Implementing Clinical Research in the High Acuity Setting of the Emergency Department

Wednesday, 1 August 2012

Holli A. DeVon, PhD, RN1
Frances Patmon, MS, RN2
Michelle M. Fennessy, PhD, APRN, BC1
Daphene Francis, BSN, RN3
Anne G. Rosenfeld, PhD, RN4
(1)Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA
(2)Betty Irene Moore School of Nursing, University of California Davis, Sacramento, CA
(3)School of Nursing, University of California Davis, Sacramento, CA
(4)School of Nursing, Oregon Health & Science University, Portland, OR

Learning Objective 1: The learner will be able to identify barriers to launching clinical research in the high acuity setting of the emergency department.

Learning Objective 2: The learner will identify strategies to meet the challenges of clinical research in the emergency department.

Purpose: The purpose is to describe the launch of a multi-site clinical research study in the high acuity setting of the emergency department (ED) and to describe barriers and lessons learned. The primary aim of the study is to examine the influence of gender on symptom characteristics during acute coronary syndromes (ACS). In 2008, there were nearly 5 million visits to the ED for chest pain. Current guidelines call for rapid evaluation of chest pain with an electrocardiogram (ECG) within the first 10 minutes. Conducting clinical research in this setting is challenging.

Methods: Symptoms are recorded prospectively in the ED. Target enrollment is 630 patients admitted to the ED with symptoms suggestive of ACS: 522 patients with confirmed ACS and 108 patients ruled out. Patients are being enrolled in 3 urban EDs in California, Oregon, and Illinois since January, 2011. Ongoing communication between clinicians and the research team were used to identify barriers to the study launch and adjust protocols.

Results: Modifiable barriers to the study launch were lack of staff engagement in research, difficulty identifying eligible patients, perception of interference in clinical care, variability in research staff education and training, and patient refusals. Non-modifiable barriers were boarding of patients, undifferentiated patients, and time sensitive quality improvement indicators necessitating acceleration in care.

Conclusions: Several important strategies to meet these challenges can aid other investigators conducting research in high acuity settings; 1) unit champions in nursing and medicine were identified and supported, 2) minor modifications that did not change study aims but could improve enrollment goals  were made based on staff input, 3) specific written expectations, roles, research protocols, and algorithms were developed, and 4) successes were shared between sites via e-mail, phone calls, and regularly scheduled meetings.