Describe the setting and access to potential subjects. If there is a need for a consent or approval form, then one must be created. Include a draft of the form as an appendix at the end of your paper

Assignment: Describe the setting and access to potential subjects. If there is a need for a consent or approval form, then one must be created.

In 1250-1500 words discuss the implementation plan for your evidence-based practice project proposal. When required, create the appropriate form, table, image, or graph to fully illustrate that aspect of the intervention plan and include them in an appendix of your paper. You will use the implementation plan, including the associated documents in your appendices, in the Topic 8 assignment, during which you will synthesize the various aspects of your project into a final paper detailing your evidence-based practice project proposal.

Include the following:

1. Describe the setting and access to potential subjects. If there is a need for a consent or approval form, then one must be created. Include a draft of the form as an appendix at the end of your paper.
2. Create a timeline. Make sure the timeline is general enough that it can be implemented at any date. Based on the timeline you created, describe the amount of time needed to complete this project. Include a draft of the timeline as an appendix at the end of your paper.
3. Develop a budget and resource list. Consider the clinical tools or process changes that would need to take place. Based on the budget and resource list you developed: (a) describe the resources (human, fiscal, and other) or changes needed in the implementation of the solution; (b) outline the costs for personnel, consumable supplies, equipment (if not provided by the institute), computer-related costs (librarian consultation, database access, etc.), and other costs (travel, presentation development). Include a draft of the budget and resource list as an appendix at the end of your paper.
4. Explain whether you would select a qualitative or quantitative design to collect data and evaluate the effectiveness of your evidence-based practice project proposal. Provide rationale to support your selection.
5. Describe the methods and instruments (questionnaire, scale, or test) to be used for monitoring the implementation of the proposed solution. Include the method or instrument as an appendix at the end of your paper.
6. Explain the process for delivering the intervention and indicate if any training will be needed.
7. Discuss the stakeholders that are needed to implement the plan.
8. Consider all of the aspects of your implementation plan and discuss potential barriers or challenges to the plan. Propose strategies for overcoming these.
9. Establish the feasibility of the implementation plan.

Refer to the “Evidence-Based Practice Project Proposal – Assignment Overview” document for an overview of the evidence-based practice project proposal assignments.

Evidence-Based Practice Project Proposal Implementation Plan – Sample Answer

Postoperative complications following coronary artery bypass graft (CABG) surgery remain a significant concern in clinical practice. Early mobilization has emerged as a promising intervention to prevent complications and enhance recovery in CABG surgery patients. This paper presents an evidence-based practice project proposal aimed at evaluating the impact of early mobilization on postoperative outcomes in adult patients undergoing CABG surgery.

Setting And Access to Potential Subjects

The intervention will take place within the inpatient hospital setting at Baylor St. Luke’s Medical Center, focusing on adult patients who have undergone coronary artery bypass graft (CABG) surgery. The target population for this project will be patients in the first week of their postoperative period. Early mobilization will be implemented in the hospital’s cardiovascular recovery unit and continued when the patient is transferred to the cardiovascular surgical unit. To access potential subjects, patients scheduled for CABG surgery will be identified during preoperative assessments.

After surgery, patients will receive additional orientation about the intervention as soon as they are alert and oriented to person, time, place, and situation, indicating their full capacity to provide consent. Informed consent will be obtained through a consent form provided to prospective participants for this EBP project (Drisko, 2021). The consent form will outline the purpose of the project, the nature of the intervention, potential risks and benefits, confidentiality measures, and the voluntary nature of participation. 

Project Timeline

The proposed EBP project will be implemented over the course of 3 months, starting in June and ending in September. The project will begin with the identification of participants scheduled for CABG surgery between June and July, with the peak season for surgeries at Baylor St. Luke’s Medical Center. Prior to surgery, identified participants will receive an email providing information about the planned intervention to prepare them for what to expect.

Budget and Resource List

Total Estimated Cost: $100

The budget and resource list for the proposed EBP project on early mobilization postoperative CABG surgery primarily utilize existing human resources within the hospital, including nurses, physical therapists, physical therapy assistants, clinical nursing aides, and physicians. The intervention will be integrated into the current postoperative protocol, minimizing fiscal costs. Essential clinical data will be gathered using the hospital’s Electronic Health Record system, “EPIC,” without additional expenses. The only direct cost incurred will be for presentation development, with the EBP project manager covering printing expenses for dissemination purposes.

Research Design

For the evaluation of the effectiveness of the evidence-based practice project proposal on early mobilization postoperative CABG surgery, a quantitative research design would be more appropriate. A quantitative approach is based on a design that provides for the measurement and analysis of numerical data, which is good for finding out how the decreases in intervention leads to the decrease in outcomes (Smith & Hasan, 2020).

In this particular scenario, the application of an experimental study design within the quantitative framework would allow for an in-depth, careful and accurate analysis of the causal relationships between early mobilization and postop complications. The effectiveness of early mobilization could be precisely measured through considerably adopting parameters like clinical outcomes, the rate of complications, and the functional status. 

Qualitative research allows for more in-depth interpretations and connections. It also empowers the researchers to conduct statistical analysis so that they can highlight any significant differences or correlations that exist between various variables (Smith & Hasan, 2020). Through the use of quantitative approaches, the project can produce quantitative evidence of a high level that will support clinical decisions making and be the information landmark in creation of postoperative care best practices for CABG surgery patients. Quantitative data of trial participants can also be time-saving, steaming and replicable, thereby increasing the generalizability of the findings across different populations and healthcare conditions.

Methods and Instruments

For monitoring the implementation of the proposed solution, a combination of structured surveys, direct observation, and electronic health records (EHR) will be utilized (Chipps et al., 2020). Structured surveys will enable the systematic collection of data from participating patients regarding their experiences with early mobilization postoperative CABG surgery, including perceived benefits and challenges. Direct observation, supplemented by EHR data, will provide valuable insights into patients’ physical responses and recovery progress during early mobilization sessions.

Process for Delivering the Intervention

The process for delivering the intervention of early mobilization postoperative CABG surgery involves multiple steps and collaboration among healthcare team members. Initially, the early mobilization will be conducted by the assigned Physical Therapist for the patient, ideally starting as early as day 1 postoperative if the patient’s condition allows.

The Physical Therapist will assess the patient’s readiness and safety for mobilization and initiate appropriate activities (Linke et al., 2020). Mobilization activities will be carried out daily, with a goal of three sessions per day during the first week of the postoperative period, as tolerated by the patient. Physical Therapy Assistants will be responsible for conducting daily mobilization activities for participants within this timeframe. 

Stakeholders Needed to Implement the Plan

The key stakeholders must come together to develop and implement the plan for early mobilization postoperative CABG surgery. These stakeholders include the nurses, who will help with immediate attention through sternal precautions and also provide continued assistance whenever the patient engages in mobilization activities (Berkel et al., 2020). Physical therapy assistants are in charge of assessing daily mobilization activities and tracking participants progress, which are therefore, essential (Williams et al., 2021).

The clinical nurse assistants are an integral part of the beneficial process of controlled early mobilization, which begins after the first assessment and the therapy started being administered by the physical therapist. Doctors are also stakeholders who keep patients well-informed about the early adoption of mobilization activities and are constantly monitoring the implementation of the process from the beginning to end of the activities (Berkel et al., 2020).

Potential Barriers or Challenges to the Plan

Several types of possible hurdles or difficulties could be realized in a course of the EBP execution on the early mobilization issue after the open-heart surgery. These include worker burn-out and resistance by the clinic personnel, and the challenge of inadequate pain control that could prevent follow-up physical therapy after surgery if the patient is in severe pain (Naghibi et al., 2021). To overcome these barriers, techniques like, availing personnel and listening to their ideas before the commencement of the initiative may resolve their concerns and receive support of the plan (Crawford et al., 2023).

Putting forth engaging, prudent interventions that address the needs of the postoperative CABG surgery patients can soothe pain and get them into movement. Moreover, training and engaging of the participants and who are linked with the project can assist in reducing reluctance to change by way of creating knowledge and support to the value of mobilization early (Crawford et al., 2023). Through pre-emptively tackling these limitations and implementing these tailored approaches, we can ensure the best outcome for patients keeping in mind the quality of care given.

Feasibility of the Implementation Plan

The conduct has been reasonable and attainable due to a number of factors behind the plan of early mobilization after open-heart surgery (CABG). The incorporation of diverse stakeholders thus airs physicians, clinical nurse assistants, physical therapy assistants, and nurses further contributes to comprehensive care and teamwork themes throughout the implementation.

Plans for coping with potential obstacles are designed by input from staff and sources of guidance, efficient treatment of pain, and conducting training for people and stakeholders to overcome problems and facilitate the deliveries (Berkel et al., 2020). For instance, the use of resources through the staff members as well as the infrastructure like the existing Electronic Health Record system eliminates the financial need caused by additional personnel. 

Conclusion

The proposed evidence-based practice project on early mobilization postoperative CABG surgery holds promise for improving patient outcomes and enhancing recovery. Through rigorous evaluation and continuous quality improvement efforts, this project has the potential to inform best practices and enhance the standard of care for CABG surgery patients. Generally, the integration of stakeholders’ participation, targeting chosen strategies, and utilization of resources leads to improved success of a proposed plan to allow early mobilization after coronary artery bypass graft surgery.

References

Berkel, C., Rudo‐Stern, J., Abraczinskas, M., Wilson, C., Lokey, F., Flanigan, E., … & Smith, J. D. (2020). Translating evidence‐based parenting programs for primary care: Stakeholder recommendations for sustainable implementation. Journal of Community Psychology, 48(4), 1178-1193. https://doi.org/10.1002/jcop.22317 

Chipps, E., Tucker, S., Labardee, R., Thomas, B., Weber, M., Gallagher‐Ford, L., & Melnyk, B. M. (2020). The impact of the electronic health record on moving new evidence‐based nursing practices forward. Worldviews on Evidence‐Based Nursing, 17(2), 136-143. https://doi.org/10.1111/wvn.12435 

Crawford, C. L., Rondinelli, J., Zuniga, S., Valdez, R. M., Tze‐Polo, L., & Titler, M. G. (2023). Barriers and facilitators influencing EBP readiness: Building organizational and nurse capacity. Worldviews on Evidence‐Based Nursing, 20(1), 27-36. https://doi.org/10.1111/wvn.12618 

Drisko, J. W. (2021). Incorporating evidence-based practice into informed consent practice. Families in Society, 102(1), 67-77. https://doi.org/10.1177/1044389420929625 

Linke, C. A., Chapman, L. B., Berger, L. J., Kelly, T. L., Korpela, C. A., & Petty, M. G. (2020). Early mobilization in the ICU: a collaborative, integrated approach. Critical care explorations, 2(4), e0090. https://doi.org/10.1097/CCE.0000000000000090 

Naghibi, D., Mohammadzadeh, S., & Azami-Aghdash, S. (2021). Barriers to evidence-based practice in health system: a systematic review. Evidence Based Care, 11(2), 74-82. https://doi.org/10.22038/ebcj.2021.60075.2561 

Smith, J. D., & Hasan, M. (2020). Quantitative approaches for the evaluation of implementation research studies. Psychiatry research, 283, 112521. https://doi.org/10.1016/j.psychres.2019.112521 

Williams, N. J., Candon, M., Stewart, R. E., Byeon, Y. V., Bewtra, M., Buttenheim, A. M., … & Beidas, R. S. (2021). Community stakeholder preferences for evidence-based practice implementation strategies in behavioral health: a best-worst scaling choice experiment. BMC psychiatry, 21, 1-12. https://doi.org/10.1186/s12888-021-03072-x

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Research Setting and Subject Access for Evidence-Based Practice Implementation

Introduction

Implementing evidence-based practice (EBP) in healthcare requires careful consideration of research settings and ethical protocols for subject access. This comprehensive guide addresses the critical components of describing research settings, accessing potential subjects, and creating necessary consent or approval forms for evidence-based practice projects.

Understanding Research Settings in Evidence-Based Practice

What is a Research Setting?

A research setting refers to the physical and organizational environment where evidence-based practice implementation occurs. Although the science of translating research into practice is fairly new, there is some guiding evidence of what implementation interventions to use in promoting patient safety practices. The setting significantly impacts the success of EBP implementation.

Types of Research Settings

Accessing Potential Subjects: A Step-by-Step Guide

1. Stakeholder Identification

Before accessing potential subjects, identify key stakeholders:

• Healthcare administrators
• Department heads
• Clinical staff
• Patients and families
• Regulatory bodies

2. Subject Selection Criteria

Establish clear inclusion and exclusion criteria:

Inclusion Criteria Examples:

• Age requirements (e.g., 18+ years)
• Diagnosis-specific conditions
• Treatment status
• Cognitive capacity for consent

Exclusion Criteria Examples:

• Inability to provide informed consent
• Pregnancy (if applicable)
• Severe cognitive impairment
• Language barriers without interpreter services

3. Recruitment Strategies

When Consent or Approval Forms Are Required

IRB Approval Requirements

The completed sample form should be typed to enhance its readability by the subjects. The form finally approved by the IRB should be an exact copy of the form that will be presented to the research subjects.

Situations Requiring Consent Forms

1. Human subjects research involving:
   • Interventions or interactions with individuals
   • Private information collection
   • Biospecimen collection
2. Quality improvement projects that:
   • Collect identifiable information
   • Involve experimental interventions
   • Pose more than minimal risk
3. Evidence-based practice implementation when:
   • Evaluating patient outcomes
   • Collecting performance data
   • Implementing new protocols

Recent Regulatory Updates

The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations. This rule is effective January 22, 2024.

Creating Effective Consent and Approval Forms

Essential Elements of Informed Consent

According to current regulations, informed consent must include:

1. Study purpose and procedures
2. Risks and benefits
3. Alternatives to participation
4. Confidentiality protections
5. Compensation information
6. Contact information
7. Voluntary nature of participation

Sample Consent Form Template

INFORMED CONSENT FOR RESEARCH PARTICIPATION

Title: [Project Title]
Principal Investigator: [Name and Credentials]
Institution: [Organization Name]

PURPOSE OF THE STUDY
You are being asked to participate in a research study about [brief description].

PROCEDURES
If you agree to participate, you will be asked to:
- [List specific procedures]
- [Estimated time commitment]
- [Number of visits/sessions]

RISKS AND BENEFITS
Risks may include: [List potential risks]
Benefits may include: [List potential benefits]

CONFIDENTIALITY
Your information will be kept confidential through:
- [Specific protection measures]
- [Data storage methods]
- [Access limitations]

VOLUNTARY PARTICIPATION
Your participation is voluntary. You may withdraw at any time without penalty.

CONTACT INFORMATION
If you have questions, contact:
[Principal Investigator contact information]
[IRB contact information]

CONSENT
I have read and understood the information above. I voluntarily agree to participate in this study.

Participant Signature: _________________ Date: _______
Participant Name (print): _________________________
Researcher Signature: _________________ Date: _______

Implementation Planning Statistics

EBP Implementation Success Rates

Recent research shows varying success rates for evidence-based practice implementation:

Source: Systematic review of EBP implementation studies, 2024

Cost Considerations

The costs associated with implementing an evidence-based program are a critical consideration for organizations seeking to improve practice in accordance with research findings. Implementation costs typically include:

• Staff training time
• Technology infrastructure
• Consultation fees
• Evaluation activities

Best Practices for Setting Description

Environmental Factors to Document

1. Physical characteristics
   • Size and layout
   • Equipment availability
   • Technology infrastructure
   • Accessibility features
2. Organizational factors
   • Staffing patterns
   • Patient volume
   • Workflow processes
   • Quality metrics
3. Cultural considerations
   • Patient demographics
   • Language preferences
   • Cultural practices
   • Health literacy levels

Documentation Template

RESEARCH SETTING DESCRIPTION

Setting Type: [Hospital unit, clinic, etc.]
Location: [Geographic location]
Size: [Patient capacity, square footage]
Staffing: [Number and types of staff]
Patient Population: [Demographics, diagnoses]
Daily Operations: [Typical workflow, patient flow]
Technology: [Electronic health records, monitoring systems]
Access Considerations: [Barriers, facilitators]

Regulatory Compliance

Expertise Requirements

Ensure your implementation team includes:

• Doctoral-prepared researchers
• Clinical subject matter experts
• IRB-trained personnel
• Biostatisticians
• Quality improvement specialists

Authority and Trustworthiness

Establish credibility through:

• Institutional affiliations
• Published research
• Professional certifications
• Peer review processes
• Transparent methodologies

Experience Documentation

Document team experience:

• Years of clinical practice
• Previous EBP projects
• Publication record
• Training credentials
• Professional memberships

Common Challenges and Solutions

Challenge 1: Gaining Administrative Support

Solution: Develop a compelling business case highlighting:

• Patient outcome improvements
• Cost savings potential
• Regulatory compliance benefits
• Staff satisfaction increases

Challenge 2: Subject Recruitment Difficulties

Solution: Implement multiple recruitment strategies:

• Provider education about study importance
• Patient-friendly materials
• Flexible scheduling options
• Incentive programs (when appropriate)

Challenge 3: Consent Form Complexity

Solution: Use plain language principles:

• 8th-grade reading level
• Short sentences
• Active voice
• Clear formatting
• Visual aids when helpful

Quality Assurance and Monitoring

Ongoing Oversight Requirements

1. Data Safety Monitoring
   • Regular safety assessments
   • Adverse event reporting
   • Protocol deviation tracking
2. Consent Process Monitoring
   • Staff training verification
   • Documentation audits
   • Subject comprehension checks
3. Regulatory Compliance
   • IRB continuing review
   • Policy updates
   • Training renewals

Future Considerations

Emerging Trends in EBP Implementation

Based on an analysis of EBP-promoting and project-oriented strategy under the guidance of the i-PARIHS framework. The strategy was implemented for six years and evaluated by a longitudinal design. Key trends include:

• Digital health integration
• Artificial intelligence support
• Patient-centered approaches
• Sustainability frameworks
• Global health applications

Technology Integration

Modern EBP implementation increasingly relies on:

• Electronic consent platforms
• Mobile health applications
• Telemedicine capabilities
• Data analytics tools
• Cloud-based storage systems

Conclusion

Successful evidence-based practice implementation requires careful attention to research settings, subject access protocols, and ethical considerations. Findings indicate that EBPs improve patient outcomes and ROI for healthcare systems. By following established guidelines for describing settings, accessing subjects, and creating appropriate consent forms, researchers can ensure their EBP projects meet regulatory requirements while maximizing the potential for positive healthcare outcomes.

The key to successful implementation lies in thorough planning, stakeholder engagement, and adherence to ethical principles. As healthcare continues to evolve, the importance of evidence-based practice will only grow, making these foundational elements even more critical for success.

References

1. FDA. (2024). Institutional Review Board waiver of informed consent for minimal risk investigations. Federal Register. Retrieved from https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical
2. HHS.gov. (2024). Informed consent FAQs. Office for Human Research Protections. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html
3. NCBI. (2024). The evidence for evidence-based practice implementation. Patient Safety and Quality. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK2659/
4. PCORI. (2024). The cost of implementation of evidence-based practices. Patient-Centered Outcomes Research Institute. Retrieved from https://www.pcori.org/research/pcori-literature/cost-implementation-evidence-based-practices-special-article-collection-medical-care
5. Connor, L. (2023). Evidence-based practice improves patient outcomes and healthcare system return on investment. Worldviews on Evidence-Based Nursing. Retrieved from https://pubmed.ncbi.nlm.nih.gov/36751881/