Are LOIs required?
Yes. All applicants must submit an LOI before submitting an application. LOI review will be competitive, and only applicants whose LOIs are deemed most responsive to this PFA will be invited to submit a full application.
What information is required for the LOI?
The LOI for the proposed project should contain all information described below.
- Title of proposed project
- Original PCORI research award number, original research project title, and name of original PI
- Clear indication of whether you are:
- Proposing to implement an SDM strategy that was formally tested and demonstrated to be effective in a PCORI research award
- Proposing an implementation project that will incorporate new PCORI CER evidence into an existing and tested SDM strategy, and then implement the updated strategy
- Objective and specific aims of the proposed implementation project
- Identification of the preference-sensitive decision the proposed SDM strategy addresses and clear indication of how this new PCORI evidence contributes to patient or provider decision making
- Description of the implementation problem (e.g., use of the evidence, gaps in informed decision making) that motivate the proposed project
- Description of the PCORI research findings and related evidence most relevant to your proposed implementation project
- If the PCORI project tested an SDM approach, describe the PCORI study results, including effectiveness on patient-centered decisional outcomes. Describe the body of evidence associated with the SDM approach and how the study findings contributed to this evidence base.
- Further, describe the evidence that was summarized and presented within this SDM approach in the PCORI research study and how it relates to the body of evidence related to this health decision. If the evidence will be updated for the proposed project, describe and explain the revised presentation of evidence.
- If the PCORI project produced new evidence that will be incorporated into an existing effective SDM approach, describe the most relevant results of the PCORI study, the evidence base surrounding those findings, and the evidence base relevant to the chosen SDM approach.
- Identification and description of the setting(s) in which implementation will take place, the immediate target of the implementation activity, and a logical pathway describing how affecting change in the proposed target audience and setting will ultimately change healthcare outcomes and delivery
- Description of the multi-component approach being proposed for implementing the SDM strategy
- Description of the evaluation plan that assess the effectiveness of the proposed implementation approach as well as the continued effectiveness of the SDM strategy on relevant decisional, clinical, and utilization outcomes. The evaluation plan should include an appropriate balance of measurable process, proximal, and distal outcomes. Additionally, all evaluation plans must include the CollaboRATE measure for SDM.
- Description of how patients and other relevant stakeholder groups are involved in the planning and implementation of this effort
How much can the protocol proposed in my application differ from that initially described in my LOI?
Applicants should not make major changes to their application, including changes to implementation approach, specific aims, institution, or PI without prior approval from the D&I Program. Applicants are invited to apply based on the information provided in the LOI. If you need to change any of this information or have any questions, email email@example.com.
Can I list a different PI in the final application than was listed in the LOI?
No. If the PI changes between the LOI phase and the application phase, applicants must speak with a Program Officer before the deadline to obtain approval. Failure to obtain written approval before the deadline may result in the application being rejected.
I missed the deadline to submit an LOI. Can I still submit an application?
No. Unfortunately, only applicants who submit an LOI can submit an application.
Can the PI submit the LOI via his or her account, or does the LOI need to be submitted by the institutional AO?
The PI should submit the LOI for the project because he or she will be PCORI’s main point of contact. An AO is required to submit the full application.
Can multiple people access the LOI?
Yes. The PI may assign a “PI Designee” to access and edit the LOI. Only one person can work on the application in PCORI Online at a time.
What budget information is required for the LOI? How detailed does it need to be?
Only a budget estimate is required to complete the LOI. A full budget will need to be provided at the application stage.
How soon after I submit my LOI can I begin my application?
Only applicants whose LOIs are deemed most responsive to this PFA will be invited to submit a full application. Invited applicants may begin the application process as soon as they receive their LOI feedback—about a month after the LOI due date. However, the PCORI DFRR must be accepted and/or a manuscript must be accepted for publication in a peer-reviewed scientific journal before the application deadline.
How should I format my LOI using the template PCORI provides?
All LOIs should be completed using Calibri font size 11 and single spacing. Replace the italicized gray and any instructional text with your response. You must retain the bold headings and question numbers, and write your responses directly after the bold headings. Applicants are also required to use half-inch margins. (The header may fall within the top margin, but the body text should not begin closer than a half-inch from the edge of the page.) You do not have to provide spaces between questions. Please view the Sample SDM LOI.