Strategies to Prevent Unsafe Opioid Prescribing in Primary Care among Patients with Acute or Chronic Non-Cancer Pain Applicant Town Hall Cycle 3, 2016 November 3, 2016
Agenda • Research Strategy • Patient Engagement and Engagement Plan • Additional sections required for your application • The Merit Review Process • Questions Submit questions via the chat function in Meeting Submitting Questions: Bridge. Ask a question via phone (an operator will standby to take your questions).
Introductions Bridget Gaglio Bill Lawrence Penny Mohr Andrea Brandau Senior Program Officer Senior Program Officer Senior Program Officer Program Officer Carolyn Mohan Merit Review Officer Mercedes Alexander Michelle Henton Program Associate Contracts Administrator
Your letter of intent (LOI) was reviewed and you have been invited to submit a full application…….. CONGRATULATIONS!
Letter of Intent and Application You were invited to submit a full application based on the information provided in the LOI; changes after the LOI require PCORI approval. Show stoppers include: Changes Changes Changes to the Changes to Changes Changes to the Changes to to the Budget/ Period Research to Specific to the PI Study Comparators Institution of Performance Question Aim Design
Application Requirements
Preparing Your Application • To begin, all applicants should: • Read the funding announcement and review the PCORI Application Guidelines Document • Review the PCORI Research Plan Template • Have a copy of your approved LOI readily accessible 7
Tips for Success • Clearly identify which of the two priority questions (or both) you are trying to address in the application. • Clearly describe comparators for the study • Document evidence of efficacy/effectiveness for the intervention and comparator(s) and/or demonstrate that they are in widespread use • Clearly demonstrate the feasibility of the study • Show that have the team to do this and you are the right team • Define and support your recruitment and retention plan • Document that sites are already committed to participating • Include realistic timelines for site start-up, IRB approval, and recruitment
Research Strategy: Overview • Use the Research Plan Template as your guide • Background • Significance • Study Design or Approach • Specific Aims • Methods • Patient Population • Recruitment Plan • Estimated Racial/Ethnic and Gender Enrollment Table • Research Team and Environment • Engagement Plan • PLEASE provide all the information requested, as Page outlined in the template. Limit 20 9
Research Strategy: Study Design/Approach • Document how proposed study will fill the evidence gap. • Include a clear conceptual framework, theory or model that anchors the background, significance, and informs the design, key variables, and relationships being tested. • Clearly describe and justify comparators, including usual care. • Document efficacy/effectiveness and/or frequency of proposed comparator(s) in clinical practice. • Provide clear justification for the study design and outcome measures. • Include clear rationale for sample sizer, power estimates, and effect sizes, and support rationale with evidence or pilot work. • Demonstrate that your study is feasible by outlining realistic strategies for participant recruitment and retention or by providing preliminary data analysis for observational approaches.
Research Strategy: Methodology Standards In any study, methods are critical . PCORI’s Methodology Committee developed Methodology Standards to which patient-centered CER must adhere Methodology Standards: 11 Specific Categories • • Data Networks Formulating Research Questions • Data Registries • Patient-Centeredness • Adaptive and Bayesian • Data Integrity and Rigorous Trial Designs Analyses • Causal Inference • Preventing/Handling Missing • Studies of Diagnostic Data Tests • Heterogeneity of Treatment • Systematic Reviews Effects
Research Strategy: Patient Population and Recruitment • Provide numbers for the pool of potential participants, those estimated to be eligible, and the expected participation rate • Discuss past experience with recruitment of the target population • Provide preliminary evidence of the potential for successful recruitment and document rationale for proposed retention rate • Discuss barriers to recruitment and retention and how you plan to overcome them • Discuss how and why study sites were selected • Complete Recruitment Plan for Prospective Studies table • Complete Estimated Racial/Ethnic and Gender Enrollment table
Research Strategy: Engagement Plan • Describe the plan to engage patients and stakeholders meaningfully in the various phases of the proposed research • Planning the study • Designing the study • Conducting the study • Evaluating the study
Research Plan Template: Dissemination & Implementation Potential • Describe the potential for disseminating and implementing the results of this research in other settings • Describe possible barriers to disseminating and implementing the results of this research in other settings • Describe how you will make study results available to study participants after you complete your analyses PCORI does not expect applicants to disseminate Page and implement findings at this time Limit 2
Research Plan Template: Replication & Reproducibility of Research and Data Sharing • Describe the ability to reproduce potentially important findings from this research in other data sets and populations • Describe your data management and sharing plan, including how you will make study data sets available in a manner that is consistent with applicable privacy, confidentiality and other legal requirements, if requested. • Propose a budget to cover costs of your data-sharing plan, if requested Page Limit 2
Research Plan Template: Protection of Human Subjects • Provide a Data and Safety Monitoring Plan that operates under the auspices of your institution • Assure that key personnel are educated on human subjects protections • Assure appropriate informed consent • Establish procedures to minimize risks to participants • Establish procedures to protect privacy and maintain confidentiality • If you anticipate seeking waiver of individual informed consent, provide the rationale • Refer to NIH standards for research involving Page human subjects Limit 5
Research Plan Template: Consortium Contractual Arrangement • Describe the proposed research projects that will be performed by subcontracted organizations • Explain the strengths that these partners bring to the overall project Page Limit 5
Research Plan Template: References Cited • Following scholarly citation practice, list the source material cited in the Research Plan. Page Limit 10
Research Plan Template: Appendix • PCORI applications may include an appendix for additional materials the investigators think may be useful • Reviewers will not be required to include the appendices in the review and assessment of the project • Examples of additional materials are: • Survey instruments • Papers and publications Page Limit 10
Milestones/Deliverables Template Milestones: Significant events or accomplishments within the project; may have deliverables associated with them Deliverables: Measurable and verifiable outcomes or objects that a project team must create and deliver according to the contract terms
Example of Milestone Schedule
People and Places Template: Biosketch • You may use the NIH biosketch or PCORI’s format • Biosketches are required for all key personnel • List all partners within the Key Personnel section • Patient/Stakeholder Biosketch Page Limit 5 Per person
People and Places Template: Project / Performance Site(s) • Demonstrate that the proposed facilities have the appropriate resources required to conduct the project to plan, within budget, and on time. • Provide a description of the facilities that will be used during the project, including capacity, capability, characteristics, proximity, and availability to the project Page Professional Limit Profile/Biosketch 15
Leadership Plan Template ( Dual PI application) • Describe the governance and organizational structure of the leadership team and the research project; • Delineate the administrative, technical, scientific, and engagement responsibilities for each PI and the rationale for submitting a dual-PI application; • Discuss communication plans and the process for making decisions on scientific and engagement direction; Page • Describe the procedure for resolving conflicts. Limit 5
Letters of Support • Save all letters of support as single PDF file prior to uploading to the PCORI Online System. • All letters of support should be addressed to the PI and demonstrate the commitment of key personnel and supporting organizations to your proposed project. • Letters of support should clearly reflect the substantive involvement and material contribution to be provided by the signatory parties, and are meant to substantiate the commitment of collaboration of all forms. • Each letter of support should be unique.
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