ABSTRACT: BACKGROUND:Acceptability of mobile phone text messaging as a means of asynchronous communication between health care systems and patients is growing. The US Department of Veterans Affairs (VA) has adopted an automated texting system (aTS) for national rollout. The aTS allows providers to develop clinical texting protocols to promote patient self-management and allows clinical teams to monitor patient progress between in-person visits. Texting-supported hepatitis C virus (HCV) treatment has not been previously tested. OBJECTIVE:Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), we developed an aTS HCV protocol and conducted a mixed methods, hybrid type 2 effectiveness implementation study comparing two programs supporting implementation of the aTS HCV protocol for medication adherence in patients with HCV. METHODS:Seven VA HCV specialty clinics were randomized to usual aTS implementation versus an augmented implementation facilitation program. Implementation process measures included facilitation metrics, usability, and usefulness. Implementation outcomes included provider and patient use of the aTS HCV protocol, and effectiveness outcomes included medication adherence, health perceptions and behaviors, and sustained virologic response (SVR). RESULTS:Across the seven randomized clinics, there were 293 facilitation events using a core set of nine implementation strategies (157 events in augmented implementation facilitation, 136 events in usual implementation). Providers found the aTS appropriate with high potential for scale-up but not without difficulties in startup, patient selection and recruitment, and clinic workflow integration. Patients largely found the aTS easy to use and helpful; however, low perceived need for self-management support contributed to high declination. Reach and use was modest with 197 patients approached, 71 (36%) enrolled, 50 (25%) authenticated, and 32 (16%) using the aTS. In augmented implementation facilitation clinics, more patients actively used the aTS HCV protocol compared with usual clinic patients (20% vs 12%). Patients who texted reported lower distress about failing HCV treatment (13/15, 87%, vs 8/15, 53%; P=.05) and better adherence to HCV medication (11/15, 73%, reporting excellent adherence vs 6/15, 40%; P=.06), although SVR did not differ by group. CONCLUSIONS:The aTS is a promising intervention for improving patient self-management; however, augmented approaches to implementation may be needed to support clinician buy-in and patient engagement. Considering the behavioral, social, organizational, and technical scale-up challenges that we documented, successful and sustained implementation of the aTS may require implementation strategies that operate at the clinic, provider, and patient levels. TRIAL REGISTRATION:Retrospectively registered at ClinicalTrials.gov NCT03898349; https://clinicaltrials.gov/ct2/show/NCT03898349.
