Preventing Posttraumatic Stress in ICU Survivors: A Single-Center Pilot Randomized Controlled Trial of ICU Diaries and Psychoeducation.

OBJECTIVES: Critical illness can have a significant psychological impact on patients and their families. To inform the design of a larger trial, we assessed feasibility of ICU diaries and psychoeducation to prevent posttraumatic stress disorder, depression, and anxiety following ICU stays. DESIGN: Four-arm pilot randomized controlled trial. SETTING: A 10-bed tertiary ICU in Winnipeg, MB, Canada. PATIENTS: Critically ill patients greater than 17 years old with predicted ICU stays greater than 72 hours and mechanical ventilation duration greater than 24 hours. INTERVENTIONS: Patients were randomized to usual care, ICU diary, psychoeducation, or both ICU diary and psychoeducation. MEASUREMENTS AND MAIN RESULTS: Our primary objective was to determine feasibility measured by enrollment/mo. Secondary outcomes included acceptability of the ICU diary intervention and psychological distress, including patients' memories 1 week post ICU using the ICU Memory Tool, posttraumatic stress disorder (Impact of Events Scale-Revised), depression, and anxiety symptoms (Hospital Anxiety and Depression Scale) 30 and 90 days post ICU. Over 3.5 years, we enrolled 58 patients, an average of 1.9 participants/mo. Families and healthcare providers wrote a mean of 3.2 diary entries/d (SD, 2.9) and indicated positive attitudes and low perceived burden toward ICU diary participation. A majority of patients reported distressing memories of their ICU stay. Those who received the diary intervention had significantly lower median Hospital Anxiety and Depression Scale anxiety (3.0 [interquartile range, 2-6.25] vs 8.0 [interquartile range, 7-10]; p = 0.01) and depression (3.0 [interquartile range, 1.75-5.25] vs 5.0 [interquartile range, 4-9]; p = 0.04) symptom scores at 90 days than patients who did not receive a diary. CONCLUSIONS: ICU diaries are a feasible intervention in a tertiary Canadian ICU context. Preliminary evidence supports the efficacy of ICU diaries to reduce psychological morbidity following discharge.

Time required to initiate outbreak and pandemic observational research.

PURPOSE: Observational research focused upon emerging infectious diseases such as Ebola virus, Middle East respiratory syndrome, and Zika virus has been challenging to quickly initiate. We aimed to determine the duration of start-up procedures and barriers encountered for an observational study focused upon such infectious outbreaks. MATERIALS AND METHODS: At 1 pediatric and 5 adult intensive care units, we measured durations from protocol receipt to a variety of outbreak research milestones, including research ethics board (REB) approval, data sharing agreement (DSA) execution, and patient study screening initiation. RESULTS: The median (interquartile range) time from site receipt of the protocol to REB submission was 73 (30-126) days; to REB approval, 158 (42-188) days; to DSA completion, 276 (186-312) days; and to study screening initiation, 293 (269-391) days. The median time from REB submission to REB approval was 43 (13-85) days. The median time for all start-up procedures was 335 (188-335) days. CONCLUSIONS: There is a lengthy start-up period required for outbreak-focused research. Completing DSAs was the most time-consuming step. A reactive approach to newly emerging threats such as Ebola virus, Middle East respiratory syndrome, and Zika virus will likely not allow sufficient time to initiate research before most outbreaks are advanced.