PCORI Grant Application

LEAVE BLANK—FOR PCORI USE ONLY. Patient-Centered Outcomes Type Activity Number Research Institute Review Group Formerly Form A: Grant Application Council/Board (Month, Year) Date Received 1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)

2. RESPONDING TO THE FOLLOWING PCORI FUNDING ANNOUNCEMENT: Number: PI-12-001 Title: PCORI PILOT PROJECTS 3. PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR 3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. eRA Commons User Name

3c. POSITION TITLE 3d. MAILING ADDRESS (Street, city, state, zip code)

3e. ORGANIZATION & DEPARTMENT, SERVICE, OR EQUIVALENT

3f. MAJOR SUBDIVISION

3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS: TEL: FAX: 4. HUMAN SUBJECTS RESEARCH 4a. Research Exempt If “Yes,” Exemption No. No Yes No Yes 4b. Federal-Wide Assurance No. 4c. RESERVED 4d. RESERVED

5. RESERVED 5a. RESERVED

6. DATES OF PROPOSED PERIOD OF 7. COSTS REQUESTED FOR INITIAL 8. COSTS REQUESTED FOR PROPOSED SUPPORT (month, day, year—MM/DD/YY) BUDGET PERIOD PERIOD OF SUPPORT From Through 7a. Direct Costs ($) 7b. Total Costs ($) 8a. Direct Costs ($) 8b. Total Costs ($)

9. APPLICANT ORGANIZATION 10. TYPE OF ORGANIZATION Name Public:  Federal State Local Address Private:  Private Nonprofit

For-profit:  General Small Business Woman-owned Socially and Economically Disadvantaged

11. ENTITY IDENTIFICATION NUMBER Cong. District

12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE 13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION

Name Name

Title Title Address Address

TEL: FAX: TEL: FAX: E-Mail: E-Mail:

14. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that SIGNATURE OF OFFICIAL NAMED IN 13. DATE the statements herein are true, complete and accurate to the best of my knowledge, and (In ink. “Per” signature not acceptable.) accept the obligation to comply with PCORI terms and conditions if a grant is awarded as a result of this application. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties.

PCORI Grant Application (Rev. 09/11) Page 1 Form A: Face Page Program Director/Principal Investigator (Last, First, Middle): FORM B: PCORI GRANT APPLICATION TABLE OF CONTENTS

Page Numbers Form A: Face Page...... 1 Form B: Table of Contents...... 2 Form C: Description...... 3 Form D: Project/Performance Sites...... Form E: Senior and Key Personnel and Other Significant Contributors...... Form F: Consolidated Budget Summary for Entire Proposed Project Period...... Form G: Direct Costs Budget Summary(ies) (for Applicant Organization)...... Forms G-1—G-7 Direct Costs Budget Details (for Applicant Organization)...... Form G: Direct Costs Budget Summary(ies) (for Consortium/Contracts) ...... Forms G-1—G-7 Direct Costs Budget Details (for Consortium/Contracts) ...... Form H: Resources...... Form I: Biographical Sketches...... Form J: Checklist...... Addendum Forms (only as required by the specific PFA)...... Research Plan...... 1. Specific Aims...... 2. Research Strategy...... 3. References Cited ...... 4. Protection of Human Subjects ...... 5. Consortium/Contractual Arrangements ...... 6. Letters of Support ...... 7. Resource Sharing Plan(s) ......

PCORI Grant Application (Rev. 09/11) Page 2 Form B

Program Director/Principal Investigator (Last, First, Middle): FORM C: DESCRIPTION

PROJECT SUMMARY (See instructions)

RELEVANCE (See instructions)

PCORI Grant Application (Rev. 09/11) Page 3 Form C Program Director/Principal Investigator (Last, First, Middle): FORM D: PROJECT/PERFORMANCE SITE(S) (Duplicate this page as needed for additional responses) Project/Performance Site Primary Location

Organizational Name: Street 1: Street 2: City: County: State: Province: Country: Zip/Postal Code: Project/Performance Site Congressional District: Additional Project/Performance Site Location

Organizational Name: Street 1: Street 2: City: County: State: Province: Country: Zip/Postal Code: Project/Performance Site Congressional Districts: Additional Project/Performance Site Location

Organizational Name: Street 1: Street 2: City: County: State: Province: Country: Zip/Postal Code: Project/Performance Site Congressional District: Additional Project/Performance Site Location

Organizational Name: Street 1: Street 2: City: County: State: Province: Country: Zip/Postal Code: Project/Performance Site Congressional District:

PCORI Grant Application (Rev. 09/11) Page Form D Program Director/Principal Investigator (Last, First, Middle): FORM E: SENIOR & KEY PERSONNEL (Use continuation pages as needed to provide the required information in the format shown below.) Name Organization Role on Project

OTHER SIGNIFICANT CONTRIBUTORS Name Organization Role on Project

PCORI Grant Application (Rev. 09/11) Page Form E

Program Director/Principal Investigator (Last, First, Middle):

FORM F: BUDGET SUMMARY FOR ENTIRE PROPOSED PROJECT PERIOD

5th ADDITIONAL INITIAL BUDGET 2nd ADDITIONAL 3rd ADDITIONAL 4th ADDITIONAL BUDGET CATEGORY YEAR OF PERIOD YEAR OF SUPPORT YEAR OF SUPPORT YEAR OF SUPPORT TOTALS SUPPORT REQUESTED REQUESTED REQUESTED REQUESTED SECTION 1: DIRECT COSTS

PERSONNEL: (Salary and fringe benefits)

CONSULTANT COSTS

EQUIPMENT

SUPPLIES

TRAVEL

OTHER EXPENSES

CONSORTIUM/ CONTRACTUAL DIRECT COSTS

SUBTOTAL DIRECT COSTS

TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD $ SECTION 2: INDIRECT COSTS

APPLICANT AGENCY INDIRECT COSTS CONSORTIUM/ CONTRACTUAL INDIRECT COSTS

TOTAL COSTS

TOTAL COSTS FOR ENTIRE PROPOSED PROJECT PERIOD $

PCORI Grant Application (Rev. 09/11) Page Form F

Program Director/Principal Investigator (Last, First, Middle): FORM G: DIRECT COSTS BUDGET SUMMARY (FOR A SINGLE BUDGET YEAR)

BUDGET FOR: BUDGET YEAR: START DATE END DATE

PROPOSED BUDGET CATEGORY COSTS DIRECT COSTS TOTALS Line

1 PERSONNEL COSTS (Salary and fringe benefits)

2 CONSULTANT COSTS

3 EQUIPMENT COSTS

4 SUPPLY COSTS

5 TRAVEL COSTS

6 OTHER DIRECT COSTS

7 DIRECT CONSORTIUM/CONTRACTUAL COSTS

8 TOTAL DIRECT COSTS

PCORI Grant Application (Rev. 09/11) Page Form G

Program Director/Principal Investigator (Last, First,Middle): FORM G-1: DIRECT PERSONNEL COSTS BUDGET DETAIL (FOR A SINGLE BUDGET YEAR)

ROLE ON % TIME ON INST.BASE SALARY FRINGE NAME PROJECT PROJECT SALARY REQUESTED BENEFITS COST PD/PI

SUBTOTAL FOR PERSONNEL COSTS

BUDGET JUSTIFICATION:

PCORI Grant Application (Rev. 09/11) Page Form G-1

Program Director/Principal Investigator (Last, First, Middle): FORM G-2: DIRECT CONSULTANT COSTS BUDGET DETAIL (FOR A SINGLE BUDGET YEAR)

ORGANIZATIONAL Expected CONSULTANT NAME AFFILIATION Hours Fees Travel Other COST

SUBTOTAL FOR CONSULTING COSTS

PCORI Grant Application (Rev. 09/11) Page Form G-2 Program Director/Principal Investigator (Last, First, Middle): FORM G-3: DIRECT EQUIPMENT COSTS BUDGET DETAIL (FOR A SINGLE BUDGET YEAR)

ITEM OF EQUIPMENT COST

SUBTOTAL FOR EQUIPMENT COSTS

Program Director/Principal Investigator (Last, First, Middle): FORM G-4: DIRECT SUPPLY COSTS BUDGET DETAIL (FOR A SINGLE BUDGET YEAR)

SUPPLY CATEGORY COST

SUBTOTAL FOR SUPPLY COSTS

Program Director/Principal Investigator (Last, First, Middle): FORM G-5: DIRECT TRAVEL COSTS BUDGET DETAIL (FOR A SINGLE BUDGET YEAR)

NUMBER OF PURPOSE DESTINATION PEOPLE COST

SUBTOTAL FOR TRAVEL COSTS

PCORI Grant Application (Rev. 09/11) Page Form G-5 Program Director/Principal Investigator (Last, First, Middle): FORM G-6: DIRECT OTHER COSTS BUDGET DETAIL (FOR A SINGLE BUDGET YEAR)

ITEMIZED EXPENSE COST

SUBTOTAL FOR OTHER DIRECT COSTS

PCORI Grant Application (Rev. 09/11) Page Form G-6 Program Director/Principal Investigator (Last, First, Middle): FORM G-7: DIRECT CONSORTIUM & CONTRACTUAL COSTS BUDGET DETAIL (FOR A SINGLE BUDGET YEAR)

CONSORTIUM MEMBER ORGANIZATION OR CONTRACTOR COST

SUBTOTAL FOR CONSORTIUM & CONTRACTUAL COSTS

BUDGET JUSTIFICATION

PCORI Grant Application (Rev. 09/11) Page Form G-7 Program Director/Principal Investigator (Last, First, Middle):

FORM H: RESOURCES

RESOURCES:

PCORI Grant Application (Rev. 09/11) Page Form H Program Director/Principal Investigator (Last, First, Middle): FORM I: BIOGRAPHICAL SKETCH (Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form E. Follow this format for each person. Do not exceed four pages per person.)

NAME POSITION TITLE

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION DATE FIELD OF STUDY (if applicable)

SKETCH (use headings found in the instructions, adding continuation sheets, as needed, up to 4 total pages)

PCORI Grant Application (Rev. 09/11) Page Form I Program Director/Principal Investigator (Last, First, Middle):

FORM J: CHECKLIST

1. TYPE OF APPLICATION. (Check all that apply.)

NEW application. (This application is being submitted to PCORI for the first time.)

RESUBMISSION of application. (This replaces an unfunded version.) Enter original application no:

RENEWAL of grant. (Requests additional funding beyond current year.) Enter current grant no:

SUPPLEMENT to grant. (Requests additional funding for current year.) Enter current grant no:

CHANGE of principal investigator. (Enter name of former PI in the following box)

CHANGE of grantee organization. (Enter name of former organization in the following box)

FOREIGN application Domestic grant with foreign involvement (Enter countries involved)

2. PATIENT-FOCUSED AREAS. (Select all patient-centered questions applicable to proposed research)

“Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” “What are my options, and what are the benefits and harms of those options?”

“What can I do to improve the outcomes that are most important to me?”

“How can the health care system improve my chances of achieving the outcomes I prefer?”

3. TARGET POPULATIONS. (Select all populations that the proposed research will specifically target)

Underserved or disadvantaged populations

Specific ethnic or cultural populations

Disabled populations

Urban Rural Both Urban and Rural

Other (enter information):

Not applicable

4. CERTIFICATION In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions and PFA, including all Check to certify agreement references within them, when applicable. If unable to certify compliance, where applicable, provide an explanation and place it after this page.

PCORI Grant Application (Rev. 09/11) Page Form J

Program Director/Principal Investigator (Last, First, Middle): ADDENDUM FORM: PCORI PILOT PROJECTS AREAS OF INTEREST

Eligible projects under this PFA must address one or more of the following PCORI areas of interest. Please check all that apply to the proposed research project:

Developing, testing, refining, and/or evaluating new or existing methods (qualitative and quantitative) and approaches that can inform the process of establishing and updating national priorities for the conduct of patient-centered outcomes research (PCOR). This may include research prioritization approaches (such as Value of Information (VOI), burden of illness, peer review/expert opinion/Delphi approaches) or methods for incorporating the perspectives of patients or other stakeholders into the development of national priorities. Developing, testing, and/or refining existing methods for bringing together patients, caregivers, clinicians including non-traditional partners, and other stakeholders in all stages of a multi-stakeholder research process, from the generation and prioritization of research questions to the conduct and analysis of a study to dissemination of study results – including methods for training participants in participatory research and the potential use of new technologies to facilitate engagement. Developing, refining, testing, and/or evaluating patient-centered approaches, including decision-support tools, for translating evidence-based care into health care practice in ways that account for individual patient preferences for various outcomes. This may include developing or comparing conceptual models of translation or dissemination of CER research findings from the patient perspective. Developing, refining, testing, and/or evaluating methods to identify gaps in CE knowledge such as tools for the ongoing collection and assessment of gaps as perceived by patients and providers. Of special interest are gaps that are particularly relevant to vulnerable populations, including but not limited to, low-income populations; minorities; children; the elderly; women; and people with disabilities, chronic, rare, and/or multiple medical conditions. Identifying, testing, and/or evaluating patient-centered outcomes instruments. This may include predictive tools (e.g.: instruments that measure or predict outcomes of interest to patients) or identifying standards for measurement properties of patient-reported outcomes for use in comparative effectiveness research, across a variety of interventions and patient populations. Identifying, testing, and evaluating methods that can be used to assess the patient perspective when for researching behaviors, lifestyles, and choices within the patient’s control that may influence their outcomes. Identifying, testing, refining and/or evaluating methods for studying the patient care team interaction in situations where multiple options for wellness, prevention, diagnosis or treatment exist. Of special interest are strategies that respect patient autonomy and promote informed decision-making, incorporating the best health care knowledge into the application of care. Advancing analytical methods for CER. Examples include but are not limited to the incorporation of mixed methods research designs (qualitative/quantitative), identifying existing methodology to statistically accommodate irregularly spaced multivariate longitudinal data, the use of instrumental variables; and potential solutions for assessing treatment heterogeneity in observational and randomized CER studies.

PCORI Pilot Projects Page Addendum Form