Module Components

• Overview
• Assignments

Topics

• Non-Human Subject Research (NHSR)
• NHSR Application Example
• NHSR Application Process
• NHSR Determination

NDNP 811 - DNP Project Development

Module 2:HRPO Submission Process

NHSR Application Example

KEY POINTS

• When writing the project summary in the CICERO application, you should identify the clinical site at which the project will take place by name. This is in contrast to your site proposal, where you must protect the site’s identity.
• Succinctly state your methods – the HRPO is focused on ethical protections and generalizability
• You must provide a strong and thorough rationale for why the anticipated findings from the project will not be generalizable. Examples of language as to why the project applies to the practice site and is not generalizable to other sites:
  • The leadership within the Division of Vascular Surgery has identified a need for more accurate cardiac risk stratification among patients undergoing open abdominal aortic aneurysm repair.
  • A recent audit performed at ABC Medical Center revealed poor sepsis recognition among patients presenting to the Emergency Department (ED).
  • The use of the clinical practice guideline is not intended to be generalizable to other settings as it was designed to solely meet the specific needs of the specified long-term care organization.
• If significant changes are made to a project after the HRPO has made a determination, you must submit a new application for a NHSR determination
  

PROJECT SUMMARY EXAMPLE

Name: Student First Last, Professor Last 
Abbreviated Title: NDNP 811: Implementation of Child Abuse Screening and Management 
Full Title: NDNP811: Implementation of Child Abuse Screening and Management 

Approximately 15% of physical injuries sustained by children presenting to the 16-bed University of Maryland Medical Center Pediatric Emergency Department (UMMC-PED) in Baltimore, Maryland are thought to be caused by abuse. The Child Protective Services (CPS) referral rate for abuse at the project site is 5%, raising organizational concerns for child abuse under-surveillance and safety risk to children. The purpose of this Quality Improvement (QI) project is to implement child abuse screening to improve child abuse detection, referral, and management. The initiative will be implemented over a 15-week period in the fall of 2022. The project is expected to impact 7,000 children/year. Published evidence demonstrates that abuse is accurately and precisely detected using the reliable and validated Escape Instrument. Child safety has improved following screening and referral as the result of better detection, interdisciplinary management, and the disposition to a safer environment. Provider attitudes in the literature regarding ease-of-use of the instrument are favorable. 

In the months preceding the project, the QI Project Lead (QI-PL) will mobilize an interdisciplinary team of stakeholders at the project site to plan evidence-based structure and workflow changes, including integration of the 6-item, yes/no Escape Instrument in the electronic health record (EHR) and establish a referral process (Appendix A). Four physicians, 8 Advanced Practice Registered Nurses (APRNs), 48 staff nurses, and 4 social workers (SW) will be trained on the screening and referral practice change. Self-described, anonymous survey data on providers’ change process understanding post training will be recorded onto REDCap via a link accessed at the end of the training (Appendix B). Following training, the new screening and referral practice will commence using the Escape Instrument for all pediatric patients aged 8 or younger who present to the site with an injury-related chief complaint, including falls, head injuries, lacerations, fractures, bruising, and/or burns. The triage nurse, as the first point of contact, will record a non-identifying code and associated medical record number of each project eligible patient on a separate REDCap code key form via a link. The entered data will only be accessible to the QI-PL (Appendix C). The Escape Instrument screening will be completed by the physician or APRN, prompted by a pop-up in the EHR during the clinical encounter. In the instance of a positive screen, the physician or APN will consult with SW regarding further diagnostic evaluation and determine the safest disposition management. All care provided will be documented in the EHR.  

Number of patients eligible for screening from the UMMC-PED daily census and the number of patients entered the code key will be retrieved weekly by the QI-PL from the unit and recorded onto a REDCap Project Form. Electronic Health Record chart audits will be conducted weekly by the QI-PL on each patient screened to include screening outcome, SW referral, diagnostic evaluation and results, discharge disposition, and basic demographic data for description purposes, and will be recorded on the REDCap Project Form (Appendix D). Non-identifying project data will be assembled on a secure data set spreadsheet in REDCap for analysis purposes, password protected, accessed only by authorized users (Appendix E).   

Staff training will be conducted in-person, in a private area free from distractions. Data collection from the medical record and review of the code key will be done in a private area using HIPAA privacy practices. The project data (staff training and chart review) will be recorded onto REDCap, a HIPAA compliant, password protected server. Identifiers will be recorded on a separate REDCap code key form only accessible to the QI-PL to further protect confidentiality of the data. Data set spreadsheets and reports will not contain any identifiers. The design of this QI project is intended to improve child abuse surveillance at the UMMC-PED site. The outcomes are not generalizable to other settings/populations because the project is specifically designed to address the resources, practice gap, and workflow at the UMMC-PED. Project data will be analyzed weekly by the QI-PL with aggregate reporting to the site stakeholders for project monitoring, goal achievement determination, and for discussion of the quality improvement effort; external dissemination with site permissions.