RESUMO
BACKGROUND: Emergency departments (EDs) manage many patients with suicide risk, but effective interventions for suicidality are challenging to implement in this setting. ReachCare is a technology-facilitated version of an evidence-based intervention for suicidal ED patients. Here, we present findings on the acceptability and quality of ReachCare in the ED, as well as a comparison of these measures across 3 potential delivery modalities. OBJECTIVE: Our aim was to test the feasibility of the ReachCare intervention in its entirety through conducting a pilot study with patients presenting with suicidality to the ED. We tested three different ways of receiving the ED-based components of ReachCare: (1) self-administered on the tablet app using a chatbot interface, (2) administered by an in-person clinician, or (3) administered by a telehealth clinician. METHODS: In total, 47 ED patients who screened positive for suicide risk were randomly allocated to receive one of three delivery modalities of ReachCare in the ED: (1) self-administered on the patient-facing tablet app with a chatbot interface, (2) delivered by an in-person clinician, or (3) delivered by a telehealth clinician, with the latter two using a clinician-facing web app. We measured demographic and clinical characteristics, acceptability and appropriateness of the intervention, and quality and completeness of the resulting safety plans. RESULTS: Patients assigned high ratings for the acceptability (median 4.00/5, IQR 4.00-4.50) and appropriateness (median 4.00/5, IQR 4.00-4.25) of ReachCare's ED components, and there were no substantial differences across the 3 delivery modalities [H(acceptability)=3.90, P=.14; H(appropriateness)=1.05, P=.59]. The self-administered modality took significantly less time than the 2 clinician modalities (H=27.91, P<.001), and the usability of the self-administered version was in the "very high" range (median 93.75/100, IQR 80.00-97.50). The safety plans created across all 3 modalities were high-quality (H=0.60, P=.74). CONCLUSIONS: Patients rated ReachCare in the ED as highly acceptable and appropriate regardless of modality. Self-administration may be a feasible way to ensure patients with suicide risk receive an intervention in resource constrained EDs. Limitations include small sample size and demographic differences between those enrolled versus not enrolled. Further research will examine the clinical outcomes of patients receiving both the in-ED and post-ED components of ReachCare. TRIAL REGISTRATION: ClinicalTrials.gov NCT04720911; https://clinicaltrials.gov/ct2/show/NCT04720911.
RESUMO
BACKGROUND: Many individuals with suicide risk present to acute care settings such as emergency departments (EDs). However, staffing and time constraints mean that many EDs are not well equipped to deliver evidence-based interventions for patients experiencing suicidality. An existing intervention initiated in the ED for patients with suicide risk (Emergency Department Safety Assessment and Follow-up Evaluation [ED-SAFE]) has been found to be effective but faces trenchant barriers for widespread adoption. OBJECTIVE: On the basis of the ED-SAFE intervention, we aimed to develop 2 apps for patients with suicide risk: a web app guiding patients through safety planning in the ED (ED app) and a smartphone app providing patients components of the ED-SAFE program on their phones after discharge (patient app). We then tested the usability of these apps with patients presenting to the ED with suicide risk. METHODS: Using a user-centered design framework, we first developed user personas to explore the needs and characteristics of patients who are at risk for suicide using inputs from clinicians (n=3) and suicidologists (n=4). Next, we validated these personas during interviews with individuals with lived experience of suicidality (n=6) and used them to inform our application designs. We field-tested the apps with ED patients presenting with suicide risk (n=14) in 2 iterative cycles to assess their usability and engagement using a mixed methods approach. We also rated the quality and fidelity of the safety plans created. RESULTS: We developed 2 interoperable and complementary apps. The first is a web app designed for use on a tablet device during ED admission that guides the patient by creating a safety plan using a chatbot-style interface. The second is a smartphone app for use after discharge and allows the patient to view, edit, and share their completed safety plan; access self-care education, helplines, and behavioral health referrals; and track follow-up appointments with the study clinician. The initial prototype usability testing (n=9) demonstrated satisfactory scores (ED app System Usability Scale [SUS], mean 78.6/100, SD 24.1; User Engagement Scale, mean 3.74/5, SD 0.72; patient app SUS, mean 81.7/100, SD 20.1). After refining the apps based on participant feedback, the second cycle testing (n=5) showed improvement (ED app SUS, mean 90.5/100, SD 9.9; User Engagement Scale, mean 4.07/5, SD 0.36; patient app SUS, mean 97.0/100, SD 1.9). The quality ratings for completed safety plans were satisfactory (Safety Planning Intervention Scoring Algorithm-Brief, mean 27.4, SD 3.4). CONCLUSIONS: By adopting a user-centered approach and creating personas to guide development, we were able to create apps for ED patients with suicide risk and obtain satisfactory usability, engagement, and quality scores. Developing digital health tools based on user-centered design principles that deliver evidence-based intervention components may help overcome trenchant implementation barriers in challenging health care settings.
RESUMO
Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration and washing prototypes for pharmaceutical process development and small-scale manufacture. Here, we address the challenge of static drying of a solvent-wet crystalline API in a fixed bed to facilitate the design of a continuous filter dryer for pharmaceutical development, without excessive particle breakage or the formation of interparticle bridges leading to lump formation. We demonstrate the feasibility of drying small batches on a time scale suitable for continuous manufacturing, complemented by the development of a drying model that provides a design tool for process development. We also evaluate the impact of alternative washing and drying approaches on particle agglomeration. We conclude that our approach yields effective technology, with a performance that is amenable to predictive modeling.
