Informing primary care physicians of patients' involvement in clinical trials carried out at a specialist care level

Abstract

Background: Patients enrolled in clinical trials continue to have frequent contacts with primary care physicians because of comorbidities or toxicities. The aim of the present study was to analyze the information provided at different levels, when participants are included in clinical trials organized at a specialized care level. The purpose was to verify if informing the patient's primary care physician is contemplated in the inclusion process. Methods:The authors conducted a cross-sectional study that included the clinical trials approved in the last 2 years by the hospital's Institutional Review Board. In addition, some of the participants in the included clinical trials were interviewed in order to check their knowledge of the type of research taking place. Results: In total, 67 protocols and the accompanying informed consent documents were reviewed. Half of the reviewed protocols (48%) did not provide participants with an identification card. Regarding the role of the primary care physician, 68.6% of clinical trials (46/67) had taken it into account in different ways. In only four trials, the method used to contact the primary care physician was documented. In total, 20 participants were interviewed. Only 3 (15%) knew the title of the study in which they were participating, 14 (70%) were aware of their illness and 6 (30%) did not know how to answer any of these two questions. Almost all participants in the study knew the name of the physician who was the principal investigator in the trial. Conclusion: Information given to health care practitioners, who are not directly involved in clinical trials conducted by specialized medical staff, is still scarce. In our clinical setting, patients participating in clinical trials have a low awareness of such studies.

Feasibility of Wearable Universal Serial Bus Utilization to Support Clinical Trial Participant Safety Management

“…In one study, almost half (48%) of the 67 reviewed trials did not disperse wallet cards, while only four trials specified the method by which external providers should be informed of trial proceedings, typically by a letter. 7 The burden is then subsequently placed on the participant and family to have the capacity to recall use of the card and present it to the external provider. This leaves the participant and the trial highly vulnerable if this card is not presented and interventions are carried out that may be contraindicated to the investigational product or device.…”

“…The wallet card is portable, economical, and updated as needed but also can then be prone to wear and tear, lost, or forgotten. In one study, almost half (48%) of the 67 reviewed trials did not disperse wallet cards, while only four trials specified the method by which external providers should be informed of trial proceedings, typically by a letter 7 . The burden is then subsequently placed on the participant and family to have the capacity to recall use of the card and present it to the external provider.…”

Nursing’s Role in Translating Safe Communication Practices to Clinical Trial Management

“…Traditionally, the wallet card outlines the name of the Principal Investigator, a contact number, study sponsor, and title of the trial. A study of 67 trials showed only 48% provided cards and of participants interviewed at their primary care physician's office for ancillary care, only 15% even knew the title of the study in which they were participating (Schoenenberger et al, 2017). Antoni et al ( 2017) noted that in their cross-sectional study of 67 research protocols, less than half of studies even provided an identification card to participants.…”

Developing a Preclinical Nurse-Nurse Communication Framework for Clinical Trial Patient-Related Safety Information

“…Yet, media used to communicate these details (such as wallet cards and Dear Provider letters) are fallible. 3 The novel use of wearable devices is now heralded as the next level of effective communication efforts related to disseminating safety information to healthcare providers outside the research team. 4,5 However, there is a gap in modeling the communication pathway of this safety-related information from the wearable device and the incorporation of the role of the nurse in supporting effective communication.…”

“…Of paramount importance is the communication of safety-related information, such as contraindicated medications and side effects of investigative products. Yet, media used to communicate these details (such as wallet cards and Dear Provider letters) are fallible 3 . The novel use of wearable devices is now heralded as the next level of effective communication efforts related to disseminating safety information to healthcare providers outside the research team 4,5 .…”