ABSTRACT
Rationale: Cardiorespiratory diseases are common causes of persistent psychological distress symptoms. To fill this gap, we developed Blueprint, a month-long mobile app-based adaptive coping skills training intervention based on lessons learned about intervention delivery and population targeting from a multicenter RCT of a hybrid telephone- and web-based intervention (Figure). However, Blueprint requires further testing before broader use. Methods: The objectives were to (1) Optimize the usability of the new Blueprint system by incorporation of features based on lessons learned and (2) Test two Blueprint iterations vs. usual care in a pilot 3-arm RCT with 3-month follow up among a targeted sample of 45 patients. Usability was assessed using the Systems Usability Scale (SUS). The two Blueprint iterations differed by their response to weekly changes in Hospital Anxiety and Depression Scale (HADS) scores within the app (app-based response with additional digital content vs. therapist response). The key inclusion criterion was hospitalization in an ICU or stepdown unit with a need for cardiorespiratory support (e.g., ventilation, vasopressors) plus a HADS total score ≥8 just after arrival home. Method of minimization was used to balance across strata (ICU service, baseline HADS, age). The 1-month HADS score was the primary outcome, with secondary outcomes at 1 and 3 months including HADS, Post-Traumatic Stress Scale (PTSS), and physical symptoms (PHQ-10) Results: Usability testing was performed among 5 patients asked to perform core tasks in the Blueprint app. The mean (SD) SUS score was 83.5 (9.5), exceeding the benchmark target of 80. Subsequently, the RCT was initiated. A total of 1,133 were screened, 416 (37%) appeared to be eligible, 229 (55%) were approached, 65 (28%) consented, and 45 (69%) randomized in a 1:1:1 ratio by group. A total of 19 (29%) were excluded post-consent for low baseline HADS scores. To date, 25 have completed the trial and 20 are still active in the protocol. The relatively high refusal rate reflects the conduct of the RCT by the study team completely by distance via telephone and SMS texting (including screening and consenting) during the COVID pandemic. Conclusion: We successfully transformed an adaptive coping skills intervention into a highly usable, fully self-guided, mobile app-based version called Blueprint that delivers content responsive to weekly changes in psychological distress symptoms. We reached the target sample size and follow-up for the RCT continues. We anticipate completion by January 2022 with full results ready for presentation by the time of ATS 2022.