- Watch the webinar - https://nih.zoomgov.com/rec/share/wMguDomg125JbrPEsG7kQrMzJb35aaa803cZ-_Bbn0dnnwpK9e2_hKq5wI0LSqjz - Passcode: ^Mrj?5E0
*Note - this webinar is not fully accessible. If you are having difficulty viewing this information and need help, please contact Shelley Su, Ph.D. or Mike Freed, Ph.D.
- HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional) (PDF, 1.8MB)
- Technical Assistance Webinar: RFA-DA-21-030, RFA-DA-21-029, RFA-MH-21-145 (PDF, 507KB)
Frequently Asked Questions (FAQs)
In addition to PIs and PWLE/stakeholders, are Research Centers expected to budget for travel for other key personnel to executive committee and other in person meetings?
IMPOWR: Budgets should include funds for travel for the PD(s)/PI(s), 1 stakeholder partner, 1 PWLE/patient organization representative, and up to three additional project staff to participate in in-person executive committee meetings once per year, every year of the award, in Rockville, MD. In addition to the annual in-person executive committee meeting, representatives from each research center are expected to participate in virtual executive committee meetings that will occur quarterly. PI(s), 1 stakeholder partner, and 1 PWLE/patient organization representative should be present from each research center at these virtual meetings.
An additional in-person kickoff meeting to be held in Rockville, MD should be included in year one budget of the award to discuss data harmonization policies and procedures.
Stakeholder and PWLE partners from each research center will form a community workgroup to provide guidance on network activities. This group is expected to convene every 6 months. Time and support should be budgeted to participate in such activities.
At least 1 PI should also be present at the HEAL Investigators meeting that convenes annually. Awardees are expected to participate in break-out sessions with other HEAL programs of relevance to this initiative (e.g., PRISM, ERN, BACPAC, BRIM, etc.) at the annual HEAL Investigator meeting. Time and support should be budgeted to participate in such activities.
How will the process of harmonizing the methods be conducted?
IMPOWR: The network will be required to use the HEAL Pain Core common data elements (CDEs; CP Core CDEs) and to select from coded HEAL Pain Supplemental CDEs. With regard to other CDEs, representatives from the awarded research centers within IMPOWR and Optimizing Multi-component service delivery RFA (RFA-MH-21-145) will gather in Fall 2021 to select measures that must be collected across studies, when appropriate, and optional measures to be included. These representatives will need to balance pragmatic feasibility of collecting the required CDEs against the potential insights gained from cross-study data meta-analysis.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Researchers funded through RFA-MH-21-145 are required to participate in joint meetings with IMPOWR project teams and use common data elements as described in the RFA (e.g., see NOT-MH-20-067). The purpose of collaborations with IMPOWR project teams is to a) develop or harmonize common data elements, standard measures, and uniform data collection procedures; b) participate in a bidirectional pipeline to facilitate practice-based research and improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery, and health outcomes in people affected by the opioid epidemic; and c) identify innovative assessment, intervention, and quality improvement practices for broad dissemination. While project teams funded through RFA-MH-21-145 are required to collaborate with IMPOWR project teams, RFA-MH-21-145 invites applications for distinct R01 projects. Thus, applicants should propose measures and methods that adhere to guidance in the RFA and that are most appropriate for the research project.
Are stakeholders and PWLE expected to participate at the same level in the NIMH RFA, as in EMPOWR?
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): The requirements for stakeholder participation differ between the IMPOWR RFAs and RFA-MH-21-145. Researchers funded through RFA-MH-21-145 are expected to leverage research practice partnerships and take a deployment focused approach to design and testing to help ensure findings have end user relevance. The RFA describes these expectations in greater detail.
Define “site” - some organizations have multiple campuses or locations
IMPOWR: Sites are defined from the perspective of subject recruitment. A health care setting selected for this funding opportunity should consistently serve a high volume of patients with comorbid CP and OUD and support ongoing adherence, retention, and follow-up care for this patient population. Selection of the health care setting should include a justification as to why this setting is expected to be a high impact setting from a public health perspective.
Projects that examine integrated care models between CP and OUD services and projects that test different implementation strategies to maximize existing EBPs in different health care settings must propose a multisite research design. Projects that integrate evidenced-based interventions for treating CP or OUD to effectively treat both conditions do NOT have to meet a multisite requirement, but applicants are encouraged to do so if it is feasible. For multi-site projects, applicants are encouraged to be thoughtful about low-resource communities and/or rural areas that face unique challenges in addressing comorbid CP and OUD.
Letters of support are required for each proposed research site.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Sites should be selected so that interventions can be tested as naturalistically as possible in order to increase the generalizability of research findings as well as to minimize barriers to translating any positive research findings into real-world practice. Accordingly, study designs should consider practical aspects of service delivery (e.g., use of technologies, telehealth, clinical workflows, screening, and assessment of patient outcomes). Studies should furnish services through existing providers/vendors of such services, versus developing services specifically for this research. Similarly, studies should rely as much as possible on existing financing mechanisms that support clinical care.
Will you please elaborate a little more about the operationalization of different sites for trials, especially the concept of rural and under-resourced settings?
IMPOWR: Please see the previous Q&A for the definition of a clinical site. With regard to rural and under-resourced settings, applicants are encouraged to be thoughtful about the generalizability of the proposed intervention(s) to these settings. Alternatively, applicants may develop interventions/approaches that specifically address challenges faced by low resourced or rural settings.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): See above for guidance on site selection.
Are you planning that the individual research centers will do data analysis, or will that be done at the data coordinating center?
IMPOWR: Individual research centers will execute the data analysis the proposed studies in the RM1 application. These plans should be included in Sub-section F – Data Collection, Management, and Harmonization (3 pages) and under each proposed research project to be described in Sub-section C-E.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Each project team will conduct its own data analysis.
Can genomically guided diagnosis used for OUD etc?
IMPOWR: PIs are encouraged to justify any measures proposed for inclusion in the application. The RFAs uses the DSM-5 definition of OUD as a problematic pattern of opioid use leading to clinically significant impairment or distress. OUD severity can range from mild (2-3 symptoms), to moderate (4-5 symptoms) and severe (6 or more symptoms). Individuals who are in OUD recovery can also be included in these studies.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Genomically guided diagnosis tools are not prohibited per se. However, research funded through RFA-MH-21-145 should be practice relevant, and PIs should justify approaches to assessment.
Do you anticipate the coordination center having any input into design, data collection methods, or analysis of the research projects?
IMPOWR: With respect to data, The Coordination and Dissemination center (C&DC) is responsible for two key activities:
- Leading logistical and support efforts towards data harmonization across the research centers funded in IMPOWR and awardees from the Optimizing Multi-component service delivery RFA (RFA-MH-21-145). Awardees and key team members will gather in Fall 2021 to determine the set of required common data elements and optional common data elements. For any outcomes related to chronic pain, applicants must use the CP Core CDEs. Importantly, the C&DC are not selecting the common and optional CDEs by themselves.
- facilitate data sharing agreements between institutions in service of cross-center data analysis. Any trans-center data analysis are expected be executed by the research center(s), not the C&DC.
The research centers will be responsible for the design of the proposed studies, data collection and data analysis (with input from PWLE and stakeholders relevant to the research projects).
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Researchers funded through RFA-MH-21-145 are required to participate in joint meetings with IMPOWR project teams.
While purposes of those collaborations include the development or harmonization of common data elements, standard measures, and uniform data collection procedures, RFA-MH-21-145 invites applications for distinct R01 projects. Applicants should propose strong designs, data collection methods, and analyses that adhere to guidance in the RFA and that are most appropriate for the research project.
Will reviewers read entire applications, or will different reviewers be assigned to different components in one application?
IMPOWR: Assigned reviewers will read the entire application.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Yes. NIMH reviewers will also be assigned to the entire application.
Can you say a little more about selecting measure versus the coordination center selecting measures?
IMPOWR: The Coordination and Dissemination center (C&DC) is responsible for supporting the data harmonization meeting in Fall 2021 and any ongoing efforts that may follow the Fall 2021 meeting. Representatives from the IMPOWR network and the Optimizing Multi-component service delivery program (RFA-MH-21-145) will determine required and optional common data elements that are required to be collected across studies. For any outcomes related to chronic pain, applicants must use the CP Core CDEs. The final selection of measures is determined by the collective IMPOWR network and the Optimizing Multi-component service delivery program.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Researchers funded through RFA-MH-21-145 are required to participate in joint meetings with IMPOWR project teams and use common data elements as described in the RFA (e.g., see NOT-MH-20-067). While goals of IMPOWR collaborations include developing and harmonizing common data elements, RFA-MH-21-145 invites applications for distinct R01 projects. Applicants should propose measures consistent with the guidance in the RFA and that are most appropriate for the research project.
An economic evaluation was mentioned as important for the IMPOWR projects. Do each Project and/or Pilot project MUST have an economic evaluation?
IMPOWR: To ensure robust adoption of findings and implementation strategies, rigorous economic evaluations, especially cost-effectiveness analyses, such as those following the recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine, are strongly recommended. Economic evaluations that consider relevant economic outcomes of proposed interventions from a societal perspective (e.g., that measure or model the actual or potential impact of specific interventions, approaches, or strategies on health-related behaviors, healthcare utilization, and health outcomes) are especially encouraged, but not required. Economic evaluations are not required for the pilot projects.
To push the planning a bit further, the primary role of the coordinating center is to monitor recruitment, data collection (and development of Pain/OUD tool), but no roles in data or analysis? is that correct?
IMPOWR: Each research center is responsible for monitoring participant recruitment and enrollment, data collection, and data analysis. Each research center must provide commitment to the C&DC to submit subject enrollment metrics on a quarterly basis for NIH reporting purposes.
The C&DC is responsible for developing novel assessment and/or diagnostic tools, including a single composite outcome measures for CP and OUD that is required. It is recommended that research centers utilize this single composite measures tool once the tool has been created and validated, so participation from research center representatives is strongly recommended. The C&DC is not responsible for data analysis across the network, but will facilitate data sharing agreements and a data harmonization meeting in Fall 2021 to establish common data elements for the network.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): The C&DC will serve in a coordination capacity for project teams funded through RFA-MH-21-145 to help achieve the circumscribed collaboration goals stated in the RFA.
Dr. Freed, could you clarify your comment about academic sites. Is this a concern about the representativeness and diversity of the treatment population served (e.g. inclusive of low-income, minority, and other important subgroups)? And would interventions based in urban, university-based systems that heavily serve such populations be appropriate?
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): “Yes” to both questions. As stated elsewhere in this Q&A document, interventions should be tested as naturalistically as possible. Research funded though this RFA should yield practice relevant information. Thus, effectiveness studies conducted in community practice settings are optimal for projects funded through this RFA (versus academic research laboratories using research therapists or other features that are not representative of typical practice settings).
Regarding research cluster #1 – Can you please clarify what is required to be “integrated”? Does this refer primarily to integrated treatment for both chronic pain and OUD, or does it require that the interventions to be tested include an integrated model of care, e.g. engaging multiple specialties?
IMPOWR: Research cluster 1 solicits efficacy/effectiveness trials on novel interventions for CP and OUD/misuse. This FOA invites a wide range of treatment approaches ranging from pharmacological, behavioral, and/or medical devices (e.g., TMS) that has demonstrated efficacy for treating CP or OUD/misuse. The PI must provide supporting evidence to justify the selection of the intervention for treating both CP and OUD/misuse. A multi-site design is recommended, but not required for this research cluster.
Research cluster 2 solicits the development and evaluation of integrated care delivery models for CP and OUD/misuse across clinical sites/health care systems. Of note, for this research cluster, study designs must ensure coordinated and sustained linkage between CP and OUD/misuse specialists to provide meaningful and integrated care delivery for the patient. Study designs that propose referrals to a pain or OUD/misuse health care provider as a model of care are not appropriate for this FOA. A multi-site design is required for this research cluster.
Could the sites include the VA?
IMPOWR: Yes, and applicants are encouraged to be thoughtful about how the proposed intervention may generalize to other health care system without the infrastructure and other supports found in the VA health care system.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): Yes. VA sites can be included.
There have been other HEAL initiatives / RFAs where once individual research centers are funded, they are asked to work together to identify/select which research projects that individual sites proposed might work best across all research sites. Do you anticipate something similar will happen here?
IMPOWR: No, there are no plans to identify a single intervention or set of interventions to be tested in IMPOWR. This network was structured to field as many effective interventions and health care delivery strategies as possible to quickly bring treatments to this complex population. The only space that requires some coordination across research studies lies in harmonization efforts to establish common data elements.
Optimizing Multi-Component Service Delivery Interventions (RFA-MH-21-145): No. Expectations for collaboration are outlined in the RFA. Up to three distinct R01s will be funded through RFA-MH-21-145.
For IMPOWR, even if the projects will be different, are we expecting all projects to start at year 2?
IMPOWR: Research centers are expected to begin the studies following appropriate approvals from the IRB and DSMB, and common data element establishment during the data harmonization meeting in Fall 2021. Applicants should anticipate starting these trials as quickly as possible, including the possibility of fielding the studies in year 1.
The intent of the pre-application webinar is to provide an overview of RFA-DA-21-029, RFA-DA-21-030, and RFA-MH-21-145, identify areas of synergies and distinctions between the two programs, and to address questions from potential applicants. Since researchers funded through any of the three aforementioned FOAs are expected to coordinate with one another, a joint pre-application informational webinar will be provided on January 29, 2021. The webinar is optional and not required for application submission.
- RFA-DA-21-030 HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
- RFA-DA-21-029 HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional)
- RFA-MH-21-145 HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)