The core objective of our Stakeholder Engagement Work Group is to develop respectful and productive partnerships that will maximize our ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Work Group will provide the forum within which these stakeholders can bring their different perspectives and expertise to develop and enact a comprehensive, evidence-based, and stakeholder-informed approach to address previously identified organizational, clinician, and patient-level barriers to access, engagement and participation in pragmatic clinical trials of non-pharmacological approaches for the management of chronic pain and to optimize the VA and DoD as learning health care systems.
The goals of the work group are to identify reliable and clinically meaningful phenotypes among participants, for use in examining important treatment effect moderators and for enhanced understanding of study results, Promote harmonization of measurement approaches, when feasible, especially for key outcomes proposed, and provide a forum for discussing analytic, technical, and regulatory issues that arise related to harmonization of measurement approaches.
The Ethics and Regulatory work group seeks to identify areas of ethical and regulatory importance and works with the selected pragmatic trial teams to address these complexities within the VA and DoD health care systems. The goals of this work group are (1) to develop processes and agreements needed to address regulatory requirements for single and multiple health care systems that provide services to military personnel, veterans and their families, and (2) to identify and disseminate information that facilitates the ethical conduct of pragmatic clinical trials in eligible health care settings, obtaining input from health care system leadership, patients, family members, providers and researchers.
This Data Sharing work group will address a wide array of issues related to planning, designing and implementing the Demonstration Projects, including data and software sharing plans, and the data standards that will be required for the study implementation, execution and conduct. Monthly teleconferences will provide a forum for discussion of informatics challenges and solutions across projects. This work group will seek to harmonize data sharing standards and templates while developing best practices and guidelines for data sharing.
Providing guidance and collaboration on the design and implementation of PMC pragmatic trials, the Biostatistics and Study Design Work Group ensures efficient and robust study design and analysis plans.
This project will test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM). SBIRT-PM can provide an effective and cost-effective approach to reducing Veterans’ pain and risky substance use, primarily by increasing the use of nonpharmacological approaches to pain management.
Co-Principal Investigators:
Marc Rosen, MD and Steve Martino, PhD
The goals of the EHR Work Group are to optimize use of existing EHR data, support integration of patient reported data, and to create new data from unstructured text in EHRs using innovative ML and NLP tools.
The overall goal of this project is to conduct a pragmatic trial to examine the real world effectiveness of an IVR-based form of CBT-CP called Co-operative Pain Education and Self-management (COPES) versus in-person CBT-CP provided by clinicians previously trained through VHA’s evidence based psychotherapy program.
Co-Principal Investigators:
Alicia Heapy, PhD and Diana Higgins, PhD
Dr. Steve Martino and Dr. Marc Rosen, both substance use researchers at VA Connecticut Healthcare System in New Haven, aim to introduce the array of services available through VA to Veterans who are suffering from pain.
Twelve research projects will focus on developing, implementing, and testing cost-effective, large-scale, real-world research on non-drug approaches for pain management.
