The MPOG team put together a list of the most frequently asked questions about the 2023 Initiative for Multicenter Pragmatic Anesthesiology Clinical Trials (IMPACT) call for applications. If you have a question that is not on this list, please contact our team at mpog-research@med.umich.edu.
Updated on 11/03/2023
Include enough detail with the assumption that not everyone in the study section will be familiar with all MPOG measures. There is also variability in terms of how well reviewers within MPOG know the data as well. Study section members will be experienced anesthesiologists who have experience with clinical trials or informatics.
Study teams are free to utilize their own statistician, especially since no statistical support from the DCC is offered for proposal development. We recognize that there is variability in the statistical expertise of each study team. The intention of the DCC is to make the statistician resource available and no assumptions will be made regarding the use of statisticians at the study site. The DCC statistician can also be involved for consults if needed.
The MPOG DCC is aware of the centers that are active MPOG sites, so no further explanation is needed. All current LOIs that were invited to submit a proposal are from active MPOG sites. The other aspect of this guideline is to ensure that the project can be generalizable to other MPOG sites. A key aspect is to ensure feasibility with multi-center participation.
Whereas a letter of support is required from the PI’s Department Head of Practice / Chairperson and suggested from a proposed performance site Department Head of Practice / Chairpersons, there are no requirements for other letters of support or any certain number of letters. We recommend that you follow any experience you have with the NIH. Ensure that the letters are useful and do not become a burden to the reviewers. Be prepared to address any comments concerning whether discussion has happened among other sites who you intend to include in the study.
IRB approval is not required at this stage. IRB approval is required during feasibility phase in order to move on to full scale phase. However, justification for waiver of consent will continue to be important in the proposal phase. Also specify who you propose the IRB of record to be.
Updated on 9/21/2023
The funding details for the LOI should include distribution of funds between the CCC and performance sites in Years 2 and 3, as well as types of personnel support in Year 1.
The LOI should not include a biosketch for the PI or co-PIs. The biosketch must be included in the full proposal stage of the application process.
Your local site PI does not need to be the PI on the study. Study teams may find it helpful to include their local MPOG site PI (as a co-PI or co-investigator) since they will be most familiar with MPOG data and therefore would have insight into the feasibility of the study.
The initial data should be submitted at month 10 during Year 1 of the study. This is to ensure that there is enough time to review the data and determine that the study is feasible before the end of Year 1.
Updated on 9/05/2023
The selection criteria do not mandate or encourage a specific sample size or number of sites. The call for proposals clearly indicates the need for a multicenter performance site design. However, the specific sample size and number of performance sites should be driven by the balance of statistical / clinical significance (as determined by a power analysis, considering estimated outcome rates, intervention adherence rates, and intervention effect sizes) as well as generalizability (considering diversity of institutions and practices). It is possible that a well-executed trial enlisting a small number of diverse institutions may provide more reliable and reproducible evidence than an adequately-executed trial enlisting substantially more institutions. However, the optimal number depends on the specific research question posed. We defer to the study team and their statistician(s) to determine what is optimal for their individual project. This rationale should be communicate effectively in the LOI and full proposal.
No. There is no limit on the number of MPIs. However, we do need one contact PI to maintain the primary correspondence between the study team and MPOG Data Coordinating Center and for funding and administrative processes.
No. There is no requirement that the PI or study team members need to be members of the AUA. The project and team should align with the vision of the of the AUA: “The advancement of academic anesthesiology as a dynamic specialty that makes substantive contributions to medicine, science, and society.”
To successfully complete the pilot phase/feasibility stage of IMPACT, the minimum requirement is that one site (e.g., the PI’s site) should demonstrate the ability to obtain IRB approval, implement the intervention, demonstrate intervention adherence and obtain outcomes of interest. Study teams may wish to demonstrate during the feasibility phase that the pragmatic trial can be successfully implemented at additional sites, however, given the time constraint of one year, this is not a requirement.
We defer to the study team regarding whether a single, centralized IRB or separate IRB approvals at each performance site should be obtained. There is no IMPACT requirement.
No, the 2023-2024 IMPACT award will only be awarded to a maximum of one study team for the full funding amount.
There is no advantage to considering the University of Michigan as a secondary site during the feasibility phase (i.e. LOI and full proposal scoring will not be more or less favorable). Study teams should feel free to collaborate with the most appropriate institution(s), if any, during this phase.
The proposed project should be a prospective study using the electronic health record data that is routinely collected, especially for the primary exposures/outcomes. We recommend focusing on measures that the researcher is confident are already in the EHR dataset with sufficient completeness and accuracy. Data quality and completeness can vary across centers and the trial design and performance sites may choose to focus on centers that have demonstrated high quality data and high data completion rates for specific elements of interest. IMPACT applicants are encouraged to reach out to candidate performance sites to assess their local EHR data, and if applicable, local MPOG extract.
Our budget for the in-kind MPOG support includes the following proposed roles and percent effort across the feasibility and full-scale phases. This is a maximal effort available and offered to applicants as in-kind support separate from the $700,000. Applicants are not required to use these resources and they should not be included in the proposed budget. LOIs and full proposals should clarify where these activities would be fulfilled.
No. Study teams can use the awarded funds for expenses deemed helpful for a successful trial. Examples include travel, conference presentation, collaboration, devices relevant to the study, etc.
Updated on 8/22/2023
In general, IMPACT is encouraging teams to propose innovative approaches to trial execution, participant engagement, and informed consent. Increasingly, Institutional Review Boards are supporting waiver of informed consent for comparative effectiveness trials. Other consent mechanisms, such as inclusion of research consent into an existing clinical consent document, are viable, pragmatic approaches. However, if an IMPACT LOI simply focuses on decreasing consent team burden by asking clinical team members to perform it, this will likely receive lower priority compared to other novel informed consent approaches. All applicants are encouraged to include their innovative approaches into the LOI. These approaches will be evaluated by the LOI review process.
Yes. Please see the listed studies below for examples.
Yes. Your local MPOG site PI is a great resource and will be very familiar with local and national MPOG data. You can also examine your local MPOG data and expect that multi-site data will be similar to what you observe at your own site.
Data Direct is also a great tool to determine the feasibility of your project and can provide case counts, practice patterns, and some outcomes. This will provide a better understanding of the cohort that will be included in your study. The link to DataDirect can be found under the Tools section on the MPOG website. In order to access the tool, you will need to make sure you have a DataDirect affidavit on file. There is a Tips and Tricks module on the MPOG website, which is a great starting point for learning how to use this tool. If you have any further questions, please contact us at mpog-research@med.umich.edu.
It is largely dependent on the frequency and data quality of data uploads from performance sites. Most MPOG sites contribute data on a monthly basis, allowing data to be provided this frequently for quality improvement and research purposes. For the THRIVE study, MPOG built a phenotype that defines intervention adherence compliance (TIVA versus INVA). Using this phenotype, the THRIVE DCC is able to provide intervention adherence feedback as soon the participant’s case data arrives to the coordinating center. Given enhanced data uploads for THRIVE (typically weekly or every two weeks), this is more than adequate for trial intervention adherence reporting. For the IMPACT LOI, applicants should assume trial operational metrics are available every two weeks to monthly, dependent upon trial performance site data upload frequency.
Previous IMPACT pilot grant awardees have been able to implement cluster randomization at their pilot site within the first year. The ideal feasibility phase would involve obtaining IRB approval at the CCC and demonstrate the ability to leverage existing clinical equipoise for clinicians adherence to the randomization allocation.
The study section will not be composed of anyone from the DCC. This section will be composed of colleagues that are from non-applicant MPOG institutions. Partnership with the DCC will be based on preference of the IMPACT investigators. Given existing data flows and access, the MPOG CC will extract the trial-specific data for MPOG centers.
The IMPACT award encourages innovative approaches to data integration. However, MPOG central will not be able to acquire, evaluate, integrate, and implement new data sources for the IMPACT awardee. Existing, production ready data integrations (e.g., surgical registries, CMS data) are reasonable to implement in during the IMPACT award period. Unfortunately, the MPOG DCC is unable to commit to leading any new data integrations for trial performance sites.
The IMPACT application can propose and demonstrate the feasibility of awardee-led data integrations to supplement the existing MPOG contributions.
Finally, there are many raw data elements currently contributed by MPOG sites which are not currently processed into research or quality-ready phenotypes (e.g., some ventilator parameters, medication totals, physiologic signals) which are readily available for IMPACT awardees data use and innovative proposals.
We defer to the applicant. Study teams are welcome to use their own statisticians as long as they are at an MPOG site (due to MPOG data use agreement limitations). MPOG Central will be involved to the extent that the CCC and performance site study teams would like them to be. The MPOG Central team is happy to explore innovative statistical methods proposed by the applicants. In addition, collaboration with University of Michigan School of Public Health Biostatistics faculty with appointments in Anesthesiology is possible. These faculty are familiar with SMART, cluster crossover, stepped-wedge, adaptive, and Bayesian methods.
Yes. Consultations will be available before the LOI due date for study teams who wish to discuss their projects in greater detail with an MPOG coordinating center faculty and research facilitation team. If you would like to schedule a consultation, see the Research Consultation Form or email MPOG Central at mpog-research@med.umich.edu.
Updated on 8/14/2023
There is a critical need to answer anesthesiology-related research questions using randomized controlled trial techniques. However, limited multicenter pragmatic trial infrastructure in the United States challenges efforts to address this need. Demonstrating a successful pragmatic, cluster randomized trial platform may lead to federally funded clinical trial efforts in perioperative medicine, critical care, pain management, and peri-/post-partum care.
To ensure prudent use of research funding support, the Year 1 Feasibility Phase is designed to (i) develop the clinical, technical, and operational processes for executing the pragmatic trial, and (ii) demonstrate that the proposed pragmatic trial design can be successfully completed at a single pilot site. Success of the Feasibility Phase will be determined by objective milestones as detailed in the full application instructions and adjudicated by the MPOG Executive Board. Pending successful completion of the Feasibility Phase, the research team will receive approval and funding to perform the Years 2-3 Full Scale Phase, with the definitive pragmatic trial implemented across multiple sites.
In the final quarter of Year 1, the MPOG Executive Board will review and adjudicate whether the pre-specified Year 1 Feasibility Phase milestones were met for the research team. If they are not met, the MPOG Executive Board may recommend a no-cost extension of the Feasibility Phase implementing alternative strategies (with re-evaluation at the end of the no-cost extension), or decline the research team’s Years 2-3 Full Scale phase funding.
The Clinical Coordinating Center (CCC) is an MPOG active member site that engages clinicians in the research mission and provides the training, study design, project management, and professional development to ensure effective clinical trial participation by: (i) recruiting and maintaining performance sites and participants; and (ii) educating and training investigators, study coordinators, and other research staff. The CCC supports the Principal Investigator (PI) and manages the project through each milestone and project phase from start-up through closeout and manuscript publication(s). The CCC will serve as the prime awardee for any performance site subcontracts.
The University of Michigan will act as Data Coordinating Center (DCC) for the trial. The DCC will manage the data collected for the trial (including both observational clinical data routinely collected as part of existing MPOG research processes), as well as serving as a centralized repository for any additional trial-specific data collected within the constraints of the IMPACT budget, MPOG infrastructure, and regulatory approvals. The DCC will provide additional technical, research process, and statistical support for the project as necessary to maintain data collection and quality assurance, rigorous analytic strategies, and activities described in the Data and Safety Monitoring Plan (DSMP).
The direct financial support for the IMPACT award is $700,000 for the Clinical Coordinating Center (CCC) and performance sites ($100,000 during Year 1 Feasibility Phase, and $300,000 per year during Years 2-3 Full Scale Phase). In addition, MPOG will provide support in-kind as the Data Coordinating Center (DCC) for the trial with the necessary technical, research process, and statistical support. This totals approximately $250,000 in personnel costs and data infrastructure resources including faculty, data extracts, research facilitations, clinical informatics, statistical design, and statistical analysis.
The proposed work should address a question around which clinical equipoise exists and can be ethically addressed without individual patient consent.
Performance sites do not have to be active MPOG member sites; however, they must demonstrate the ability to submit monthly trial-specific data to the DCC in an agreed-upon format consistent with the proposed data specification for MPOG sites.
The LOI may be submitted to mpog-research@med.umich.edu.
Principal Investigator(s) (PIs) must have primary faculty appointments (i.e., not affiliated or adjunct faculty appointments) at an active MPOG center. PIs and active MPOG centers may submit more than one LOI (and potentially more than one full proposal, if selected). PIs must be established clinical investigators (i.e. the IMPACT trial is not a career development proposal).
All performance sites will need to obtain additional site-specific IRB approvals, separate from the IRB approval necessary to participate and contribute data to MPOG upon which active membership in MPOG is contingent. It is recommended that the CCC distributes example IRB templates to performance sites during the Year 1 Feasibility Phase.
No, a single IRB is not required. The specific human subjects research regulatory structure will be determined by the CCC and performance sites.
An optional informational webinar for interested applicants will be held on August 18, 2023. A recording of the webinar will be available on the MPOG website one week after the webinar. Other questions may be directed to the MPOG Research Facilitation Team at mpog-research@med.umich.edu.
Proposals are not required to use the MPOG Coordinating Center as a comprehensive trial Data Coordinating Center (DCC). However, the MPOG Coordinating Center will need to be involved in extracting the necessary data from MPOG contributing, trial performance sites. Applicants can propose to use their own statistical analysis, DSMB management, and trial operational metrics team. However, the MPOG Coordinating Center staff have experience in managing multi-center data in a secure enclave, completing data quality checks, creating trial operations reports, managing a DSMB and conducting rigorous statistical analyses. Therefore, the MPOG Coordinating Center is happy to offer those services as part of the IMPACT award with in-kind support distinct from the $700,000 funds allocated to the CCC and performance sites.
