Key to validation of any clinical trial is having a standard process by which patient information and clinical data obtained outside of the standard of care are coordinated and collected. A team of nurses from a phase I clinical trial unit at the Arthur G. James Cancer Hospital and the Richard J. Solove Research Institute, Columbus, Ohio, developed an electronic flow sheet to help staff nurses optimize data capture during clinical trials. Roxann Scheerens, RN, BSN, OCN, discussed the project at a poster session during the 37th annual Oncology Nursing Society Congress (meeting abstract 1334725).
As Ms. Scheerens and her poster coauthor, Mindy Bowers, BS, CCRC, multiple myeloma project manager at The James, pointed out, clinical trials research often requires nurses to perform multiple blood draws on patients and perform other procedures that are outside the standard of care, and it is critical to accurately and comprehensively record information related to this sampling (such as blood collection times, site of infusion/blood draw) and to the other necessary procedures.
Although paper clinical trial flow sheets had been created previously at The James, for nurses to capture this information and then add it to the patient’s medical record, nurses found that the paper flow sheets were just not cutting it.
“The paper files were always getting lost, or didn’t get scanned into the chart after we started doing electronic charting, so we wanted to see if we could get [all of the data we needed captured] directly into our electronic chart, ” Ms. Scheerens explained. Importantly, she said, some of the trial procedures were not documented in the patients’ medical records and/or were difficult to locate, and some of the routinely collected clinical data were not specific enough to meet the requirements of a particular clinical trial.
Staff from her institution’s clinical treatment unit (CTU), an ambulatory outpatient chemotherapy unit doing phase I clinical trials that had helped to develop the paper clinical trial flow sheets, got the ball rolling by approaching the clinical trials office to collaborate on ways to improve data collection for clinical trials at The James. A committee formed by three groups—the CTU, the clinical trials office process committee, and the clinical trials processing laboratory—worked together to develop an electronic clinical trial flow sheet template for use within their Integrated Health Care Information System (IHIS). A manual was created with detailed instructions on how to work with the all-electronic flow sheets, and this information was supported by an instructional video.
To appropriately populate the new all-electronic flow sheet at The James, the clinical research specialist/clinical research coordinator (who does not have to be a nurse) decides what data should be captured for a given clinical trial and shares it with staff nurses by entering each piece of information into the electronic flow sheet as a "SmartPhrase." SmartPhrases are notes/instructions that have been pre-entered into the IHIS system and which can be inserted into the daily trial-specific flow sheet, known as a “progress note,” via a shared code.
In a sample clinical trials flow sheet included on the poster discussed by Ms. Scheerens, examples of information captured included the patient’s height, weight, and BSA; treatment cycle/day, dose level, today’s date; contact information (phone/pager) for the study coordinator and lead nurse contact; and specific action time points and activity (for assessing vitals including weight, body temperature, RR, HR, BP; for monitoring specific laboratory values and serum Ig; and for recording administration of the study drug). For all action items (vitals, labs, drug delivery), columns are provided for recording of both schedule time and actual time as well as blood draw type/number of tubes, special instructions, comments, and the initials of the nurse entering the data.
The clinical trial flow sheets were successfully adapted to the electronic record and were trialed in the CTU and another outpatient chemotherapy unit. Ms. Scheerens noted that following implementation of the new all-electronic system, there have been improvements in nursing staff documentation, communication, and compliance. “Nurses like this because we know where those electronic templates are [for a specific trial]—we don’t have to worry about trying to find them,” she said. “Also, there’s no more copying of the actual flow sheet, so we don’t lose things. And [the electronic flow sheet] looks much better, because you can read it, too!”
The clinical trials office has taken over implementation of the electronic clinical trials flow sheet and is training more of their staff so that it can be used in all inpatient and outpatient areas of the hospital. Monitoring of electronic flow sheet use in clinical trials at The James is ongoing, so that further quality improvements can be made.