Measuring Patient-Reported Use and Outcomes From Complementary and Integrative Health Therapies: Development of the Complementary and Integrative Health Therapy Patient Experience Survey.

Background: Assessing the use and effectiveness of complementary and integrative health (CIH) therapies via survey can be complicated given CIH therapies are used in various locations and formats, the dosing required to have an effect is unclear, the potential health and well-being outcomes are many, and describing CIH therapies can be challenging. Few surveys assessing CIH therapy use and effectiveness exist, and none sufficiently reflect these complexities. Objective: In a large-scale Veterans Health Administration (VA) quality improvement effort, we developed the "Complementary and Integrative Health Therapy Patient Experience Survey", a longitudinal, electronic patient self-administered survey to comprehensively assess CIH therapy use and outcomes. Methods: We obtained guidance from the literature, subject matter experts, and Veteran patients who used CIH therapies in designing the survey. As a validity check, we completed cognitive testing and interviews with those patients. We conducted the survey (March 2021-April 2023), inviting 15,608 Veterans with chronic musculoskeletal pain with a recent CIH appointment or referral identified in VA electronic medical records (EMR) to participate. As a second validity check, we compared VA EMR data and patient self-reports of CIH therapy utilization a month after survey initiation and again at survey conclusion. Results: The 64-item, electronic survey assesses CIH dosing (amount and timing), delivery format and location, provider location, and payor. It also assesses 7 patient-reported outcomes (pain, global mental health, global physical health, depression, quality of life, stress, and meaning/purpose in life), and 3 potential mediators (perceived health competency, healthcare engagement, and self-efficacy for managing diseases). The survey took 17 minutes on average to complete and had a baseline response rate of 45.3%. We found high degrees of concordance between self-reported and EMR data for all therapies except meditation. Conclusions: Validly assessing patient-reported CIH therapy use and outcomes is complex, but possible.

Using a person-centered approach in clinical care for patients with complex chronic conditions: Perspectives from healthcare professionals caring for Veterans with COPD in the U.S. Veterans Health Administration's Whole Health System of Care.

BACKGROUND: The largest nationally integrated health system in the United States, the Veterans Health Administration (VHA), has been undergoing a transformation toward a Whole Health (WH) System of Care. WH Clinical Care, a component of this system, includes holistically assessing the Veteran's life context, identifying what really matters to the Veteran, collaboratively setting and monitoring personal health and well-being goals, and equipping the Veteran with access to conventional and complementary and integrative health resources. Implementation of WH Clinical Care has been challenging. Understanding healthcare professionals' perspectives on the value of and barriers and facilitators to practicing WH Clinical Care holds relevance for not only VHA's efforts but also other health systems, in the U.S. and internationally, that are engaged in person-centered care implementation. OBJECTIVES: We sought to understand perspectives of healthcare professionals at VHA on providing WH Clinical Care to Veterans with COPD, as a lens to understand the broader issue of WH Clinical Care for Veterans living with complex chronic conditions. DESIGN: We interviewed 25 healthcare professionals across disciplines and services at a VA Medical Center in 2020-2021, including primary care providers, pulmonologists, palliative care providers, and chaplains. Interview transcripts were analyzed using qualitative content analysis. KEY RESULTS: Each element of WH Clinical Care raised complex questions and/or concerns, including: (1) the appropriate depth/breadth of inquiry in person-centered assessment; (2) the rationale for elicitation of what really matters; (3) the feasibility and appropriate division of labor in personal health goal setting and planning; and (4) challenges related to referring Veterans to a broad spectrum of supportive services. CONCLUSIONS: Efforts to promote person-centered care must account for healthcare professionals' existing comfort with its elements, advocate for a team-based approach, and continue to grapple with the conflicting structural conditions and organizational imperatives.

Yoga Versus Education for Veterans with Chronic Low Back Pain: a Randomized Controlled Trial.

BACKGROUND: Yoga is effective for chronic low back pain (cLBP) in civilians but understudied among Veterans. OBJECTIVE: Determine whether yoga is more effective than an educational book for improving disability and pain among Veterans with cLBP. DESIGN, SETTING, AND PARTICIPANTS: Veterans diagnosed with cLBP at a VA medical center enrolled in a randomized controlled trial from March to December of 2015. INTERVENTIONS: Twelve weekly hatha yoga classes or education using The Back Pain Helpbook. MEASURES: Co-primary outcomes were changes from baseline at 12 weeks in back-related disability on the modified Roland Morris Disability Questionnaire and pain on the Defense & Veterans Pain Rating Scale. Secondary outcomes were global improvement, patient satisfaction, pain medication use, and post-traumatic stress symptoms. An intention-to-treat approach was used in primary analyses. RESULTS: One hundred twenty Veterans (mean age, 55.5 [SD = 16.9]; 11 [9%] women; mean number of chronic conditions, 5.5) were randomized to yoga (n = 62) and education (n = 58). At 12 weeks, reductions in back-related disability in yoga (mean difference [MD] = - 3.50, 95% CI: - 5.03, - 1.97) were not significantly different than education (MD = - 2.55, 95% CI: - 4.10, - 0.99; between-group difference: - 0.95 [95% CI: - 3.14, 1.23], p = 0.39). For pain, there was no significant difference between yoga (MD = - 1.01, 95% CI: - 1.67, - 0.35) and education (MD = - 0.81, 95% CI: - 1.36, - 0.27; between-group difference: - 0.20, 95% CI: - 1.06, 0.66, p = 0.65). More yoga than education participants reported being very much or extremely improved (39% vs 19%, OR = 3.71, 95% CI: 1.37, 10.02, p = 0.01) and very satisfied with treatment (60% vs 31%, OR = 4.28, 95% CI: 1.70, 10.77, p = 0.002). No differences in pain medication use or post-traumatic stress symptoms were observed at 12 weeks. No serious adverse events were reported in either group. CONCLUSION: Twelve weekly yoga classes were not more effective than an education intervention for improving pain or disability outcomes among mostly older male Veterans with cLBP and multiple comorbid health conditions. GOV IDENTIFIER: NCT02224183.

Assessing the Relative Effectiveness of Combining Self-Care with Practitioner-Delivered Complementary and Integrative Health Therapies to Improve Pain in a Pragmatic Trial.

BACKGROUND: Many health care systems are beginning to encourage patients to use complementary and integrative health (CIH) therapies for pain management. Many clinicians have anecdotally reported that patients combining self-care CIH therapies with practitioner-delivered therapies report larger health improvements than do patients using practitioner-delivered or self-care CIH therapies alone. However, we are unaware of any trials in this area. DESIGN: The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the value of veterans participating in practitioner-delivered CIH therapies alone or self-care CIH therapies alone compared with the combination of self-care and practitioner-delivered care. The study is being conducted in 18 Veterans Health Administration sites that received funding as part of the Comprehensive Addiction and Recovery Act to expand availability of CIH therapies. Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage, and self-care therapies include tai chi/qi gong, yoga, and meditation. The primary outcome will be improvement on the Brief Pain Inventory 6 months after initiation of CIH as compared with baseline scores. Patients will enter treatment groups on the basis of the care they receive because randomizing patients to specific CIH therapies would require withholding therapies routinely offered at VA. We will address selection bias and confounding by using sites' variations in business practices and other encouragements to receive different types of CIH therapies as a surrogate for direct randomization by using instrumental variable econometrics methods. SUMMARY: Real-world evidence about the value of combining self-care and practitioner-delivered CIH therapies from this pragmatic trial will help guide the VA and other health care systems in offering specific nonpharmacological approaches to manage patients' chronic pain.

Participating in Complementary and Integrative Health Approaches Is Associated With Veterans' Patient-reported Outcomes Over Time.

BACKGROUND: Veterans Affairs is dedicated to providing a Whole Health approach to care, including offering complementary and integrative health (CIH) approaches to Veterans. OBJECTIVE: The objective of this study was to examine the association of CIH participation with Veterans' patient-reported outcomes over time. RESEARCH DESIGN: A survey of patient-reported outcomes at 5 timepoints: baseline, 2, 4, 6, and 12 months. SUBJECTS: Veterans participating in any type of CIH approach at 2 Veterans Affairs medical centers. MEASURES: Mixed hierarchical models with repeated variables were used to test the hypothesis that participating in any CIH approach would be associated with Veterans' overall physical/mental health [Patient-Reported Outcomes Measurement Information System 28 (PROMIS 28)], pain intensity, perceived stress (Perceived Stress Scale-4), and engagement in their care (Patient Activation Measure-13), controlling for age, male sex, site, participation in other CIH approaches, and surveys completed. RESULTS: We received 401 surveys from 119 Veterans (72% male, age range: 29-85 y) across all timepoints. Yoga participation was related to decreases in perceived stress (P<0.001), while tai chi participation was associated with improvements in overall PROMIS 28 physical and mental health functioning (P<0.02). Specific types of CIH were associated with significant improvements in PROMIS 28 subscales: meditation participation with physical functioning at 2, 6, and 12 months; tai chi participation with anxiety at 2 and 6 months, and ability to participate in social role activities at 2 months. No CIH approach was associated with Veterans' pain or engagement in their care. CONCLUSION: As specific CIH approaches are associated with improvements in patient-reported outcomes, clinicians, Veterans, and family members may use this information in discussions of nonpharmacological options to address health and well-being.

Using Electronic Data Collection Platforms to Assess Complementary and Integrative Health Patient-Reported Outcomes: Feasibility Project.

BACKGROUND: The Veteran Administration (VA) Office of Patient-Centered Care and Cultural Transformation is invested in improving veteran health through a whole-person approach while taking advantage of the electronic resources suite available through the VA. Currently, there is no standardized process to collect and integrate electronic patient-reported outcomes (ePROs) of complementary and integrative health (CIH) into clinical care using a web-based survey platform. This quality improvement project enrolled veterans attending CIH appointments within a VA facility and used web-based technologies to collect ePROs. OBJECTIVE: This study aimed to (1) determine a practical process for collecting ePROs using patient email services and a web-based survey platform and (2) conduct analyses of survey data using repeated measures to estimate the effects of CIH on patient outcomes. METHODS: In total, 100 veterans from one VA facility, comprising 11 cohorts, agreed to participate. The VA patient email services (Secure Messaging) were used to manually send links to a 16-item web-based survey stored on a secure web-based survey storage platform (Qualtrics). Each survey included questions about patient outcomes from CIH programs. Each cohort was sent survey links via Secure Messaging (SM) at 6 time points: weeks 1 through 4, week 8, and week 12. Process evaluation interviews were conducted with five primary care providers to assess barriers and facilitators to using the patient-reported outcome survey in usual care. RESULTS: This quality improvement project demonstrated the usability of SM and Qualtrics for ePRO collection. However, SM for ePROs was labor intensive for providers. Descriptive statistics on health competence (2-item Perceived Health Competence Scale), physical and mental health (Patient-Reported Outcomes Measurement Information System Global-10), and stress (4-item Perceived Stress Scale) indicated that scores did not significantly change over time. Survey response rates varied (18/100, 18.0%-42/100, 42.0%) across each of the 12 weekly survey periods. In total, 74 of 100 participants provided ≥1 survey, and 90% (66/74) were female. The majority, 62% (33/53) of participants, who reported the use of any CIH modality, reported the use of two or more unique modalities. Primary care providers highlighted specific challenges with SM and offered solutions regarding staff involvement in survey implementation. CONCLUSIONS: This quality improvement project informs our understanding of the processes currently available for using SM and web-based data platforms to collect ePROs. The study results indicate that although it is possible to use SM and web-based survey platforms for ePROs, automating scheduled administration will be necessary to reduce provider burden. The lack of significant change in ePROs may be due to standard measures taking a biomedical approach to wellness. Future work should focus on identifying ideal ePRO processes that would include standardized, whole-person measures of wellness.

Exploring how different types of yoga change psychological resources and emotional well-being across a single session.

OBJECTIVES: Yoga demonstrates beneficial effects in many populations, yet our understanding of how yoga brings about these effects is quite limited. Among the proposed mechanisms of yoga are increasing psychological resources (mindfulness, body consciousness, self-transcendence, spiritual peace, and social connectedness) that may bring about salutary effects on emotional wellbeing. Further, yoga is a complex practice comprising meditation, active and restorative postures, and breathwork; however little is known about how different components may affect mechanisms. We aimed to determine how an acute session of yoga (and its specific components) related to pre- to post- session changes in proposed mechanisms (psychological resources) and whether those changes were associated with positive changes in emotions. DESIGN: 144 regular yoga practitioners completed measures of mindfulness, body consciousness, self-transcendence, social connectedness, spiritual peace, and exercise-induced emotions (positive engagement, revitalization, tranquility, exhaustion) immediately before and after a yoga session (N = 11 sessions, each a different type of yoga). Perceived properties of each yoga session, exercise exertion and engagement with the yoga teacher were assessed immediately following the session. RESULTS: Pre-to post- yoga, levels of positive emotions (engagement, tranquility and revitalization) increased while exhaustion decreased. Further, all psychological resources increased and closely tracked improved emotions. Additionally, aspects of the yoga session correlated with changes in psychological resources (mechanisms) and emotions. CONCLUSIONS: Yoga may influence multiple psychological mechanisms that influence emotional well-being. Further, different types of yoga may affect different mechanisms. Results can inform yoga interventions aiming to optimize effects through specific mechanisms such as mindfulness or spirituality.

Recommendations for the Evaluation of Cross-System Care Coordination from the VA State-of-the-art Working Group on VA/Non-VA Care.

In response to widespread concerns regarding Veterans' access to VA care, Congress enacted the Veterans Access, Choice and Accountability Act of 2014, which required VA to establish the Veterans Choice Program (VCP). Since the inception of VCP, more than two million Veterans have received care from community providers, representing approximately 25% of Veterans enrolled in VA care. However, expanded access to non-VA care has created challenges in care coordination between VA and community health systems. In March 2018, the VA Health Services Research & Development Service hosted a VA State of the Art conference (SOTA) focused on care coordination. The SOTA convened VA researchers, program directors, clinicians, and policy makers to identify knowledge gaps regarding care coordination within the VA and between VA and community systems of care. This article provides a summary and synthesis of relevant literature and provides recommendations generated from the SOTA about how to evaluate cross-system care coordination. Care coordination is typically evaluated using health outcomes including hospital readmissions and death; however, in cross-system evaluations of care coordination, measures such as access, cost, Veteran/patient and provider satisfaction (including with cross-system communication), comparable quality metrics, context (urban vs. rural), and patient complexity (medical and mental health conditions) need to be included to fully evaluate care coordination effectiveness. Future research should examine the role of multiple individuals coordinating VA and non-VA care, and how these coordinators work together to optimize coordination.

VA Provider Perspectives on Coordinating COPD Care Across Health Systems.

BACKGROUND: More and more Veterans are receiving care from community providers, increasing the need for effective coordination across health systems. For Veterans with chronic obstructive pulmonary disease (COPD), this need is intensified by complex comorbidity patterns that often include multiple providers co-managing patient care. OBJECTIVES: We sought to understand how VA providers perceive coordination with community providers for Veterans with COPD. DESIGN: Qualitative study of VA providers. METHODS: We selected six geographically diverse VA sites and conducted semi-structured telephone interviews with providers practicing in inpatient and/or outpatient settings who care for Veterans with COPD. MAIN MEASURES: Interviews focused on communication with community providers about discharge information and clinic management. We analyzed responses according to the principles of conventional content analysis, allowing inductive themes to emerge. KEY RESULTS: We interviewed 25 providers during the period of June to October 2017. Qualitative data analysis yielded five themes: (1) VA providers perceive communication challenges between VA and community providers, including difficult, inadequate, and delayed communication; (2) communication is facilitated by personal relationships across health systems; (3) the lack of electronic health record (EHR) interoperability impairs communication, resulting in transmission of unstructured data; (4) poor communication leads to duplicative efforts and wasted resources; and (5) providers frequently rely on patients to communicate about care taking place in the community. CONCLUSIONS: VA providers described major challenges in coordinating with community providers, leading to perceptions of delayed, missed, or duplicative care and jeopardizing the overall quality, safety, and efficiency of Veteran care. Our study highlights the need for system-level solutions to support coordination across health systems for Veterans with COPD and may have implications for other conditions that lead to recurrent hospitalization and/or care in the community.

What Should Health Care Systems Consider When Implementing Complementary and Integrative Health: Lessons from Veterans Health Administration.

OBJECTIVES: Health care systems are increasingly interested in becoming whole health systems that include complementary and integrative health (CIH) approaches. The nation's largest health care system, the Veterans Health Administration (VA), has been transforming to such a system. However, anecdotal evidence suggested that many VA medical centers have faced challenges in implementing CIH approaches, whereas others have flourished. We report on a large-scale, research-operations partnered effort to understand the challenges faced by VA sites and the strategies used to address these to better support VAs implementation of CIH nationally. DESIGN: We conducted semi-structured, in-person qualitative interviews with 149 key stakeholders at 8 VA medical centers, with content based on Greenhalgh's implementation framework. For analysis, we identified a priori categories of content aligned with Greenhalgh's framework and then generated additional categories developed inductively, capturing additional implementation experiences. These categories formed a template to aid in coding data. RESULTS: VA sites commonly reported that nine key factors facilitated CIH implementation: (1) organizing individual CIH approaches into one program instead of spreading across several departments; (2) having CIH strategic plans and steering committees; (3) strong, professional, and enthusiastic CIH program leads and practitioners; (4) leadership support; (5) providers' positive attitudes toward CIH; (6) perceptions of patients' attitudes; (7) demonstrating evidence of CIH effectiveness; (8) champions; and (9) effectively marketing. Common challenges included are: (1) difficulties in hiring; (2) insufficient/inconsistent CIH funding; (3) appropriate patient access to CIH approaches; (4) difficulties in coding/documenting CIH use; (5) insufficient/inappropriate space; (6) insufficient staff's and provider's time; and (7) the health care cultural and geographic environments. Sites also reported several successful strategies supporting CIH implementation. CONCLUSIONS: VA sites experience both success and challenges with implementing CIH approaches and have developed a wide range of strategies to support their implementation efforts. This information is potentially useful to other health care organizations considering how best to support CIH provision.

Yoga therapy for military personnel and veterans: Qualitative perspectives of yoga students and instructors.

OBJECTIVE: Millions of military personnel and veterans live with chronic mental and physical health conditions that often do not respond well to pharmacological treatments. Serious side effects and lack of treatment response have led to widespread efforts to study and promote non-pharmacological and behavioral health treatments for many chronic health conditions. Yoga is an increasingly popular mind-body intervention that has growing research support for its efficacy and safety. Our objective was to explore the attitudes, perspectives, and preferences of military personnel and veterans toward yoga as a therapeutic modality, thus providing needed information for designing and promoting yoga interventions for this population. METHODS: Participants included 24 individuals with yoga experience and current or past military service and 12 instructors who have taught yoga for military personnel and/or veterans. A semi-structured set of questions guided interviews with each participant. RESULTS: Five themes emerged from the interviews: (1) mental health benefits experienced from yoga practice; (2) physical health benefits experienced from yoga practice; (3) important yoga elements and conditions that support effective practice; (4) facilitators for engaging military in yoga practice; and (5) challenges and barriers to yoga practice for military. CONCLUSIONS: The study highlights consistent reports of mental and physical benefits of yoga practice, ongoing stigma resulting in the need for combatting and demystifying yoga and other complementary and integrative health (CIH) practices, the importance of designing interventions to address the unique mental health issues and perspectives of this population, and the importance of efforts by military leadership to bring CIH to military personnel and veterans. Rigorous research addressing these findings, along with further research on the efficacy and effectiveness of yoga interventions for treating various conditions are needed.

Overcoming Challenges to Evidence-Based Policy Development in a Large, Integrated Delivery System.

OBJECTIVE: To describe a new Veterans Health Administration (VHA) program to foster the learning health system paradigm by rigorously evaluating health care initiatives and to report key lessons learned in designing those evaluations. PRINCIPAL FINDINGS: The VHA's Quality Enhancement Research Initiative and its Health Services Research and Development Service are cooperating on several large, randomized program evaluations aimed at improving the care veterans receive and the efficiency with which it is delivered. The evaluations we describe involve collaborative design, outcomes assessment, and implementation science through partnerships between VHA operations and researchers. We review key factors to assess before committing to an evaluation. In addition to traditional design issues (such as ensuring adequate power and availability of data), these include others that are easily overlooked: the stability of intervention financing, means of controlling and commitment to adhering to randomized roll-out, degree of buy-in from key implementation staff, and feasibility of managing multiple veto points for interventions that span several programs, among others. CONCLUSIONS: Successful program implementation and rigorous evaluation require resources, specialized expertise, and careful planning. If the learning health system model is to be sustained, organizations will need dedicated programs to prioritize resources and continuously adapt evaluation designs.

Individual Treatment of Posttraumatic Stress Disorder Using Mantram Repetition: A Randomized Clinical Trial.

OBJECTIVE: Previous studies suggest that group "mantram" (sacred word) repetition therapy, a non-trauma-focused complementary therapy for posttraumatic stress disorder (PTSD), may be an effective treatment for veterans. The authors compared individually delivered mantram repetition therapy and another non-trauma-focused treatment for PTSD. METHOD: The study was a two-site, open-allocation, blinded-assessment randomized trial involving 173 veterans diagnosed with military-related PTSD from two Veterans Affairs outpatient clinics (January 2012 to March 2014). The mantram group (N=89) learned skills for silent mantram repetition, slowing thoughts, and one-pointed attention. The comparison group (N=84) received present-centered therapy, focusing on currently stressful events and problem-solving skills. Both treatments were delivered individually in eight weekly 1-hour sessions. The primary outcome measure was change in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS) and by self-report. Secondary outcome measures included insomnia, depression, anger, spiritual well-being, mindfulness, and quality of life. Intent-to-treat analysis was conducted using linear mixed models. RESULTS: The mantram group had significantly greater improvements in CAPS score than the present-centered therapy group, both at the posttreatment assessment (between-group difference across time, -9.98, 95% CI=-3.63, -16.00; d=0.49) and at the 2-month follow-up (between-group difference, -9.34, 95% CI=-1.50, -17.18; d=0.46). Self-reported PTSD symptom severity was also lower in the mantram group compared with the present-centered therapy group at the posttreatment assessment, but there was no difference at the 2-month follow-up. Significantly more participants in the mantram group (59%) than in the present-centered therapy group (40%) who completed the 2-month follow-up no longer met criteria for PTSD (p<0.04). However, the percentage of participants in the mantram group (75%) compared with participants in the present-centered therapy group (61%) who experienced clinically meaningful changes (≥10-point improvements) in CAPS score did not differ significantly between groups. Reductions in insomnia were significantly greater for participants in the mantram group at both posttreatment assessment and 2-month follow-up. CONCLUSIONS: In a sample of veterans with PTSD, individually delivered mantram repetition therapy was generally more effective than present-centered therapy for reducing PTSD symptom severity and insomnia.

The Essential Properties of Yoga Questionnaire (EPYQ): Psychometric Properties.

Yoga interventions are heterogeneous and vary along multiple dimensions. These dimensions may affect mental and physical health outcomes in different ways or through different mechanisms. However, most studies of the effects of yoga on health do not adequately describe or quantify the components of the interventions being implemented. This lack of detail prevents researchers from making comparisons across studies and limits our understanding of the relative effects of different aspects of yoga interventions. To address this problem, we developed the Essential Properties of Yoga Questionnaire (EPYQ), which allows researchers to objectively characterize their interventions. We present here the reliability and validity data from the final phases of this measure-development project. Analyses identified fourteen key dimensions of yoga interventions measured by the EPYQ: acceptance/compassion, bandhas, body awareness, breathwork, instructor mention of health benefits, individual attention, meditation and mindfulness, mental and emotional awareness, physicality, active postures, restorative postures, social aspects, spirituality, and yoga philosophy. The EPYQ demonstrated good reliability, as assessed by internal consistency and test-retest reliability analysis, and evidence suggests that the EPYQ is a valid measure of multiple dimensions of yoga. The measure is ready for use by clinicians and researchers. Results indicate that, currently, trained objective raters should score interventions to avoid reference frame errors and potential rating bias, but alternative approaches may be developed. The EPYQ will allow researchers to link specific yoga dimensions to identifiable health outcomes and optimize the design of yoga interventions for specific conditions.