Q519--Prolonged Exposure Study Consultant

The Department of Veterans Affairs, Veterans Health Administration (VHA), Network Contracting Office 20 (NCO 20) is conducting a market survey/sources sought notification and is seeking potential sources for an This Sources Sought Notice is issued for information and planning purposes only. This is not a solicitation or a request for proposal and shall not be construed as an obligation or commitment by the Government. An award will not be made on any offers submitted in response to this notice, and it shall not be implied the Government is committed to providing any solicitation or award following this notice. The Government will not pay for any information received in response to this request, nor will the Government compensate a respondent for any costs incurred in developing the information provided. - Responses shall be submitted to Nick Price at contact@example.gov by COB 06/17/2022 SUBJECT: RFI 36C26022Q0566 This notice is intended strictly for market research. 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This notice shall not be construed as a commitment by the Government to issue a solicitation, or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. STATEMENT OF WORK Prolonged Exposure Study Consultant Trial of Prolonged Exposure (PE) vs. PE with PE Coach Among Veterans with PTSD , IRB Net Study Number 1628436-1 2. Background. A research study funded by VA s Office of Research and Development includes the possibility of a multi-year study with ongoing, regularly occurring expert research and clinical consultation and treatment fidelity reviews related to the research delivery of Prolonged Exposure psychotherapy.. Randomized Trial of Prolonged Exposure (PE) vs. PE with PE Coach Among Veterans with PTSD , IRB Net Study Number 1628436-1. There are no parallel contracts and no prior related contracts. . 3. Scope. This contract covers consultation and treatment fidelity reviews provided by a consultant to the funded study s principal investigator and the VA study team that will be working on the study. This study team is located at VA Puget Sound Health Care System and is in support of the funded proposal Randomized Trial of Prolonged Exposure (PE) vs. PE with PE Coach Among Veterans with PTSD . The aims of this study include: Aim 1: Compare the efficacy of PE Coach vs. Usual PE for PTSD-related functional outcomes. Compared to Usual PE, PE Coach will result in greater improvements in PTSD-related social and occupational functioning (primary aim; H1) and quality of life (H2) and greater reduction in functional impairment (H3), neurobehavioral symptoms (H4), depression (H5), and suicidal ideation (H6). Aim 2: Study the comparative efficacy of PE with PE Coach vs. Usual PE in Veterans with PTSD. Hypothesis 7: PE Coach will improve symptom severity of PTSD relative to Usual PE according to the Clinician Administered PTSD Scale for DSM-5. Aim 3: Test the impact of PE Coach on treatment adherence and engagement. We hypothesize (H8) that PE coach will facilitate increased treatment adherence, as measured by adherence with assigned PE homework. We will also explore the impact of PE Coach on improved treatment engagement as measured by reduced treatment dropout. Finally, we will also explore the number of sessions required to achieve criteria for treatment termination. 4. Specific Tasks. This study requires a pre-eminent PTSD psychotherapy researcher and expert in the study s treatment protocol, namely Prolonged Exposure. The consultant will provide the study principal investigator, and other members of the study team, consultation on matters related to clinical research utilizing Prolonged Exposure. The vendor will also provide treatment fidelity reviews for selected research sessions. Task 1 Consultant would communicate with the Department of Veterans Affairs Principal Investigator and study team as needed to consult on clinical research topics related to clinical research on Prolonged Exposure psychotherapy among Veterans. Topics for consultation may include, but are not limited to: the Prolonged Exposure treatment protocol, utilization of the Prolonged Exposure treatment protocol in particular clinical cases and situations, addressing barriers to care that occur during treatment, advanced stills in the utilization of Prolonged Exposure, and psychotherapy research design and methods issues that occur during psychotherapy research utilizing Prolonged Exposure. Task 2 Consultant would communicate with the Department of Veterans Affairs Principal Investigator and study team on weekly via telephone or video conferencing to provide clinical consultation to study therapists, the Principal Investigator, and members of the study team. The consultant will provide approximately weekly remote (off-site) consultation to the study team to discuss progress in Prolonged Exposure treatment at the individual patient/case level, how to best address challenging clinical situations, and to build skills in advanced Prolonged Exposure. The consultant will provide study therapists feedback on the utilization of specific Prolonged exposure interventions.. Task 3 Consultant would provide Prolonged Exposure Treatment Fidelity Reviews and reports. The consultant will provide The Vendor will review audio recordings of a randomly selected subset of Prolonged Exposure psychotherapy sessions and code the sessions for the quality of services provided. The PE psychotherapy sessions will be recorded in accordance with established, VA approved recording procedures for supervision of psychotherapy. Recordings will be stored on a Department of Veterans Affairs approved research R drive. Sessions selected for fidelity review by the Vendor will be copied to a CD or DVD and mailed to the fidelity reviewer by tracked mail. After coding, the contracted fidelity reviewer will send the paper scores of the quality of psychotherapy and the CD or DVD back to the VA research team. The VA research team will destroy the CD or DVD medium in accordance with VA policy. 5. Performance Monitoring (if applicable). The POC or COR will monitor the performance of the contractor. The contractor will provide to the study team ad hoc consultation (Task 1) up to once a week, for up to one hour per consultation episode. Consultation requests will be submitted to the contractor via email. Ad hoc consultation will be provided within two weeks of the request for consultation. If the contractor is unavailable to provide ad hoc consultation within two weeks, the contractor will propose alternative time frames of availability. Inability to provide ad hoc consultation within a two-week timeframe 5 or more times during a year-long period of performance will be considered unacceptable contractor performance. The contractor will provide weekly clinical consultation (Task 2) at a mutually agreeable day and time. Weekly consultation will be provided at least 40 out of 52 weeks per year of performance. Requests to reschedule or cancel weekly clinical consultation will be received at least 24-hours prior to the scheduled consultation. Failure to provide 24-hours of notice 8 times or more during a year-long period of performance will be considered unacceptable contractor performance. Consultation will be provided to the study team in a professional and respectful manner. Consultants to the government will avoid hostile, harassing, or discriminatory conduct. Reports of unprofessional communication or conduct will be provided to the POC or COR for consideration of unacceptable contractor performance. Prolonged Exposure Treatment Fidelity reviews will be completed within 3-months of sending the Vendor the associated CD or DVD. Eight or more failures to return Treatment Fidelity Reviews within 3 months of sending the associated CD or DVD within a year-long period of performance will be considered unacceptable contractor performance. Storage or management of CDs/DVDs or paper treatment fidelity reviews in a manner other than described in this agreement will be considered unacceptable contractor performance. 6. Security Requirements. The contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The contractor employees shall require intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required. The C&A requirements do not apply, and a Security Accreditation Package is not required. VA retains ownership of the CD/DVDs and paper ratings of treatment fidelity. Copies of sent recordings may not be saved to the Vendor s devices nor can copies of CD/DVDs be retained by the Vendor. Copies of treatment fidelity ratings and scores may also not be retained by the Vendor. When not in use, CDs/DVDs and paper ratings of treatment fidelity shall be in a locked box or locked file drawer. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). Not applicable 8. Other Pertinent Information or Special Considerations. a. Specialized Experience and Expertise required (This is mandatory and nonnegotiable) This research study requires consultation from an internationally recognized expert in PTSD and Prolonged Exposure psychotherapy, which will be evidenced by the following experience and expertise: Doctoral level training in psychology Academic rank at the level of full professor Subject matter expertise in PTSD evidenced by 200 peer reviewed scientific publications on trauma and the treatment of PTSD Experience as a principal investigator on clinical trials studying Prolonged Exposure on 4 or more competitive, Federally funded randomized clinical trials of Prolonged Exposure Experience as a principal investigator on 2 or more clinical trials of Prolonged Exposure psychotherapy with U.S. active duty military or Veteran patients Experience training Department of Veteran Affairs therapists in Prolonged Exposure psychotherapy b. Identification of Possible Follow-on Work. Research does not always proceed at the anticipated pace. As a research trial approaches the end of its proposed period of performance, it is often the case that the principal investigator requests and is approved for No Cost Extensions of the study s timeline. Should this occur for the current study, the period of performance may need to extend beyond this contract s initial base, plus 3-years. A fourth option year maybe needed, and funded with previously unspent consultation resources.