Integrating a Community Advisory Board Into a Pragmatic Trial of Mindfulness for Chronic Low Back Pain.

Background: To improve the implementation of clinical trial interventions, there is a need to facilitate communication between key stakeholders and research teams. Community Advisory Boards (CAB) bring together a range of stakeholders not historically included in the research process to inform and work collaboratively with research teams. Objective: To describe our procedures and processes for (1) integration of a CAB into a pragmatic clinical trial of a telehealth-delivered group mindfulness program for persons with chronic low back pain (cLBP) within primary care, and (2) for the rapid uptake and implementation of CAB recommendations. Methods: The CAB we convened includes persons with cLBP who have undergone the mindfulness intervention, health care system leadership, advocacy groups, and mindfulness experts. The CAB members underwent a two hour initial training that introduced the research process and the CAB's role as research partners. The CAB met monthly for 1 hour. We used the Lighting Report method to summarize meetings and share feedback with the research team. Results: The recommendations of the CAB during the first year they met were divided into recruitment, informed consent, and survey recommendations. The study website also was overhauled based on recommendations, including a more engaging first page with rotating images of nature and testimonials. The language on the website was edited to be more concise and participant-friendly. The CAB recommended talking points to discuss with participants during screening or informed consent about the benefits of participating in research. Conclusion: We established a CAB that represented diverse perspectives, organizations, and experience with cLBP and mindfulness. The differing perspectives of the CAB resulted in recommendations that the research team itself would not have decided on their own. The Lightning Reports were also an effective way to efficiently communicate the CAB recommendations to the research team.

Pilot Observational Study of Patient Reported Outcome Measures for Long COVID Patients in Virtual Integrative Medical Group Visits.

Background: Long COVID is a common, debilitating post-infectious illness for which effective management is unknown. Integrative Medical Group Visits (IMGV) are effective interventions for chronic conditions and could benefit Long COVID patients. More information is needed regarding existing patient reported outcome measures (PROMs) to evaluate efficacy of IMGV for Long COVID. Objective: This study assessed the feasibility of specific PROMS to evaluate IMGVs for Long COVID. Findings will inform future efficacy trials. Methods: The Perceived Stress Scale (PSS-10), General Anxiety Disorder two-question tool (GAD-2), Fibromyalgia Symptom Severity scale (SSS), and Measure Yourself Medical Outcome Profile (MYMOP®) were collected pre- and post-group by teleconferencing platform or telephone and compared using paired t-tests. Patients were recruited from a Long COVID specialty clinic where they participated in 2-hour - 8 weekly IMGV sessions online. Results: Twenty-seven participants enrolled and completed pre-group surveys. Fourteen participants were reachable by phone post-group and completed all pre and post PROMs (78.6% female, 71.4% non-Hispanic White, mean age 49). MYMOP® primary symptomatology was fatigue, shortness of breath and "brain fog". Symptoms decreased in interference when compared to pre-group levels (mean difference -1.3 [95% CI-2.2, -.5]). PSS scores decreased (-3.4 [95% CI -5.8, -1.1]), and GAD-2 mean difference was -1.43 (95% CI -3.12, .26). There were no changes in SSS scores of fatigue (-.21 [95% CI -.68,0.25]), waking unrefreshed (.00 [95%CI -.32, -.32]), or trouble thinking (-.21 [95% CI -.78,0.35]). Conclusion: All PROMs were feasible to administer via teleconferencing platform or telephone. The PSS, GAD-2 and MYMOP® are promising PROMs to track Long COVID symptomatology among IMGV participants. The SSS, while feasible to administer, did not change compared to baseline. Larger, controlled studies are needed to determine the efficacy of virtual IMGVs to address the needs of this large and growing population.

Self-compassion training to improve well-being for surgical residents.

CONTEXT: Burnout remains prevalent among surgical residents. Self-compassion training may serve to improve their well-being. OBJECTIVE: To evaluate the impact on well-being of a self-compassion program modified for surgical residents. DESIGN: This is a 3-year, mixed-methods study using pre-post surveys and focus groups to identify areas for programmatic improvement and the subsequent impact of the modifications. SETTING: A single academic institution. PARTICIPANTS: Surgical residents participating in a self-compassion program. INTERVENTIONS: A self-compassion program adapted from a larger course to fit the needs of surgical residents. MAIN OUTCOME MEASURES: Themes relating to the program's strengths and weaknesses were identified through participant focus groups. Well-being was assessed through validated measurement tools, including The Maslach Burnout Inventory (MBI), Patient Health Questionnaire-9, Perceived Stress Scale, and Spielberger State-Trait Anxiety Inventory-6. RESULTS: 95 residents participated in the self-compassion program, of which 40 residents completed both surveys (total response rate: 42%). All participants demonstrated severe burnout pre-program, based on scores of at least one of the MBI subscales. Emotional exhaustion scores improved post-program, with larger improvements seen after program modifications (2018: 58% vs 2020: 71%). Focus group findings demonstrated that residents need a safe and distraction-free space to practice self-compassion, and program engagement improved following modifications.

Cultural Transformation in Healthcare: How Well Does the Veterans Health Administration Vision for Whole Person Care Fit the Needs of Patients at an Academic Rehabilitation Center?

Background: The Veterans Health Administration is undergoing a cultural transformation toward person-driven care referred to as the Whole Health System of Care. Objective: This pilot study evaluated whether the Whole Health model resonates with patients of a large public university rehabilitation clinic. Methods: Thirty participants completed the Veterans Health Administration's Personal Health Inventory (PHI), and six attended the course "Taking Charge of My Life and Health." Researchers analyzed PHI responses and post-course focus group transcripts. A short post-PHI survey and post-course evaluation were collected. Results: Participants agreed the PHI is a simple, useful tool. The course, while well attended, did not meet participants' expectations. Participants wanted access to integrative therapies and opportunities to contribute to healthcare transformation. Conclusion: Rehabilitation patients resonated with the Whole Health vision. They expressed enthusiasm for the cultural transformation represented by the model along with frustration that standard healthcare experiences fall short of this vision.

The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.

Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov: NCT04129450.

Feasibility of Implementation Mapping for Integrative Medical Group Visits.

Objectives: Implementation science is key to translating complementary and integrative health intervention research into practice as it can increase accessibility and affordability while maximizing patient health outcomes. The authors describe using implementation mapping to (1) identify barriers and facilitators impacting the implementation of an Integrative Medical Group Visit (IMGV) intervention in an outpatient setting with a high burden of patients with chronic pain and (2) select and develop implementation strategies utilizing theory and stakeholder input to address those barriers and facilitators. Design: The authors selected a packaged, evidence-based, integrative pain management intervention, the IMGV, to implement in an outpatient clinic with a high burden of patients with chronic pain. The authors used implementation mapping to identify implementation strategies for IMGV, considering theory and stakeholder input. Stakeholder interviews with clinic staff, faculty, and administrators (n = 15) were guided by the Consolidated Framework for Implementation Research. Results: Based on interview data, the authors identified administrators, physicians, nursing staff, and scheduling staff as key stakeholders involved in implementation. Barriers and facilitators focused on knowledge, buy-in, and operational procedures needed to successfully implement IMGV. The implementation team identified three cognitive influences on behavior that would impact performance: knowledge, outcome expectations, and self-efficacy; and three theoretical change methods: cue to participate, communication, and mobilization. Implementation strategies identified included identifying and preparing champions, participation in ongoing training, developing and distributing educational materials, and organizing clinician implementation team meetings. Conclusions: This study provides an example of the application of implementation mapping to identify theory-driven implementation strategies for IMGV. Implementation mapping is a feasible method that may be useful in providing a guiding structure for implementation teams as they employ implementation frameworks and select implementation strategies for integrative health interventions.

Mindful Opportunity to Reflect on Experience: Interdisciplinary Mind-Body Medicine Skills Training for Health-care Professionals.

Interventions that support employee wellness and resilience hold potential to improve patient care, increase staff engagement, and decrease burnout. This repeat-measures study evaluated whether an abbreviated version of mind-body medicine skills training could decrease stress and improve mindfulness among an interdisciplinary cohort of health-care professionals. The study also assessed whether participants incorporated the mind-body medicine skills into their personal and professional lives. Aggregate results from this unpaired cohort showed decreased stress and increased mindfulness. Postcourse surveys demonstrated increased personal and professional use of mind-body medicine skills. There was high favorability among participants. These preliminary results suggest that a modest investment of time and resources to learn mind-body medicine skills may positively affect employee wellness among health-care professionals. In addition, skills learned could translate into improved patient care and increased staff engagement. Further study with larger cohorts and a paired design is needed.