Patient-reported pain and physical health for acupuncture and chiropractic care delivered by Veterans Affairs versus community providers.

BACKGROUND: Acupuncture and chiropractic care are evidence-based pain management alternatives to opioids. The Veterans Health Administration (VA) provides this care in some VA facilities, but also refers patients to community providers. We aimed to determine if patient-reported outcomes differ for acupuncture and chiropractic care from VA versus community providers. MATERIALS AND METHODS: We conducted an observational study using survey outcome data and electronic medical record utilization data for acupuncture and chiropractic care provided in 18 VA facilities or in community facilities reimbursed by VA. Study participants were users of VA primary care, mental health, pain clinic, complementary and integrative therapies, coaching or education services in 2018-2019. Patients received 1) 4+ acupuncture visits (N = 201) or 4+ chiropractic care visits (N = 178) from a VA or community provider from 60 days prior to baseline to six-months survey and 2) no acupuncture or chiropractic visits from 1 year to 60 days prior to baseline. Outcomes measured included patient-reported pain (PEG) and physical health (PROMIS) at baseline and six-month surveys. Multivariate analyses examined outcomes at six months, adjusting for baseline outcomes and demographics. RESULTS: In unadjusted analyses, pain and physical health improved for patients receiving community-based acupuncture, while VA-based acupuncture patients experienced no change. Unadjusted analyses also showed improvements in physical health, but not pain, for patients receiving VA-based chiropractic care, with no changes for community-based chiropractic care patients. Using multivariate models, VA-based acupuncture was no different from community-based acupuncture for pain (-0.258, p = 0.172) or physical health (0.539, p = 0.399). Similarly, there were no differences between VA- and community-based chiropractic care in pain (-0.273, p = 0.154) or physical health (0.793, p = 0.191). CONCLUSIONS: Acupuncture and chiropractic care were associated with modest improvements at six months, with no meaningful differences between VA and community providers. The choice to receive care from VA or community providers could be based on factors other than quality, like cost or convenience.

Understanding Washington State's Low Uptake of Lung Cancer Screening in Two Steps: A Geospatial Analysis of Patient Travel Time and Health Care Availability of Imaging Sites.

BACKGROUND: Early detection of lung cancer reduces cancer mortality; yet uptake for lung cancer screening (LCS) has been limited in Washington State. Geographic disparities contribute to low uptake, but do not wholly explain gaps in access for underserved populations. Other factors, such as an adequate workforce to meet population demand and the capacity of accredited screening facility sites, must also be considered. RESEARCH QUESTION: What proportion of the eligible population for LCS has access to LCS facilities in Washington State? STUDY DESIGN AND METHODS: We used the enhanced two-step floating catchment area (E2SFCA) model to evaluate how geographic accessibility in addition to availability of LCS imaging centers contribute to disparities. We used available data on radiologic technologist volume at each American College of Radiology (ACR)-accredited screening facility site to estimate the capacity of each site to meet potential population demand. Spearman rank correlation coefficients of the spatial access ratios were compared with the 2010 Rural-Urban Commuting Area (RUCA) codes and area deprivation index quintiles to identify characteristics of populations at risk for lung cancer with greater and lesser levels of access. RESULTS: A total of 549 radiologic technologists were identified across the 95 ACR-accredited screening facilities. We observed that 95% of the eligible population had proximate geographic access to any ACR facility. However, when we incorporated the E2SFCA method, we found significant variation of access for eligible populations. The inclusion of the availability measure attenuated access for most of the eligible population. Furthermore, we observed that rural areas were substantially correlated, and areas with greater socioeconomic disadvantage were modestly correlated, with lower access. INTERPRETATION: Rural and socioeconomically disadvantaged areas face significant disparities. The E2SFCA models demonstrated that capacity is an important component and how geographic access and availability jointly contribute to disparities in access to LCS.

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.

Pain Care Disparities and the Use of Virtual Care Among Racial-Ethnic Minority Groups During COVID-19.

BACKGROUND AND OBJECTIVE: COVID-19 led to an unprecedented reliance on virtual modalities to maintain care continuity for patients living with chronic pain. We examined whether there were disparities in virtual specialty pain care for racial-ethnic minority groups during COVID-19. DESIGN AND PARTICIPANTS: This was a retrospective national cohort study with two comparison groups: primary care patients with chronic pain seen immediately prior to COVID-19 (3/1/19-2/29/20) (N = 1,649,053) and a cohort of patients seen in the year prior (3/1/18-2/28-19; n = 1,536,954). MAIN MEASURES: We assessed use of telehealth (telephone or video) specialty pain care, in-person care specialty pain care, and any specialty pain care for both groups at 6 months following cohort inclusion. We used quasi-Poisson regressions to test associations between patient race and ethnicity and receipt of care. KEY RESULTS: Prior to COVID-19, there were Black-White (RR = 0.64, 95% CI [0.62, 0.67]) and Asian-White (RR = 0.63, 95% CI [0.54, 0.75]) disparities in telehealth use, and these lessened during COVID-19 (Black-White: RR = 0.75, 95% CI [0.73, 0.77], Asian-White: RR = 0.81, 95% CI [0.74, 0.89]) but did not disappear. Individuals identifying as American Indian/Alaska Native used telehealth less than White individuals during early COVID-19 (RR = 0.98, 95% CI [0.85, 1.13] to RR = 0.87, 95% CI [0.79, 0.96]). Hispanic/Latinx individuals were less likely than non-Hispanic/Latinx individuals to use telehealth prior to COVID-19 but more likely during early COVID-19 (RR = 0.70, 95% CI [0.66, 0.75] to RR = 1.06, 95% CI [1.02, 1.09]). Disparities in virtual pain care occurred over the backdrop of overall decreased specialty pain care during the early phase of the pandemic (raw decrease of n = 17,481 specialty care encounters overall from pre-COVID to COVID-era), including increased disparities in any VA specialty pain care for Black (RR = 0.81, 95% CI [0.80, 0.83] to RR = 0.79, 95% CI [0.77, 0.80]) and Asian (RR = 0.91, 95% CI [0.86, 0.97] to RR = 0.88, 95% CI [0.82, 0.94]) individuals. CONCLUSIONS: Disparities in virtual specialty pain care were smaller during the early phases of the COVID-19 pandemic than prior to the pandemic but did not disappear entirely, despite the rapid growth in telehealth. Targeted efforts to increase access to specialty pain care need to be concentrated among racial-ethnic minority groups.

Changes in Patient-Reported Outcomes Associated with Receiving Whole Health in the Veteran Health Administration (VHA)'s National Demonstration Project.

BACKGROUND: Whole Health (WH) is a patient-centered model of care being implemented by the Veterans Health Administration. Little is known about how use of WH services impacts patients' health and well-being. OBJECTIVE: We sought to assess the association of WH utilization with pain and other patient-reported outcomes (PRO) over 6 months. DESIGN: A longitudinal observational cohort evaluation, comparing changes in PRO surveys for WH users and Conventional Care (CC) users. Inverse probability of treatment weighting was used to balance the two groups on observed demographic and clinical characteristics. PARTICIPANTS: A total of 9689 veterans receiving outpatient care at 18 VA medical centers piloting WH. INTERVENTIONS: WH services included goal-setting clinical encounters, Whole Health coaching, personal health planning, and well-being services. MAIN OUTCOME MEASURES: The primary outcome was change in pain intensity and interference at 6 months using the 3-item PEG. Secondary outcomes included satisfaction, experiences of care, patient engagement in healthcare, and well-being. KEY RESULTS: By 6 months,1053 veterans had utilized WH and 3139 utilized only CC. Baseline pain PEG scores were 6.2 (2.5) for WH users and 6.4 (2.3) for CC users (difference p = 0.028), improving by - 2.4% (p = 0.006) and - 2.3% (p < 0.001), respectively. In adjusted analyses, WH use was unassociated with greater improvement in PEG scores compared to CC - 1.0% (- 2.9%, 1.2%). Positive trends were observed for 8 of 15 exploratory outcomes for WH compared to CC. WH use was associated with greater improvements at 6 months in likelihood to recommend VA 2.0% (0.9%, 3.3%); discussions of goals 11.8% (8.2%, 15.5%); perceptions of healthcare interactions 2.5% (0.4%, 4.6%); and engagement in health behaviors 2.2% (0.3%, 3.9%). CONCLUSION: This study provides early evidence supporting the delivery of WH patient-centered care services to improve veterans' experiences of and engagement in care. These are important first-line impacts towards the goals of better overall health and well-being outcomes for Veterans.

Examining the Veterans Health Administration whole health model of care within the context of posttraumatic stress disorder.

The Veterans Health Administration's Whole Health system of care focuses on offering veterans holistic health approaches and tailoring health care to individual's goals and preferences. The present study assessed factors associated with Whole Health use and its potential benefits among veterans with posttraumatic stress disorder (PTSD) receiving Veterans Health Administration care. This cohort study used retrospective electronic health records combined with survey data (baseline, 6 months) from 18 Veterans Affairs Whole Health pilot implementation sites and compared patient-reported outcomes between veterans who used Whole Health services versus those who did not, among veterans with (n = 1,326) and without (n = 3,243) PTSD. Patient-reported outcomes assessed were pain (PEG), patient-reported outcomes measurement information system physical and mental health functioning, and a one-item global meaning and purpose assessment. Veterans with PTSD were more likely to have used Whole Health (38% vs. 21%) than those without PTSD. Veterans with PTSD who used Whole Health services experienced small improvements over 6 months in physical (Cohen's d = .12) and mental (Cohen's d = .15) health functioning. Veterans without PTSD who used Whole Health services experienced small improvements in physical health (Cohen's d = .09) but not mental health (Cohen's d = .04). Veterans with PTSD were frequently connected with Whole Health services even though implementation efforts were not explicitly focused on reaching this population. Results suggest Whole Health may play an important role in how veterans with PTSD engage with health care. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Protocol for a pragmatic trial testing a self-directed lifestyle program targeting weight loss among patients with obstructive sleep apnea (POWER Trial).

BACKGROUND: Obesity comprises the single greatest reversible risk factor for obstructive sleep apnea (OSA). Despite the potential of lifestyle-based weight loss services to improve OSA severity and symptoms, these programs have limited reach. POWER is a pragmatic trial of a remote self-directed weight loss care among patients with OSA. METHODS: POWER randomizes 696 patients with obesity (BMI 30-45 kg/m2) and recent diagnosis or re-confirmation of OSA 1:1 to either a self-directed weight loss intervention or usual care. POWER tests whether such an intervention improves co-primary outcomes of weight and sleep-related quality of life at 12 months. Secondary outcomes include sleep symptoms, global ratings of change, and cardiovascular risk scores. Finally, consistent with a hybrid type 1 approach, the trial embeds an implementation process evaluation. We will use quantitative and qualitative methods including budget impact analyses and qualitative interviews to assess barriers to implementation. CONCLUSIONS: The results of POWER will inform population health approaches to the delivery of weight loss care. A remote self-directed program has the potential to be disseminated widely with limited health system resources and likely low-cost.

Introducing the integrated model of co-occurring chronic pain and posttraumatic stress disorder: Adding meaning-making and existential concepts to current theory.

OBJECTIVE: Making meaning out of the experience of chronic pain and posttraumatic stress disorder (PTSD) is a core process of recovery and symptom management of the comorbidity and a key active ingredient in the treatment for these conditions. Managing the effects of chronic pain and PTSD symptoms often evokes anxieties that could be considered existential (e.g., loss of meaning in life and concerns about one's identity). However, current theoretical models of co-occurring chronic pain and PTSD do not capture core meaning-making processes involved in either condition, resulting in the potential to overlook their centrality. The objective of the current work is to integrate current theoretical models of co-occurring chronic pain and PTSD with theory and science related to meaning-making and existential anxiety. METHOD: A targeted literature review was used to develop a novel model of co-occurring chronic pain and PTSD. RESULTS: The present work introduces the integrated model of co-occurring chronic pain and PTSD, which is a first attempt at integrating current theoretical perspectives of co-occurring chronic pain and PTSD with the literature on meaning-making and closely related existential perspectives. We outline model-specific hypotheses and describe model implications and future directions. CONCLUSIONS: The model provides clinicians and researchers with a more thorough conceptualization of how chronic pain and PTSD interact, which symptoms to target, and which outcomes may be important for individuals who have both chronic pain and PTSD. As a result, the model has the potential to improve pain and PTSD outcomes, and perhaps health outcomes more broadly, within this population. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

VHA Whole Health Services and Complementary and Integrative Health Therapies: a Gateway to Evidence-Based Mental Health Treatment.

BACKGROUND: Engagement in evidence-based psychotherapy (EBP) among veterans with behavioral health conditions is often low. The Veterans Health Administration (VHA) is implementing a "Whole Health (WH)" system of care, to identify veteran personal health goals, align care with those goals, and offer services designed to engage and empower veterans to achieve well-being. OBJECTIVE: To examine the relationship between veteran WH utilization and subsequent engagement in EBP. DESIGN: Retrospective analysis of VHA administrative records from 18 facilities implementing WH. SUBJECTS: Veterans (n = 265,364) with a diagnosis of depression, post-traumatic stress disorder (PTSD), and/or anxiety who had a mental healthcare encounter but no EBP use in fiscal year (FY) 2018. Among this cohort, 33,146 (12.5%) began using WH in FY2019. MAIN MEASURES: We examined use of an EBP for depression, anxiety, and/or PTSD within 1 year of the index date of WH use compared to use of an EBP anytime during FY2019 for veterans not identified as using WH. We used multiple logistic regression to examine the association between veteran WH use and EBP engagement. KEY RESULTS: Approximately 3.0% (n = 7,860) of the veterans in our overall cohort engaged in an EBP in the year following their index date. Controlling for key demographic, health, and utilization variables, WH users had 2.4 (95% CI: 2.2-2.5) times higher odds of engaging in an EBP the following year than those with no WH utilization. Associations between utilization of specific WH services (vs. no utilization of that service) and engagement in an EBP in the subsequent year ranged from 1.6 (95% CI: 1.0-2.6) to 3.5 (95% CI: 3.2-3.9) across the different types of WH services used. CONCLUSIONS: WH use was associated with increased engagement in EBPs among veterans with depression, anxiety, and/or PTSD. Future interventions intended to promote veteran engagement in EBPs may benefit from leveraging WH services and therapies.

Racial and Ethnic Variation in Complementary and Integrative Health Therapy Use Among US Veterans.

Importance: White individuals are the greatest users of complementary and integrative health (CIH) therapies in the general population, but this might partially be due to differences in age, health condition, and location. Identifying the nuances in racial and ethnic differences in care is one important step to addressing them. Objective: To evaluate racial and ethnic differences in Veterans Affairs (VA)-covered CIH therapy use in a more nuanced manner by examining the association of 5 demographic characteristics, health conditions, and medical facility locations with those differences. Design, Setting, and Participants: Retrospective cross-sectional observational study of VA health care system users, using electronic health record and administrative data at all VA medical facilities and community-based clinics. Participants included veterans with nonmissing race and ethnicity data using VA-funded health care between October 2018 and September 2019. Data were analyzed from June 2022 to April 2023. Main Outcome and Measure: Any use of VA-covered acupuncture, chiropractic care, massage therapy, yoga, or meditation/mindfulness. Results: The sample consisted of 5 260 807 veterans with a mean (SD) age of 62.3 (16.4) years and was 91% male (4 788 267 veterans), 67% non-Hispanic White (3 547 140 veterans), 6% Hispanic (328 396 veterans), and 17% Black (903 699 veterans). Chiropractic care was the most used CIH therapy among non-Hispanic White veterans, Hispanic veterans, and veterans of other races and ethnicities, while acupuncture was the most commonly used therapy among Black veterans. When not accounting for the location of the VA medical facilities in which veterans used health care, Black veterans appeared more likely to use yoga and meditation than non-Hispanic White veterans and far less likely to use chiropractic care, while those of Hispanic or other race and ethnicity appeared more likely to use massage than non-Hispanic White veterans. However, those differences mostly disappeared once controlling for medical facility location, with few exceptions-after adjustment Black veterans were less likely than non-Hispanic White veterans to use yoga and more likely to use chiropractic care. Conclusions and Relevance: This large-scale, cross-sectional study found racial and ethnic differences in use of 4 of 5 CIH therapies among VA health care system users when not considering their medical facility location. Given those differences mostly disappeared once medical facilities were accounted for, the results demonstrated the importance of considering facilities and residential locations when examining racial differences in CIH therapy use. Medical facilities could be a proxy for the racial and ethnic composition of their patients, CIH therapy availability, regional patient or clinician attitudes, or therapy availability.

Utilization of Whole Health and Longitudinal Outcomes After Screening Positive for Possible Depression Documented in Veterans Health Administration's Electronic Health Record.

Objectives: Depression is common among Veterans. Veterans Health Administration (VHA) is transforming into a Whole Health system of care that includes holistic treatment planning, well-being programs, and health coaching. This evaluation explores the impact of Whole Health on improving symptoms of depression among Veterans who screen positive for possible depression diagnosis. Materials and Methods: We examined a cohort of Veterans who started using Whole Health after screening positive for possible depression (having a PHQ-2 score ≥3) at 18 VA Whole Health sites. We compared Whole Health users with non-Whole Health users on their follow-up PHQ-2 scores (9-36 months after baseline), using propensity score matching with multivariable regression to adjust for baseline differences. Results: Of the 13,559 Veterans screening positive for possible depression on the PHQ-2 and having a follow-up PHQ-2, 902 (7%) began using Whole Health after their initial positive PHQ-2. Whole Health users at baseline were more likely than non-Whole Health users to have posttraumatic stress disorder or acute stress (43% vs. 29%), anxiety (22% vs. 12%), ongoing opioid use (14% vs. 8%), recent severe pain scores (15% vs. 8%), or obesity (51% vs. 40%). Both groups improved at follow-up, with mean PHQ-2 scores decreasing from 4.49 to 1.77 in the Whole Health group and 4.46 to 1.46 in the conventional care group, with the Whole Health group significantly higher at follow-up. Also, the proportion continuing to screen positive at follow-up trended higher in the Whole Health group (26% and 21%, respectively). Conclusions: After screening positive for depression, Veterans with more mental and physical health conditions were more likely to subsequently use Whole Health services, suggesting that Whole Health is becoming a tool used in VHA to address the needs of complex patients. Nevertheless, the Whole Health group did not improve compared to the Conventional Care group. Results add to the growing body of literature that Whole Health services may play an important role among patients with complex symptom presentations by promoting self-management of symptoms and targeting "what matters most" to Veterans.

Changes in Use of Complementary and Integrative Health Therapies at the Veterans Affairs: Findings from a Whole Health System Pilot Program.

Introduction: The Department of Veterans Affairs (VA) launched a Whole Health System pilot program in 18 VA "Flagship" medical centers in 2018 in part to expand the provision of complementary and integrative health (CIH) therapies. Materials and methods: A longitudinal quasi-experimental design was used to examine Veterans' use of at least 1 of 12 CIH therapies 2 years after initiation of the Flagship pilot program compared with the year before the program started. The sample included Veterans with chronic musculoskeletal pain with at least one visit to a VA primary care, mental health care, or pain clinic in each of the 3 study years. A population-average logit model was used to measure changes in the percentage of Veterans using at least one the CIH therapies over time. Results: Among Veterans with chronic musculoskeletal pain receiving health care at Flagship sites, 9.7% used a CIH therapy before the Flagship program initiation, whereas 14.2% used a therapy in the second year of the program (46.0% increase). In comparison, CIH therapy use among Veterans at non-Flagship sites increased from 10.3% to 12.0% over the same period (16.5% increase). Results from the population-average logit model show that Veterans at Flagship sites were significantly more likely to be CIH therapy users in the first (p < 0.001) and second (p < 0.001) years of the implementation compared with non-Flagship sites. Discussion: The Flagship pilot program was successful in terms of increasing the use of CIH therapies among Veterans with chronic musculoskeletal pain compared with non-Flagship sites. Conclusions: The Whole Health System implementation that included financial incentives, education, and other support to 18 VA "Flagship" medical centers helped to increase the use of CIH therapies in the VA. Future research should examine which of these efforts were most effective in expanding CIH therapy provision.

We Built it, But Did They Come: Veterans' Use of VA Healthcare System-Provided Complementary and Integrative Health Approaches.

BACKGROUND: Interest in complementary and integrative health (CIH) approaches, such as meditation, yoga, and acupuncture, continues to grow. The evidence of effectiveness for some CIH approaches has increased in the last decade, especially for pain, with many being recommended in varying degrees in national guidelines. To offer nonpharmacological health management options and meet patient demand, the nation's largest integrated healthcare system, the Veterans Health Administration (VA), greatly expanded their provision of CIH approaches recently. OBJECTIVE: This paper addressed the questions of how many VA patients might use CIH approaches and chiropractic care if they were available at modest to no fee, and would patients with some health conditions or characteristics be more likely than others to use these therapies. DESIGN: Using electronic medical records, we conducted a national, three-year, retrospective analysis of VA patients' use of eleven VA-covered therapies: chiropractic care, acupuncture, Battlefield Acupuncture, biofeedback, clinical hypnosis, guided imagery, massage therapy, meditation, Tai Chi/Qigong, and yoga. PARTICIPANTS: We created a national cohort of veterans using VA healthcare from October 2016-September 2019. KEY RESULTS: Veterans' use of these approaches increased 70% in three years. By 2019, use was 5.7% among all VA patients, but highest among patients with chronic musculoskeletal pain (13.9%), post-traumatic stress disorder (PTSD; 10.6%), depression (10.4%), anxiety (10.2%), or obesity (7.8%). The approach used varied by age and race/ethnicity, with women being uniformly more likely than men to use each approach. Patients having chronic musculoskeletal pain, obesity, anxiety, depression, or PTSD were more likely than others to use each of the approaches. CONCLUSIONS: Veterans' use of some approaches rapidly grew recently and was robust, especially among patients most in need. This information might help shape federal/state health policy on the provision of evidence-based CIH approaches and guide other healthcare institutions considering providing them.

Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence.

Nonpharmacological treatments are considered first-line pain management strategies, but they remain clinically underused. For years, pain-focused pragmatic clinical trials (PCTs) have generated evidence for the enhanced use of nonpharmacological interventions in routine clinical settings to help overcome implementation barriers. The Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) framework describes the degree of pragmatism across 9 key domains. Among these, "flexibility in delivery" and "flexibility in adherence," address a key goal of pragmatic research by tailoring approaches to settings in which people receive routine care. However, to maintain scientific and ethical rigor, PCTs must ensure that flexibility features do not compromise delivery of interventions as designed, such that the results are ethically and scientifically sound. Key principles of achieving this balance include clear definitions of intervention core components, intervention monitoring and documentation that is sufficient but not overly burdensome, provider training that meets the demands of delivering an intervention in real-world settings, and use of an ethical lens to recognize and avoid potential trial futility when necessary and appropriate. PERSPECTIVE: This article presents nuances to be considered when applying the PRECIS-2 framework to describe pragmatic clinical trials. Trials must ensure that patient-centered treatment flexibility does not compromise delivery of interventions as designed, such that measurement and analysis of treatment effects is reliable.

Telehealth Complementary and Integrative Health Therapies During COVID-19 at the U.S. Department of Veterans Affairs.

Background: Complementary and integrative health (CIH) therapies, such as in-person acupuncture, chiropractic care, and meditation, are evidence-based nonpharmaceutical treatment options for pain. During COVID-19, the Veterans Health Administration (VA) delivered several CIH therapies virtually. This study explores veterans' utilization, advantages/disadvantages, and delivery issues of yoga, Tai Chi, meditation/mindfulness (self-care), and massage, chiropractic, and acupuncture (practitioner-delivered care), using telephone/video at 18 VA sites during COVID-19. Methods: Use of virtual care was examined quantitatively with VA administrative data for six CIH therapies before and after COVID-19 onset (2019-2021). Advantages/disadvantages and health care delivery issues of these CIH therapies through virtual care were examined qualitatively using interview data (2020-2021). Results: Overall, televisits represented a substantial portion of all CIH self-care therapies delivered by VA in 2020 (53.7%) and 2021 (82.1%), as sites developed virtual group classes using VA secure online video platforms in response to COVID-19. In contrast, a small proportion of all encounters with acupuncturists, chiropractors, and massage therapists was telephone/video encounters in 2020 (17.3%) and in 2021 (5.4%). These were predominantly one-on-one care in the form of education, follow-ups, home exercises, assessments/evaluations, or acupressure. Delivery issues included technical difficulties, lack of access to needed technology, difficulty tracking virtual visits, and capacity restrictions. Advantages included increased access to self-care, increased patient receptivity to engaging in self-care, and flexibility in staffing online group classes. Disadvantages included patient preference, patient safety, and strain on staffing. Conclusion: Despite delivery issues or disadvantages of tele-CIH self-care, veterans' use of teleself-care CIH therapies grew substantially during the COVID-19 pandemic.

Effectiveness of a whole health model of care emphasizing complementary and integrative health on reducing opioid use among patients with chronic pain.

BACKGROUND: The opioid crisis has necessitated new approaches to managing chronic pain. The Veterans Health Administration (VHA) Whole Health model of care, with its focus on patient empowerment and emphasis on nonpharmacological approaches to pain management, is a promising strategy for reducing patients' use of opioids. We aim to assess whether the VHA's Whole Health pilot program impacted longitudinal patterns of opioid utilization among patients with chronic musculoskeletal pain. METHODS: A cohort of 4,869 Veterans with chronic pain engaging in Whole Health services was compared with a cohort of 118,888 Veterans receiving conventional care. All patients were continuously enrolled in VHA care from 10/2017 through 3/2019 at the 18 VHA medical centers participating in the pilot program. Inverse probability of treatment weighting and multivariate analyses were used to adjust for observable differences in patient characteristics between exposures and conventional care. Patients exposed to Whole Health services were offered nine complementary and integrative health therapies alone or in combination with novel Whole Health services including goal-setting clinical encounters, Whole Health coaching, and personal health planning. MAIN MEASURES: The main measure was change over an 18-month period in prescribed opioid doses starting from the six-month period prior to qualifying exposure. RESULTS: Prescribed opioid doses decreased by -12.0% in one year among Veterans who began complementary and integrative health therapies compared to similar Veterans who used conventional care; -4.4% among Veterans who used only Whole Health services such as goal setting and coaching compared to conventional care, and -8.5% among Veterans who used both complementary and integrative health therapies combined with Whole Health services compared to conventional care. CONCLUSIONS: VHA's Whole Health national pilot program was associated with greater reductions in prescribed opioid doses compared to secular trends associated with conventional care, especially when Veterans were connected with complementary and integrative health therapies.

Association Between Exposure to Complementary and Integrative Therapies and Opioid Analgesic Daily Dose Among Patients on Long-term Opioid Therapy.

OBJECTIVES: To describe the association between exposure to selected complementary and integrative health (CIH) modalities and the trajectory of prescribed opioid analgesic dose within a national cohort of patients receiving long-term opioid therapy (LTOT) in the Veterans Health Administration (VHA). MATERIALS AND METHODS: Using national data from VHA electronic health records between October 1, 2017 and September 30, 2019, CIH use was analyzed among 57,437 patients receiving LTOT within 18 VHA facilities serving as evaluation sites of VHA's Whole Health System of Care. Using linear mixed effects modeling controlling for covariates, opioid dose was modeled as a function of time, CIH exposure, and their interaction. RESULTS: Overall, 11.91% of patients on LTOT used any of the focus CIH therapies; 43.25% of those had 4 or more encounters. Patients used acupuncture, chiropractic care, and meditation modalities primarily. CIH use was associated with being female, Black, having a mental health diagnosis, obesity, pain intensity, and baseline morphine-equivalent daily dose. Mean baseline morphine-equivalent daily dose was 40.81 milligrams and dose decreased on average over time. Controlling for covariates, patients with any CIH exposure experienced 38% faster dose tapering, corresponding to a mean difference in 12-month reduction over patients not engaging in CIH of 2.88 milligrams or 7.06% of the mean starting dose. DISCUSSION: Results support the role of CIH modalities in opioid tapering. The study design precludes inference about the causal effects of CIH on tapering. Analyses did not consider the trend in opioid dose before cohort entry nor the use of other nonopioid treatments for pain. Future research should address these questions and consider tapering-associated adverse events.

From patient outcomes to system change: Evaluating the impact of VHA's implementation of the Whole Health System of Care.

OBJECTIVE: To describe how a partnered evaluation of the Whole Health (WH) system of care-comprised of the WH pathway, clinical care, and well-being programs-produced patient outcomes findings, which informed Veterans Health Administration (VA) policy and system change. DATA SOURCES: Electronic health records (EHR)-based cohort of 1,368,413 patients and a longitudinal survey of Veterans receiving care at 18 WH pilot medical centers. STUDY DESIGN: In partnership with VA operations, we focused the evaluation on the impact of WH services utilization on Veterans' (1) use of opioids and (2) care experiences, care engagement, and well-being. Outcomes were compared between Veterans who did and did not use WH services identified from the EHR. DATA COLLECTION: Pharmacy records and WH service data were obtained from the VA EHR, including WH coaching, peer-led groups, personal health planning, and complementary, integrative health therapies. We surveyed veterans at baseline and 6 months to measure patient-reported outcomes. PRINCIPAL FINDINGS: Opioid use decreased 23% (31.5-6.5) to 38% (60.3-14.4) among WH users depending on level of WH use compared to a secular 11% (12.0-9.9) decrease among Veterans using Conventional Care. Compared to Conventional Care users, WH users reported greater improvements in perceptions of care (SMD = 0.138), engagement in health care (SMD = 0.118) and self-care (SMD = 0.1), life meaning and purpose (SMD = 0.152), pain (SMD = 0.025), and perceived stress (SMD = 0.191). CONCLUSIONS: Evidence developed through this partnership yielded key VA policy changes to increase Veteran access to WH services. Findings formed the foundation of a congressionally mandated report in response to the Comprehensive Addiction and Recovery Act, highlighting the value of WH and complementary, integrative health and well-being programs for Veterans with pain. Findings subsequently informed issuance of an Executive Decision Memo mandating the integration of WH into mental health and primary care across VA, now one lane of modernization for VA.

Clinical-community linkages as a strategy for increasing evidence-based program reach: Results of the PT-REFER randomized controlled trial with older adults and YMCA associations.

BACKGROUND: Most older adults do not meet recommended guidelines for physical activity. Referrals from physical therapists (PTs) to community- and evidence-based physical-activity programs like Enhance®Fitness have potential to address this gap. We tested an intervention intended to increase referrals of older adults to Enhance®Fitness programs offered at YMCAs. MATERIALS AND METHODS: We developed a capacity-building intervention that included a structured toolkit and technical-assistance calls. From April 2016 to September 2018, using stratified randomization, we conducted a trial with 20 YMCA Associations randomized into intervention and control arms. The primary outcome was the number of new Enhance®Fitness enrollees during the trial period. Using both quantitative and qualitative methods, we also conducted process and intermediate-outcome evaluations to assess intervention implementation and Association outreach activities, barriers, and facilitators. RESULTS: The intervention was implemented as intended, but PT outreach was similar for both intervention and control YMCA Associations. The intervention arm had similar enrollment (1695 new enrollees) to the control arm (1326 new enrollees; 95% confidence interval, -47%-199%, P = 0.61). Interviews revealed that barriers, including lack of staff and time for outreach, limited capacity for Enhance®Fitness program growth, and competing priorities, outweighed facilitators, including existing partnerships, presence of an outreach team, senior leadership support, and infrastructure for referrals. CONCLUSIONS: YMCA Associations in the intervention arm were unable to increase their outreach to PTs and enrollment in Enhance®Fitness. Our evaluation findings indicate that community organizations that prioritize program growth, have support at all organizational levels, and allocate staff and time for outreach and partnership development may be more successful in creating sustainable linkages with clinical partners and increasing evidence-based-program reach.