5 - 2019 EBP Award.pdf

TRISERVICE NURSING RESEARCH PROGRAM:

EVIDENCE-BASED PRACTICE AWARD INSTRUCTIONS

Purpose

The purpose of the Evidence-Based Practice (EBP) Award is to expand the use of EBP in military nursing practice. This award supports the development of evidence-based clinical practice guidelines (CPGs) OR the implementation and evaluation of CPGs to help military nurses make important decisions to improve clinical outcomes, standardize patient care, and promote cost-effective care.

TSNRP encourages funding recipients who develop CPGs to apply for a subsequent EBP Award to implement them into practice.

Award Amount

You may request funding of up to $250,000 in direct costs, plus indirect costs as appropriate, for up to a 2-year performance period.

Special Requirement - Mentoring

If you have not previously received an EBP Award from TSNRP, you must have a mentor and a mentoring plan for your EBP project. The primary mentor must be a Federal government nurse with a doctoral degree and extensive military experience. TSNRP promotes mentoring as a way to achieve its goal of expanding the cadre of military nurse scholars.

A mentor is an experienced EBP practitioner and subject matter expert who supports, guides, and assists a novice awardee. Your mentor must be a member of your EBP project team and be available to support you in accordance with your mentoring plan.

The specific mentoring plan must be included as an attachment to your grant application (this is a new process compared to previous years). Required elements of the mentorship plan are listed in the Attachment Forms section on page 10 of this document.

Your mentor’s evaluation of your progress on your identified goals/objectives will be required in each progress report that you submit to TSNRP after receiving your grant award.

Application Forms

1. SF 424 (R&R), Application for Federal Assistance (also called the “Face Page”)

Complete highlighted areas, as appropriate

2. Project/Performance Site Location(s) Form

Provide the information for each site at which the project will be conducted. Depending on your study, you may have more than one performance site, which may not necessarily be your assigned duty station or academic institution.

3. Research & Related Senior/Key Person Profile Form

Provide the required (‘starred’) information for each senior/key person on the project.

https://www.usuhs.edu/tsnrp/grant-management-forms

Senior/key personnel are people who contribute substantively to the scientific development or execution of the study and devote measurable effort to the study/project, not occasional or as-needed effort. Ensure the mentor is included as key personnel.

Attach a biographical sketch for each senior/key person (limited to five pages for each person) using the PHS 398 Biosketch form (available at http://grants.nih.gov/grants/forms/biosketch.htm)

4. Research & Related Other Project Information Form

Complete all information, as appropriate. This form also requires the following documents which do not need to be submitted on any particular form. However, ensure the formatting requirements are followed as directed in the funding opportunity announcement.

a. Project Summary/Abstract - Attach a Project Abstract that does not exceed one page and contains a summary of the proposed activity suitable for dissemination to the public. It should provide a complete overview of the entire study/project to a reader who might not read the rest of your grant application. Make sure to include the PICO (Population, Intervention, Comparison, Outcomes) question, and describe the proposed design, rationale, and methods for achieving the project objectives and aims. Conclude this section with a relevance statement, describing how the proposed study/project is relevant to the body of military nursing science.

b. Project Narrative – Attach a document that describes your Project Plan. Your plan will contain the following items in this order:

i. For revise/resubmit applications only: Introduction and response to reviewer table

ii. PICO (Population, Intervention, Comparison, Outcome) Question - one page limit

The following items are limited to 12 pages total, to include any figures or tables.

iii. Background and Significance

iv. Preliminary Studies/Prior Work

v. Project Plan

The following items do not have a specific page limit.

vi. Protection of Human Subjects

vii. Inclusion of Children

viii. Consortium/Contractual Arrangements

i. Revise/Resubmit Table (only if needed)

A table with major reviewer comments/concerns/suggestions, changes made, and specific pages with relevant changes must be provided to summarize the revisions.

ii. PICO Question (one page limit)

This item is the foundation on which the rest of your grant application is built. The PICO Question should clearly identify the Population, Intervention, Comparison, and Outcome (PICO) for the project and provide a framework for the evidence and proposed project plan.

iii. Background and Significance

Briefly describe the background that led to your proposed project. Be sure to:

● Cite research literature that supports the significance of your PICO Question and identifies gaps your proposed project intends to fill.

● Describe the effect of the studies you cite on the concepts, methods, technologies, treatments, services, interventions, and outcomes that form the basis of your proposed project.

● State how your project will advance scientific knowledge or clinical practice.

● Include any economic impact that you expect the findings to have.

● For projects that propose to implement a CPG, also include the following:

− A description of how you carried out evidence synthesis in a previous project in order to develop the CPG(s) that you propose to implement and evaluate in your grant application OR how you chose the CPG(s) you propose to implement and evaluate.

− A discussion of the results of any data collection during CPG development, if applicable.

− Results from a quality appraisal of the selected guideline, using an instrument such as the Appraisal of Guidelines for Research & Evaluation (AGREE) Instrument (refer to http://www.agreetrust.org for more information).

iv. Preliminary Studies/Prior Work

Highlight preliminary work that you (or your team) have done in the proposed area of study. Provide evidence demonstrating that your team has mastered the technical aspects of the proposed practice, including accessing the proposed sample population and pilot testing the proposed instruments.

The objective is to convince the reviewers that your team is prepared to undertake the proposed project and has a competitive advantage over other researchers or clinicians working in the same field.

Be sure to:

● Include relevant data from unpublished research or previous evidence-based practice.

● Describe what your preliminary data show and why the findings are significant to the proposed study/project.

● Report only research/evidence-based practice conducted by members of your proposed study/project team.

v. Project Plan

Before describing the details of the methodology, identify which EBP model will be used to guide the development or implementation of your CPG.

Use enough detail (including methodology, statistics, controls, etc.) to clarify what will be done, how it will be done, who will do it, and how data will be interpreted, fully describing every step in the data collection procedures. Be sure to include details of the instrumentation, data collection procedures, and data analysis.

For projects developing a CPG:

- Clearly describe your plan for developing the CPG.

http://www.agreetrust.org/ o Present the criteria that will be used to evaluate the evidence.

o Outline how you will develop your guideline(s) using the evidence you gather.

o Discuss how you will receive multidisciplinary input into the guideline(s) and demonstrate the support of all levels of stakeholders.

o Identify all individuals who will be involved in the development of the guideline(s).

o Indicate how the CPG will be tested to determine appropriateness.

For projects implementing a CPG:

- Describe in detail how you will implement the practice recommendations from synthesized evidence at your project site. Include:

o Both individual and organizational implementation strategies.

o The potential number and type of patients who could benefit annually from your EBP project.

o The number and type of clinicians who will implement the CPG(s) from your project in their practices.

o Methods for gaining the support for the EBPs you are introducing from key stakeholders. These methods may include educational strategies and system changes.

o The rationale for the strategies you will use to gain stakeholder support.

o Challenges you anticipate during implementation and strategies for overcoming these challenges.

o Include enough detail in your description of your implementation strategies to enable other researchers to replicate your project at another site.

- Discuss how you will determine the success of your EBP implementation. You should employ a variety of evaluation methods throughout your project. Describe:

o The outcome and process variables or indicators you will use.

o The rationale for using the methods you describe.

o Your data collection plan, including data collection methodology, data sources, and a table of instrument reliability and validity.

o Methods for data analysis, including statistical methods.

o Methods for evaluating implementation success or failure.

o Plans for overcoming potential organizational obstacles to evaluation.

o In an appendix to your grant application, include samples of any existing data collection tools, instruments, or surveys that you will use in your project.

The sample selection that you describe should be realistic and feasible, and follow directly from your PICO Question. Include:

• The parameters describing your population.

• The number of individuals available for sampling at each site.

• Support letters demonstrating your access to settings and populations.

• Specific details of how you will identify and recruit subjects to your study.

Include a table that lists the reported validity and reliability for any tools, instruments, surveys, or other measures that you will use in your project.

Finish with a thoughtful dissemination plan. This should explain the strategies that you will use to disseminate the results of your study/project to the military nursing community and how you will inform military nursing policy.

vi. Protection of Human Subjects

EBP Projects may have a data collection process that requires IRB approval. Ensure you confirm what is required with the IRB at the performance site. It is highly recommended this is completed prior to submitting the grant application, so the appropriate requirements for this section can be completed.

Use this section to describe any potential risks to your subjects caused by participation in your study and the actions that you and your team will take to minimize these risks.

Include discussion of:

● Confidentiality.

● Coercion.

● Volunteerism.

● Data safety.

● Your monitoring plan.

● Health Insurance Portability and Accountability Act (HIPAA) compliance.

● Any other issue related to the protection of human subjects.

Consult the current U.S. Department of Defense (DoD) Service- and site-specific human subjects protection requirements and ensure that your plan for human protection meets those requirements. Research involving human subjects must be conducted in full compliance with all applicable Federal regulations and DoD policies.

Research taking place on DoD installations or using DoD beneficiaries must have the approval of all appropriate IRBs. Academic institutions’ human use approval is not a substitute for the appropriate DoD IRB approval at the performance site. Because the Uniformed Services University of the Health Sciences (USU) is the grantor, its IRB will conduct a secondary review of your study, in addition to the review(s) conducted by your performance site(s) IRB(s). (Note: If you plan on including vulnerable populations, your study will be subject to strict scrutiny; obtaining approval for your study may be a lengthy and difficult process.)

Documented evidence of IRB approval of your research is not required with your grant application, but you must provide this documentation to TSNRP for each performance site if you receive an award.

(Note: Only an IRB can determine whether your research is exempt from human subject regulations.)

vii. Inclusion of Children

If your proposed research involves vulnerable populations, such as children, it must follow the additional protections and regulations described in Subparts B, C, and D of 45 CFR Part 46. A child is a person who has not attained the legal age for consent to treatment or procedures involved in your research under the applicable laws.

If your study involves children, describe:

● The rationale for selecting a specific age range of children.

● Planned procedures for protecting against or minimizing potential risks to the children. This plan must include a description of:

○ Your investigative team’s expertise in working with children of the age(s) you include.

○ The appropriateness of the available facilities to accommodate the children.

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

○ The inclusion of a sufficient number of children to allow a meaningful analysis.

Also describe your process for meeting parental permission and child assent requirements, including:

● The circumstances under which you will seek and obtain consent.

● Who will seek and obtain consent and, if applicable, assent.

● The nature of the information that you will provide to prospective child subjects.

● The method for documenting consent.

viii. Consortium/Contractual Arrangements

Explain the programmatic, fiscal, and administrative arrangements to be made between your Applicant Organization and any consortium organization(s). Include letters of collaboration and budget plans for each contractual agreement (including PHS 398 budget pages for both the initial budget period and the entire proposed period). Place the letters of collaboration in an appendix to your grant application.

Some military treatment facilities will require a Cooperative Research and Development Agreement (CRADA) between themselves and your grantee organization. This is an agreement between a government agency and a private company or university to work together on research and development. Before selecting a performance site(s) for your study, you should find out whether your grantee organization has a CRADA in place with the specific facility that you are considering using. The process to create a CRADA can take several months. You may need to include this process in your project’s timeline.

c. Bibliography & References Cited – Attach a document that contains a list of references from your Project Narrative. Use a consistent style of your choice for the bibliography — one that includes the article and journal or book titles, volume number, page numbers, and year of publication in the bibliographical references.

d. Facilities & Other Resources – Attach a document that describes the resources at each performance site that are available for the proposed study/project. Reviewers will use this information to assess the capability of the organizational resources available to perform your study. Consider the following:

• Identify the facilities that will be used for the study/project (e.g., laboratory, clinical, research animals, computer[s], office). If appropriate, indicate capacities, pertinent capabilities, relative proximity and extent of availability to the study. Describe only those resources that are directly applicable to the proposed study.

• Provide any information describing the Other Resources available to the study/project (e.g., machine shop, electronic shop) and the extent to which they would be available.

• Describe how the scientific environment that would contribute to the probability of success (e.g., institutional support, physical resources, intellectual rapport). In describing this environment, discuss ways in which the study/project will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.

• Describe the Applicant Organization’s investment in the success of the project director/principal investigator (e.g., resources for classes, travel, and training; collegial support, such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the study, and availability of organized peer groups; logistical support, such as administrative management and oversight, and best practices training; and financial support, such as protected time for research with salary support).

• If there are multiple performance sites, describe the resources available at each site.

• Describe any special facilities used for working with biohazards or other potentially dangerous substances, if applicable. (Note: Information about select agents must be described in the Project Narrative.)

e. Equipment – this information is provided as part of the budget document, and is not required on this form.

5. Research & Related Budget Form

Provide the required information for the initial (12-month) budget, adding a budget period for each additional 12-months.

a. Senior/Key Person - In this section, list each person involved in your proposed study/project, beginning with you (the PI). Also include any individuals who will not receive compensation.

Designate each person’s role on the study, avoiding any duplication of roles or responsibilities.

Enter the number of months that each person will spend on the study. This number must be greater than zero and cannot be “as needed” or another non-number. Use only the column labeled Cal. Mnths (calendar months) for each individual, unless the person in question has different appointments throughout the calendar year. If the person will have one appointment during the academic months and another during the summer months, complete the columns labeled Acad. Mnths (academic months) and Summer Mnths (summer months) with the months during each period that the individual will spend on your project; leave the calendar month column blank.

Enter the Base Salary for any personnel on the study who are neither Federal employees nor active duty military personnel; this should remain blank for active duty and Federal employees. You may not use a TSNRP grant award to pay salaries to active duty personnel or Federal employees. For each such individual involved in your project, leave the funds requested.

Indicate the salary requested for each person listed in the column labeled Salary Requested.

Regardless of the number of months that each individual will devote to the project, indicate only the amount of salary for this budget period for each individual.

In the column labeled Fringe Benefits, list the benefits for each individual that are included with his or her salary. Your Applicant Organization will provide you with this information.

Total the amounts listed in the Salary Requested and Fringe Benefits columns in the column indicated.

b. Other Personnel - Provide the names and organizational affiliations of all consultants not involved in consortium/contractual arrangements. Include any consultant physicians in connection with patient care and persons who are confirmed to serve on external monitoring or advisory committees. Include the number of days of anticipated consultation, the expected rate of compensation, travel, per diem, and other related costs for each consultant. You will describe each consultant’s services in the Budget Justification.

c. Equipment Description – list each piece of equipment exceeding $5,000. All other equipment (less than $5,000) is considered ‘materials and supplies’ and included on the other direct costs.

d. Travel - Travel to attend the TSNRP Dissemination Course is required for the PI or a designated team member for each year of the award. The TSNRP Dissemination Course is a 3.5-day course for military nurse scholars, and projected to be held the end of April in San Diego, CA in 2019 and San Antonio, TX in 2020. It is expected that awardees will submit an abstract to be considered for presentation, which can be submitted between 1 December and 31 January each year.

First-time awardees will be expected to attend a one-day Award Management Workshop immediately following the TSNRP Dissemination Course during the first year.

In addition to attending the TSNRP Dissemination Course, you may also request funding to scientific conferences or meetings for the purpose of dissemination within the broader scientific community.

e. Participant/Trainee Support Costs – Include any incentive costs that would be provided to those that participate in the study/project. This includes any inpatient or outpatient care costs directly required due to participation in the study (not part of their usual healthcare).

f. Other Direct Costs

• Computer equipment and software costs in excess of $3,000 will be carefully evaluated during the review process.

• In most cases, TSNRP awards do not pay for Cooperative Research and Development

Agreement (CRADA) or IRB fees. However, if required, a one-time maximum of $2,500 may be budgeted for IRB/CRADA fees.

g. Budget Justification – Attach a single file with the following information included in the budget justification, which does not require any particular form. However, ensure the formatting requirements are followed as directed in the funding opportunity announcement. You must justify your request for:

● The inclusion of each senior/key personnel listed on the study. Describe each individual’s specific function. Include any “to-be-appointed” positions.

● The inclusion of any consultants, other than those involved in consortium/contractual arrangements. Describe the services that each consultant will perform. Include the number of days of anticipated consultation.

● Required equipment (exceeding $5,000).

● Travel. List each travel request and travel cost separately. This travel should be necessary for the completion or outcomes dissemination of the proposed project.

Any international travel for dissemination purposes must be fully justified and clearly benefit both TSNRP and the U.S. military nursing community.

For each travel request and for each individual, list:

− Purpose of the travel.

− Potential destination.

− Estimated round-trip airfare or car mileage.

− Estimated hotel prices.

− Estimated per diem costs.

− The registration fee, if applicable.

If you plan to take multiple trips, you may create a table for this section and include it as an appendix to your grant application.

● Participant Costs

● Materials and Supplies: For supplies that total less than $1,000, list each category of supplies that you will purchase with the award along with the total cost for the category. If the total is greater than $1,000, list each item and cost in that category individually. Computer equipment or software should be based on the needs of the study/project and should be well justified.

● Any significant increase in budget between subsequent years of your proposed study.

● Inclusion of active duty, Reserve, or National Guard personnel. For each study team member (including the PI) who is an active duty, Reserve, or National Guard member, provide details about his or her deployment or permanent change of station/assignment dates and the plan for continuing his or her research role in the event of deployment or assignment away from the performance site. If you are an active duty, Reserve, or National Guard applicant, include another nurse scientist who has agreed to continue the research in the event that you are away for more than 3 months and describe the contingency plan. Include a letter of support from this person as an appendix to your application.

● Other Expenses: Itemize any other direct costs that you anticipate in your research study, such as:

− Animal maintenance (cost of care per animal and number of care days).

− Publication costs.

− Equipment rental.

− Communication costs.

− Transcription costs.

− Advertising costs (to recruit study participants).

Note: Provide the hours and rates for all equipment rentals and services that you list.

Consortium/Contractual Costs

Each participating consortium/contractual organization must submit a separate detailed budget for both the initial budget period and the entire proposed research period.

Consortium arrangements may involve personnel costs, supplies, and other allowable costs, including F&A costs. Contractual costs for support services, such as laboratory testing of biological materials, clinical services, or data processing, are occasionally sufficiently high to warrant a similar categorical breakdown of costs.

For each budget from a participating consortium/contractual organization, leave the Consortium/Contractual Direct Costs category blank and use the Subtotal Direct Costs category to total the consortium direct costs. When F&A costs are requested by a consortium organization, enter those costs in the Consortium/Contractual F&A Costs category for each supplementary budget. Provide the F&A cost base and rate information in the budget Justification section. The Total Direct Costs for Initial Budget Period category can be used for the consortium/contractual Total Costs (Direct Costs plus F&A).

If you will be conducting a multisite study, each additional site beyond that at which you will work must enter into a consortium/contractual arrangement with you and with your Applicant Organization. This is a formalized agreement whereby you and one or more other organizations that are separate legal entities carry out a research study. Each of these other organizations must have a lead associate investigator (AI) who will be in charge of the study at his or her site.

Under the agreement, you must perform a substantive role in conducting the planned research and not merely serve as a conduit of funds to another party or parties. These agreements typically involve a specific percentage of effort from the consortium organization’s lead AI and a categorical breakdown of costs, such as supplies and other allowable expenses, including F&A costs. Provide the details of any consortium/contractual arrangements in your Research/Study Plan.

6. Attachment Forms

a. Cover Letter from Applicant Organization – as described in the Funding Opportunity Announcement document

b. TSNRP Grant Application Summary and Evaluation – as described in the Funding Opportunity Announcement

c. Mentorship Plan (if needed) – The mentorship plan must include the following elements:

● Three to five developmental goals/objectives to be achieved during the course of the project.

● At least one measurable outcome for each goal/objective that can be achieved by the completion of the project.

● Three to five action steps for each goal/objective for BOTH the mentor and mentee.

These can be actions taken throughout the course of the project, or completed in phases.

● Clearly articulate how, and how often, you and your mentor will communicate.

d. Timeline – Provide a detailed timeline that delineates how your study will progress. This timeline should include major tasks and milestones as well as the time periods within which you will accomplish them. The timeline should include IRB processing. (Note: If you plan to study vulnerable populations or use multiple performance sites, IRB processing will take longer.)

e. Letters of Support – Include letters of support on letterhead from:

● Commander, director, supervisor, or manager of the military installation, medical facility, department, or unit that might be affected by any aspect of your project. These letters should demonstrate that you and your team have access to the population and facilities you need to conduct the study. (Examples: a letter of support to access a military treatment facility or other clinical site; a letter of support to access data in a secure database or data registry.)

● Associate investigators.

● Consultants. These letters should include the scope of the consultants’ work and responsibilities, level of commitment and percentage of effort, and duration of the commitment.

● Site commanders (if relevant).

f. Additional Information – Provide any additional material relevant to your grant application but not suited for the main body of the grant application, such as:

● Copies and/or detailed descriptions of data collection tools, instruments, surveys, or other measures.

● Letters of permission for the use of any instruments not in the public domain. Using instruments not in the public domain requires the authors’ permission. If you are using any such instruments, include letters from the authors or their legal representatives granting you permission for their use.

● Informed consent document.

● HIPAA authorization form.

Further Questions

If there are any further questions that have not been fully addressed by these instructions, please contact Col Jennifer Hatzfeld via email at jennifer.hatzfeld@usuhs.edu or by telephone at 301-319-0596.

Answers to frequently asked questions will be posted to the TSNRP Call for Proposal web page at https://www.usuhs.edu/tsnrp/call-for-proposals and may be a helpful resource.

mailto:jennifer.hatzfeld@usuhs.edu https://www.usuhs.edu/tsnrp/call-for-proposals

Further Questions