The VERDICT project will evaluate patient and clinician perceptions of non-specific treatment factors, effectiveness of study interventions, and the impact of varying doses of standard chiropractic care and chronic pain management on clinical outcomes across three VA facilities.
Co-Principal Investigators:
Christine Goertz, DC, PhD and Cynthia Long, PhD
The overarching goal of the (w)HOPE study is to establish and implement a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that reduces pain symptoms and improves overall functioning and quality of life in veterans.
Co-Principal Investigators:
Karen Seal, MD and William Becker, MD
The Sequential Multiple Randomization Trial for Low Back Pain (SMART LBP Trial) will enable better integration of the biopsychosocial model and improve Stepped Care management with a pragmatic, randomized controlled trial targeting chronic low back pain at four large military installations in the United States.
Co-Principal Investigators:
Julie M. Fritz, PT, PhD, FAPTA and Dan Rhon, PT, DPT, DSc, OCS, FAAOMPT
There are critical unanswered questions surrounding best practices for addressing chronic back pain in the veteran population. This pragmatic trial compares the effectiveness of two nonpharmacological care pathways and seeks to improve access to recommended therapies, minimize utilization of higher-risk treatments such as opioids and surgery, and optimize long-term outcomes for reduced pain.
Co-Principal Investigators:
Steven George, PT, PhD and Susan Nicole Hastings, MD
This multi-site PCT will compare an active CPG implementation model with the current usual physical therapy care in Service Members and Veterans with Low Back Pain (LBP) in order to evaluate an education/audit/feedback model, as well as compare it to usual care for decreasing pain and lessening reliance on analgesic medication.
Co-Principal Investigators:
Shawn Farrokhi, PT, DPT, PhD, and Christopher Dearth, PhD
In this trial, we will determine the effect of a novel, nonpharmacologic analgesic technique—percutaneous peripheral nerve stimulation (PNS)—on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life.
Principal Investigator:
Brian Ilfeld, MD, MS
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.
