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Page 9 of 9 Page 9 of 9 Request for Information National Center for Posttraumatic Stress Disorder (NC-PTSD), Dissemination and Implementation Science Division at the VAPAHCS Menlo Park Division RFI In... Page 9 of 9 Page 9 of 9 Request for Information National Center for Posttraumatic Stress Disorder (NC-PTSD), Dissemination and Implementation Science Division at the VAPAHCS Menlo Park Division RFI Instructions This Request for Information (RFI) is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. In accordance with (IAW) Federal Acquisition Regulation (FAR) 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. The purpose of this RFI is to obtain market information on capable sources of supply, industry practices, and input specific to the information provided. The Government is not responsible for any cost incurred by industry in furnishing this information. All costs associated with responding to this RFI will be solely at the interested party s expense. Not responding to this RFI does not preclude participation in any future Request for Quote, if any is issued. Any information submitted by respondents to this RFI is strictly voluntary. All submissions become Government property and will not be returned. Responses should clearly mark any information that is proprietary, restricted or competition sensitive information. The Department of Veterans Affairs (VA) Technology Acquisition Center is issuing this RFI to determine Contractor capabilities in executing the Government requirements identified below and in Appendix 1. 2.0 Background The rapid growth and diffusion of digital mental health interventions is changing the landscape of PTSD care. Beyond traditional face-to-face psychotherapy, veterans may now choose evidence-based services through telemental health (both video and phone), web-based programs, or mobile apps (either as part of therapist-delivered treatment or as a self-management tool). Given the many barriers to accessing effective in-person PTSD treatment, providing patients with a choice of modality for receiving effective services is a promising advancement, both in terms of increasing overall access to care and increasing engagement by involving patients in determining how they want to receive care. However, successful dissemination and implementation of health interventions requires a clear understanding of the demand for each type of service and the segmentation of this demand across customers (veterans). There has been some research on the use (e.g., Connolly et al., 2020) and acceptability (Goetter, Blackburn, Bui, Laifer, & Simon, 2019) of video telemental health. In addition, usage data can offer insights into the demand for specific mobile mental health apps among the general population. However, almost nothing is known about the demand for the different types of digital mental health interventions among veterans specifically, or how geographic, demographic, or psychological factors may moderate this demand. To address this gap, we propose to examine attitudes toward different modalities of PTSD interventions and the facilitators and barriers to their use among a diverse sample of veterans with PTSD symptoms. Identifying the sub-groups of veterans who are most receptive to certain intervention types would facilitate tailoring of outreach and marketing efforts so that they meet veterans needs and preferences and thereby have the best chance of successful uptake. Goals The goal of the study is to understand attitudes toward different modalities of PTSD interventions and the facilitators and barriers to their use among 400 veterans with clinically significant PTSD symptoms (as determined by a PCL-5 score 31) who are fluent in English. Participants will be recruited online and invited to complete a one-time survey. Data will be collected through Redcap (behind VA firewall). Participants will be recruited using online advertisements. After screening and consent, they will complete a survey administered online via RedCap. Participants will be sent an electronic gift card as compensation. NCPTSD will develop all procedures for the study design, including participant inclusion and exclusion criteria, the assessment, and the procedures. NCPTSD will oversee participant consent and enrollment, data collection, and participant compensation for completing assessments. NCPTSD will analyze study data and report study findings. The contractor will be a technology company that has experience building software for clinical research. The contractor must have an existing HIPAA-compliant web-based clinical research recruitment and engagement platform to recruit online and manage enrollment for this study and experience with recruiting clinical samples. The contract will be responsible for recruiting and enrolling the 400 participants that meet the study inclusion/exclusion criteria noted above. Targeted outreach ad campaigns should be used to reach the target population using social media and/or search engine advertising platforms. Contractor must have experience using social media sites, such as Facebook, to target advertising. Experience recruiting clinical samples with PTSD strongly preferred. The contractor will provide advanced analytics on the recruitment campaign performance with views, clicks, surveys, signups. The contractor will develop a user-friendly, interactive study-specific participant recruitment and engagement platform (i.e., a study landing page) that is linked to the advertisements where potential participants can read more about the study, share with others, save the link for future reference, or take the next step towards study participation by signing up online or being redirected to download the study application. This landing page will be integrated with the study pre-screening questions that will determine participant eligibility with branching logic, counting, etc. seamlessly integrated. The contractor will provide a portal for NCPTSD study staff to manage potential participants (e.g., notes, status updates) and connect with potential participants via text messaging. The contractor will be local to NCPTSD to permit in person meetings. Contractor shall store patient health information (PHI) within a HIPAA and HITRUST compliant server that can only be accessed by select staff members with limited and controlled access. The clinical data collected as part of the proposed research studies (to be reviewed by the Institutional Review Board) will be connected to a non-identifiable participant username only and as they are not accessing VA system or our data. Selected NCPTSD staff will have access to a research dashboard where limited and agreed upon data will be available. All staff who access these data will have completed CITI training. Additional information on associated to the delivery schedule associated deliverables are each phase can be found in Appendix 1. 4.0 Response VA is seeking interested vendors that are capable of providing a clinical research participant Solution for the Department of Veterans Affairs as a managed service. An initial set of minimum Government requirements for the desired solution are detailed in Appendix 1. The response must be limited to 5 pages and should clearly specify the following: Contractors experience with recruiting participants in the context of clinical research using a variety of social media outlets Contractor s approach to the development and design of a study-specific participant recruitment and management platform that is linked to the study advertisements. Contractors approach to integrating the study landing page with study pre-screening questions to determine participant eligibility. The tools and processes used to maintain the data including a portal for managing participant flow throughout the study. Formulate Contractor s approach to attending regular status update meetings. The RFI response describing this capability must be clear, concise, and complete. VA is under no obligation to provide feedback to the company, or to contact the company for clarification of any information submitted in response to this request. However, VA may contact certain respondents to seek further information as market research. Be advised that set-aside decisions may be made based on the information provided in response to this RFI. Responses should be as complete and informative as possible. As part of your RFI response, please provide the following information. At this time, VA is seeking responses for the National Center for Posttraumatic Stress Disorder (NC-PTSD), Dissemination and Implementation Science Division at the VAPAHCS Menlo Park Divisions (see Appendix 1). Please provide responses for scalability as requested. Provide a summary of your technical solution(s) for recruiting participants in order to effectively test the Renew application as described by the Government s requirements in Appendix 1. Be specific of the nature of the targeted recruitment campaign solution, the software and/or tools used, the participant data storage options, etc. For any requirement not met by the proposed solution, describe any third-party integration arrangements that currently exist to address the gaps. Please identify the requirement, third party solution, and contribution to the solution. The summary should address the following: Provide a brief summary of your technical approach to meet the requirements. How the data can be leveraged to perform predictive, real time and other forms of advanced analysis Describe how your capability supports the VA in creating a user dashboard to manage participants flow throughout the study. Please include any processes that will be used for data to ensure the quality and accuracy of the data. Please provide a Rough Order of Magnitude (ROM) (Not a Quote) detailing all costs associated with meeting VA s requirements including any required licensing, installation and configuration, and maintenance activities if required. The ROM shall include costs associated for VA to incorporate another clinical research study with different clinical research participants at a later time. Describe similar work efforts of this scope and complexity that you have been involved in. Have you performed this type of work with the Federal Government? Provide supporting detail indicating whether you were the prime contractor or a subcontractor. If a small business, describe your type of small business. Are you able to comply with FAR 52.219-6 and 52.219-14 in execution of this effort? Are you able to comply with VAAR 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside and with subcontracting limitations in 13 CFR 125.6 in execution of this effort? Describe how collected patient health information (PHI) is stored. Explain if information is stored within a HIPAA and HITRUST compliant server. For SDVOSB/VOSB firms, indicate whether at least 50% of the cost of performance incurred is planned to be expended for employees of your concern or employees of other eligible SDVOSB/VOSB firms. Identify existing contract vehicles (VA, GSA, NASA SEWP, etc.) of which you are a contract holder and can be utilized to procure the Phase-III Pilot Randomized Controlled Trial of Self-Guided Exposure App for Posttraumatic Stress Disorder Symptoms: The Role of Coaching Support. Please provide your technical and functional comments/recommendations on elements of VA s requirements that are necessary to develop a complete solution for the Department of Veterans Affairs. The page limit for the response is no more than 5 pages. Responses should also include the company profile (to include, but not limited to, history, business size and socioeconomic category, applicable North American Industry Classification (NAICS). The response should also include a list of all subcontractors proposed and their respective role in the performance of this requirement. Please send your questions and responses regarding this announcement to Contract Specialist Cheryl Cassagne Cheryl.Cassagne@va.gov -and Contracting Officer Matthew Newell Matthew.Newell@va.gov Please Note: VA may elect to contact individual companies based upon the content of their RFI submission. VA may engage these companies to gather further information through email correspondence, telephone calls, virtual or physically located meetings, and/or other means. VA may elect to conduct capability demonstrations. Responses are due no later than 15:00 PM Eastern Standard Time (EST) on Tuesday, June 29, 2021. Faxed copies are not acceptable. Contracting Office Address: Department of Veterans Affairs Office of Procurement, Acquisition and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724 Primary Points of Contact: Primary Contract Specialist Name: Cheryl Cassagne Email: Cheryl.Cassagne@va.govPhone: 732-440-9719 Contracting Officer Name: Matthew Newell Email: Matthew.Newell@va.govPhone: 732-440-9691 Appendix 1 Requirements The Contractor shall develop a targeted study recruitment campaign solution that will meet the goals identified in Section 3.0 above. The Contractor shall be responsible for recruiting and enrolling the 400 participants that meet the study inclusion/exclusion criteria identified below. Contractor shall use targeted outreach ad campaigns to attain the target population using social media and/or search engine advertising platforms including but not limited to social media sites, such as Facebook, to target advertising. Experience recruiting clinical samples with PTSD strongly preferred. The contractor will provide advanced analytics on the recruitment campaign performance with views, clicks, surveys, signups. The contractor must have an existing HIPAA-compliant web-based clinical research recruitment and engagement platform to recruit online and manage enrollment for this study and experience with recruiting clinical samples. The contract will be responsible for recruiting and enrolling the 400 participants that meet the study inclusion/exclusion criteria noted above. Targeted outreach ad campaigns should be used to reach the target population using social media and/or search engine advertising platforms. Contractor must have experience using social media sites, such as Facebook, to target advertising. Experience recruiting clinical samples with PTSD strongly preferred. The contractor will provide advanced analytics on the recruitment campaign performance with views, clicks, surveys, signups. The contractor shall collect patient health information (PHI) will stored within a HIPAA and HITRUST compliant server that can only be accessed by select staff members with limited and controlled access. The contractor shall collect clinical data collected as part of the proposed research studies (to be reviewed by the IRB) will be connected to a non-identifiable participant username only and as they are not accessing VA system or our data. Selected NCPTSD staff will have access to a research dashboard where limited and agreed upon data will be available. All staff who access these data will have completed CITI training. The contractor will develop a user-friendly, interactive study-specific participant recruitment and engagement platform (i.e., a study landing page) that is linked to the advertisements where potential participants can read more about the study, share with others, save the link for future reference, or take the next step towards study participation by signing up online or being redirected to download the study application. This landing page will be integrated with the study pre-screening questions that will determine participant eligibility with branching logic, counting, etc. seamlessly integrated. The contractor will provide a portal for NCPTSD study staff to manage potential participants (e.g., notes, status updates) and connect with potential participants via text messaging. The contractor will be local to NCPTSD to permit in person meetings. Participant Requirements: The participants shall consist of four hundred veterans who, have significant PTSD symptoms (as determined by a PCL-5 score 31), who are fluent in English, and who own a mobile device. Participants must reside in the continental US and not be engaged in treatment for PTSD during the study period. Veteran status in neither an inclusion nor an exclusion criterion for this study. Task 1.1. The contractor shall develop a targeted study recruitment campaign. Deliverable 1.1.1 Provide technical information for IRB application. Deliverable 1.1.2. Provide ongoing updates. Brief weekly status updates, conducted by phone will indicate the status of the recruitment campaign and the study-specific participant recruitment and engagement platform. Deliverable 1.1.3. Monthly meetings will be held by phone and will indicate the status of the recruitment campaign and the study-specific participant recruitment and engagement platform. See Reporting Requirements below. Deliverable 1.1.4. Submit mockups of study advertisements and the recruitment and engagement platform for approval by NCPTSD, with up to 3 iterations at NCPTSD discretion. Mockups will be based on review of available study materials from NCPTSD (protocol, informed consent, ct.gov listing, etc.) to distill most relevant information and developed using 8th grade language. Deliverable 1.1.5. Submit final study advertisements and participant screening procedure approval by NCPTSD. Deliverable 1.1.6. Recruit and enroll a minimum of 400 study participants meeting following inclusion and exclusion criteria and screening procedures provided by NCPTSD. Deliverable 1.1.7. Provide study page portal access to NCPTSD study staff to monitor participants through all stages of study participation, including data collection and participant compensation. 1.2 Schedule for Mandatory Deliverables. 1.2.1 Summary Table of Contract Deliverables REFERENCE DELIVERABLE Delivery Schedule 1.1.1 Provide technical information for IRB application Within 1 month after contract award 1.1.2 Weekly status updates about project progress Weekly 1.1.3 Monthly progress reports Monthly 1.1.4 Submit mockups of study advertisements and participant screening procedure Within 1 months after contract award 1.1.5 Submit final study advertisements and participant screening procedure Within 4 months after contract award 1.1.6 Recruit and screen participants Months 4 - 9 1.1.7 Provide portal access to track participant participation throughout study Months 4 - 12