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Perspectives on a Multidisciplinary Team Approach to Implementation of Planned Emergent Use Research.

Racedo Africano CJ, Gallo de Moraes A, Smischney NJ - Med. Sci. Monit. (2015)

Bottom Line: In this paper we present the viewpoints of three members of a research team, on the approach to teamwork in the development of an emergent use clinical trial when dealing with diversity of opinions, in order to facilitate stakeholder buy-in.We also discuss a specific approach to the coordination of the team members, which in our opinion had a positive impact on the implementation of the project.We also comment on the influence of the team organization in the timeline and completion of a clinical trial.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine - Pulmonary and Critical Care Division, Mayo Clinic, Rochester, MN, USA.

ABSTRACT
In this paper we present the viewpoints of three members of a research team, on the approach to teamwork in the development of an emergent use clinical trial when dealing with diversity of opinions, in order to facilitate stakeholder buy-in. We also discuss a specific approach to the coordination of the team members, which in our opinion had a positive impact on the implementation of the project. We also comment on the influence of the team organization in the timeline and completion of a clinical trial. We hope to start a conversation on team dynamics in the design of clinical trials, especially in the context of emergent use research.

No MeSH data available.


Organizational flow chart of study sections and tasks within each section.
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Related In: Results  -  Collection


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f1-medscimonit-21-2794: Organizational flow chart of study sections and tasks within each section.

Mentions: We realized that by splitting the clinical trial even further into additional components (e.g., nursing section, respiratory therapy section, and publicity) and empowering the members, we would create a sense of personal involvement (i.e., ”buy-in”) in the project. Each section was then treated with unique relevance that was perceived by the members of the team. In turn, the team members felt as if their contribution was uniquely important, which ultimately led to increased commitment and efficiency. When asking for information and empowering them with the protocol, these relevant stakeholders were more likely to support the proposed clinical trial. Furthermore, they were more likely to achieve buy-in from their respective divisions with the view that they shared the same high stakes. More importantly, relevant stakeholders were able to add modifications to the protocol and planned procedures that were more in-line with what was the standard of care when performing their tasks. Empowering the team members allowed opportunities to advise on certain elements under their expertise in order to have buy-in with the rest of the members on their team. For example, the nursing manager advised the investigators on how to implement the mixing of study medications in a way that staff nurses would be comfortable with. By compartmentalizing the clinical trial, sense of ownership and clinical trial progress increased significantly (only 3 months to overcome all logistical hurdles and submission to IRB, as compared to 8 months in a clinical trial of similar complexity [personnel communication]). Likewise, financial costs were much lower than if several study coordinators/research assistants were assigned to each section (essentially no extra charge for empowering already paid staff to develop a protocol that “fits” their needs vs. roughly $70,000 per study coordinator). In the end, the respective divisions included: Regulatory, Ethics, Pharmacy, Respiratory Therapy, Critical Care Nursing, and Publicity sections. All divisions had approximately three members with experience regarding the assigned tasks. Each division had a team captain who was the most experienced individual in that division, based on prior study experiences/publications. The team captain reported to the research liaison of that division, who would then communicate regularly with the principal investigator. After approval from the other investigators, the principal investigator signed off on implementation strategies (see Figure 1 for the organizational chart and study tasks). The timeline estimates noted above are important because the clinical trial discussed herein is the first planned emergent use research clinical trial at our institution.


Perspectives on a Multidisciplinary Team Approach to Implementation of Planned Emergent Use Research.

Racedo Africano CJ, Gallo de Moraes A, Smischney NJ - Med. Sci. Monit. (2015)

Organizational flow chart of study sections and tasks within each section.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4581686&req=5

f1-medscimonit-21-2794: Organizational flow chart of study sections and tasks within each section.
Mentions: We realized that by splitting the clinical trial even further into additional components (e.g., nursing section, respiratory therapy section, and publicity) and empowering the members, we would create a sense of personal involvement (i.e., ”buy-in”) in the project. Each section was then treated with unique relevance that was perceived by the members of the team. In turn, the team members felt as if their contribution was uniquely important, which ultimately led to increased commitment and efficiency. When asking for information and empowering them with the protocol, these relevant stakeholders were more likely to support the proposed clinical trial. Furthermore, they were more likely to achieve buy-in from their respective divisions with the view that they shared the same high stakes. More importantly, relevant stakeholders were able to add modifications to the protocol and planned procedures that were more in-line with what was the standard of care when performing their tasks. Empowering the team members allowed opportunities to advise on certain elements under their expertise in order to have buy-in with the rest of the members on their team. For example, the nursing manager advised the investigators on how to implement the mixing of study medications in a way that staff nurses would be comfortable with. By compartmentalizing the clinical trial, sense of ownership and clinical trial progress increased significantly (only 3 months to overcome all logistical hurdles and submission to IRB, as compared to 8 months in a clinical trial of similar complexity [personnel communication]). Likewise, financial costs were much lower than if several study coordinators/research assistants were assigned to each section (essentially no extra charge for empowering already paid staff to develop a protocol that “fits” their needs vs. roughly $70,000 per study coordinator). In the end, the respective divisions included: Regulatory, Ethics, Pharmacy, Respiratory Therapy, Critical Care Nursing, and Publicity sections. All divisions had approximately three members with experience regarding the assigned tasks. Each division had a team captain who was the most experienced individual in that division, based on prior study experiences/publications. The team captain reported to the research liaison of that division, who would then communicate regularly with the principal investigator. After approval from the other investigators, the principal investigator signed off on implementation strategies (see Figure 1 for the organizational chart and study tasks). The timeline estimates noted above are important because the clinical trial discussed herein is the first planned emergent use research clinical trial at our institution.

Bottom Line: In this paper we present the viewpoints of three members of a research team, on the approach to teamwork in the development of an emergent use clinical trial when dealing with diversity of opinions, in order to facilitate stakeholder buy-in.We also discuss a specific approach to the coordination of the team members, which in our opinion had a positive impact on the implementation of the project.We also comment on the influence of the team organization in the timeline and completion of a clinical trial.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine - Pulmonary and Critical Care Division, Mayo Clinic, Rochester, MN, USA.

ABSTRACT
In this paper we present the viewpoints of three members of a research team, on the approach to teamwork in the development of an emergent use clinical trial when dealing with diversity of opinions, in order to facilitate stakeholder buy-in. We also discuss a specific approach to the coordination of the team members, which in our opinion had a positive impact on the implementation of the project. We also comment on the influence of the team organization in the timeline and completion of a clinical trial. We hope to start a conversation on team dynamics in the design of clinical trials, especially in the context of emergent use research.

No MeSH data available.