Breaking Down Barriers: The Impact of Off-Site Clinical Research Coordinators on Collaborative Research

Background

In April 2023, the Irving Institute Clinical Research Resource (CRR) published a support model for off-site research coordinators in intensive and specialty care units to share the knowledge and successes of CRR’s Off Site Clinical Research Coordinators program. This program, led by Dr. Ismael Castaneda, proved to be an effective catalyst in promoting collaborative research across multiple domains, a central goal of the Clinical Translational Science Award (CTSA).

Under the direction of Dr. Henry Ginsberg from 2007-2017 and now led by Dr. Muredach Reilly, the Irving Institute for Clinical and Translational Research, Columbia University’s CTSA Hub, began to recognize that accelerating health benefits “from bench to bedside” required fully integrated, multiple-disciplinary researchers, doctors, and patients, with the multitude of resources at Columbia. As part of this push, Dr. Ginsberg initiated a training program for Clinical Research Coordinators (CRCs) to enhance their interactions within Irving Institute services. Now this initiative is a fully established resource of the Irving institute, funding and training research coordinators and nurses to support clinical research activities

A key element in integrating research into patient care is engaging the Columbia University Irving Medical Center (CUIMC) clinical staff in every stage of translational research. The presence of clinical research coordinators fully embedded into the workflow of clinical units promotes the kind of cooperative research that CTSA hubs strive for.

Clinical Research Coordinators at CUIMC

The Off-Site Clinical Research Coordinator program recognizes that CRCs are the primary liaisons between investigators and human participants in clinical research studies. They are involved in every aspect of many protocols, including participant recruitment, patient care, data collection, specimen processing and follow-up. The program, directed by Karen Marder, MD, MPH, with Associate Directors Michael Rosenbaum, MD, Natalie Neu, MD, MPH, and Clinical Research Nurse Manager Ismael Castaneda, DrPH, CCRP, CRM, leverages the multi-level skills exemplified in CRCs to liaise across intricate levels of care and coordination.

In intensive care units (ICUs) and emergency departments (ED), CRCs must interact regularly with health care providers who are primarily focused on providing optimal patient care, often involving very complex patients, rather than research. These off-site CRCs require additional training and support outside of the typical research-oriented environment.

“Patient care and well-being will always be of top importance whether in research, clinical care, or both, and in a rapidly moving and complex setting like an ICU or ED. The effective CRC is able to integrate the research into routine patient care without disruption. This is best accomplished by having CRCs within the units to facilitate multiple different studies.” - Dr. Rosenbaum, CRR Associate Program Director and Professor of Pediatrics and Medicine, CUIMC.

A Win-Win Model: Integrating research for state-of-the-art treatment

In clinical research, consideration of burdens to the participants and the investigators is essential.

“We are asking individuals who are primarily involved in clinical care to leverage their skills to optimize research. Avoiding any disruption of workflow and patient care encourages other research projects and provides valuable insights into improved patient care. It’s a win-win situation,” explains Dr. Marder, Sally Kerlin Professor of Neurology, CUIMC and Associate Director for the Irving Institute for Clinical and Translational Research.

This model illustrates collaboration between researchers at all levels and clinical care in units that have not traditionally been part of the CRR because of the immobility of participants and the acuity of care.

According to Drs. Rosenbaum, Marder, and Castaneda, the program is an evolving entity and the feedback from the units has helped to not only improve the program but could also inform and improve the culture of research and clinical collaboration at other clinical research resources.

Read the full case study here.

Note: Dr. Sudha Kashyap was the Associate Director of CRR at the time this study was written and is a co-publisher of the article.