Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

HLC Accreditation Evidence Document

Herzing University

September 2022

Title: Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project

Approval

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

1

Herzing University’s Institutional Review Board (IRB) reviews all student quality improvement or

innovation project protocol requests to determine if it is human subject research that meets

definitions in The Common Rule and therefore requires review and oversight by the IRB. It is the

investigator’s responsibility to give complete information regarding the planned quality

improvement processes. After submitting the application, the IRB will notify the applicant, in

writing, of its decision or if additional information is needed.

Checklist

Please make sure to submit the following items along with this application for your submission:

☐ This application with signatures from you and your DNP Project Faculty

☐ A copy of all questionnaires and surveys, if used

☐ A copy of your CITI Certification (free certification for Herzing affiliates through Canvas)

☐ A copy of the application and approval letter from any external IRB (if applicable)

☐ Letter of approval from the Program Chair of the affiliated institution (if applicable)

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

2

Step 1: Your Information

Project Title: Ramona Wilkersom

Doctorate Student Name:

Check One: X Herzing University Student

☐ Student not affiliated with Herzing University – list institution this

project is affiliated with: __________________________________

Email: [email protected]

Primary Phone Number: 201-706-1511

Step 2: Location, Faculty, and Date Information

Location/Sponsor: Hudson Regional Hospital

Faculty Information:

Faculty Name: Colleen Bartlett

Faculty Email:[email protected]

Faculty Phone:

352-428-7472

Anticipated Start Date: 2-1-24

Anticipated Completion

Date:

5-1-24

Step 3: Aim Statement Overview

Aim Statement

Key elements of the aim statement needed to be included:

1. What? What’s the problem or opportunity? 2. How much? By how much will you improve? Or

“how good” do you want to get? 3. By when? What is the date by which you will achieve the level of improvement you’ve set out to accomplish? 4. For whom? Who is the customer or population who will benefit from the improvement? 5. Where? What are the boundaries of the

process or system you’re trying to improve? Where does it begin and end?

The problem/opportunity is to enhance the management of mentally ill patients on a medical surgical unit, improving overall care. Budget will be set at $5500 to include staff training, handouts salary for staff for block hours for training and coverage by prn staff. This project will Aim to achieve a significant improvement in patient outcomes, measured through indicators like reduced adverse incidents,enhanced staff compliance.The improvement goal will be reached within two months.The primary beneficiaries

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

3

are mentally ill patients on the medical-surgical unit, ensuring their well-being and satisfaction with the provided care. At Hudson Regional Hospital 3 west The improvement efforts focus on the entire process of managing mentally ill patients on the medical surgical unit, from admission to discharge, encompassing all relevant stakeholders and departments involved in their care.

Project Overview

Please provide a summary of the proposed quality improvement or innovation project including

the purpose, proposed strategy to be utilized, proposed project measures that will be utilized to

evaluate outcomes, and the anticipated/desired outcomes.

The proposed quality improvement project aims to enhance the management of mentally ill patients on a medical surgical unit. The purpose is to improve patient care and outcomes. The strategy involves implementing targeted staff training on mental health care protocols. Project measures include patient satisfaction surveys, staff compliance rates, and incident reports. Anticipated outcomes include better patient mental health, increased staff competence, and a decrease in adverse incidents.

QI Framework

Please provide an overview of the framework that will be utilized in the proposed project (e.g. KTA,

PDSA, ADKAR, Lean, Six Sigma, DMAIC, etc.).

The proposed Quality Improvement (QI) framework for managing mentally ill patients on a medical surgical unit involves employing the Plan-Do-Study-Act (PDSA) cycle. This iterative framework allows for planning interventions, implementing changes, studying their effects, and adjusting strategies based on continuous assessment. PDSA facilitates a flexible approach to address the unique challenges in enhancing mental health care on the medical surgical unit.

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

4

Data Security

Please provide a description of your data security plan for both physical and electronic data that

includes protected or identifying personal information. Include where the data will be stored, the

security of the location or computer system, the length of retention of the data, and the method

of disposition of old data.

The data security plan for managing mental health illness on a medical surgical unit involves storing electronic data in a secure, encrypted system with restricted access. Physical documents containing protected information will be kept in locked cabinets within controlled-access areas. Both electronic and physical storage locations will comply with relevant privacy regulations. Data retention will adhere to legal requirements, and obsolete records will be securely disposed of through methods such as shredding for physical documents and secure digital deletion for electronic data. Regular audits will be conducted to ensure ongoing compliance and identify areas for continuous improvement in data security

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

5

Step 4: Acknowledgement of Responsibilities and Signatures

Please note that:

– Any data collected from Herzing University students, alumni, faculty and/or staff

and/or any other constituents for purposes of this project is proprietary. Any

publication of findings may not identify or implicate Herzing University. Any external

report produced on findings generated by this study, including any presentation or

publication, may not identify, reference or implicate Herzing University in any way.

– Upon completion of the project, a copy of the final deliverable will be submitted

to Herzing University.

– Any additional publications or presentations produced based upon this project will be

submitted to Herzing University.

I certify to the best of my knowledge the information presented is an accurate

reflection of the proposed research project.

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

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Doctorate Student Signature: Date:

DNP Project Faculty Signature: Date:

Verified by PDFFiller

01/23/2024

1-23-24

HLC Accreditation Evidence Document Herzing University

September 2022

Title: Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

1

Herzing University’s Institutional Review Board (IRB) reviews all student quality improvement or

innovation project protocol requests to determine if it is human subject research that meets

definitions in The Common Rule and therefore requires review and oversight by the IRB. It is the

investigator’s responsibility to give complete information regarding the planned quality

improvement processes. After submitting the application, the IRB will notify the applicant, in

writing, of its decision or if additional information is needed.

Checklist

Please make sure to submit the following items along with this application for your submission:

☐ This application with signatures from you and your DNP Project Faculty

☐ A copy of all questionnaires and surveys, if used

☐ A copy of your CITI Certification (free certification for Herzing affiliates through Canvas)

☐ A copy of the application and approval letter from any external IRB (if applicable)

☐ Letter of approval from the Program Chair of the affiliated institution (if applicable)

XX

XX

XX

; links to surveys and other project resource tools are included in the Data Security section

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

2

Step 1: Your Information

Project Title: Implementing an Evidence-Based Social Determinants of Health

Screening Tool

Doctorate Student Name: Ozzie A Hubbard

Check One: X Herzing University Student

☐ Student not affiliated with Herzing University – list institution this project is affiliated with: __________________________________

Email: [email protected]

Primary Phone Number: 614-376-3139

Step 2: Location, Faculty, and Date Information

Location/Sponsor: Compass Health / Shannon Prescott ARNP

Faculty Information:

Faculty Name: Colleen Bartlett DNP, CPNP, FNP-C

Faculty Email: [email protected]

Faculty Phone: (352) 428-7472

Anticipated Start Date: 03/18/2024

Anticipated Completion Date:

05/18/2024

Step 3: Aim Statement Overview Aim Statement

Key elements of the aim statement needed to be included: 1. What? What’s the problem or opportunity? 2. How much? By how much will you improve? Or

“how good” do you want to get? 3. By when? What is the date by which you will achieve the level of improvement you’ve set out to accomplish? 4. For whom? Who is the customer or population who will benefit from the improvement? 5. Where? What are the boundaries of the process or system you’re trying to improve? Where does it begin and end?

Over the course of 8 weeks, an evidence-based social determinant of health screening tool will be

implemented in an intensive outpatient therapy program aimed at identifying the need for community

resource referral.

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

3

Project Overview

Please provide a summary of the proposed quality improvement or innovation project

including the purpose, proposed strategy to be utilized, proposed project measures that will

be utilized to evaluate outcomes, and the anticipated/desired outcomes.

Social determinants of health play a significant role in influencing individuals' mental well-

being. Kirkbride et al. (2024) emphasize that people exposed to unfavorable social

circumstances are more vulnerable to experiencing poor mental health outcomes over their

lifetime, often as a result of underlying structural factors that contribute to intergenerational

cycles of disadvantage and poor health (Kirkbride et al., 2024). Addressing these challenges is not

just important but imperative for achieving social justice and maintaining mental health. This

highlights the necessity of having tools to identify individuals affected by these social

determinants of health, allowing for targeted interventions to improve mental health outcomes

for all. Social determinants of health (SDOH) are described as “the circumstances in which

people are born, grow up, live, work, and age and the systems put in place to deal with illness”

(Marmot et al., 2008, p. 1661).

Throughout my experiences as a provider for an intensive outpatient therapy program I have

identified the problem of unmet social determinants of health among adolescent patients who

come for medication management appointments. These patients often experience distress due to

not having their basic needs met, such as access to shelter, food, school supplies, employment,

and personal hygiene products. This, in turn, has led to solvable issues causing an increase in

depressive symptoms, self-harm, and anxiety among these adolescents.

To address the issues listed above, the purpose of the proposed project is to implement an

evidence-based screening tool with patients being seen in the intensive outpatient treatment

program. Implementing this tool will allow for identification of unmet SDOH needs revealing

the need for referral to community social support services. To provide the best care and address the

social needs of patients, physicians and practices should consider integrating the screening and

documentation of social determinants of health (SDOH) into their approach (Social Determinants of

Health – Healthy People 2030 | Health.gov, n.d.). By doing so, they can identify and address the social

determinants that have a significant impact on people's health, well-being, and quality of life (Social

Determinants of Health – Healthy People 2030 | Health.gov, n.d.). By addressing factors such as

poverty, inequality, social exclusion, and lack of access to resources, interventions can aim to

reduce the burden of mental health disorders and improve overall mental well-being among

individuals (Alegrı́A et al., 2018).

The proposed strategy for the DNP student project will be the implementation of an evidenced-

based practice screening tool to identify patients with met or unmet SDOH. The proposed tool

for implementation is the Protocol for Responding to and Assessing Patients’ Assets, Risks, and

Experiences (PRAPARE®) tool (LaForge et al., 2018). PRAPARE® is both a standardized

patient risk assessment tool as well as a process and collection of resources to

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

4

identify and act on the social drivers of health (SDOH). The PRAPARE tool, consisting of 15

items, is utilized to assess social determinants of health by evaluating participants' risks. The

tool calculates a score ranging from 0 to 22, indicating the extent of reported risks. A score of 0

represents no reported risks, while a score of 22 indicates the presence of all measured risks.

This scoring system allows for the identification of unmet needs and risks in specific areas. This

approach, as described by LaForge et al. (2018), enables a comprehensive measurement of

social determinants of health and facilitates targeted interventions to address identified needs. This coalition created, piloted, and disseminated the “Protocol for Responding to and Assessing

Patient Assets, Risks, and Experiences” (PRAPARE) (National Association of Community

Health Centers, 2016).

For those identified with unmet SDOH, a referral to community based social resources will be

provided and supported by providing the patient with a Street Card. For example, patient’s

struggling with obtaining food will be given a list of local pantries and churches that offer daily

food services. Similarly, patients in need of housing will be provided with information including

addresses and telephone numbers of free overnight accommodations.

Process Measures will be utilized to evaluate the outcome of the project.

The first process measure will be providing a narrative discussion about the implementation of

the PRAPARE® tool into the practice.

The second process measure will be in conducting an observation of and collecting data on the

amount of time required for the PRAPARE® tool to be administered. This is an important

process to evaluate as the anticipated time for administering the tool is 9 minutes. Sustainability

of the use of the PRAPARE® tool will be promoted if the administration process proves to be

time efficient.

The next process to evaluate is to determine the value of providing referral to community social

resources via the Street Card. For those patients that screening revealed unmet SDOH needs, a

patient engagement survey is to be administered orally by the DNP student on a subsequent visit

at a 4-week and an 8-week time frame to determine if they engaged in using any of the listed

community social resources.

The desired outcome of the project is for those patients whom the PRAPARE® tool indicates

have unmet SDOH engage in utilizing resources of Street Card. This approach is expected to aid

patients in utilizing the appropriate resources while reducing disparities in domains with unmet

needs.

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

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Below is a brief list of references that provide support for the project of implementing an

evidence based SDOH screening tool aimed at identifying the need for referral to

community social resources:

Alegrı́A, M., NeMoyer, A., Bagué, I. F., Wang, Y., & Álvarez, K. (2018). Social determinants of mental health: Where we are

and where we need to go. Current Psychiatry Reports, 20(11). https://doi.org/10.1007/s11920-018-0969-9

Kirkbride, J., Anglin, D. M., Colman, I., Dykxhoorn, J., Jones, P. B., Patalay, P., Pitman, A., Soneson, E., Steare, T., Wright, T.,

& Griffiths, S. L. (2024). The social determinants of mental health and disorder: evidence, prevention and

recommendations. World Psychiatry, 23(1), 58–90. https://doi.org/10.1002/wps.21160

LaForge, K., Gold, R., Cottrell, E., Bunce, A., Proser, M., Hollombe, C., Dambrun, K., Cohen, D. J., & Clark, K. D. (2018b).

How 6 Organizations developed tools and processes for social determinants of health screening in primary care. The

Journal of Ambulatory Care Management, 41(1), 2–14. https://doi.org/10.1097/jac.0000000000000221

Marmot, M., Friel, S., Bell, R., Houweling, T. a. J., & Taylor, S. (2008). Closing the gap in a generation: health equity through

action on the social determinants of health. The Lancet, 372(9650), 1661–1669. https://doi.org/10.1016/s0140-

6736(08)61690-6

National Association of Community Health Centers. (2016). PRAPARE. (n.d.). http://www.nachc.org/research-and-data/prapare.

Social Determinants of Health – Healthy People 2030 | Health.gov. (n.d.). https://health.gov/healthypeople/priority-areas/social-

determinants-health

World Health Organization. (2022). World mental health report: transforming mental health for all [Report].

https://archive.hshsl.umaryland.edu/bitstream/handle/10713/20295/WHO%20Report%202022.pdf?sequence=1&isAllowed=y

QI Framework Please provide an overview of the framework that will be utilized in the proposed project (e.g. KTA, PDSA, ADKAR, Lean, Six Sigma, DMAIC, etc.).

The proposed quality improvement student DNP project will be framed using the Plan-Do-Study-Act (PDSA) cycle.

Institutional Review Board (IRB) Application for Quality Improvement or Innovation Project Approval

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The project design is focused on implementing an evidence based SDOH screening tool. Patients for whom the PRAPARE® tool indicates unmet SDOH referral to community social resources will be provided and supported by providing them with the Street Card.

The Street Card provides information and locations of appropriate community resources that correlate to each need identified while encompassing other available resources.

For the implementation process, the DNP student will serve as the project lead.

Over an 8-week period, implementation of the PRAPARE® tool will be conducted by the provider seeing the patient for their scheduled outpatient intensive treatment program visits.

It is anticipated that implementation of the PRAPARE® tool will result in appropriate identification of unmet SDOH for patient receiving services in the program. Through appropriately identifying this social determinant of health needs the clinical provider will be able to develop plans of care that include referring patients with unmet SDOH with community resources that have input on a Street Card to utilize for obtaining listed resources.

As previously stated, process

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