PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):

LETTER OF INTENT (LOI) TEMPLATE: STRATEGIES TO PREVENT UNSAFE OPIOID PRESCRIBING

Instructions:

An LOI is required for all applications. Provide the information requested on the attached template. You must answer all questions listed in the template. Aside from removal of the questions under each section header, no other modifications may be made to this template; any modifications will result in administrative withdrawal of the LOI. Applicants are required to follow the rules and guidelines listed below.

  1. Replace the questions on the next page with your response, but retain the question numbers.
  2. Do not include figures or general tables. Tables can only be included for power calculations.
  3. References will not be included within the three-page limit.
  4. Do not upload this cover page.
  5. Do not include supplemental materials (e.g., supporting journal articles and Letters of Support) or additional information not requested on the template (e.g., responses to reviewer comments). Their inclusion will result in LOI rejection without review.

Any additional template modifications will result in disqualification of your LOI. The LOI must be submitted as a PDF in PCORI Online.

Formatting Guidelines:

  • Header: Include the Principal Investigator’s (PI) full name on every page in the top-left corner
  • Font: Calibri size 11
  • Spacing: Single
  • Margins: Half-inch (The header may fall within the top margin, but the body text may not begin closer than a half-inch from the edge of the page.)
  • Page numbers: Consecutive
  • Page limit:Three pages (exluding references)
  • File name format:PI Last Name_(last four digits of Request ID)_LOI.pdf. A Request ID number will be automatically generated once the LOI has been saved. Upon selecting the “Save and Review” button, the new Request ID number will be visible at the top of the web page inPCORI Online.
  • References:PCORI suggests including all references as in-text citations using American Medical Association citation style, but other citation styles are accepted.

LOIs are competitive and will be screened by PCORI staff. The information included in this template will be used as the primary source of information for the screening process. Focus on including critical information because space is limited. Provide a description that allows the scientific community to understand the project—including the aims and study design—without reviewing the full application.If you have any additional questions, contact PCORI at or 202-627-1885 for administrative inquiries and or 202-627-1884 for programmatic inquiries.

LETTER OF INTENT (LOI) TEMPLATE: STRATEGIES TO PREVENT UNSAFE OPIOID PRESCRIBING

TITLE OF PROPOSED STUDY

IMPORTANCE

  1. What is the precise question listed in the funding announcement your research is designed to address?
  2. Why is this particular comparison important to a patient or other decision maker for addressing this question? How would you characterize the decision dilemma faced by patients, clinicians, and other decision makers in choosing among the specific set of options you propose to compare?

OBJECTIVES

  1. What are the specific aims of the study?

METHODS

  1. Describe:

a)Study design

b)Study population and proposed inclusion and exclusion criteria; specifically, is your study targeting the acute and/or chronic pain population

c)Comparators (the two or more options being compared)

d)Definition of unsafe prescribing of opioids, including how it will be measured

e)Study outcomes, including measures important to patients and families

  1. Have the comparators been shown to be efficacious or effective for preventing unsafe prescribing for opioids for new users or patients who have been on opioids for less than three months, or are they commonly used in clinical practice? Provide documentation supporting your response.
  2. If not, have they been shown to be efficacious or effective in other populations? Provide arationale for why they may be effective in addressing the primary aims of the specific question in this funding announcement that your study is addressing.
  3. What is the estimated sample size? Explain the rationale for this sample size and cite references that support the assumptions underlying the estimate, including the estimated effect size.
  4. If you are proposing a prospective, observational study, what methods will you use to address concerns about causal inference?
  5. What are the particular pertinent clinical subpopulation groups? Document the pre-specified subgroup analysis and any methodological or statistical considerations. Provide the rationale that the proposed study is adequately powered to allow a rigorous and valid analysis comparing these subgroups.

PATIENT AND STAKEHOLDER ENGAGEMENT

  1. Identify the patients and other relevant stakeholders you consulted in determining that the proposed study addresses their needs for evidence to help decision making. Recommend the potential national organization(s) who needs to be involved in collaborating with you on all aspects of the study, including study planning, execution, and dissemination of study findings. Describe your commitment to actively engaging them in the conduct of the study.

PRIOR RELEVANT EXPERIENCE

  1. What is your previous experience with recruiting and retaining study participants in trials of a similar size, study design, and target population(s)? Describe potential barriers to achieving the targeted sample size and potential methods to overcome the barriers.

ANTICIPATED IMPACT

  1. If the proposed intervention is found to be effective, what factors (e.g., characteristics of the intervention or the target environment) will facilitate or impede its sustainability and scalability in real-world settings?

DURATION AND TOTAL DIRECT COSTS

  1. What are the estimated total costs, and what is the project duration of the proposed study?

a)Provide a brief justification indicating how the funds will be used and why the level of funding and duration requested are appropriate. Answers such as “will not exceed $5 million” are not adequate and will be deemed nonresponsive.

b)Include the names of any organizations or institutions that you plan to list as subcontractors or partners on your project.

  1. If you are requesting funding for a project with a budget that exceeds the PFA limits, please provide:

a)The total dollar amount requested

b) A justification for the additional funds requested for your proposed study

(Write “Not Applicable” if not relevant.)

REFERENCES

1

PCORI Cycle 2 2017 Letter of Intent Template: Strategies To Prevent Unsafe Opioid Prescribing