Imagine you are a research nurse/clinical research coordinator (CRC) for an in-patient randomized, double-blind study that aims to lower “bad” cholesterol. One of your subjects is seen by a resident who is not on the study team, and who orders a lipid panel, the positive results of which are then shared with your subject by a non-team nurse before you realize what’s going on. Whoops. So much for blinding the patient from knowing if she was receiving the active treatment or a placebo.
Shannon Huffaker, RN, MSN, CCRC, doesn’t have to imagine this frustrating scenario. As a clinical research supervisor at Lehigh Valley Health Network in Allentown, Pa., she has witnessed this and similar circumstances, and now uses the anecdote as an example of the importance of effective communication between researchers and the nurses who are providing the standard care for trial participants who are also hospitalized patients.
“Communication is frequently discussed in healthcare in general, but infrequently discussed regarding its role in the conduct of research trials,” Huffaker noted in a session she presented at the recent ACRP 2016 Meeting & Expo in Atlanta, Ga. “The complexity of studies that makes communication so challenging in hospital settings includes such factors as study procedures that may seem ‘tacked on’ to standard of care to staff who are not directly involved in the study; the fact that several medical disciplines are often involved in any given study; and the likelihood that there are differences in local nursing practices from one hospital to another in multisite studies.”
In addition to the accidental unblinding of a study patient, the potential consequences of poor communication between CRCs and other nurses can include:
- missed/incorrectly timed study labs or assessments
- missed/incorrectly timed study medications
- administration of medications prohibited by the study protocol
- inadequate data collection
“All of these can have dire consequences for the patient, institution, and nursing staff,” Huffaker warns.
Although there is a need for research staff to communicate with providers and other members of the healthcare team, nurses spend the most time with the patients, and are central to coordinating their care in the hospital. Saying that “a one-time study in-service or education session for the nursing staff is not the end of communication,” Huffaker also addressed several strategies for increasing communication levels for the benefit of hospital-based clinical trials.