SOURCES SOUGHT
D -- TAC-19-55071 _The Role of Coaching Support
- Notice Date
- 4/23/2019
- Notice Type
- Synopsis
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Veterans Affairs;Technology Acquisition Center;23 Christopher Way;Eatontown NJ 07724
- ZIP Code
- 07724
- Solicitation Number
- 36C10B19Q0350
- Response Due
- 5/6/2019
- Archive Date
- 8/4/2019
- Point of Contact
- Tinamarie.Giraud@va.gov
- Small Business Set-Aside
- N/A
- Description
- Page 8 of 8 Request for Information Phase-II Pilot Randomized Controlled Trial of Self-Guided Exposure App for Posttraumatic Stress Disorder Symptoms: The Role of Coaching Support 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 National Center for Posttraumatic Stress Disorder (PTSD), Dissemination and Training Division (NCPTSD), part of the U.S. Department of Veterans Affairs (VA), is responsible for creating training and educational products to support evidence-based care of Veterans with PTSD and related problems. PTSD is very common among Veterans and has a significant impact on Veterans quality of life. Most Veterans with PTSD do not access evidence-based treatments for PTSD, and many Veterans are either unable or choose not to access available mental health services of any kind. Lack of available services, distance from clinics, and stigma associated with mental health care are just a few of the barriers to providing care for Veterans and those living with a Veteran with PTSD. Delivering PTSD interventions via mobile health (mHealth) applications (apps) is an innovative way to increase the reach of evidence-based treatments with minimal resources relative to face-to-face therapy. The efficacy of previously developed mHealth treatments for PTSD is promising, including online interventions of written exposure (Interapy; e.g., Knaevelsrud & Maercker, 2007) and mobile apps of self-management tools (PTSD Coach; Kuhn et al., 2017). Although mobile app interventions are popular with users, engagement with and completion of such programs is notoriously low. Engagement with mobile app interventions can be conceptualized as a dynamic process beginning with a cue to initiate (e.g., peer recommendation), followed by initial use, and then either sustained engagement or disengagement. Human support is one design feature that has been shown to increase sustained engagement. It can be used to provide guidance, emotional support, encouragement, and accountability. However, many critical questions remain about how best to integrate human support, such as whether external support from a professional (e.g., staff person, peer specialist) is superior to natural support from one s social support network. In FY 2018, National Center for PTSD center funds were used to develop a self-management app for symptoms of PTSD, called Renew. Renew focuses on three core activities: 1) in vivo exposure (Approach exercises), 2) written exposure (Process exercises), and 3) Self-Care exercises (designed to promote behavioral activation, relaxation, and social connectedness). Users have access to psychoeducation via a whiteboard video and short texts as well as Motivation content (quotes, videos, images, and songs) related to confronting challenges and overcoming fears. For each exercise that is completed, the user earns points that are connected to levels and visually reinforcing images (i.e., a growing tree). Users are encouraged to complete a 5-item assessment periodically to monitor progress and receive individualized feedback. Users are also encouraged to select a support person(s) who is notified when the user engages with the app or if they have not engaged for 7 days. Support persons are provided with psychoeducation material including information about how to be an effective support person for the user and direct messaging capacity to respond to app notifications about user engagement (e.g., user earned X points, user achieved a new level). The most innovative features of this app are the inclusion of self-guided exposure exercises, the gamification of the app using the points and level structure, and the ability to connect with a support person/team that can provide positive reinforcement for engaging with the app. Goals The overall goal of this study is to test Renew in a mixed-methods Phase II pilot randomized clinical trial (RCT) to evaluate treatment acceptability and to estimate design elements and statistical parameters for a subsequently fully powered Phase III trial. Phase II pilot trials are a fundamental step in the research process and the clinical trials literature consistently recommends the use of pilot trials prior to conducting Phase III studies (Leon, et al., 2011; Thabane, et al., 2010). Participants will be randomized to either: 1) delayed treatment, 2) Renew with study staff support, or 3) Renew without study staff support. A delayed treatment control condition will yield a rich dataset of both between (intervention conditions vs. control) and within subjects (the impact of intervention on all participants) estimates of the treatment effect. Specifically, the VA aims to: 1. Examine the acceptability of Renew with participants during a posttreatment qualitative interview. 2. Examine the efficacy of Renew relative to the delayed treatment condition on change in PTSD symptom severity (primary) as well as depression symptom severity, coping self-efficacy, and perceived social support (secondary). 3. Examine the impact of professional support over and above natural support on participant engagement with the app (primary) as well PTSD symptom severity, depression symptom severity, coping self-efficacy, and perceived social support (secondary). After screening and consent, they will complete a baseline assessment and be randomized to either: 1) delayed treatment, 2) Renew with study staff support, or 3) Renew without study staff support. Participants will be instructed to use the app for 12 weeks before completing a post-treatment and 3-month follow-up assessment. All assessments will be administered online via RedCap. Participants randomized to receive study staff support will be instructed to assign a study staff person (study RA) as a support member in Renew, and will receive a minimum of 3 messages per week from the staff member (or more depending on app usage). Participants randomized to either of the Renew conditions may utilize the app s support feature with friends or family as they choose. This design allows us to test the effect of professional support on participant engagement and outcomes. After post-treatment, participants in the delayed treatment condition will be offered the Renew condition of their choice. The participants shall consist of ninety adult men and women who have experienced a traumatic event more than 1 month ago, have significant PTSD symptoms (as determined by a PCL-5 score 31), who are fluent in English, and who own an Android mobile device. Participants must reside in the continental US and not be engaged in treatment for PTSD during the study period. A sample size of 15-30 participants per cell is expected for feasibility testing and initial outcomes testing in pilot trials (Rounsaville, 2001). Veteran status in neither an inclusion nor an exclusion criterion for this study. 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 20 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 Phase-II Pilot Randomized Controlled Trial of Self-Guided Exposure App for Posttraumatic Stress Disorder Symptoms: The Role of Coaching Support (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 If on premise and off premise meeting options exist, please describe differences and limitations between the two and indicate the implications of pricing associated following: Explain the reliability of these solution(s). Include information such as meeting platform, frequency, subject matter experts and duration. 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? 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-II 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 Tinamarie Giraud tinamarie.giraud@va.gov and Contracting Officer Kevin Monahan kevin.monahan@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 12:00 PM Eastern Standard Time (EST) on Monday, May 6, 2019. 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: Tinamarie Giraud Email: Tinamarie.Giraud@va.gov Phone: 732-440-9641 Contracting Officer Name: Kevin Monahan Email: kevin.monahan@va.gov Phone: 732-440-9695 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 90 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. Participant Requirements: The participants shall consist of ninety adult men and women who have experienced a traumatic event more than 1 month ago, have significant PTSD symptoms (as determined by a PCL-5 score 31), who are fluent in English, and who own an Android mobile device. Participants must reside in the continental US and not be engaged in treatment for PTSD during the study period. A sample size of 15-30 participants per cell is expected for feasibility testing and initial outcomes testing in pilot trials (Rounsaville, 2001). Veteran status in neither an inclusion nor an exclusion criterion for this study. Deliverable 1.1.1. Provide technical information for Institutional Review Bord 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 in person and will focus on reviewing the projected schedule and the contractor s recommendations for recovering from any schedule slippage, as well as discussing/reviewing project content in depth. 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 90 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 NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (23-APR-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
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- SN05290048-F 20190425/190423230021 (fbodaily.com)
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