Effect of mobile voice calls on treatment initiation among patients diagnosed with tuberculosis in a tertiary care hospital of Puducherry: A randomized controlled trial

Abstract

Objective: In India, about one third of tuberculosis (TB) patients diagnosed at tertiary hospitals are missed during a referral to peripheral health institutes for treatment. To address this, we assessed whether mobile voice call reminders to TB patients after diagnosis at a tertiary hospital decrease the proportion of "pretreatment loss to follow-up" (PTLFU), compared with the conventional paper-based referral.

Design: A two-group parallel-arm randomized controlled trial was conducted.

Setting: The study was conducted in a tertiary care hospital at Puducherry, South India.

Participants: All newly diagnosed TB patients, both pulmonary and extrapulmonary, who were referred for treatment from the selected tertiary care hospital and possessed a mobile phone were eligible to participate. The participants were enrolled between March 2015 and June 2016 and were randomized to study groups using the block randomization with allocation concealment.

Intervention: The participants in the intervention arm received standardized mobile voice calls reminding them to register for anti-TB treatment on the second and seventh day after referral in addition to the conventional paper-based referral received by the control group.

Primary outcomes: Patients not started on anti-TB treatment within 14 days of referral were considered as PTLFU. The outcome of PTLFU was ascertained through phone calls made on the 14^th day after referral. The intention-to-treat analysis was used, and the proportion of PTLFU in the study groups and the risk difference with 95% confidence interval (CI) were calculated.

Results: Of the 393 patients assessed for eligibility, 310 were randomized to the intervention (n = 155) and control (n = 155) arms. In the intervention arm, 14 (9%) out of 155 were PTLFU compared with 28 (18%) of the 155 patients in the control arm. The absolute risk difference was 9% (95% CI [1.5, 16.6], P = 0.01).

Conclusion: Mobile voice call reminder to patients is a feasible intervention and can reduce PTLFU among referred TB patients.

Keywords: mHealth; operational research; pretreatment loss to follow-up; voice call.

Figure 1

Depiction of flow of patients diagnosed and referred for treatment in the study setting * Dotted line indicates the existing feedback system Point of dropout and delay: A- Identified presumptive TB patient in getting investigations done; B- Presumptive TB patient collecting the results of investigations; C- TB patient not reaching the RNTCP medical officer/referral unit; D- TB patient referred from tertiary care hospital not reaching the referred PHI; E- TB patient reaching the PHI but not started on treatment

Figure 2

CONSORT diagram depicting eligibility screening, enrollment, randomization, and analysis