The rapid spread of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), the causative agent of COVID-19, is placing an unprecedented strain on the nation's health care systems. The initial lack of adequate testing data, conflicting studies of low methodological quality, and rapid spread of the virus in the US population have created challenges to design an appropriate clinical response.1,2 The pandemic has created unexpected challenges for health care system leaders who are responsible for providing medical care to large patient populations while needing to learn quickly what is and is not working. Organizing, prioritizing, and implementing research are key to informing new care delivery methods, addressing COVID-19–related health effects, and improving future preparedness efforts.3
WHY RESEARCH AT INTERMOUNTAIN IS UNIQUELY POSITIONED TO CONTRIBUTE DURING COVID-19
Several broad principles frame the structure and alignment of our research organization at Intermountain Healthcare.4
First, a strong and persistent linkage between research leaders, investigators, clinicians, and executive leadership exists. Research discovery and high-quality care align with the core mission and goals of the organization. Transparent communication among research and health care leaders contributes to the development of a research agenda responsive to the health system's needs. Early in the pandemic, this included the clarion call for clinical trials and a multidisciplinary Therapeutics Committee to understand whether existing drugs impact COVID-19 health outcomes.
Second, coordinated alignment across system research teams allows individuals and teams to mobilize quickly, generating solutions to pressing health care problems, such as treatment of COVID-19. The Intermountain Research Guidance Council (RGC) governs systemwide research, sets organization research strategy, and monitors a review process to determine scientific merit and priority including standing up a new COVID research committee.
Finally, a balanced evaluation approach is used when responding to systemwide research needs while advancing an innovative research agenda. Research is patient focused and considers how proposed studies may impact reputation and stature, operational productivity, and financial stewardship for the organization. This approach increases the likelihood that scarce internal research resources get allocated to the most pressing research questions.
These principles allow the research organization to marshal a coordinated response to complicated health care questions affecting our frontline caregivers, such as the prevention, diagnosis, and treatment of COVID-19 during the current pandemic.
FRAMING THE COVID-19 RESEARCH RESPONSE
So, how is Intermountain applying these research principles to respond to health system questions related to COVID-19?
Observe and respond to a rapidly evolving set of research priorities that directly align with Intermountain's COVID-19 Incident Management System response plans. On March 15, 2020, Intermountain's chief executive officer announced significant changes: an incident command management structure, postponement of all elective surgical procedures, remote/virtual outpatient visits, visitor restrictions, conservation of personal protective equipment, and employee redeployment.
In partnership with Incident Command leadership and in response to worldwide interest in antimalarial medications for COVID-19 treatment despite limited evidence of efficacy and ongoing concern about side effect profiles, Intermountain launched 2 randomized controlled trials to determine the efficacy and safety of hydroxychloroquine among hospitalized patients5 and assess its role in preventing hospitalization when administered to outpatients.6 Focused leadership attention enabled efficient action of research, regulatory, clinical, and operational personnel, allowing both trials to move from conception to patient enrollment within 14 days. Trial enrollment has been expanded across the state of Utah—implementation is occurring at most of Intermountain's 23 hospitals. COVID-19 trial investigators have standing appointments to brief Incident Command leaders on clinical trial enrollment.
A systemwide COVID-19 Therapeutics Committee with key clinical, pharmacy, and research leaders assess broad COVID-19 treatment in the context of limited efficacy, ongoing concern of clinical harm versus benefit, and a diminishing supply chain for therapeutic medications. Daily huddles are conducted to evaluate all hospitalized COVID-19 patients and potential expanded use of a broad line of therapies. Pharmaceutical trials have been activated providing a “menu” of clinical trials that leverages the research organization as a public health strategy to provide safe and ethical access to unproven medications while investigating potential safety concerns. Access to investigational therapies would likely not be available without research fully integrated into operations and valued by health system leadership.
Encourage those in research to be more responsive, nimble, and collaborative to further mission critical COVID-19 activities. Rarely have so many in research focused so urgently on a single topic. This urgency has created an imperative to learn quickly, inform medical practice, and work collaboratively as it is a matter of survival in terms of lives lost and health care capacity sustained. At Intermountain, integration of research in the rapid implementation of a complex, multimodal, technological response to COVID-19 was developed to extract real-time data and fine-tune development. A comprehensive data registry acts as a unifying and efficient hub to store COVID-19 data, reducing data collection redundancies and informing criteria for admissions and hospital-at-home programs. Clear examples of an efficient learning loop that enables continuous improvement are to be embedded in routine practice and operations.
Operationalizing clinical trials to answer relevant COVID-19 questions requires teams with multiple perspectives, areas of expertise, and resources to be shared. Studies are being implemented and led across multiple institutions in Utah, including public-private partnerships and academia. Internal grant funding streams have shifted focus to COVID-19–related studies to ensure financial stewardship. New and existing funding from federal agencies is being adapted to supplement COVID-19 research. To be agile, yet deliberate, regulatory reviews are occurring as needed and legal teams can provide same-day trial agreements. Redeployment and load balancing of research personnel (ie, project managers and research coordinators) across research teams allow new studies to be operationalized efficiently across the enterprise.
Continued oversight to coordinate alignment of COVID-19 studies and focus research resources. As of April 15, 2020, Intermountain Healthcare has overseen 35 316 diagnostic tests for SARS-CoV-2, with 1558 patients testing positive (4.4% positivity rate). So far, 210 patients have been hospitalized since the beginning of March. In the 4 weeks that followed the first diagnosed case of COVID-19 in Utah, more than 36 new COVID-19 research studies were proposed across 14 research teams. This indicates a serious potential for research redundancy in the population to be studied and a significant potential to overwhelm the operations and research capacity needed for COVID-19 therapeutics trials mentioned earlier.
Balancing research priorities warrants an aligned process agreed upon by the organization and research leaders. Preexisting scientific review boards in each clinical area continue to evaluate new studies based on clinical need, research operational capacity, scientific merit, and innovation. A new systemwide COVID-19 Oversight Committee was charged by the RGC to evaluate how studies strategically aligned with overall COVID-19 priorities—including prioritizing studies that directly impact our caregivers and provide critical access to therapeutics. Members include individuals with scientific, medical, and operational roles.
Prioritize safety for patients and those conducting research. The Intermountain research organization performed parallel activities to ensure and prioritize safety for patients and employees. Enrollment in clinical research studies was temporarily suspended while continuing research deemed essential to the participant's health or well-being was transitioned to “no touch” principles to limit risk of infection spread. This includes electronic consenting with texting capabilities, disallowing any in-person clinical trial monitoring (now performed remotely), issuing travel restrictions for research activities, and physical distancing recommendations for all research staff and investigators. No touch activities also included remote/virtual research follow-ups and coordination among clinical teams using telehealth capabilities, requiring rapid changes to research regulatory practices.
Community-based health systems such as Intermountain Healthcare invest in research to improve disease prevention, diagnosis, treatment, and delivery of care. By adopting a nimble structure that can organize and respond to rapidly shifting health system priorities, a research function is an important asset that can make a critical contribution during times of a pandemic and the associated medical uncertainty.
1. Fontanarosa PB, Bauchner H. COVID-19—looking beyond tomorrow for health care society. JAMA. 2020. doi:10.1001/jama.2020.6582.
2. Johnson C. Chaotic search for coronavirus treatments undermines efforts, experts say. The Washington Post. https://www.washingtonpost.com/health/2020/04/15/coronavirus-treatment-cure-research-problems
. Accessed April 17, 2020.
3. DeCosta D, Simpson L, Luft H, Savitz LA. Health systems respond to COVID-19: priorities for rapid-cycle evaluations. https://www.academyhealth.org/publications/2020-04/report-identifies-health-systems-priority-research-questions-covid-19
. Accessed April 17, 2020.
4. Knighton AJ, Grissom CK, Knowlton KU, Sean Esplin M, Graydon T, Srivastava R; Intermountain Healthcare Research Guidance Council. How community-based health systems can embrace research in the fee-for-value era. Qual Manag Health Care. 2018;27(3):180–182.
5. NIH US National Library of Medicine. Hydroxychloroquine vs. azithromycin for hospitalized patients with suspected or confirmed COVID-19 (HAHPS). https://clinicaltrials.gov/ct2/show/NCT04329832
. Accessed April 17, 2020.
6. NIH US National Library of Medicine. Hydroxychloroquine vs. azithromycin for outpatients in Utah with COVID-19 (HyAzOUT). https://clinicaltrials.gov/ct2/show/NCT04334382
. Accessed April 17, 2020.