PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
LETTER OF INTENT TEMPLATE: IMPROVING HEALTHCARE SYSTEMS
Please provide the information requested below. Statements in gray italics denote how each response will be evaluated. Replace the italicized
gray text with your response. Please note that the total word count may not exceed 1,700 words, including the template, which is
847 words. Citations are not included in the word count and should be included at the end of the document. We recognize that you will not be able
to include many details.
NOTE: This Letter of Intent Template is for screening purposes only. If you are invited to submit an application, other criteria are required and will be
reviewed.
TITLE OF PROPOSED STUDY:
Study Size: State whether the study is small (up to $1.5 million in total direct costs for up to three years) or large (up to
$5 million in total direct cost for up to five years).
State the study size, small or large, estimated budget, and time frame. Include justification for the size.
Specific Aims*: State the specific aims of this study.
Specific aims should be clearly stated.
Burden and Impact of Condition or System-Level Issue: Briefly state the importance of the condition and/or systemlevel issue in terms of prevalence and/or impact.
High prevalence and/or association with significant suffering for populations or significant burden of disease for
individuals, or significant impact on the healthcare system.
Research Priorities/Gap Analysis: State if you are addressing a research priority listed in the Improving Healthcare
Systems (IHS) funding announcement. The proposal should align with at least one of the IHS program intervention
targets listed in the “Background” section of the funding announcement.
Indicate if you are testing the effectiveness of novel uses of technology, incentives, or organizational initiatives, for
example.**
Description of Patients: Describe the study population, including the age range, demographics, sources of study
population, and main eligibility criteria.
Provide a clear description of the patient population.
Description of Outcomes: Describe and justify outcome measures in terms of goals of strategies (e.g., preventing stroke,
improving quality of life).
Describe the patient-centeredness of outcomes; be sure they are clearly defined and measurable, documented
validations of the outcome measure.
PCORI LOI Technical Abstract Template (PFAs #1-4)
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
Comparators: List options that are being compared.
Comparators should be clearly stated; applications using usual care as a comparator must provide some definition of
usual care beyond just those words.
1.
2.
3.
“Real-Life” Applicability of Strategies: State how the intervention will be delivered and received in “real-life” clinical
settings and will provide practical information that can help patients and other stakeholders make informed decisions
about their health care and health outcomes.
Provide a description of how the strategies will be delivered in actual “real-life” care strategies.
Established Efficacy or Effectiveness: Provide evidence of efficacy or effectiveness of comparator(s) or that comparator
is accepted practice despite inadequate evidence of efficacy.
Known efficacy, effectiveness, or established practice should be documented; lack of this information suggests that the
proposal is intended to establish efficacy, which is discouraged.
Engagement: Briefly state how patients and stakeholders (e.g., insurers, payers, healthcare systems, employers, and
clinical societies) are involved, and list specific organizations involved.
Involvement throughout planning and conduct of the project should be discussed.
Study Design: Indicate whether the main comparative effectiveness research (CER) question in the study is to be
addressed as a randomized trial (individual level or cluster); observational study (retrospective, prospective); quasiexperimental study; or other (please specify).
Study design clearly described and defended, including description of how selection bias and confounding will be
mitigated in any nonrandomized design.
Sample Size: Provide the total sample size for the main CER analysis and the number per arm (N1, 2, 3, 4 . . .), as applicable.
As a general guide, <50 per arm will be viewed skeptically, unless the condition is rare.
N (total)
N1
N2
N3
Hypothesized Effect Size for Intervention on Main Patient-Centered Outcome: State hypothesized effect size and cite
references to support that the effect size is (a) realistic and (b) clinically meaningful.
Effect size is documented to be realistic, based on published evidence, and meaningful to patients.
PCORI LOI Technical Abstract Template (PFAs #1-4)
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
Power Calculations: State the power of the proposed study to detect the hypothesized effect, including support for all
assumptions, including type-1 error level, standard deviation in outcome measure, underlying event rate, etc. Note
power for important subgroups, if applicable.
Assumptions are clearly stated and supported.
Timing: State duration of intervention and length of follow-up.
Follow-up is realistic within three-year time frame (if small study) or five years (if large) and sufficient to produce
meaningful outcomes.
*Applicants should make sure that specific aims of their research do not include a formal cost-effectiveness analysis or
direct comparison of costs of care as the criterion for choosing the preferred alternative.
**The Improving Healthcare Systems program has funded a large number of projects that focus on novel deployment of
new personnel, such as case managers, liaisons, and other roles for coordinating care. Applications that aim to study
these types of interventions will undergo additional scrutiny to ensure that the studies do fill a significant gap within the
program’s portfolio.
WORD COUNT: ____ (Must be <1,700 words in total; note that the template is 847 words.)
PCORI LOI Technical Abstract Template (PFAs #1-4)
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