RESUMO
OBJECTIVE: Posttraumatic stress disorder (PTSD) symptoms (PTSS) are common after minor injuries and can impair recovery. We sought to understand whether an evidence-based mobile phone application with self-help tools (PTSD Coach) could be useful to improve recovery after acute trauma among injured emergency department (ED) patients. This pilot study examined the feasibility, acceptability, and potential benefit of using PTSD Coach among acutely injured motor vehicle crash (MVC) patients. METHODS: From September 2017 to September 2018, we recruited adult patients within 24 hours post-MVC from the EDs of two Level I trauma centers in the United States. We randomly assigned 64 injured adults to either the PTSD Coach (n = 33) or treatment as usual (TAU; n = 31) condition. We assessed PTSS and associated symptoms at 1 month (83% retained) and 3 months (73% retained) postenrollment. RESULTS: Enrollment was feasible (74% of eligible subjects participated) but usability and engagement were low (67% used PTSD Coach at least once, primarily in week 1); 76% of those who used it rated the app as moderately to extremely helpful. No differences emerged between groups in PTSS outcomes. Exploratory analyses among black subjects (n = 21) indicated that those in the PTSD Coach condition (vs. TAU) reported marginally lower PTSS (95% CI = -0.30 to 37.77) and higher PTSS coping self-efficacy (95% CI = -58.20 to -3.61) at 3 months. CONCLUSIONS: We demonstrated feasibility to recruit acutely injured ED patients into an app-based intervention study, yet mixed evidence emerged for the usability and benefit of PTSD Coach. Most patients used the app once and rated it favorably in regard to satisfaction with and helpfulness, but longitudinal engagement was low. This latter finding may explain the lack of overall effects on PTSS. Additional research is warranted regarding whether targeting more symptomatic patients and the addition of engagement and support features can improve efficacy.
Assuntos
Acidentes de Trânsito/psicologia , Aplicativos Móveis , Transtornos de Estresse Pós-Traumáticos , Telefone , Adulto , Humanos , Tutoria , Veículos Automotores , Projetos Piloto , Transtornos de Estresse Pós-Traumáticos/terapiaRESUMO
OBJECTIVES: Exception from informed consent (EFIC) for research in emergency settings requires investigators to notify enrolled subjects, family members, or legally authorized representatives about inclusion in the study. We examined the success rate of a notification strategy including mail services for subjects enrolled in EFIC trials. METHODS: We describe notification attempts for subjects in three out-of-hospital cardiac arrest clinical trials in both urban and rural areas around Pittsburgh, Pennsylvania, between the years 2000 and 2014. We examined the time required to notify subjects and the success of contacting subjects or their representatives when notified in person (if alive), by mail (if alive and unable to reach in person), or by mail (if the subject was deceased). We characterized comments received from subjects or their representatives as positive, neutral, or negative. RESULTS: We attempted notification on a total of 1,912 subjects, 1,762 by mail, and 163 in person. Of these, 1,767 (92%) notification forms were successfully delivered, and 431 (24%) were signed and returned. Only 16 subjects or representatives (0.91%) requested to withdraw from the study. In-person notifications were more likely to be signed than mailed notifications (69% vs. 20%; p < 0.001). A total of 3.2% of recipients contacted investigators by phone or letter in response to notifications, but only five recipients expressed negative attitudes toward the trial. Ninety percent of subjects were notified within 35 days of the incident. Time to notification was shorter for in person (median = 5 days, interquartile range [IQR] = 2 to 10 days) than for deceased and mailed (11 days, IQR = 8 to 14 days) or alive and mailed (20 days, IQR = 14 to 29 days). CONCLUSIONS: It is possible to successfully notify recipients of enrollment in a study using EFIC over 90% of the time within 35 days, although only 24% of recipients will sign and return a form. Fewer than 1% of subjects withdraw from the study, and fewer than 5% contact investigators, usually for neutral reasons.