Decentralized Clinical Trials: A Flexible and Efficient Adjunct to Accelerate Pregnancy Complication Research

INTRODUCTION: This study sought to determine whether a decentralized, mobile-friendly, virtual model could achieve appropriate enrollment for a pregnancy health study after COVID-19 closed most clinical research. Preterm birth continues to be a significant and growing issue with 2021 rates exceeding 10%. There is urgent need for new research and technology to improve the ability to predict, prevent, and personalize treatment for complications such as preterm birth, preeclampsia, and gestational diabetes. METHODS: This was a prospective, observational study of a cell-free RNA platform utilizing direct-to-participant recruitment via targeted social media from July 2020 to December 2021. The IRB-approved study was open to patients aged 18–45 with a singleton pregnancy in the United States. Participants signed informed consent, provided record release forms, completed a short questionnaire, and scheduled mobile phlebotomy via a web-based platform. RESULTS: One thousand eight hundred ninety-four participants submitted samples in less than 18 months. Because of delays in shipping, insufficient volume, temperature stability, and hemolysis, 63 samples (3.3%) were not useable. Medical records were received for over 85% of participants. The cohort is geographically and ethnically diverse representing 1,220 zip codes across 30 states. CONCLUSION: This work demonstrates a decentralized, mobile-friendly, virtual study is feasible, efficient, scalable, and flexible, enabling clinical research during a global pandemic. The rate of medical records receipt is likely affected by the large quantity of unique providers and hospitals. This is a rapid, patient-accepted way to conduct clinical research as a supplement to traditional enrollment models. [ FROM AUTHOR] Copyright of Obstetrics & Gynecology is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Evaluating Toronto Hospitals' COVID-19 Visitor Policy Using Accountability for Reasonableness.

In March 2020, the Toronto Region COVID-19 Hospital Operations Table developed a policy to guide visitor restrictions at six hospitals (Toronto Region COVID-19 Hospital Operations Table 2021). We conducted nine interviews with the developers and implementers of the policy based on the accountability for reasonableness (A4R) framework. Participants agreed that the A4R principles were met suggesting fair development and implementation of the policy. However, recurrent themes suggested that the policy disadvantaged those unable to advocate for themselves and that there were unaccounted costs to patients, such as lost time and function. We suggest that visitor policies incorporate equity considerations upfront and predetermine metrics to measure harms to patients.

Providers' perspectives on implementing resilience coaching for healthcare workers during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic severely exacerbated workplace stress for healthcare workers (HCWs) worldwide. The pandemic also magnified the need for mechanisms to support the psychological wellbeing of HCWs. This study is a qualitative inquiry into the implementation of a HCW support program called Resilience Coaching at a general hospital. Resilience Coaching was delivered by an interdisciplinary team, including: psychiatrists, mental health nurses allied health and a senior bioethicist. The study focuses specifically on the experiences of those who provided the intervention. METHODS: Resilience Coaching was implemented at, an academic hospital in Toronto, Canada in April 2020 and is ongoing. As part of a larger qualitative evaluation, 13 Resilience Coaches were interviewed about their experiences providing psychosocial support to colleagues. Interviews were recorded, transcribed, and analyzed for themes by the research team. Interviews were conducted between February and June 2021. RESULTS: Coaches were motivated by opportunities to support colleagues and contribute to the overall health system response to COVID-19. Challenges included finding time within busy work schedules, balancing role tensions and working while experiencing burnout. CONCLUSIONS: Hospital-based mental health professionals are well-positioned to support colleagues' wellness during acute crises and can find this work meaningful, but note important challenges to the role. Paired-coaches and peer support among the coaching group may mitigate some of these challenges. Perspectives from those providing support to HCWs are an important consideration in developing support programs that leverage internal teams.

Resilience coaching for healthcare workers: Experiences of receiving collegial support during the COVID-19 pandemic.

OBJECTIVE: To explore experiences of receiving collegial support from the department of psychiatry at an acute care hospital during the COVID-19 pandemic. METHOD: The Resilience Coaching program launched in April 2020, with the aim of offering a timely response to supporting psychosocial needs of healthcare workers (HCWs), leveraging collegial relationships and mental health training to offer support. Twenty-four HCWs were interviewed about their experiences receiving support from resilience coaches. RESULTS: Participants reported that Resilience Coaching offered hospital staff opportunities for connection, encouragement to attend to personal wellness, and avenues to learn practical skills to assist with coping. Coaching also assisted HCWs in accessing clinical mental health support when that was requested by staff. CONCLUSIONS: Resilience Coaching is a model for supporting colleagues in an acute care hospital during a pandemic. It is generally regarded positively by participants. Further study is warranted to determine how best to engage some occupational subcultures within the hospital, and whether the model is feasible for other healthcare contexts.

An Academic Health Sciences Centre's Strategy to Enhance Nurse Resilience and Psychological Safety.

The rapid cadence of change and the fear of acquiring and spreading COVID-19 - coupled with moral distress exacerbated by fulfilling one's duty to care under extremely challenging conditions - continue to impact nurses' coping ability, resilience and psychological safety globally (McDougall et al. 2020). This paper provides an overview of how an academic health sciences centre (AHSC) has responded to the evolving waves of the COVID-19 pandemic. Specifically, we share our context and the strategies we used to build and enhance nurse resilience and psychological safety at the organizational, clinical team and individual levels. This is followed by a description of our nurses' achievements amid the pandemic.