Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes.

BACKGROUND: The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the 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 Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. DESIGN: Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study's target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? SUMMARY: Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

Whole Health Options and Pain Education (wHOPE): A Pragmatic Trial Comparing Whole Health Team vs Primary Care Group Education to Promote Nonpharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans-Rationale, Methods, and Implementation.

BACKGROUND: The Whole Health model of the U.S. Department of Veterans Affairs (VA) emphasizes holistic self-care and multimodal approaches to improve pain, functioning, and quality of life. wHOPE (Whole Health Options and Pain Education) seeks to be the first multisite pragmatic trial to establish evidence for the VA Whole Health model for chronic pain care. DESIGN: wHOPE is a pragmatic randomized controlled trial comparing a Whole Health Team (WHT) approach to Primary Care Group Education (PC-GE); both will be compared to Usual VA Primary Care (UPC). The WHT consists of a medical provider, a complementary and integrative health (CIH) provider, and a Whole Health coach, who collaborate with VA patients to create a Personalized Health Plan emphasizing CIH approaches to chronic pain management. The active comparator, PC-GE, is adapted group cognitive behavioral therapy for chronic pain. The first aim is to test whether the WHT approach is superior to PC-GE and whether both are superior to UPC in decreasing pain interference in functioning in 750 veterans with moderate to severe chronic pain (primary outcome). Secondary outcomes include changes in pain severity, quality of life, mental health symptoms, and use of nonpharmacological and pharmacological therapies for pain. Outcomes will be collected from the VA electronic health record and patient-reported data over 12 months of follow-up. Aim 2 consists of an implementation-focused process evaluation and budget impact analysis. SUMMARY: This trial is part of the Pain Management Collaboratory, which seeks to create national-level infrastructure to support evidence-based nonpharmacological pain management approaches for veterans and military service personnel.

Qualitative analysis of US Department of veterans affairs mental health clinician perspectives on patient-centered care.

OBJECTIVE: Enhanced patient involvement in care has the potential to improve patient experiences and health outcomes. As such, large national and global healthcare systems and organizations, including the US Department of Veterans Affairs (VA), have made patient-centered care a primary goal. Little is known about mental health clinician perspectives on, and experiences with, providing patient-centered care. Our main objective was to better understand VA mental health clinicians' perceptions of patient-centered care, and ascertain possible facilitators and barriers to patient-centered practices in mental health settings. DESIGN: Qualitative study of six focus groups conducted in late 2013. SETTING AND PARTICIPANTS: Thirty-five mental health clinicians and staff from a large VA Medical Center. OUTCOMES: Transcripts were analyzed using an inductive and deductive thematic analysis approach. RESULTS: Participants described patient-centered care ideally as a process of shared discovery, and expressed general enthusiasm for patient-centered care. Participants described several ongoing patient-centered care practices but conveyed concerns about the practicalities of its full implementation. Participants expressed a strong desire to change the current biomedical culture and policies of the institution that may hinder clinicians' flexibility and clinician-clinician collaboration when serving patients. In particular, clinicians worried about being held responsible for addressing all of the needs or goals that a patient may identify. CONCLUSIONS: If patient-centered care is to be practiced fully in mental health settings, healthcare institutions need to develop multimodal strategies to enhance clinician-clinician and clinician-patient collaborations to promote and support a focus on discovery and shared accountability for outcomes.

Complementary and alternative medicine use among veterans with chronic noncancer pain.

We describe prior use and willingness to try complementary and alternative medicine (CAM) among 401 veterans experiencing chronic noncancer pain and explore differences between CAM users and nonusers. Participants in a randomized controlled trial of a collaborative intervention for chronic pain from five Department of Veterans Affairs (VA) primary care clinics self-reported prior use and willingness to try chiropractic care, massage therapy, herbal medicines, and acupuncture. Prior CAM users were compared with nonusers on demographic characteristics, pain-related clinical characteristics, disease burden, and treatment satisfaction. A majority of veterans ( n = 327, 82%) reported prior use of at least one CAM modality, and nearly all (n = 399, 99%) were willing to try CAM treatment for pain. Chiropractic care was the least preferred option, whereas massage therapy was the most preferred (75% and 96%, respectively). CAM users were less likely to have service-connection disabilities (54% vs 68%; chi square = 4.64, p = 0.03) and reported having spent a larger percentage of their lives in pain (26% vs 20%; Z = 1.40, p = 0.04) than nonusers. We detected few differences between veterans who had tried CAM and those who had not, suggesting that CAM may have broad appeal among veterans with chronic pain. Implications for VA policy and practice and for clinicians treating veterans with chronic pain are discussed.