| Literature DB >> 32011429 |
Roshun R Sankaran, Jessica M Ameling, Amy E M Cohn, Cyril M Grum, Jennifer Meddings.
Abstract
OBJECTIVES: Engineering and operations research have much to contribute to improve patient safety, especially within complex, highly regulated, and constantly evolving hospital environments. Despite new technologies, clinical checklists, and alarm systems, basic challenges persist that impact patient safety, such as how to improve communication between healthcare providers to prevent hospital-acquired complications. Because these collaborations are often new territory for both clinical researchers and engineers, the aim of the study was to prepare research teams that are embarking on similar collaborations regarding common challenges and training needs to anticipate while developing multidisciplinary teams.Entities:
Mesh:
Year: 2021 PMID: 32011429 PMCID: PMC7392784 DOI: 10.1097/PTS.0000000000000667
Source DB: PubMed Journal: J Patient Saf ISSN: 1549-8417 Impact factor: 2.243
FIGURE 1Research project approach. This figure illustrates the iterative approach applied by our multidisciplinary team for better understanding the problem(s) being targeted for interventions (e.g., problem analysis) and then designing and developing prototype interventions, that are evaluated initially by formative evaluations (in simulation settings) before a summative evaluation by pilot testing in a clinical setting.
Challenges Anticipated in Multidisciplinary Collaborations and Proposed Solutions
| Challenge | Solutions |
|---|---|
| 1. Trust within the team | • Alternate meeting locations to mitigate travel burden |
| 2. Trust beyond the team | • Prepare flyer with description of project and team members’ roles for hospital units |
| 3. Vernacular language | • Ensure continuous involvement of clinical and nonclinical team members in meetings |
| 4. Privacy | • Develop formal training program (Table |
| 5. Variation in skill sets and expertise | • Maximize face-to-face meeting time |
| 6. Logistical challenges | • Be explicit about expectations from all project team members to help students feel more involved and accountable |
Required Training Checklist for Team Members joining Medical Research Projects+
| Status++ | Task for Completion | |
| 1. Ethical Research and Patient Privacy Training+++ | ||
|---|---|---|
| □ | Complete your institution’s training on research ethics and compliance (e.g., Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) Module(s), or the Collaborative Institutional Training Initiative (CITI Program) training). | |
| □ | Complete your institution’s Health Insurance Portability and Accountability Act (HIPAA) Module, and any additional institution-specific permission and documentation requirements (e.g., Without Compensation “WOC” appointment application for Veterans Affairs projects). | |
| □ | Review the project’s study protocol that was approved by your institution’s Institutional Review Board (IRB), and ensure you have been added to the study protocol. | |
| 2. Clinical Environment Training and Requirements | ||
| □ | Complete your team’s orientation to the clinical environment (e.g., watch the “Orientation to Hospital Projects: Professionalism, Ward Culture, and Mandatories” presentation: | |
| □ | Review the Emergency Code Terminology for the clinical environment you will be entering (example: Emergency Room, ICU, Operating Room). | |
| □ | Review guide regarding common equipment in use in the clinical environment you will be entering (for example: Hospital Unit Guide: | |
| □ | Obtain the required photo identification card required for your institution for visiting clinical settings (note: this may need to be returned at the end of the project). | |
| □ | Complete the “Checklist for Graduating Students Leaving the M-Safety Lab” available at | |
| 3. Infection Control Training | ||
| □ | Complete Personal Protective Equipment (PPE) In-Person Training with your institution’s Infection Prevention Manager. Note: this is similar to education provided by the CDC at: | |
| □ | Complete your institution’s hand hygiene training module (e.g., Hand Hygiene for all Healthcare Providers module for University of Michigan employees). | |
| □ | Complete your institution’s other Infection Prevention modules (e.g., Standard Precautions, Tuberculosis Precautions, Transmission-based Precautions, Joint Commission Action Plan – Contact Precautions). | |
| 4. Immunizations | ||
| □ | Obtain and submit proof of receipt of all immunizations or serologic immunity required of volunteers in your institution’s hospital(s) where you will be working on this project: e.g., MMR, Tdap, Chicken Pox, TB test, Flu Shot. | |
| 5. Team Communication and Schedule Requirements | ||
| □ | Electronic contact information (email, mobile, and pager if applicable) exchanged with Project Manager to enable rapid communication about changes and status updates regarding meetings and research visit sessions. | |
| □ | Schedule research visit sessions in pair with another research team member when performing observation or survey visits with research subjects in the clinical setting or simulation center. | |
| 6. Training Related to Data Collection and Data Entry | ||
| □ | For observation tasks, review the project’s orientation materials to observation in qualitative research (e.g., “Use of Observation in Qualitative Research” materials at for example: Hospital Unit Guide: | |
| □ | For survey tasks, meet with the Project Manager to orient you to the particular survey tool, the study protocol for identifying and approaching subjects (and consenting/documenting if applicable by the project), data entry task requirements, and secure destruction of paper tools after data entry. | |
| □ | For assisting with interview or focus group tasks (for our teams, these are led by an expert in qualitative methods), meet with the Project Manager to receive training on the process for performing and documenting the informed consent to interview, audio recording processes if applicable, data entry task requirements, and secure destruction of paper records after data entry. | |
| □ | Complete your institution’s training for viewing the electronic medical record for the Research Project. | |
| □ | Complete session with Project Manager to orient you to the database management software that is approved for this project’s data collection (e.g., REDCap®), and review of principles for reliable and accurate data entry, including handling of missing data. | |
| □ | Review the expectations and plan for checking in with Project Manager before departing the clinical setting from each data collection visit, to review any unexpected issues and additional needs to address. | |
| □ | FINAL CHECK BEFORE ENTERING THE CLINICAL SETTING OR VIEWING ANY PROJECT DATA: Given all the trainings required, please check with project manager to ensure your trainings have been completed and your addition as a team member to the study protocol has been approved by the IRB. | |
| 7. Technology Development/Evaluation Requirements | ||
| □ | Review the institution’s requirements for types of evaluations and approvals required | |
| □ Hospital Biomedical Engineering Unit’s evaluation and risk assessment | □ Hospital Quality and Safety Leadership and/or Committee(s) | |
| □ Environmental Services Team | □ Nursing Research and Translation Committee | |
| □ Electronic Medical Record Team(s) involving Data Security & Research Projects | □ Physician Leadership for Clinical Unit(s) of Interest | |
| □ Infection Control Leadership and/or Committee | □ Nurse Leadership for Clinical Unit(s) of Interest | |
| □ Device Sterilization Committee | □ Leadership for Clinical Service(s) of Interest | |
| □ Others: | ||
| □ | Review your role with the Project Manager for developing and updating the new technology’s anticipated “Data Safety Monitoring Plan” as the technology evolves from design to final prototype, as well as the “Failure Analysis” report outlining potential anticipated device failures, causes, and measures taken to both monitor, prevent, and address any anticipated device failures. | |
| □ | Review the laboratory data collection and storage requirements with the Engineering faculty leading the engineering laboratory, including a well-annotated research notebook system to document the evolution of the device’s development for IP purposes. This can be a physical lab notebook or an electronic lab notebook system (e.g., | |
| □ | Check with the Engineering faculty what official and unofficial training you will need from the University to work in their laboratory (e.g., | |
| □ | Review the project’s requirements and opportunities related to Intellectual Property (IP) developed in this project with the Project Manager (e.g., “Reminders about Intellectual Property for the M-Safety Lab Research Project” at | |
+All training resources developed specifically for this project are available at: https://psep.med.umich.edu/msafetylab.html.
++Based on your specific role in the project, the Project Manager will assess which of these are required to be completed, or could be designated as not applicable. Section 1 will be required of all Team Members; sections 2-5 will be required for all team members who will be performing any tasks within clinical settings. Sections 6-7 will be assigned based on your individual role within the project.
If the study involves data collection from multiple clinical locations (such as an academic medical center and a Veterans Affairs hospital), there will often be different IRBs and requirements related to research ethics/compliance and infection control training, and data storage. Each team member should clarify with the Project Manager what is required for the specific clinical sites/data you will be working with on this project.