Annals of the American Thoracic Society
-
Randomized Controlled Trial
Nurse-Led Palliative Care Improves Knowledge and Preparedness in Caregivers of Patients with Idiopathic Pulmonary Fibrosis.
Rationale: Patients with idiopathic pulmonary fibrosis (IPF) and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life (EOL) care planning as the disease progresses. The hypothesis for this study was that the early introduction of palliative care in the course of IPF would improve knowledge and preparation for EOL, patient-reported outcomes, and advance care planning in patients with IPF and their caregivers. Objectives: We sought to determine the feasibility, acceptability, and efficacy of a nurse-led early palliative care intervention entitled "A Program of SUPPORT" (Symptom management, Understanding the disease, Pulmonary rehabilitation, Palliative care, Oxygen therapy, Research participation, and Transplantation) in patients with IPF and their caregivers. ⋯ This nurse-led intervention demonstrated acceptability and efficacy in knowledge and advance care planning completion in patients and in knowledge, disease preparedness, and confidence in caregivers. Future research should identify additional strategies, including telemedicine resources to reach additional patients and their caregivers earlier in their disease course. Clinical trial registered with clinicaltrials.gov (NCT02929017).
-
Randomized Controlled Trial
Awake-Prone Positioning Strategy for Non-Intubated Hypoxic Patients with COVID-19: A Pilot Trial with Embedded Implementation Evaluation.
Rationale: Prone positioning is an appealing therapeutic strategy for nonintubated hypoxic patients with coronavirus disease (COVID-19), but its effectiveness remains to be established in randomized controlled trials. Objectives: To identify contextual factors relevant to the conduct of a definitive clinical trial evaluating a prone positioning strategy for nonintubated hypoxic patients with COVID-19. Methods: We conducted a cluster randomized pilot trial at a quaternary care teaching hospital. ⋯ Patients in the UC group spent 42 hours (95% CI, 13-47) of the 48-hour study period with an S/F ratio below 315 versus 20 hours (95% CI, 6-39) for patients in the APPS group. Mixed-methods analyses uncovered several barriers relevant to the conduct of a successful definitive randomized controlled trial, including low adherence to prone positioning, large differences between physician-recommended and patient-tolerated prone durations, and diffusion of prone positioning into usual care. Conclusions: A definitive trial evaluating the effect of prone positioning in nonintubated patients with COVID-19 is warranted, but several barriers must be addressed to ensure that the results of such a trial are informative and readily translated into practice.
-
Randomized Controlled Trial
A Pilot Randomized Trial of an Interactive Web-based Tool to Support Surrogate Decision-makers in the ICU.
Rationale: Breakdowns in clinician-family communication in intensive care units (ICUs) are common, yet there are no easily scaled interventions to prevent this problem. Objectives: To assess the feasibility, usability, acceptability, and perceived effectiveness of a communication intervention that pairs proactive family meetings with an interactive, web-based tool to help surrogates prepare for clinician-family meetings. Methods: We conducted a two-arm, single-blind, patient-level randomized trial comparing the Family Support Tool with enhanced usual care in two ICUs in a tertiary-care hospital. ⋯ Compared with the control group, surrogates who used the tool reported higher overall quality of communication (mean, 8.9/10 ± 1.6 vs. 8.0/10 ± 2.4) and higher quality in shared decision-making (mean, 8.7/10 ± 1.5 vs. 8.0/10 ± 2.4), but the difference did not reach statistical significance. Conclusions: It is feasible to deploy an interactive web-based tool to support communication and shared decision-making for surrogates in ICUs. Surrogates and clinicians rated the tool as highly usable, acceptable, and effective.
-
Randomized Controlled Trial
Frequency and Risk Factors for Reverse Triggering in Pediatric ARDS during Synchronized Intermittent Mandatory Ventilation.
Rationale: Reverse triggering (RT) occurs when respiratory effort begins after a mandatory breath is initiated by the ventilator. RT may exacerbate ventilator-induced lung injury and lead to breath stacking. Objectives: We sought to describe the frequency and risk factors for RT among patients with acute respiratory distress syndrome (ARDS) and identify risk factors for breath stacking. ⋯ Together, these parameters were highly predictive of breath stacking (area under the curve, 0.979). Conclusions: Patients with higher tidal volume who have a set ventilator rate close to their spontaneous respiratory rate are more likely to have RT, which results in breath stacking >25% of the time. Clinical trial registered with ClinicalTrials.gov (NCT03266016).
-
Randomized Controlled Trial Multicenter Study
Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.
The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including 1) widespread, off-label use of the study drug before the availability of safety and efficacy data; 2) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic; 3) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment; 4) obtaining indistinguishable drug and placebo without delaying enrollment; and 5) rapidly obtaining administrative and regulatory approvals. ⋯ We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults. Clinical trial registered with www.clinicaltrials.gov (NCT04332991).