36C10B18Q2990-001.docx

Evaluating Online PTSD Programs with Peer Support TAC Number: TAC-18-50569

TRANSFORMATION TWENTY-ONE TOTAL TECHNOLOGY NEXT GENERATION (T4NG)

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration National Center for Posttraumatic Stress Disorder, Dissemination and Implementation Science Division

Evaluating Online PTSD Programs with Peer Support

Date: June 29, 2018

TAC-18-50569

Task Order PWS Version Number: 1.6

Disclaimer: The TAC accepts no liability for the completeness or correctness concerning the Information Technology content of this template. This template is a means to simply assist the requiring activity in developing their requirements. It is the Requiring Activity’s responsibility to ensure the correctness of all requirements within their final Performance Work Statement.

Contents

BACKGROUND

The National Center for Posttraumatic Stress Disorder (PTSD) (NCPTSD), Dissemination and Training Division, 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. NCPTSD staff have developed online PTSD treatment programs to overcome these and other barriers to care. The programs are designed to assist Veterans in understanding PTSD and related problems, tracking their improvement over time, and managing symptoms using a variety of evidence-based therapy tools.

NCPTSD staff have developed a variety of online treatment programs. Two of the most recently developed programs designed to treat PTSD are webSTAIR and Web-PE. Skills Training in Affective and Interpersonal Regulation (STAIR) (Cloitre, Cohen, & Koenen, 2006) is an evidence-based coping skills intervention for individuals who have experienced a traumatic event and are having emotion management and relationship difficulties. webSTAIR is a 10-core-module, direct-to-consumer adaptation of STAIR that is interactive, engaging, user friendly, and can be supported by coaching. Web-PE is an online, self-guided, therapist-assisted 10-module program that corresponds to the prolonged exposure (PE) treatment manual (Foa, Hembree, & Rothbaum, 2007).

Preliminary data from separate ongoing studies evaluating both programs suggests that they are effective; however, an important unanswered question is whether streamlined versions of these programs would also be effective in reducing PTSD symptom severity.

In addition, the potential role of peer support has not been fully explored for either program. Previous research on peer support during online behavioral health interventions supports the benefit of peer support services on improving clinical outcomes (Myrick & del Vecchio, 2016). However, much of the research is not peer-reviewed or methodologically rigorous (Blash et al., 2015). Important unanswered questions about the role of peer support for online behavioral health interventions include: (1) who benefits most from peer support services, (2) how the peer support interactions promote treatment engagement and improved outcomes, and (3) when transition to a clinical provider is needed.

NCPTSD is in need of support to perform the following:

1. Conduct an observational study to examine how peer support interactions relate to clinical improvement and to identify Veteran characteristics associated with benefit from peer support services and need to step-up from peer support to clinician care.

2. Conduct clinical outcomes research to examine the efficacy of brief versions (i.e., a shorter number of modules) of webSTAIR with and without trained peer support in reducing PTSD and depression symptom severity.

3. Conduct clinical outcomes research to examine the efficacy of two versions of a brief exposure therapy intervention (written versus imaginal exposure to the trauma memory) with trained peer support in reducing PTSD symptom severity.

The above studies shall be conducted using the VetsPrevail website. VetsPrevail is an online platform that provides access to a large pool of Veterans and has built-in functionality for peer support coaching of Veterans that can be used in the three studies. Software modifications are needed to conduct the three studies. For the observational study, questionnaires will need to be developed and available for study participants on the VetsPrevail website. webSTAIR and Web-PE will need to be modified and made available to the study participants through the VetsPrevail website. The Contractor needs to adapt the current programs, in terms of length, functionality, and content, to match the technical, functional and esthetic environment of VetsPrevail. Access to the current source code of these programs will be available at contract award.

The current webSTAIR application is written with .NET MVC 4.5 with Entity Framework on the backend. The front end is written with HTML/CSS/JavaScript. It uses an MSSQL database. The application has approximately 30,000 lines of code. The code repository is a Mercurial Repository hosted on Bitbucket. The current webSTAIR application is hosted on scalable cloud based servers provided by Rackspace.

The Web-PE application is developed in Visual Studio 2015 using Git with SQL Server 2013 and Entity Framework 6 on the backend. It is written with ASP.Net MVC, C#, and AutoMapper on the server side and AngularJS 1.5, TypeScript, JavaScript, JSON, and Bootstrap 3v on the client side.

APPLICABLE DOCUMENTS

The Contractor shall comply with the following documents, in addition to the documents in Paragraph 2.0 in the T4NG Basic Performance Work Statement (PWS), in the performance of this effort:

SCOPE OF WORK

The Contractor shall conduct three studies using the VetsPrevail website to examine how different conditions relate to improvement of PTSD symptom severity. Specifically, the Contractor shall:

1. Conduct an observational study to examine how peer support interactions relate to clinical improvement and to identify Veteran characteristics associated with benefit from peer support services and need to step-up from peer support to clinician care.

2. Conduct clinical outcomes research to examine the efficacy of a modified version of webSTAIR with and without trained peer support in reducing PTSD and other mental health symptom severity,

3. Conduct clinical outcomes research using a Contractor-modified version of Web-PE to examine the efficacy of two versions of a brief exposure therapy intervention (written vs. imaginal exposure to the trauma memory) with trained peer support in reducing PTSD symptom severity.

To perform the studies, the Contractor shall perform software development, to include requirements analysis, configuration management, software design, development, testing, deployment, hosting, and maintenance of the software.

As part of the studies, the Contractor shall recruit, screen, and enroll study participants, administer self-report measures of clinical variables selected by NCPTSD, and provide peer support coaching, provide de-identified data gathered from the studies to NCPTSD.

APPLICABILITY

This Task Order (TO) effort PWS is within the scope of paragraph(s) <Enter paragraph numbers> of the T4NG Basic PWS.

ORDER TYPE

The effort shall be proposed on a Firm Fixed Price (FFP) basis.

PERFORMANCE DETAILS

PERFORMANCE PERIOD

The period of performance (PoP) shall be 12 months from date of award, with three options for 12 months each.

PLACE OF PERFORMANCE

Efforts under this TO shall be performed at Contractor facilities. The Contractor shall identify the Contractor’s place of performance in their Task Execution Plan submission.

TRAVEL OR SPECIAL REQUIREMENTS

The Government does not anticipate travel to perform the tasks associated with the effort. Include all estimated travel costs in your firm-fixed price line items. These costs will not be directly reimbursed by the Government.

CONTRACT MANAGEMENT

All requirements of Sections 7.0 and 8.0 of the T4NG Basic PWS apply to this effort. This TO shall be addressed in the Contractor’s Progress, Status and Management Report as set forth in the T4NG Basic contract.

GOVERNMENT FURNISHED PROPERTY

VA will provide the source code for webSTAIR and Web-PE and access to the test site for webSTAIR and Web-PE software applications.

SECURITY AND PRIVACY

All requirements in Section 6.0 of the T4NG Basic PWS apply to this effort. Specific TO requirements relating to Addendum B, Section B4.0 paragraphs j and k supersede the corresponding T4NG Basic PWS paragraphs, and are as follows,

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical and based on the severity of the incident.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes based upon the requirements identified within the TO.

It has been determined that protected health information may be disclosed or accessed and a signed Business Associate Agreement (BAA) shall be required. The Contractor shall adhere to the requirements set forth within the BAA, referenced in Section D of the Request for Task Execution Plan (RTEP) and shall comply with VA Directive 6066.

POSITION/TASK RISK DESIGNATION LEVEL(S)

The PDT Tool is located at the following US Office of Personnel Management Website: https://www.opm.gov/investigations/suitability-executive-agent/position-designation-tool/)

In accordance with VA Handbook 0710, Personnel Security and Suitability Program , the position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

Position Sensitivity and Background Investigation Requirements by Task

The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

PROJECT MANAGEMENT

CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline and tools to be used in execution of this TO effort. The CPMP should take the form of both a narrative and graphic format that displays the schedule (in Microsoft Project), milestones, risks and resource support. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified within the PWS. The initial baseline CPMP shall be concurred upon and updated in accordance with Section B of the TO. The Contractor shall update and maintain the VA Program Manager (PM) approved CPMP throughout the PoP. The Contractor shall monitor performance against the CPMP and report any deviations. The Contractor shall communicate with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

Deliverable:

A. Contractor Project Management Plan

REPORTING REQUIREMENTS

The Contractor shall attend weekly project meetings and provide verbal reports on progress. The Contractor shall also provide brief weekly status updates via written Weekly Status Report that indicate the status of the development of the modified programs, including the work breakdown structure; the projected schedule; and the Contractor’s recommendations for recovering from any schedule slippage. Upon deployment of the software solutions to the Contractor-hosted production environment, the Weekly Status Report shall include the recruitment and enrollment numbers for each study.

Deliverable:

A. Weekly Status Report

TECHNICAL KICKOFF MEETING

The Contractor shall hold a technical kickoff meeting within 10 days after TO award. The Contractor shall present, for review and approval by the Government, the details of the intended approach, work plan, and project schedule for each effort. The Contractor shall specify dates, locations (can be virtual), agenda (shall be provided to all attendees at least five calendar days prior to the meeting), and meeting minutes (shall be provided to all attendees within three calendar days after the meeting). The Contractor shall invite the Contracting Officer (CO), Contract Specialist (CS), COR, and the VA PM.

SYSTEM DEVELOPMENT

The Contractor shall develop assessment questionnaires required for automated recruiting and screening, automated assessments, and integration of other VetsPrevail program components into the three research study programs (safety protocol, peer mentor and peer chat board use characteristics, peer review adherence, VetsPrevail platform use). The Contractor shall also adapt and modify the two existing online PTSD treatment programs, webSTAIR and Web-PE, so that they can be used for two intervention studies. NCPTSD will provide the program files for webSTAIR and Web-PE. The Contractor shall develop software solutions that meet the requirements in Appendix B.

The Contractor shall embed the assessment questionnaires and the modified versions of the existing webSTAIR and Web-PE programs onto the VetsPrevail online platform so that they are available to be accessed, through the VetsPrevail platform, to users of the VetsPrevail website who enroll in the related study (i.e., the observational study, webSTAIR study, or the Web-PE study).

The Contractor shall provide input on technical and information security aspects of the VetsPrevail platform so that the NCPTSD can prepare the Institutional Review Board (IRB) application in support of the three studies (observational, webSTAIR, and Web-PE studies). The Contractor shall provide all technical information needed for the IRB application within one month after TO award.

DEVELOPMENT

The Contractor shall conduct requirements analysis, configuration management, software design, development, testing and deployment of the software needed for the three studies. The Contractor shall work directly with NCPTSD to refine the requirements and develop solutions that meet the requirements in this PWS including Appendix B.

The Contractor shall plan, schedule, and conduct requirement review meetings with VA stakeholders to analyze, refine, and translate the requirements specified in this PWS into Agile epics, user stories including screen mockups depicting every representative screen requested by NCPTSD, and acceptance criteria. The Contractor shall be responsible for documenting and maintaining the epics, user stories, and acceptance criteria throughout the PoP. The Contractor shall ensure that the VA PM has access to the most current version of all epics, user stories, and acceptance criteria throughout the PoP.

The Contractor shall populate and maintain an Agile product backlog using the requirements in this PWS including required modifications needed to webSTAIR and Web-PE in Appendix B. The priority of the items on the product backlog shall be determined based on input from the VA PM. The Contractor shall ensure that the VA PM has access to the current product backlog throughout the PoP. The Contractor shall plan and execute Agile sprints. Prior to each sprint, the Contractor and VA shall meet to review the status of the product backlog and finalize the sprint goals.

At the end of each sprint, the Contractor shall conduct a Sprint Review with the VA PM. The Contractor shall demonstrate the work accomplished (i.e. functionality developed, bugs fixed, etc.).

The Contractor shall host and maintain a User Acceptance Testing (UAT) environment with the latest sprint code for VA to test and demonstrate the functionality between sprints. This environment shall remain operational throughout the software development phase.

The final Contractor tested software code shall not have any known defects. The Contractor shall deliver a Final Test Report summarizing the testing that was performed, including both functional and scalability testing.

The Contractor shall deliver the final tested Software Source Code, Compiled Code, and Software Build for the Observational Study, webSTAIR, and Web-PE software applications to VA.

Deliverables:

A. Final Test Report B. Observational Study Assessment Software Source Code, Compiled Code, and Software Build C. webSTAIR Software Source Code, Compiled Code, and Software Build D. Web-PE Software Source Code, Compiled Code, and Software Build

SYSTEM DOCUMENTATION

The Contractor shall develop User’s Manuals for Veterans using each program (one User’s Manual for webSTAIR and two for Web-PE-one for each condition), a Coaching Manual for webSTAIR, a Coaching Manual for Web-PE, Protocol Manuals (one for the observational study, one for webSTAIR, and one for Web-PE), and a System Administrator’s Guide and System Design Document (SDD) for webSTAIR and Web-PE. The User’s Manuals and Coaching Manuals shall give an overview of features and elements of the web programs and how to access them. The Coaching Manuals for each study shall provide tips and guidelines for how to coach Veterans in using each of the programs. The Protocol Manuals shall be more detailed guides to the policies and procedures of the research protocols. The System Administrator’s Guide and SDD will provide information for NC-PTSD investigators on how to access the programs, research dashboards, and recruitment procedures. Both the User’s Manual and System Administrator’s Guide shall provide illustrated, step-by-step instructions for each system function/capability. The SDD shall include a detailed explanation of the complete technical architecture including all system components and interfaces. The document shall also provide a detailed explanation of the software design. The Contractor shall use the VA Process Asset Library (PAL) (at https://www.va.gov/process/) System Design Document template in creating the SDD. All documents shall be delivered in an editable, electronic format and shall become the property of VA. VA shall be granted unrestricted permission to edit and reproduce the documents.

Deliverables:

A. User’s Manual for webSTAIR B. User’s Manual for Web-PE with Written Exposure C. User’s Manual for Web-PE with Imaginal Exposure D. Coaching Manual for webSTAIR E. Coaching Manual for Web-PE F. Protocol Manual for Observational Study G. Protocol Manual for webSTAIR Study H. Protocol Manual for Web-PE Study I. System Administrator’s Guide J. System Design Document

USER ACCEPTANCE TESTING

The Contractor shall facilitate VA User Acceptance Testing (UAT). Upon successful implementation and Contractor testing of the requirements specified in Appendix B, the Contractor shall deploy the completed software solutions to a Contractor-hosted UAT environment. The Contractor shall develop test scenarios, test cases, and test scripts necessary to test the functional requirements as specified within this PWS. The Contractor shall provide and input any sample data required by the systems in order to complete the testing of the functional requirements. The Contractor shall track, resolve, and retest all defects found during UAT and provide updated Software Source Code, Compiled Code, and Software Builds for the Observational Study, webSTAIR, and Web-PE systems.

Deliverable:

A. UAT Test Scenarios, Test Cases, and Test Scripts B. Updates to Observational Study Software Source Code, Compiled Code, and Software Build C. Updates to webSTAIR Software Source Code, Compiled Code, and Software Build D. Updates to Web-PE Software Source Code, Compiled Code, and Software Build

SYSTEM HOSTING

Upon completion of VA UAT, the Contractor shall deploy the software solutions to the Contractor-hosted production environment so that the assessment questionnaires and modified webSTAIR and Web-PE applications are available to users of the VetsPrevail website who enroll in the studies (the observational study, webSTAIR study, or the Web-PE study).

The system shall be operational 24 hours a day, seven days a week. The system shall be available at least 99 percent of the scheduled operational time, excluding scheduled maintenance outages. The Contractor shall schedule system maintenance outages between 2 a.m. and 5 a.m. Eastern Standard Time (EST). Scheduled outages shall not occur more than once per week and shall be set up at least seven days in advance for maintenance and/or system upgrades to the greatest extent practical unless deemed emergent due to system compromise or imminent failure. The Contractor shall inform the VA PM and COR of any downtimes for planned or unplanned maintenance to include technical refreshes, upgrades, patches, or security updates.

The Contractor shall deliver a monthly System Hosting Report. The report shall summarize any planned or unplanned outages that occurred during the reporting period and any planned outages scheduled for the following reporting period. An explanation shall be provided for any unplanned outage that occurred during the reporting period, indicating the root cause of the outage and the steps that were or are being taken to correct the problem and prevent its reoccurrence.

Deliverable:

A. System Hosting Report

SOFTWARE MAINTENANCE

The Contractor shall resolve and retest any defects found while the software applications are in production. The Contractor shall document and track all defects to closure. The Contractor shall provide a Monthly Defect Report describing all defects, their status, and final resolution.

The Contractor shall deliver Updated Software Source Code, Compiled Code, and Build for the Observational Study, webSTAIR, and Web-PE software applications, and deploy bug fixes to the production environment in accordance with Task 5.2.4 System Hosting.

Deliverables:

A. Monthly Defect Report B. Updates to Software Source Code, Compiled Code, and Software Build

OBSERVATIONAL STUDY

The Contractor shall conduct an observational study to examine how peer support interactions relate to clinical improvement and identify Veteran characteristics associated with benefit from peer support services and the need to step-up from peer support to clinician care.

The Contractor shall: recruit and enroll a minimum of 500 Veterans into the observational study following inclusion and exclusion criteria, screening, and consent procedures provided by NCPTSD. The study participants shall be Veterans who are engaging with existing structured cognitive behavior therapy (CBT) programs embedded on the online VetsPrevail platform (i.e., request consent for their data used for research). This observational study shall run until all 500 participants have been enrolled and then utilize the VetsPrevail platform for six months. If this study is not completed in the Base Period, then it shall continue to run in the Option Periods, if exercised by VA, until all 500 complete the observational study.

The Contractor shall collect system usage and behavioral health outcomes data to evaluate the impacts of the Veterans’ use of the VetsPrevail platform and their interaction patterns with peer support mentors using the measures and time points specified by NCPTSD. The Contractor shall provide a structured dataset containing de-identified data on participant usage, clinical variables, and peer support behavior to NCPTSD for analysis and interpretation.

The Contractor shall administer self-report measures of clinical variables as part of existing routine outcomes monitoring. The Contractor shall provide peer support coaching that is integrated into their existing structured CBT programs. The trained peer support specialists shall be Veterans hired by the Contractor who have completed a peer support training that meets national competency standards set by VA for peer support. Peer support specialists shall connect participants to mental health and crisis resources as needed.

The Contractor shall provide NCPTSD with a Preliminary Observational Study Dataset after completion of the first five observational study participants for quality and process checks. The Contractor shall provide a Final Observational Study Dataset after meeting recruitment goals and after completing data collection.

Deliverables:

A. Preliminary Observational Study Dataset B. Final Observational Study Dataset

WEBSTAIR STUDY

The Contractor shall conduct clinical outcomes research to examine the efficacy of the Contractor-modified version of webSTAIR with and without peer support for PTSD. The study shall compare two conditions of the webSTAIR intervention: 1) webSTAIR with peer support, and 2) webSTAIR without peer support.

The Contractor shall: recruit, screen, enroll, and randomize study participants to one of the two conditions. The Contractor shall recruit and enroll a minimum of 400 Veterans (a minimum of 200 Veterans in the condition with regular peer support and 200 without peer support—outside initial and post-program check-ins) into the webSTAIR PTSD treatment program following inclusion and exclusion criteria and screening and consent procedures provided by NCPTSD. The study participants shall only be enrolled in one of the three studies at one time. After full completion of one study, a study participant can participate in another study.

During the recruitment process, the Contractor shall administer self-report measures of clinical variables selected by NCPTSD such that the study participants are prompted to answer the measure questions online. After a study participant is enrolled, they shall be randomized to one of the two conditions and then start to utilize the webSTAIR application. The intent is for each study participant to use webSTAIR for six to 10 weeks of treatment, proceeded by a 12-week follow up assessment. The webSTAIR study shall run until all 400 participants utilize webSTAIR and then complete the 12-week follow up assessment. If this study is not completed in the Base Period, then it shall continue to run in the Option Periods, if exercised by VA, until all 400 participants utilize webSTAIR and then complete the 12-week follow up assessment. The Contractor shall collect self-report measures, behavioral health outcomes data, and standard web metrics (e.g., times accessing the program, skills used and frequency of use) and submit it to NCPTSD to evaluate the efficacy of the two PTSD programs from participants using the measures and time points specified by NCPTSD.

The Contractor shall provide peer support coaching that will be included in one of the webSTAIR study conditions. The trained peer support specialists shall be Veterans hired by the Contractor who have completed a peer support training that meets national competency standards set by VA for peer support (see https://www.vacareers.va.gov/peer-to-peer/faqs.asp). Peer support specialists shall connect participants to mental health and crisis resources, provided by the Contractor, as needed.

The Contractor shall provide a structured webSTAIR Dataset containing de-identified data on participant usage (including standard, web metrics, e.g., module completion, tools accessed and frequency, etc.), clinical variables, and peer support behavior to NCPTSD in an Excel file structured for analysis and interpretation. The Contractor shall provide NCPTSD with a Preliminary webSTAIR Dataset after completion of the first five webSTAIR study participants for quality and process checks. The Contractor shall provide a Final webSTAIR Dataset after meeting recruitment goals and after completing data collection.

Deliverables:

A. Preliminary webSTAIR Dataset B. Final webSTAIR Dataset

WEB-PE STUDY

The Contractor shall conduct clinical outcomes research to examine the efficacy of two versions of exposure therapy (written versus verbal recounting of trauma) for PTSD using the Contractor-modified version of Web-PE. The study will compare (1) brief written exposure to the trauma memory and (2) imaginal exposure to the trauma memory.

The Contractor shall: recruit, screen, enroll, and randomize study participants to one of the two conditions. The Contractor shall recruit and enroll a minimum of 400 Veterans into the Web-PE PTSD treatment program following inclusion and exclusion criteria and screening and consent procedures provided by NCPTSD. If this Web-PE study is not completed in the Base Period, then it shall continue to run in the Option Periods, if exercised by VA, until all 400 participants utilize and complete the Web-PE PTSD treatment program.

The Contractor shall administer self-report measures of clinical variables selected by NCPTSD. The Contractor shall collect behavioral health outcomes data to evaluate the efficacy of the Web-PE PTSD program from study participants using the measures and time points specified by NCPTSD.

The Contractor shall provide peer support coaching that shall be integrated into both arms of the clinical intervention study. The trained peer support specialists shall be Veterans hired by the Contractor who have completed a peer support training that meets national competency standards set by VA for peer support. Peer support specialists shall connect participants to mental health and crisis resources, provided by the Contractor, as needed. The peer support specialists shall remind the participants to do the assessments at the relevant time points.

The Contractor shall provide a structured dataset containing de-identified data on participant usage, clinical variables, and peer support behavior to NCPTSD for analysis and interpretation. The Contractor shall provide NCPTSD with a Preliminary Web-PE Dataset after completion of the first five Web-PE study participants for quality and process checks. The Contractor shall provide a Final Web-PE Dataset after meeting recruitment goals and after completing data collection.

Deliverables:

A. Preliminary Web-PE Dataset B. Final Web-PE Dataset

WEBSTAIR AND WEB-PE EXPANSION (OPTIONAL TASK)

If this Optional Task is exercised by VA, the Contractor shall perform the following for a PoP of 12 months. webSTAIR and Web-PE are the property of VA and at the end of this PoP, the Contractor shall no longer use webSTAIR and Web-PE. The Contractor shall make available to all users of VetsPrevail the webSTAIR and Web-PE programs. The Contractor shall continue to host the webSTAIR and Web-PE applications in accordance with section 5.2.4 System Hosting. The Contractor shall continue to maintain the webSTAIR and Web-PE applications in accordance with section 5.2.5 Software Maintenance.

The Contractor shall continue to provide a structured webSTAIR Dataset and Web-PE Dataset containing de-identified data on participant usage (including standard, web metrics, e.g., module completion, tools accessed and frequency, etc.), clinical variables, and peer support behavior to NCPTSD in an Excel file structured for analysis and interpretation.

Deliverables:

A. webSTAIR Dataset B. Web-PE Dataset

OPTION PERIOD ONE

If Option Period One is exercised by VA, all tasks in the following sections and their sub-sections shall apply:

5.1 Project Management excluding 5.1.3 Technical Kickoff Meeting,

5.2.4 System Hosting

5.2.5 Software Maintenance

5.3 Observational Study

5.4 webSTAIR Study

5.5 Web-PE Study

OPTION PERIOD TWO

If Option Period Two is exercised by VA, all tasks in the following sections and their sub-sections shall apply:

5.1 Project Management excluding 5.1.3 Technical Kickoff Meeting,

5.2.4 System Hosting

5.2.5 Software Maintenance

5.3 Observational Study

5.4 webSTAIR Study

5.5 Web-PE Study

OPTION PERIOD THREE

If Option Period Three is exercised by VA, all tasks in the following sections and their sub-sections shall apply:

5.1 Project Management excluding 5.1.3 Technical Kickoff Meeting,

5.2.4 System Hosting

5.2.5 Software Maintenance

5.3 Observational Study

5.4 webSTAIR Study

5.5 Web-PE Study

GENERAL REQUIREMENTS

PERFORMANCE METRICS

The table below defines the Performance Standards and Acceptable Levels of Performance associated with this effort.

2. Efficient and effective in meeting requirements

3. Meets technical needs and mission requirements

4. Provides quality services/products Satisfactory or higher

2. Products completed, reviewed, delivered in accordance with the established schedule

3. Notifies customer in advance of potential problems Satisfactory or higher

2. Personnel possess necessary knowledge, skills and abilities to perform tasks

Satisfactory or higher

The COR will utilize a Quality Assurance Surveillance Plan (QASP) throughout the life of the TO to ensure that the Contractor is performing the services required by this PWS in an acceptable level of performance. The Government reserves the right to alter or change the QASP at its own discretion. A Performance Based Service Assessment will be used by the COR in accordance with the QASP to assess Contractor performance.

SECTION 508 – ELECTRONIC AND INFORMATION TECHNOLOGY (EIT) STANDARDS

On August 7, 1998, Section 508 of the Rehabilitation Act of 1973 was amended to require that when Federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology, that they shall ensure it allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. Section 508 required the Architectural and Transportation Barriers Compliance Board (Access Board) to publish standards setting forth a definition of electronic and information technology and the technical and functional criteria for such technology to comply with Section 508. These standards have been developed are published with an effective date of December 21, 2000. Federal departments and agencies shall develop all Electronic and Information Technology requirements to comply with the standards found in 36 CFR 1194.

The following Section 508 Requirements supersede Addendum A, Section A3 from the T4NG Basic PWS.

The Section 508 standards established by the Architectural and Transportation Barriers Compliance Board (Access Board) are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure Electronic and Information Technology (EIT). These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards. A printed copy of the standards will be supplied upon request. The Contractor shall comply with the technical standards as marked:

EQUIVALENT FACILITATION

Alternatively, offerors may propose products and services that provide equivalent facilitation, pursuant to Section 508, subpart A, §1194.5. Such offerors will be considered to have provided equivalent facilitation when the proposed deliverables result in substantially equivalent or greater access to and use of information for those with disabilities.

COMPATIBILITY WITH ASSISTIVE TECHNOLOGY

The Section 508 standards do not require the installation of specific accessibility-related software or the attachment of an assistive technology device. Section 508 requires that the EIT be compatible with such software and devices so that EIT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

ACCEPTANCE AND ACCEPTANCE TESTING

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the identified Section 508 standards’ requirements for accessibility and must include final test results demonstrating Section 508 compliance.

Deliverables should meet applicable accessibility requirements and should not adversely affect accessibility features of existing EIT technologies. The Government reserves the right to independently test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

Automated test tools and manual techniques are used in the VA Section 508 compliance assessment.

Deliverable:

A. Final Section 508 Compliance Test Results

ENTERPRISE AND IT FRAMEWORK

(The T4NG Basic PWS, in Section 3.8.2, contains the requirement that all Contractor Solutions must support PIV enabled authentication at Identity Assurance Level (IAL) 3, Authenticator Assurance Level (AAL) 3, and Federation Assurance Level (FAL) 3. If the requiring activity has identified through their ISO and/or OIS that their specific requirement in this PWS can be at lower Assurance Levels, or that FAL is not a requirement, then the requiring activity must add the below language, or similar (and change the “x” in the “(IAL) x”, “(AAL) x” and “(FAL) x” to the required level for all three assurance levels for this specific Task Order effort), The text should also be changed to black text and converted to “No Spacing” Style. For information regarding Assurance Level, see the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-3, at https://pages.nist.gov/800-63-3/, which includes 800-63A, 800-63B, and 800-63C. Any questions on Assurance Levels should be addressed to OIS or your ISO.)

The required Assurance Levels, in reference to the Federal Identity, Credential, and Access Management (FICAM) requirements set forth in Section 3.8.2 of the T4NG Basic PWS, are Identity Assurance Level (IAL) x, Authenticator Assurance Level (AAL) x, and Federation Assurance Level (FAL) x for this specific TO.

ORGANIZATIONAL CONFLICT of INTEREST (Add For A&A Services) All functions related to Acquisition Support shall be on an advisory basis only. Please be advised that since the awardee of this Task Order will provide systems engineering, technical direction, specifications, work statements, and evaluation services, some restrictions on future activities of the awardee may be required in accordance with FAR 9.5 and the clause entitled, Organizational Conflict of Interest, found in Section H of the T4NG basic contract. The Contractor and its employees, as appropriate, shall be required to sign Non-Disclosure Agreements (Appendix A).

(Include Appendix A if Organizational Conflict of Interest Section above is included in the PWS)

APPENDIX A

CONTRACTOR NON-DISCLOSURE AGREEMENT

This Agreement refers to Contract/Order _________________ entered into between the Department of Veterans Affairs and _________________________ (Contractor).

As an officer of <fill in name of Contractor>, authorized to bind the company, I understand that in connection with our participation in the <fill in program> acquisition under the subject Contract/Order, Contractor’s employees may acquire or have access to procurement sensitive or source selection information relating to any aspect of <fill in program> acquisition. Company <fill in name> hereby agrees that it will obtain Contractor - Employee Personal Financial Interest/Protection of Sensitive Information Agreements from any and all employees who will be tasked to perform work under the subject Contract/Order prior to their assignment to that Contract/Order. The Company shall provide a copy of each signed agreement to the Contracting Officer. Company <fill in name> acknowledges that the Contractor - Employee Personal Financial Interest/Protection of Sensitive Information Agreements require Contractor’s employee(s) to promptly notify Company management in the event that the employee releases any of the information covered by that agreement and/or whether during the course of their participation, the employee, his or her spouse, minor children or any member of the employee’s immediate family/household has/or acquires any holdings or interest whatsoever in any other private organization (e.g., contractors, offerors, their subcontractors, joint venture partners, or team members), identified to the employee during the course of the employee’s participation, which may have an interest in the matter the Company is supporting pursuant to the above stated Contract/Order. The Company agrees to educate its employees in regard to their conflict of interest responsibilities.

Company <fill in name> further agrees that it will notify the Contracting Officer within 24 hours, or the next working day, whichever is later, of any employee violation. The notification will identify the business organization or other entity, or individual person, to whom the information in question was divulged and the content of that information. Company <fill in name> agrees, in the event of such notification, that, unless authorized otherwise by the Contracting Officer, it will immediately withdraw that employee from further participation in the acquisition until the Organizational Conflict of Interest issue is resolved.

This agreement shall be interpreted under and in conformance with the laws of the United States.

Signature and Date Company

Printed Name Phone Number

CONTRACTOR EMPLOYEE

PERSONAL FINANCIAL INTEREST/PROTECTION OF SENSITIVE INFORMATION AGREEMENT

This Agreement refers to Contract/Order _____________________ entered into between the Department of Veterans Affairs and ____________________ (Contractor).

As an employee of the aforementioned Contractor, I understand that in connection with my involvement in the support of the above-referenced Contract/Order, I may receive or have access to certain “sensitive information” relating to said Contract/Order, and/or may be called upon to perform services which could have a potential impact on the financial interests of other companies, businesses or corporate entities. I hereby agree that I will not discuss or otherwise disclose (except as may be legally or contractually required) any such “sensitive information” maintained by the Department of Veterans Affairs or by others on behalf of the Department of Veterans Affairs, to any person, including personnel in my own organization, not authorized to receive such information.

“Sensitive information” includes:

(a) Information provided to the Contractor or the Government that would be competitively useful on current or future related procurements; or

(b) Is considered source selection information or bid and proposal information as defined in FAR 2.101, and FAR 3.104-4; or

(c) Contains (1) information about a Contractor’s pricing, rates, costs, schedule, or contract performance; or (2) the Government’s analysis of that information; or

(d) Program information relating to current or estimated budgets, schedules or other financial information relating to the program office; or

(e) Is properly marked as source selection information or any similar markings.

Should “sensitive information” be provided to me under this Contract/Order, I agree not to discuss or disclose such information with/to any individual not authorized to receive such information. If there is any uncertainty as to whether the disclosed information comprises “sensitive information”, I will request my employer to request a determination in writing from the Department of Veterans Affairs Contracting Officer as to the need to protect this information from disclosure.

I will promptly notify my employer if, during my participation in the subject Contract/Order, I am assigned any duties that could affect the interests of a company, business or corporate entity in which either I, my spouse or minor children, or any member of my immediate family/household has a personal financial interest. “Financial interest” is defined as compensation for employment in the form of wages, salaries, commissions, professional fees, or fees for business referrals, or any financial investments in the business in the form of direct stocks or bond ownership, or partnership interest (excluding non-directed retirement or other mutual fund investments). In the event that, at a later date, I acquire actual knowledge of such an interest or my employer becomes involved in proposing for a solicitation resulting from the work under this Contract/Order, as either an offeror, an advisor to an offeror, or as a Subcontractor to an offeror, I will promptly notify my employer. I understand this may disqualify me from any further involvement with this Contract/Order, as agreed upon between the Department of Veterans Affairs and my company.

Among the possible consequences, I understand that violation of any of the above conditions/requirements may result in my immediate disqualification or termination from working on this Contract/Order pending legal and contractual review.

I further understand and agree that all Confidential, Proprietary and/or Sensitive Information shall be retained, disseminated, released, and destroyed in accordance with the requirements of law and applicable Federal or Department of Veterans Affairs directives, regulations, instructions, policies and guidance.

This Agreement shall be interpreted under and in conformance with the laws of the United States.

I agree to the Terms of this Agreement and certify that I have read and understand the above Agreement. I further certify that the statements made herein are true and correct.

Signature and Date Company

Printed Name Phone Number

APPENDIX B: ASSESSMENT QUESTIONNAIRES, Observational Study, WEBSTAIR, AND WEB-PE REQUIREMENTS

The Contractor shall create the assessment questionnaires for the observational study, webSTAIR study, and Web-PE study and modify the existing webSTAIR and Web-PE software programs to meet the following functional and non-functional requirements:

1. Security

a. The Contractor’s solution shall meet all VA system security requirements identified within this PWS. The system will collect and store Veteran’s Personally Identifiable Information (PII) and Protected Health Information (PHI). The PII and PHI will not be provided to VA.

b. Collected PHI shall be stored within a Health Insurance Portability and Accountability Act (HIPAA) and Health Information Trust Alliance (HITRUST) compliant server that can only be accessed by select staff members with limited and controlled access.

c. The clinical data collected as part of the research studies (to be reviewed by the IRB) shall be connected to a non-identifiable unique participant username/ID only, which is assigned by VetsPrevail.

2. Platforms

a. The assessment questionnaires for all three studies and the webSTAIR and Web-PE programs shall run on the VetsPrevail website.

3. Research Dashboards

a. There shall be a research dashboard for each of the three studies: observational study, webSTAIR study, and Web-PE study.

b. The dashboards shall display data on:

i. Participant enrollment (e.g., number consented, random assignment condition if applicable, progress through programs, completion status).

ii. Program usage (e.g., mean and mode of time spent completing various…