PETS_SOW_FINAL.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Patient-Empowering Technology for Serious Mental Illness (PETS): Technology assisted implementation of Coordinated Specialty Care (CSC) for early psychosis.

Statement of Need and Purpose:

The purpose of this requirement is to comission a review and evaluation of currently available digital health technology applications to identify any that may be directly suitable, or readily adaptable, for use in augmenting the delivery of CSC for early psychosis, including extending CSC services into underserved areas.

Background Information and Objective:

The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), is the largest scientific organization in the world dedicated to research focused on transforming the understanding, treatment, and prevention of mental disorders and the promotion of mental health. The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

The National Insitute of Mental Health (NIMH) Coordinated Specialty Care (CSC) for early psychosis is an evidence-based, multi-component team intervention that has been shown to improve clinical and functioning outcomes, reduce inpatient days, and potentially also reduce costs, among young people who are identified and engaged in treatment soon after initial onset of psychotic symptoms. The number of CSC programs in the United States has increased twenty-fold over the last decade, supported in part by research studies initiated by the NIMH as well as dedicated funding from the Substance Abuse and Mental Health Administration (SAMHSA) Community Mental Health Services Block Grant program. Currently, almost every state has at least one CSC program, with a total of more than 260 nationwide.

While this growth has made CSC services much more widely available, it is important to recognize that most programs are in urban areas and that many persons in need of this intervention may live some distance from the CSC program, which limits access to needed interventions. As such, it may be particularly valuable to utilize patient-empowering technology (PET) to facilitate various components of the CSC intervention, to maintain and enhance engagement, reduce patient and family burden, and ultimately improve outcomes.

Examples of technologies that are relevant to CSC include, but are not limited to:

• Regular engagement with CSC patients regarding goal attainment, treatment adherence, side effects, clinical symptoms and social and academic/vocational functioning (including communication with clinical providers and family, with appropriate patient consent).

• Scheduling patient appointments with members of the CSC treatment team, with reminders and prompts that can facilitate productive collaboration during sessions.

• Requesting medication refills.

• Patient education, including ways for patients to ask questions of their care team.

• Telehealth delivery of psychotherapy, vocational/educational rehabilitation, and case management services.

• Availability of CSC team members to facilitate and coach effective crisis management skills in real time so that situations are managed in home, potentially avoiding the need for emergency department of inpatient hospital services.

The goal of this contract is to comission a review and evaluation of currently available digital health technology applications to identify any that may be directly suitable, or readily adaptable, for use in augmenting the delivery of CSC for early psychosis, including extending CSC services into underserved areas.

Period of Performance:

The period of performance is for 12-months from date of award. The Contract includes two (2) option periods for an additional 12-months

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contractor shall survey the scientific and health technology literature to identify digital technology applications that have been applied to facilitate the key roles, clinical services, and core functions of CSC for early psychosis. Components of CSC are outlined in the NIMH white paper, “Evidence-Based Treatments for First Episode Psychosis: Components of Coordinated Specialty Care” (https://www.nimh.nih.gov/health/topics/schizophrenia/raise/nimh-white-paper-csc-for-fep_147096.pdf).

The contractor shall identify and/or develop a standardized, reliable, multidimensional evaluation process to classify, and rate the quality and evidence of relevant PETS. Evaluation factors might include: ease of use, reliability, quality, efficiency, evidence base, effectiveness, security, engagement, customization, cost, and suitability to the CSC environment.

The contractor shall identify PETS that meet core requirements and are directly suitable, or readily adaptable, for implementation in augmenting the delivery of CSC for early psychosis, including extending CSC services into underserved populations. From the list of promising digital technology applictions, develop probe questions to structure needs assessment interviews with a sample of CSC providers and service users.

The Contractor shall identify at least 8 CSC clinics from the pool of ~265 programs supported through SAMHSA’s Mental Health Block Grant set-aside for first episode psychosis programs.

(See “Snapshot of State Plans for Using the Community Mental Health Block Grant 10 Percent Set-Aside to Address First Episode Psychosis”.) CSC programs selected should represent geographically disparate and ethnically diverse patient populations. The Contractor shall https://www.nimh.nih.gov/health/topics/schizophrenia/raise/nimh-white-paper-csc-for-fep_147096.pdf https://www.nimh.nih.gov/health/topics/schizophrenia/raise/nimh-white-paper-csc-for-fep_147096.pdf https://www.nasmhpd.org/sites/default/files/Snapshot_of_State_Plans.pdf https://www.nasmhpd.org/sites/default/files/Snapshot_of_State_Plans.pdf conduct a needs assessment with at least 3 providers and 4 patients at each of these clinics to determine if and how PETS might be integrated into the CSC care pathway.

The Contractor shall utilize the results of the needs assessment, identify key CSC services that might be augmented or in some cases replaced by PETS. For example: technology to promote medication adherence, increase engagement in care, efficiently connect patients and providers, deliver vocational/educational rehabilitation, and case management services, provide crisis management, and provide case consultation.

The Contractor shall also provide consulting services to the NIMH as follows:

• Provide technical assistance to NIMH leadership in identifying knowledge gaps and/or research opportunities to evaluate existing and new digital mental health technology.

• Provide technical expertise to NIMH on conducting portfolio analyses of the existing NIMH digital health research grant portfolio.

LEVEL OF EFFORT:

The estimated level of effort for this requirement is (1) contractor employee for not to exceed 300 hours. Each Option Period will be for not-to-exceed 300 hours.

GOVERNMENT RESPONSIBILITIES

Government shall provide a computer and data. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party. Project data will be collected and stored by the National Institute of Mental Health. The National Institute of Mental Health will provide data as needed to the Contractor each time it requests service. Data may only be stored on Government issued computer.

DELIVERY OR DELIVERABLES

Within 180 calendar days from the award of the contract, the contractor shall review a draft final report. This report will describe the methods and results of the systematic review of the scientific and technology literature and the CSC needs assessment and PETS evaluation. The draft report will also include tables that outline key CSC services that could be augmented by PETS, a detailed list of high quality evidence based PETS suitiable for use in CSC clinics and the key features and functionality of each of these digital health technologies. Within 30 business days of receiving the government’s comments the contractor will deliver an electronic copy of the final report. Of note, timely submission of deliverables is essential to successful completing this requirement.

REPORTING REQUIREMENTS

The Contractor shall provide telephone and e-mail consultations as well as written documentation of services provided to the Government as requested. Written progress reports will be sent to the Government on a monthly basis. Progress reports will include accomplishments, problems encountered, problem resolution, and unresolved problems.

OTHER CONSIDERATIONS

Travel:

Not applicable

Key Personnel:

The Contractor employee providing services for this effort shall be considered key personnel.

Key Personnel requirements are as follows:

• An M.D. or Ph.D. in the Social Sciences.

• At leat 10 years of experience in both clinical research and digital health technology development and evaluation.

• Experience in conducting mental health research.

• Experience in strategic planning and evaluation of digital health technology.

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer (CO) and shall submit a justification for the diversion or replacement and a request to replace the individual.

The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The following individual(s) is/are considered to be essential to the work being performed here under:

Name Title

To be determined in the contract award

It is required that all Contractors involved with the National Institute of Mental Health community to work collaboratively with federal staff and other contractors towards the National Institute of Mental Health’s mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Information System Security Plan:

The Government shall provide the Contractor with equipment and information necessary to perform the required tasks as well as mandatory annual on-line training per NIH requirements for badge and remote access privileges.

The Contractor shall secure and protect all Contractor-owned property and equipment brought into Government facilities during performance of work under this contract. The Government shall not be held liable for loss of or damage to Contractor-owned property or equipment brought into Government facilities. The Contractor shall remove any Contractor-owned property deemed inappropriate by the Government, for any reason, from the Government facility in which it is found.

1. Any computer used in relation to this contract must be patched with most updated IT Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard.

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

5. Contractors are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

8. Any computers used in reference to this contract must be assessed for vulnerabilities.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication.

12. Any computer used in relation to this contract must be password protected. All

Passwords must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters:

a. capital letters

b. lower case letters

c. numeric characters

d. special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./)

Data Rights:

The National Institute of Mental Health shall have unlimited rights to all deliverables provided under this contract, including reports, data updates and statistical results. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General, ” is hereby incorporated by reference and made a part of this contract/order.

http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

Section 508—Electronic and Information Technology Standards:

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm. Unless it is an “undue burden” or compliant products or services do not exist, the products must conform to Section 508. The Contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Publications and Publicity:

Upon request of the NIMH the Contractor in collaboration with NIMH staff will write and publish articles of data produced as a result of the requirements of the SOW.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

https://www.section508.gov/ https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards