An Interdisciplinary Approach to Implementing a Phase I Oncology Clinical Trial in the Surgical Intensive Care Unit

2.50
Hdl Handle:
http://hdl.handle.net/10755/165747
Category:
Abstract
Type:
Presentation
Title:
An Interdisciplinary Approach to Implementing a Phase I Oncology Clinical Trial in the Surgical Intensive Care Unit
Author(s):
Adams-McLean, Allison
Author Details:
Allison Adams-McLean, National Institutes of Health, Bethesda, Maryland, USA
Abstract:
As collaboration on clinical trials between industry and academic medical institutions increases, nurses are faced with the challenge of coordinating interdisciplinary resources to implement new protocols and ensure protocol integrity. Our challenge was to implement a complex phase I clinical trial sponsored by an external pharmaceutical company in the surgical intensive care unit (SICU). This ongoing clinical trial is for patients with metastatic cancer who have no further conventional treatment options. It entails the intravenous administration of genetically modified Salmonella Typhimurium. A SICU nurse was assigned the role of protocol manager to educate the SICU nursing staff and collaborate with the research nurses, outpatient clinic nurses, pharmaceutical company, microbiology, epidemiology, research laboratory technicians, ancillary services, and principal investigator to implement the protocol. This interdisciplinary approach was required as each discipline played a significant role in safely implementing this protocol. The SICU protocol manager and clinical nurse specialist developed a clinical map and established toxicity criteria that needed to be documented on the SICU flow sheet. They also developed a timetable of blood draws and a special vital signs sheet as necessitated by the clinical trial protocol. Additionally, computer medical order sets were developed that included all aspects of the trial from screening to discharge. All of these instruments underwent multiple revisions by the members of the interdisciplinary team. Safety was a key concern prior to starting this trial. Nursing took an active role by developing a patient education booklet that outlines protocol requirements for safety precautions and reportable symptoms upon discharge. Additionally, the protocol manager and members of the research team developed an equipment list of items needed to implement the protocol and materials the patient needed upon discharge. As a result of intensive planning and ongoing performance improvement initiatives, the trial was implemented in the SICU with minimal problems. As a result of the diligence of the nurses and interdisciplinary team, there were no adverse outcomes in the SICU.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2002
Conference Name:
27th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Washington, D.C., USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleAn Interdisciplinary Approach to Implementing a Phase I Oncology Clinical Trial in the Surgical Intensive Care Uniten_GB
dc.contributor.authorAdams-McLean, Allisonen_US
dc.author.detailsAllison Adams-McLean, National Institutes of Health, Bethesda, Maryland, USAen_US
dc.identifier.urihttp://hdl.handle.net/10755/165747-
dc.description.abstractAs collaboration on clinical trials between industry and academic medical institutions increases, nurses are faced with the challenge of coordinating interdisciplinary resources to implement new protocols and ensure protocol integrity. Our challenge was to implement a complex phase I clinical trial sponsored by an external pharmaceutical company in the surgical intensive care unit (SICU). This ongoing clinical trial is for patients with metastatic cancer who have no further conventional treatment options. It entails the intravenous administration of genetically modified Salmonella Typhimurium. A SICU nurse was assigned the role of protocol manager to educate the SICU nursing staff and collaborate with the research nurses, outpatient clinic nurses, pharmaceutical company, microbiology, epidemiology, research laboratory technicians, ancillary services, and principal investigator to implement the protocol. This interdisciplinary approach was required as each discipline played a significant role in safely implementing this protocol. The SICU protocol manager and clinical nurse specialist developed a clinical map and established toxicity criteria that needed to be documented on the SICU flow sheet. They also developed a timetable of blood draws and a special vital signs sheet as necessitated by the clinical trial protocol. Additionally, computer medical order sets were developed that included all aspects of the trial from screening to discharge. All of these instruments underwent multiple revisions by the members of the interdisciplinary team. Safety was a key concern prior to starting this trial. Nursing took an active role by developing a patient education booklet that outlines protocol requirements for safety precautions and reportable symptoms upon discharge. Additionally, the protocol manager and members of the research team developed an equipment list of items needed to implement the protocol and materials the patient needed upon discharge. As a result of intensive planning and ongoing performance improvement initiatives, the trial was implemented in the SICU with minimal problems. As a result of the diligence of the nurses and interdisciplinary team, there were no adverse outcomes in the SICU.en_GB
dc.date.available2011-10-27T12:24:11Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:24:11Z-
dc.conference.date2002en_US
dc.conference.name27th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationWashington, D.C., USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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