Reachnet Prospective Research Request Form

Name of PI:

REACHnet Prospective Research Request Form

RESEARCH TEAM

1.)Provide a brief biosketch of the Principal Investigator or upload CV to ECO.
2.) Provide the name, role, and institution of all research team personnel. Select only one role per person.
Name / Principal Investigator / Co-Investigator / Other / Institution
a.
b.
c.
d.
e.
f.
g.
h.

TITLE AND DESCRIPTION

3.) Title of proposed study:
4.) Provide a description of the proposed project. (250 words)
Note: If applicable, upload Letter of Intent (LOI) to Eco.
5.) List the research objectives and/or specific aims of the study.If your specific aims do not address the study hypothesis, please specify.
6.) 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

7.) Funder and mechanism:
8.) Title of funding announcement (and link), if applicable:
9.) Funding amount: / 10.) Duration:
11.) Provide the due date(s), if applicable.
a.) Letter of Intent:
b.) Funding application:
12.) Are you requesting a letter of support from REACHnet to include in your submission? If so, by when are you requesting to receive this?
13.) General timeline for the proposed project:

BACKGROUND

14.) 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).
15.) Describe how variations in current practice suggest clinical uncertainty (2-5 sentences).
16.) 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).
17.) 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?

18.) Are the comparison interventions realistic options that exist in current practice? Please explain, if applicable (2-5 sentences).

STUDY POPULATION

Note: To request a prep-to-research query of the REACHnet patient population that meets the study’s inclusion/exclusion criteria, please complete the REACHnet Query Request Form. Requests will take approximately 3-4 weeks to process.

19.) Describe the study’s target population and planned subgroup analyses (2-5 sentences).
20.) List all inclusion and exclusion criteria including clinical and demographic characteristics.
21.) Desired sample size for this project:

REACHnet RESOURCES AND SERVICES

22.) Select the REACHnet resources and services that you are interested in leveraging for your project. [To learn more about these services, please visit our website (
Note: Services will require appropriate budget allotments. / Yes, I am interested in discussing this service with the REACHnet Coordinating Center / No, I am not interested in learning more about this service.
Administrative
a.)Assistance with developing and writing proposal. / Yes / No
Study Partners
b.)Assistance identifying additional REACHnet partners to serve as recruitment/performance sites for your study.
c.)Assistance developing partnerships with PCORnet Patient-Powered Research Networks (PPRNs) or Clinical Data Research Networks (CDRNs) for participation in your study. [Note: More information about PPRNs and CDRNs can be found on PCORnet’s website ()]. / Yes
Yes / No
No
Recruitment
d.)Pragmatic Trial App Suite: Patient App (use of REACHnet tablets for identification and recruitment of eligible patients at point of care)
e.)Pragmatic Trial App Suite: Researcher App (use of REACHnet tablets or online portal for monitoring and management of patient recruitment and data collection)
f.)Health in Our Hands patient registry (recruitment of eligible HiOH members via email, text, and/or the HiOH portal) / Yes
Yes
Yes / No
No
No
Study Data & Monitoring
g.)Collection of patient-reporteddata throughout study via study-specific portal
h.)Acquisition of clinical data from REACHnet Common Data Model Warehouse (Note: see question 24a)
i.)Acquisition of data elements outside of the CDM (Note: see question 24b)
j.)Prep-to-research query of REACHnet’s patient population (Note: please complete the REACHnet Query Request Form) / Yes
Yes
Yes
Yes / No
No
No
No

PARTICIPATING SITES

Note: If you selected “yes” to question 25c

23.) 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):

DATA NEEDS

24.) Describe the project’s data needs by answering the following questions.
a.)If you are interested in REACHnet’s clinical data, please check the boxes below to indicate which CDM tables house the clinical data elements needed for your project. For each box (i.e. CDM table) that you check, list the exact clinical data elements you are interested in obtaining. Reference the PCORnet Common Data Model to answer these questions (see page 5 for variables). If you are not interested in leveraging REACHnet’s clinical data for your project, leave this section blank.
Demographic (e.g. sex, age range, race/ethnicity)
Demographic variables:
Enrollment (e.g. period of observed medical events)
Enrollment variables:
Encounter (e.g. interactions between patients and providers)
Encounter variables:
Diagnosis (e.g. results of diagnostic processes)
Applicable ICD-9 and ICD-10 codes:
Procedures (e.g. medical interventions, such as surgical procedures)
Applicable CPT codes:
Vital (e.g. height, weight, diastolic, systolic)
Vital variables:
Lab Results (e.g. laboratory results from blood and other body specimens)
Applicable LOINC codes:
Condition (e.g. diagnosed or self-reported health conditions)
Condition variables:
Prescribing (e.g. medication orders)
Applicable RXNORM CUI codes:
Death (e.g. mortality information)
Please provide additional specifying information below for any boxes checked:
b.)If your study requires clinical data elements that are not included in the PCORnet Common Data Model(e.g. not listed on page 5 of the attachment), REACHnet may be able to facilitate the acquisition of this data from partner health systems. If you are interested in this assistance, please describe the data element(s), indicating whether they are structured or unstructured in EMRs.
c.)For which age group are you requesting the above data? Adults Minors Both adults and minors

PATIENT AND STAKEHOLDER ENGAGEMENT (REQUIRED)

25.) Describe the types of patients and/or other stakeholders that will be engaged in the research process (2-5 sentences).
26.) Describe how the aforementioned individuals will be involved in the following project components (5-7sentences).

• 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

27.) If applicable, describe how patients and clinicians have been involved in project development up to this point.

REQUEST FOR STAKEHOLDER ENGAGEMENT SERVICES

28.) Are you interested in accessing REACHnet engagement services during the development of your proposal or execution of your study (if funded)?
Yes—please complete questions 29-35
No—please continue to question 36
29.) Describe your project’s or study’s stakeholder engagement needs. If applicable, provide the funder’s requirements(5-7 sentences).
30.) Indicate the amount of time, money, and personnel that you have, or plan to, set aside for these needs.
31.) What do you hope to achieve by engaging patients in your project? What questions would you like to answer? (5-7 sentences).
32.) What is your or your team’s experience with “patient and community engagement in research”?
33.) Describe the timeline of this request (e.g. LOI/proposal due dates):
34.) How would you like to use REACHnet’s engagement services and resources? (Select all that apply):
I would like assistance with planning, writing, and/or revising my Engagement Plan.
I would like consultation on how to use my existing or funded stakeholder groups more successfully.
I want to send a survey to patients in the Health in Our Hands network to inform my project.
I would like to convene a group of REACHnet stakeholders to inform my project.
I would like to includeREACHnet stakeholder group(s) as an ongoing component of my project. For example, REACHnet can help you identify stakeholders to serve as co-investigators on your project or help you build a stakeholder group to advise on research activities throughout study.
Identification of stakeholders to participate as advisors and/or members of the research team (this is required for PCORI proposals)
Other (please specify):
35.) What types of stakeholders are you interested in reaching? (Select all that apply, keeping in mind that most funding announcements find value in multi-stakeholder groups):
Patients
Caregivers
Community health workers/health educators
Clinicians (doctors, nurses, medical assistants)
Other (please specify):

DISSEMINATION

Note: All studies are required to disseminate results to REACHnet’s partners and stakeholders through the network’s dissemination mechanisms. Please refer to PCORI’s Dissemination Policy for guidance.

36.) Specify dissemination mechanisms for specific stakeholder groups (e.g. study participants, the target clinical community, etc.).

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Version Date: November 2016