Collaboration Culture: How St. Joe’s research coordinators are managing dozens of concurrent COVID-19 studies
As news of a novel virus spread amongst the scientific community, the immediate need to build a body of knowledge became apparent. Since then, an immense volume of COVID-19 research has been conducted around the world, as researchers have sought to assess a variety of potential treatment options, determine risk factors, study the virus’s long-term effects, improve diagnostic testing, and much more.
In Canada, multiple levels of government and various funding agencies provided several emergency research grants. Research ethics boards prioritized and expedited their reviews of COVID-19 study protocols, and research coordinators prepared to initiate new studies in record time.
As Ontario experienced its first wave of COVID-19 in the spring of 2020, dozens of pandemic-related clinical research projects emerged at St. Joe’s. But researchers soon found themselves in a unique situation – a handful of studies were all simultaneously targeting the same population of inpatients for study recruitment.
Research coordinators Kate Nelson and Sarah Culgin, along with Dr. Waleed Alhazzani, put together packages for hospital sites participating in the Awake Prone dual-arm study
Outpatients are rarely, if ever, enrolled in more than one study at a time, which helps eliminate unknown factors that may affect study findings. However, co-enrolment in critical care research studies is much more common compared to other departments.
“St. Joe’s critical care researchers have a lot of experience with co-enrolment, but the degree of which we’ve seen during the pandemic has been unprecedented,” says Sarah Culgin, a critical care research coordinator at St. Joseph’s Healthcare Hamilton and the executive coordinator of St. Joe’s GUIDE Group. “The logistics of managing patient consent alone was a challenge, and that was only the beginning.”
TELUS For Good contributed a donation of smartphones that will be used by research participants in the Awake Prone study and other critical care research projects.
Culgin is part of a group of interdisciplinary research coordinators who are responsible for managing dozens of COVID-19 studies at St. Joe’s. During Ontario’s first wave of the pandemic, the newly formed group began working closely together to oversee co-enrolment, as there was a need to regulate access to patients admitted with COVID-19.
Balancing patient access for research consent and follow-up while minimizing the use of scarce personal protective equipment was a priority. In addition, determining the use of multiple medications and disease management strategies, as well as post-discharge follow-up, further complicated matters. The research group worked closely to address these new challenges.
“We’ve built a unique culture of collaboration at the research coordinator level here at St. Joe’s,” says Culgin. “It’s certainly helped manage the influx of pandemic studies that have arisen, allowing our Hospital to contribute to pandemic research efforts on so many levels.”
The group created visualizations to help them track the needs of each study and identify overlap between study timelines. The needs of over two dozen concurrent studies were stratified by hospitalization stage – including hospital admission, admission to the ICU, transfer to a ward, discharge, and out of hospital follow-up.
One of the visualizations used by research coordinators to help manage the influx of studies
It began in critical care, with coordinators and principal investigators meeting to collaborate on approaching patients. As further studies were established, particularly those related to diagnostic testing and long-term outcomes of the virus, more research coordinators joined the group.
“It’s crucial that we avoid overwhelming patients and their families with a barrage of research coordinators doing recruitment and follow-up,” says Culgin. “The model we’ve developed has been working well and has received a lot of positive feedback from our clinical partners and patients. We’re also able to reduce patient interactions and the amount of PPE needed, while allowing much needed research to continue.”
Research coordinators France Clarke, Laurel Kelly, Jodi Gilchrist, Liz Johnson, and Sarah Culgin have covered most inpatient recruitment for COVID-19 studies at St. Joe’s. The team has also maintained steady contact with their counterparts at Hamilton Health Sciences (HHS) to help manage any St. Joe’s studies being conducted at participating HHS sites.
The Awake Prone study has two arms, COVI-PRONE and CORONA
Efforts towards the continuation of research – at St. Joe’s and beyond – have contributed much to our understanding of the virus. In fact, St. Joe’s GUIDE Group, which develops critical care guidelines, has been working to coalesce findings from hundreds of COVID-19 studies as part of their work with the Society of Critical Care Medicine and the Surviving Sepsis Campaign.
In June 2020, an international team of researchers led by GUIDE Group co-chair, Dr. Waleed Alhazzani, published the Surviving Sepsis Campaign’s “Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19)” in Critical Care Medicine. The extensive document summarizes the best evidence using a GRADE approach and makes treatment recommendations for physicians caring for COVID-19 patients in hospital. An updated version of these guidelines was recently published in early 2021.
By conducting dozens of pandemic research projects, St. Joe’s joins research institutions around the world looking for evidence-based guidance in the fight against COVID-19.
Learn more about some of our current COVID-19 studies:
Dr. Waleed Alhazzani, associate professor of medicine and co-chair of the GUIDE Group, is leading a study on prone positioning in hypoxemic COVID-19 patients. The two-part study, COVI-PRONE and CORONA, has received support from many organizations including the Canadian Critical Care Society, the Canadian Society of Respiratory Therapists, and the Respiratory Therapy Society of Ontario.
The aim of the study is to determine if patients with hypoxemic respiratory failure (low blood oxygen) fare better in the prone position (lying face down on their stomach) as opposed to the supine position (face up). COVI-PRONE and CORONA have been recruiting patients whose goals of care include or exclude intubation for mechanical ventilation, respectively.
The study protocol was co-developed by Dr. Zainab AlDuhailib, who completed a clinical research fellowship with Dr. Alhazzani. Having completed her fellowship, Dr. AlDuhailib is now helping to lead the Saudi arm of the trial.
A CIHR grant of over $1 million was awarded to the study team, which is based at St. Joe’s. The collaborative, multi-centre trial also includes intensivists and respirologists from the University of Calgary and Saudi Arabia.
Co-investigators for CORONA include Dr. Jason Weathald and Dr. Ken Parhar. The COVI-PRONE co-investigator for the Saudi arm includes Dr. Yaseen Arabi. These studies are collectively known as “Awake Prone.”
Even a short-term stay in the intensive care unit can have a long-term impact on daily life – long after being discharged from hospital.
The FORECAST observational study, led by physical therapist and researcher Dr. Michelle Kho, examines the impacts of critical illness on patient frailty. Participants are observed at hospital discharge and at six months following their discharge.
FORECAST was already enrolling participants before the pandemic and was restarted to include COVID-19 patients. The study was awarded funding from the Canadian Frailty Network.
The 3 Wishes Project (3WP) focuses on patients receiving advanced life support who are dying in the intensive care unit (ICU). End-of-life care in this setting can be impersonal for everyone – for patients, for families, and for clinicians. By asking about and carrying out at least 3 final wishes for dying patients, the 3WP celebrates lives and supports those left behind in grief.
It has been praised by families for bringing compassion to the ICU. However, the pandemic fundamentally changed end-of-life care for those in hospital.
“While focused on reducing mortality through research, we still needed to ensure optimal end-of-life care for the many patients who would die during the pandemic – with or without COVID-19,” says Dr. Deborah Cook, an intensivist and researcher at St. Joe’s.
Clinicians bearing witness to suffering and experiencing it themselves prompted the 3 Wishes Project team to study adaptations to end-of-life care necessary during the pandemic. Listening to patients, reassuring touch, and therapeutic presence were so important. Staff began to function as the lifeline to families in the outside world, who were unable to visit due to pandemic restrictions. Staff made more intentional efforts to learn about their patients as people, honouring their lives and legacies however they could.
“Families wanted details about the final moments, and often asked staff to relay poignant messages,” notes Neala Hoad, an ICU nurse and 3WP Expansion Coordinator.
As part of their ongoing research on the 3WP, a team at St. Joe’s conducted qualitative interviews to assess the impact of the pandemic on clinicians and patient families.
“Our findings underscore our shared humanity in the face of death and despair at this time of tragedy,” says France Clarke, a veteran critical care research coordinator. “What we learned is that clinicians at St. Joe’s are truly committed to preserving compassionate end-of-life care during this pandemic – when it is needed the most.”