with eDOT.
• Issues affecting medication observations (such as operating software, schedule interferences, or unscheduled staff absences) occurred with both electronic and in-person DOT. Community-based in-person DOT observations had the greatest percentage of issues affecting the DOT session with 19% of observations having issues compared with 10% for live-video electronic DOT observations, 8% for recorded-video electronic DOT, and 6% for clinic-based in-person DOT.
• After experiencing both in-person and eDOT, 84% of the participants reported they preferred to continue treatment with eDOT.¹⁷

An economic evaluation that assessed health department and patient costs of eDOTand traditional in-person DOT in low-, medium-, and high-TB incidence settings in the United States was conducted between August 2017 and June 2018. Findings from this study indicated that patient costs were lowest for live video DOT ($1.01) and highest for clinic-based DOT ($34.53). The societal (health department + patient) costs of both video DOT types (live and recorded; $6.65 and $12.64, respectively) were less than both in-person DOT types (field-based and clinic-based; $21.40 and $46.11, respectively). Among the 4 different DOT types, both types of video DOT were associated with lower patient and health department costs when compared with traditional forms of DOT.¹⁸ Notably, when the data were examined by setting, the cost of video DOT with recorded videos was significantly lower than cost of community-based DOT for both the medium incidence and high-incidence settings. However, the cost of video DOT with recorded videos was not statistically different from cost of community DOT in the low-incident setting.  This finding demonstrates an economy of scale, in that when there are fewer patients to spread fixed costs, the cost per dose is higher.

An eDOT Resource

As of 2015, 42% (47/113) of TB programs surveyed used eDOT in some form, and 36% were planning to implement an eDOT program in the next year.⁹ To support TB programs, CDC recently published a resource for programs that are considering initiating an eDOT program. The toolkit, “Implementing an Electronic Directly Observed Therapy (eDOT) Program: A Toolkit for Tuberculosis (TB) Programs” is designed to help TB programs review the potential benefits and drawbacks of an eDOT program, gain insights related to management and regulation concerns, and use available resources.