Eco Project Space ID:
Name of PI:
REACHnet Prospective Research Request Form
RESEARCH TEAM
1.) Provide the name, role, and institution of all research team personnel. Select only one role per person.
Name
a.
b.
c.
d.
e.
f.
g.
h.
Principal
CoInvestigator Investigator
Other
Institution
TITLE AND DESCRIPTION
2.) Title of proposed study:
3.) Provide a description of the proposed project. (250 words)
Note: If applicable, upload Letter of Intent (LOI) to Eco.
4.) List the research objectives and/or specific aims of the study.
5.) What type of research will be conducted in the proposed study? Choose from the list below; you may select multiple
options:
Observational Research using de-identified or limited data (without subject contact)
Survey research
Longitudinal non-randomized study with subject recruitment and data collection
Randomized Clinical Trial
Other (please describe):
GENERAL INFORMATION
6.) Funder and mechanism:
7.) Title of funding announcement (and link), if applicable:
8.) Funding amount:
9.) Duration:
10.) If submitting a Letter of Intent (LOI) or funding application, provide the due date(s):
Version Date: November 2015
1
11.) Are you requesting a letter of support from REACHnet to include in your submission? If so, by when are you
requesting to receive this?
STUDY POPULATION
Note: To request a query of the REACHnet patient population that meets the study’s inclusion/exclusion criteria,
please complete the REACHnet Query Request Form.
12.) Describe the study’s target population and planned subgroup analyses. (2-5 sentences)
13.) List all inclusion and exclusion criteria including clinical and demographic characteristics.
14.) Desired sample size for this project:
PARTICIPATING SITES
Note: To request REACHnet’s assistance with identifying additional study sites, please see question 25c.
15.) List co-investigator(s) and/or partner(s) on this project, according to site/institution.
Site
Name of co-investigator or partner at site
Tulane University Medical Center
Ochsner Health System
LSU-affiliated sites
Baylor Scott and White Health
Partnership for Achieving Total Health
(PATH)/Greater New Orleans Health Information
Exchange (GNOHIE) sites (e.g. EXCELth, Access
Health, etc.)
Other (please describe):
INFORMED CONSENT
Note: If approved by IRB, REACHnet has the ability to administer E-Consent.
16.) Will the study require obtaining informed consent from patients?
17.) Will the study require obtaining informed consent from clinicians?
BACKGROUND
18.) Describe how the condition or disease being studied is associated with a significant burden in the US population, in
terms of prevalence, mortality, morbidity, individual suffering, or loss of productivity. Alternatively, explain how the
condition or disease imposes a significant burden on a smaller number of people who have a rare disease. (2-5
sentences)
19.) Describe how variations in current practice suggest clinical uncertainty. (2-5 sentences)
Version Date: November 2015
2
20.) Describe how the research is novel or innovative in its methods or approach, in the population being studied, or in
the intervention being evaluated in ways that make it likely to improve care. (2-5 sentences)
21.) Describe how the proposed research will help patients address one or more of the following key questions. (5-7
sentences)
 Given my personal characteristics, conditions, and preferences, what should I expect would happen to me?
 What are my options, and what are the potential benefits and harms of those options?
 What can I do to improve the outcomes that are most important to me?
 How can clinicians and the care delivery systems they work in help me make the best decisions about my health
and health care?
22.) Are the comparison interventions realistic options that exist in current practice? Please explain, if applicable. (2-5
sentences)
TIMELINE
23.) General timeline for the proposed project:
REACHnet RESOURCES AND SERVICES
24.) Describe how the proposed project will use the REACHnet Pragmatic Trial Application Suite, if applicable. (2-5
sentences)
Note: The Pragmatic Trial App Suite (PTAS) can be used for recruitment, patient-reported data collection, and trial management.
More information can be found on our website.
25.) Indicate if you would like to use any of REACHnet’s other resources.
Note: Services will require appropriate budget allotments.
a.) Assistance with developing and writing proposal.
b.) Convening stakeholder advisory groups and/or developing engagement plan.
Yes
Yes
No
No
Yes
Yes
Yes
No
No
No
Note: If you are interested in REACHnet engagement services, please complete the
Request for Engagement Services.
c.) Assistance in recruiting health systems/sites.
d.) Collecting patient-reported data.
e.) Access to REACHnet’s patient network, Health in Our Hands.
DATA NEEDS
26.) Describe the project’s data needs:
a.) Clinical data elements (please reference the PCORnet Common Data Model):
Version Date: November 2015
3
b.) Patient-Reported Outcomes (PROs), if applicable:
c.) Patient-Generated Data (PGD), if applicable:
PATIENT AND STAKEHOLDER ENGAGEMENT
27.) Describe the types of patients and/or other stakeholders that will be engaged in the research process. (2-5
sentences)
28.) Describe how the aforementioned individuals will be involved in the following project components. (5-7 sentences)
 Formulating research questions
 Defining essential characteristics of study participants, comparators, and outcomes
 Identifying and selecting outcomes that the population of interest notices and cares about (e.g., survival,
function, symptoms, health-related quality of life) and that inform decision making relevant to the topic
 Monitoring study conduct and progress
 Informing plans for dissemination and implementation activities
29.) If applicable, describe how patients and clinicians have been involved in project development up to this point.
DISSEMINATION
Note: All studies are required to disseminate results to REACHnet’s partners and stakeholders through the
network’s dissemination mechanisms.
30.) Specify dissemination mechanisms for specific stakeholder groups (e.g. study participants, the target clinical
community, etc.).
Version Date: November 2015
4