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Early Psychosis Intervention Network (EPINET) Teleconferences for Potential Applicants

NIMH held two technical assistance teleconferences for potential EPINET applicants where NIMH staff answered questions related to the funding opportunity announcements.

Transcripts

Transcript of Teleconference for RFA-MH-19-150 "Early Psychosis Intervention Network (EPINET): Practice-Based Research to Improve Treatment Outcomes (R01 Clinical Trial Optional)" held on August 15th, 2018*

Dr. Robert Heinssen, Director of the Division of Services and Intervention Research, National Institute of Mental Health (NIMH):
Welcome to the teleconference for NIMH Funding Opportunity Announcement RFA-MH-19-150, Early Psychosis Intervention Network (EPINET): Practice-Based Research to Improve Treatment Outcomes (R01 Clinical Trial Optional). My name is Robert Heinssen. I am Director of the Division of Services and Intervention Research at NIMH, and today I will be addressing questions we’ve received about the EPINET initiative. I have access to all questions that were submitted before 4:00 PM Eastern time, yesterday, August 14. If you submitted a question after that time, please ask your question later during the teleconference.

As a brief overview, this R01 announcement, EPINET Practice-Based Research to Improve Treatment Outcomes, is intended to support a national approach to learning health care in early psychosis. The announcement is based on the concept of a regional scientific hub that will establish and maintain a large and interactive data set containing de-identified, person-level information from 100 or more early psychosis patients who are enrolled and receiving services in connected coordinated specialty care (CSC) clinics. NIMH envisions a series of hub-and-spoke networks across the United States that each offer coordinated specialty care for early psychosis. For this initiative, a scientific hub is the anchor site of a network of clinics that offer coordinated specialty care services. The clinical programs function as spokes within the network. The hub provides scientific and technical expertise that supports uniform clinical assessment and data collection, data integration and analysis, and data presentation across connected coordinated specialty care clinics.

In the announcement, we refer to regional networks. We define a region as a political or geographic subdivision of the United States that could include cities, counties, congressional districts, states, or census divisions. Integrated health systems with clinics spread across geographic areas also qualify as a regional network.

The first question submitted for this teleconference was, "Must the early psychosis clinics and hub be in the same geographic region, or can they be geographically dispersed?" The answer is that a scientific hub and connected clinics may be in different geographic areas. It is permissible for a scientific hub to connect coordinated specialty care programs that are in several different states. Likewise, a hub could connect multiple CSC sites within a city, within a county, within a state, and so forth.
The critical factor is the relationship between the scientific hub and the CSC programs participating in the network. In the hub-and-spoke model, the scientific hub connects CSC programs that agree to employ standard assessment methods, common data elements, and information technology with a uniform operating system.

For this announcement, NIMH expects applications to be submitted by principal investigators from the regional scientific hubs, with input from research and clinical partners within the connected coordinated specialty care clinics. To be responsive to this announcement, regional scientific hubs will partner with four or more early psychosis intervention programs within their network.

The second question submitted was, "Is it permissible to include more than four clinics in the regional network?" The response is “yes.” The minimum number of clinics associated with a hub is four, but we recognize that certain states have developed many more coordinated specialty care programs. In these states, a larger number of clinics may be eligible for participation in the regional network. If an applicant wishes to coordinate efforts among more than four CSC clinics, that is certainly permissible. The upper limit of clinics should be determined by the hub's capacity to integrate data collection among participating sites as well as the funds available to support the proposed research. 

In aggregate, clinical programs within the regional network should collect assessment and treatment data each year from a minimum of 100 persons with early psychosis who are receiving CSC services. There were several questions related to this point. The first asks, "Are patients currently enrolled in CSC programs eligible for inclusion in the EPINET study or only new intakes accrued during the five-year study period of the grant?" Patients currently enrolled in CSC programs are eligible for inclusion in the practice-based research projects proposed as part of the grant application. If the hub is proposing a study that can utilize individuals already enrolled in the CSC programs, then it is permissible to include those patients in the subject count. However, if the proposed research requires new patients to complete the project, then new intakes should be accounted for in the application. 

A second question is, "Are 100 new patients enrolled each year of the five-year study period required, meaning a total of 500 patients enrolled over five years?" As previously noted, CSC programs within a regional network should collect assessment and treatment data from a minimum of 100 persons with early psychosis each year. The total number of patients to be enrolled over five years depends on the research project proposed by the regional hub. We expect the network to enroll a sufficient number of individuals to meet the aims of the research project. Depending on the study, this may require data from more than 100 participants.

There is no limit to the number of new patients that can be enrolled each year. At a minimum, we expect that data from any newly enrolled patients will be used in the networks’ evaluation of CSC treatment fidelity and quality, as well as feedback to participating clinics as part of the learning health care model.

The next question asks about the required length of care: "Are patients eligible to stay in the EPINET program for up to five years, or is there a minimum duration of subject involvement?" Decisions regarding the length of CSC treatment will be determined by caregivers in participating clinics. A patient’s data can be included in the EPINET database for the duration of their treatment in the CSC program, where it can be used for purposes of quality improvement, program evaluation, and practice-based research.

We received two additional questions about the R01 announcement, which I will answer right now. The first question is, "What may be typical grant expenditures for each spoke site?" Support for spoke sites depends on existing capabilities within clinics enrolled in the network; what kind of additional support clinics may need to enable participation in the multi-site data collection, sharing, and reporting envisioned for EPINET; and the scope of the research project that's being proposed. If an applicant has a specific question pertaining to their project, they are encouraged to contact Suzan Azrin, the scientific contact for the EPINET R01 announcement, for technical assistance.

The final question submitted for the R01 announcement reads, "Within the EPINET RFA, it notes that Informatics infrastructure should make it possible for patients to be re-contacted through the CSC program that shared the data with the regional hub. Since the data in the Informatics platform would be de-identified, is the expectation that the participating CSC program would have identifiable information to recontact the patient, or is there an expectation that someone else should be able to contact the patient via the informatics platform?"

In answering this question, I’ll say that our principal concern is that patients not be contacted for research purposes without the knowledge of the clinical team providing care. We allude to this in Funding Opportunity Announcement RFA-MH-19-151, Early Psychosis Intervention Network (EPINET): Data Coordinating Center (U24 Clinical Trial Not Allowed): “regional scientific hubs [should] develop a secure method of contact between investigators and individual patients, moderated by clinical care staff at participating clinics, regarding voluntary research participation.”

We envision a process by which investigators looking to contact potential research participants will be able to contact the clinical site that is providing care to the individual. Investigators will use the NIMH Global Unique Identifier (GUID) to identify prospective research participants. The clinic team should have the means for reconstructing the person’s identity and a process for presenting the research opportunity as well as assessing the person’s interest in speaking directly with researchers. If the person agrees to further contact, we expect there will be a secure mechanism for establishing direct communication between the individual and the research study.

I have now answered the seven questions submitted prior to the EPINET R01 conference call. In just a second, we'll take live questions from the listening audience. You do not need to identify yourself when asking a question. It's perfectly fine to remain anonymous.

With that introduction, we’ll unmute the lines and participants may ask questions.

Audience:
I have a question. Is it envisioned that all participants will sign informed consent to participate in the project?

Dr. Heinssen:
We understand that there are two levels of patient involvement in data collection and sharing. First, CSC programs will collect data during usual care for the purposes of improving the quality of clinical services. Second, CSC programs may propose research activities that go beyond routine clinical practice. We envision separate consent methods for these two situations. That is, an opt-out option regarding clinical data used for quality improvement, fidelity monitoring, and program evaluation purposes. Written, prospective informed consent will apply when research activities fall outside routine clinical practice.

Audience:
I have a question. Are patients who are enrolled in the EPINET cohort also able to participate in either ongoing or new additional studies involving the use of brain biomarkers of risk, illness progression, treatment response, or other treatment studies?

Dr. Heinssen:
Yes, patients enrolled in regional network clinics may participate in those types of studies. So long as patients are receiving coordinated specialty care treatment, participation in translational research projects is allowed.

I will point out that we do not require hubs to propose research projects that fall within the translational research space. We recognize that such projects may be beyond the capability of many CSC programs, and that most scientific hubs will propose research studies that fall within the health services research domain.

Audience:
Could you say a little more about incorporating an R34-type proposal within the limitations of the applications for the overall project; in other words, how to manage the level of detail?

Dr. Heinssen:
The EPINET R01 announcement provides links to NIMH R34 grant mechanisms, which describe the level of detail required for pilot research studies. I suggest that you look at those mechanisms first. If you have follow-up questions about the level of detail required for the specific project that you're thinking about, you should contact us for individual technical assistance.

Audience:
And to continue back on that, so the vision of this would be kind of proposing a center application like the ALACRITY ones that just came out, so it would be R34, like those proposals?

Dr. Heinssen:
Yes. The intention is that the proposal for the R34-scope research project will be embedded within the R01 scientific hub proposal.

Audience:
Okay.

Dr. Heinssen:
Any other questions? Okay. Well, if not, I will remind you that the recording of this session will be posted on the NIMH website and the URL can be found in the funding opportunity announcement. That should occur within a week or so. If you have follow-up questions, you can email your questions to the mailbox that is identified in the funding opportunity announcement [RFA4EPINETDCC@mail.nih.gov]. Susan Azrin, the scientific contact for this initiative, will get back to you and arrange for individual technical assistance in preparing the application.

Audience:
I'm sorry. Could I ask one question?

Dr. Heinssen:
Yes. Certainly.

Audience:
Thank you. Sorry. For the aims of the proposal, would you be expecting one set of aims for the overall network and an additional set of aims for the R34 project, or would they be one set combined?

Dr. Heinssen:
They would be combined.

Audience:
Okay. Thank you.
And sorry. Just jumping back in. So that looks different than the center application. So it will look different in our writing?

Dr. Heinssen:
Yes, the EPINET R01 application will have a different format than a center application, so you should adhere closely to the instructions in the EPINET R01 funding opportunity announcement.

Audience:
Okay.

Dr. Heinssen:
On a final note, please pay particular attention to the review criteria that are listed in Section V of the funding opportunity announcement. These criteria give clear guidance about how reviewers will be oriented to critical aspects of the network as well as the proposed scientific research projects. If you're able to provide information in your application that will allow reviewers to answer each of those review criteria questions, you will be in a very good position.

I would like to thank each of you for expressing interest in this EPINET opportunity. We are very hopeful that we'll have applications from all of you. Let me extend again the invitation to contact us directly if there are specific questions related to your own application. We will be happy arrange an individual technical assistance call. Thank you all very much.

*  Transcript has been lightly edited for readability and clarity.

Transcript of Teleconference for RFA-MH-19-151 "Early Psychosis Intervention Network (EPINET): Data Coordinating Center (U24 Clinical Trial Not Allowed)" held on August 15th, 2018*

Dr. Robert Heinssen, Director of the Division of Services and Intervention Research, National Institute of Mental Health (NIMH):
Welcome to the teleconference for NIMH Funding Opportunity Announcement RFA-MH-19-151, Early Psychosis Intervention Network (EPINET): Data Coordinating Center (U24 Clinical Trial Not Allowed). My name is Robert Heinssen. I am Director of the Division of Services and Intervention Research at NIMH. I am joined by Dr. Greg Farber, Director of the Office of Technology Development and Coordination, also at NIMH. Together we will address questions we’ve received about the EPINET initiative. I have access to all questions that were submitted before 4:00 PM Eastern time, yesterday, August 14. If you submitted an inquiry after that time, please ask your question later during the teleconference.

As a brief overview, the overall goal of the EPINET initiative is to support a national approach to learning health care in early psychosis. A companion funding announcement, RFA-MH-19-150, Early Psychosis Intervention Network (EPINET): Practice-Based Research to Improve Treatment Outcomes (R01 Clinical Trial Optional), will support up to five regional networks that bring together clinical programs that offer coordinated specialty care (CSC) for early psychosis. Each regional network will include a scientific hub and four or more community clinics. Each hub will establish and maintain a large, interactive data set that contains de-identified, person-level information from 100 or more early psychosis patients enrolled and receiving services in connected CSC programs. In aggregate, the five regional networks will include 20 or more community clinics and collect clinical and research data from 500 or more patients. The actual number of clinics and patients included in the regional networks could be considerably higher, given the number of coordinated specialty care clinics that exist in the U.S. and the success these programs have had in enrolling patients experiencing a first episode of psychosis.

This teleconference focuses on the EPINET U24 announcement, which will establish a National Data Coordinating Center to support the work of the regional networks. The role of the National Data Coordinating Center is to develop the infrastructure necessary to support (1) secure data sharing across multiple regional coordinated specialty care networks, (2) multi-site quality improvement and program evaluation studies, and (3) practice-based intervention and services research in early psychosis. Our expectation is that the National Data Coordinating Center will work closely with the regional scientific hubs to optimize data collection, data processing, and analytic methods across regional networks, and to combine regional data sets into a national repository of early psychosis common data elements, clinical measures, assessment strategies, and de-identified patient-level data. The National Data Coordinating Center will develop an integrated national database to hold de-identified person-level data from many hundreds to thousands of patients who receive coordinated specialty care services each year across the U.S., along with secure mechanisms to facilitate practice-based research with this large sample.

We expect a high degree of collaboration between the National Data Coordinating Center and the five scientific hubs funded under the companion R01 announcement. To facilitate that collaboration, principal investigators from the regional scientific hubs will serve as members of the National Data Coordinating Center Steering Committee. The Steering Committee will be chaired by the principal investigator from the National Data Coordinating Center.

Applicants should note that the U24 grant mechanism is a cooperative agreement. An NIMH program official will serve in the traditional role as Program Officer and will facilitate interactions between the National Data Coordinating Center, the Steering Committee, and members of the regional scientific hubs. In addition, an NIMH Project Scientist will be appointed as an additional member of the Steering Committee, giving NIMH a voice on Steering Committee deliberations. The NIMH Project Scientist will work with the grantee in a partnership role and will maintain substantial programmatic involvement during the performance of the grant.

Two questions were submitted in advance of the teleconference; I will address those now. The first is, “Are applicants for the EPINET Data Coordinating Center restricted to investigators who have participated in earlier early psychosis research projects?” No prior experience with early psychosis research is specifically required for the National Data Coordinating Center. Rather, reviewers will consider whether applicants possess appropriate expertise in health informatics, managing clinical and research data from community mental health clinics, using robust analytic platforms and tools to rapidly translate large amounts of pooled data into usable information for behavioral health care providers, and coordinating collaborative multi-site clinical research. These are the essential skills required for successfully fulfilling the goals of the National Data Coordinating Center.

The second question is, “May an investigator apply for both the EPINET R01 and U24 awards?” Yes, an investigator may respond to both R01 and U24 funding opportunity announcements and may submit more than one EPINET application.

I have now answered both questions submitted prior to the EPINET U24 conference call. In just a second, we'll take live questions from the listening audience. You do not need to identify yourself when asking a question. It's perfectly fine to remain anonymous. With that introduction, we’ll unmute the lines and participants may ask questions.

Audience:
Yes. Hello. I was wondering if an individual can participate as a co-investigator in more than one DCC [Data Coordinating Center] application.

Dr. Heinssen:
Yes, that is permissible.

Audience:
And as a follow-up, could a single participant also participate in the DCC [Data Coordinating Center] application as well as one regional hub application?

Dr. Heinssen:
Yes, that is permissible.

Audience:
Great. Thank you.

Audience:
I have a question about the central IRB. In the first phase for the R01s, it's more about collecting and organizing current data. Is the Data Coordinating Center responsible for having a central IRB for the first phase of the network? I assume a central IRB will be necessary for the latter phase where there may be clinical trials, but what about the initial phase?

Dr. Heinssen:
The R01 scientific hubs will propose research projects for their respective regional networks. Those hubs will be responsible for obtaining IRB approval for studies that will occur within the regional hubs. For collaborative projects that might emerge between hubs over the course of the award, we expect the National Data Coordinating Center to facilitate central IRB review. So, the answer to your question is that for the initial phase, it's up to the R01 investigators to get IRB approval for their projects. For new, multi-hub projects that might emerge over the U24 project period, we expect the National Data Coordinating Center to facilitate central IRB review.

Audience:
All right. Thank you.

Dr. Heinssen:
Any other questions? If not, I will remind you that the recording of this session will be posted on the NIMH website and the URL can be found in the funding opportunity announcement. That should occur within a week or so. If you have follow-up questions, you can email your questions to the mailbox that is identified in the funding opportunity announcement [RFA4EPINETDCC@mail.nih.gov]. Susan Azrin, the scientific contact for this initiative, will get back to you and arrange for individual technical assistance in preparing the application.

Dr. Heinssen:
On a final note, please pay particular attention to the review criteria that are listed in Section V of the funding opportunity announcement. These criteria give clear guidance about how reviewers will be oriented to critical aspects of the National Data Coordinating Center. If you're able to provide information in your application that will allow reviewers to answer each review criteria question, you will be in a very good position.

If there are no more questions, we will conclude this teleconference. I would like to thank each of you for expressing interest in this EPINET opportunity. We are very hopeful that we'll have applications from all of you. Let me extend again the invitation to contact us directly if there are specific questions related to your own application. We will be happy to arrange an individual technical assistance call. Thank you all very much.

*  Transcript has been lightly edited for readability and clarity.

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