Prescribing and Acceptance of Medications for Opioid Use Disorder in VA Primary Care: Veteran and Provider Perspectives.

BACKGROUND: Medications to treat opioid use disorder (MOUD) such as buprenorphine/naloxone can effectively treat OUD and reduce opioid-related mortality, but they remain underutilized, especially in non-substance use disorder settings such as primary care (PC). OBJECTIVE: To uncover the factors that can facilitate successful prescribing of MOUD and uptake/acceptance of MOUD by patients in PC settings in the Veterans Health Administration. DESIGN: Semi-structured qualitative telephone interviews with 77 providers (e.g., primary care providers, hospitalists, nurses, addiction psychiatrists) and 22 Veteran patients with experience taking MOUD. Interviews were recorded, transcribed, and analyzed thematically using a combination a priori/inductive approach. KEY RESULTS: Providers and patients shared their general perceptions and experiences with MOUD, including high satisfaction with buprenorphine/naloxone with few side effects and caveats, although some patients reported drawbacks to methadone. Both providers and patients supported the idea of prescribing MOUD in PC settings to prioritize patient comfort and convenience. Providers described individual-level barriers (e.g., time, stigma, perceptions of difficulty level), structural-level barriers (e.g., pharmacy not having medications ready, space for inductions), and organizational-level barriers (e.g., inadequate staff support, lack of nursing protocols) to PC providers prescribing MOUD. Facilitators centered on education and knowledge enhancement, workflow and practice support, patient engagement and patient-provider communication, and leadership and organizational support. The most common barrier faced by patients to starting MOUD was apprehensions about pain, while facilitators focused on personal motivation, encouragement from others, education about MOUD, and optimally timed provider communication strategies. CONCLUSIONS: These findings can help improve provider-, clinic-, and system-level supports for MOUD prescribing across multiple settings, as well as foster communication strategies that can increase patient acceptance of MOUD. They also point to how interprofessional collaboration across service lines and leadership support can facilitate MOUD prescribing among non-addiction providers.

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.

Are Virtual Complementary and Integrative Therapies as Effective as In-Person Therapies? Examining Patient-Reported Outcomes Among Veterans with Chronic Musculoskeletal Pain.

Background: Virtual complementary and integrative health (CIH) therapy availability increased during the COVID-19 pandemic, but little is known about effectiveness. We examined the perceived effectiveness of in-person and virtual CIH therapies for patients with chronic musculoskeletal pain who recently started using CIH therapies. Methods: The sample included Veterans (n = 1,091) with chronic musculoskeletal pain, identified in the Veterans Health Administration's electronic health record based on initiation of CIH therapy use, who responded to VA's Patient Complementary and Integrative Health Therapy Experience Survey during March, 2021, to August, 2022. Using multivariable models with self-guided virtual (apps or videos) delivery as the reference, we compared patient-reported outcomes (pain, mental health, fatigue, and general well-being) associated with any yoga, Tai Chi/Qigong, or meditation use delivered: (1) only in-person, (2) only virtually with a live provider, (3) only virtually self-guided, (4) virtually self-guided + virtually provider-guided, or (5) hybrid in-person + virtual (self-or provider-guided). Results: Under 10% of Veterans reported only in-person use; 54% used only virtual formats and 36% a hybrid of in-person and virtual. Forty-one percent reported improvement in general well-being, 40.6% in mental health, 37.1% in pain, and 22.7% in fatigue. Compared with Veterans using only self-guided virtual CIH therapies, Veterans using only in-person therapies were more likely to report improvement in fatigue (odds ratio [OR]: 1.8, confidence interval [CI]: 1.1-3.1) and general well-being (OR: 1.7, CI: 1.0-2.6). Conclusions: Many patients perceived health improvements from CIH therapies, with in-person users reporting more improvement in fatigue and well-being than those using virtual sessions and similar improvements in pain and mental health for in-person and hybrid users.

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.

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.

TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials - unique considerations for the Template for the Intervention Description and Replication (TIDieR) checklist.

BACKGROUND: Recent international health events have led to an increased proliferation of remotely delivered health interventions. Even with the pandemic seemingly coming under control, the experiences of the past year have fueled a growth in ideas and technology for increasing the scope of remote care delivery. Unfortunately, clinicians and health systems will have difficulty with the adoption and implementation of these interventions if ongoing and future clinical trials fail to report necessary details about execution, platforms, and infrastructure related to these interventions. The purpose was to develop guidance for reporting of telehealth interventions. METHODS: A working group from the US Pain Management Collaboratory developed guidance for complete reporting of telehealth interventions. The process went through 5-step process from conception to final checklist development with input for many stakeholders, to include all 11 primary investigators with trials in the Collaboratory. RESULTS: An extension focused on unique considerations relevant to telehealth interventions was developed for the Template for the Intervention Description and Replication (TIDieR) checklist. CONCLUSION: The Telehealth Intervention guideline encourages use of the Template for the Intervention Description and Replication (TIDieR) checklist as a valuable tool (TIDieR-Telehealth) to improve the quality of research through a reporting guide of relevant interventions that will help maximize reproducibility and implementation.

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.

Provider Perspectives of Battlefield Acupuncture: Advantages, Disadvantages and Its Potential Role in Reducing Opioid Use for Pain.

OBJECTIVES: Nonpharmacological options to treat pain are in demand, in part to address the opioid crisis. One such option is acupuncture. Battlefield acupuncture (BFA) is an auricular needling protocol currently used to treat pain in the Veterans Health Administration. We aimed to identify the advantages and disadvantages of BFA from providers' perspectives. METHODS: We rely on an inductive qualitative approach to explore provider perceptions through thematic analysis of semistructured interviews with 43 BFA providers across the nation. RESULTS: We identified the following themes. Disadvantages included: (1) clinical guidelines are insufficient; (2) patients often request multiple BFA visits from providers; (3) BFA can be uncomfortable; (4) BFA may not be an effective treatment option unless it can be provided "on demand"; and (5) BFA can promote euphoria, which can have deleterious consequences for patient self-care. Perceived advantages included: (1) BFA can simultaneously effectively control pain while reducing opioid use; (2) BFA may alleviate the pain that has been unsuccessfully treated by conventional methods; (3) BFA gives providers a treatment option to offer patients with substance use disorder; (4) BFA helps build a trusting patient-provider relationship; (5) BFA can create the opportunity for hope. CONCLUSIONS: Providers perceive BFA to have many benefits, both clinical and relational, including ways in which it may have utility in addressing the current opioid crisis. BFA is easy to deliver and has potential clinical and relational utility. Efforts to better understand effectiveness are warranted.

Does Offering Battlefield Acupuncture Lead to Subsequent Use of Traditional Acupuncture?

OBJECTIVES: Veterans Health Administration encourages auricular acupuncture (Battlefield Acupuncture/BFA) as a nonpharmacologic approach to pain management. Qualitative reports highlighted a "gateway hypothesis": providing BFA can lead to additional nonpharmacologic treatments. This analysis examines subsequent use of traditional acupuncture. RESEARCH DESIGN: Cohort study of Veterans treated with BFA and a propensity score matched comparison group with a 3-month follow-up period to identify subsequent use of traditional acupuncture. Matching variables included pain, comorbidity, and demographics, with further adjustment in multivariate regression analysis. SUBJECTS: We identified 41,234 patients who used BFA across 130 Veterans Health Administration medical facilities between October 1, 2016 and March 31, 2019. These patients were matched 2:1 on Veterans who used VA care but not BFA during the same period resulting in a population of 24,037 BFA users and a comparison cohort of 40,358 non-BFA users. Patients with prior use of traditional acupuncture were excluded. RESULTS: Among Veterans receiving BFA, 9.5% subsequently used traditional acupuncture compared with 0.9% of non-BFA users (P<0.001). In adjusted analysis, accounting for patient characteristics and regional availability of traditional acupuncture, patients who used BFA had 10.9 times greater odds (95% confidence interval, 8.67-12.24) of subsequent traditional acupuncture use. CONCLUSIONS: Providing BFA, which is easy to administer during a patient visit and does not require providers be formally certified, led to a substantial increase in use of traditional acupuncture. These findings suggest that the value of offering BFA may not only be its immediate potential for pain relief but also subsequent engagement in additional therapies.

Patient Feedback on the Effectiveness of Auricular Acupuncture on Pain in Routine Clinical Care: The Experience of 11,406 Veterans.

OBJECTIVES: Veterans Health Administration (VHA) launched a national initiative to train providers in a specific, protocolized auricular acupuncture treatment (also called Battlefield Acupuncture or BFA) as a nonpharmacological approach to pain management. This evaluation assessed the real-world effectiveness of BFA on immediate pain relief and identified subgroups of patients for whom BFA is most effective. RESEARCH DESIGN: In a cross-sectional cohort study, electronic medical record data for 11,406 Veterans treated with BFA at 57 VHA medical centers between October 2016 and September 2018 was analyzed. The multivariate analysis incorporated data on pain history, change in pain level on an 11-point scale, complications, and demographic information. METHODS: A total of 11,406 Veterans were treated with BFA at 57 VHA medical centers between October 2016 and September 2018 and had effectiveness data recorded in their electronic medical record. RESULTS: More than 3 quarters experienced immediate decreases in pain following administration of BFA, with nearly 60% reported experiencing a minimal clinically important difference in pain intensity. The average decrease in pain intensity was -2.5 points (SD=2.2) at the initial BFA treatment, and -2.2 points (SD=2.0) at subsequent treatments. BFA was effective across a wide range of Veterans with many having preexisting chronic pain, or physical, or psychological comorbid conditions. Veterans with opioid use in the year before BFA experienced less improvement, with pain intensity scores improving more among Veterans who had not recently used opioids. CONCLUSION: VHA's rapid expansion of training providers to offer BFA as a nonpharmacological approach to pain management has benefited many Veterans.

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.

Increasing Access to Medications for Opioid Use Disorder and Complementary and Integrative Health Services in Primary Care.

OBJECTIVES: Evidence-based therapies for opioid use disorder (OUD) and chronic pain, such as medications for OUD (MOUD) and complementary and integrative health (CIH; e.g., acupuncture and meditation) therapies, exist. However, their adoption has been slow, particularly in primary care, due to numerous implementation challenges. We sought to expand the use of MOUD and CIH within primary care by using an evidence-based quality improvement (EBQI) implementation strategy. METHODS: We used EBQI to engage two facilities in the Veterans Health Administration (VHA) from June 2018 to September 2019. EBQI included multilevel stakeholder engagement, with external facilitators providing technical support, practice facilitation, and routine data feedback. We established a quality improvement (QI) team at each facility with diverse stakeholders (e.g., primary care, addiction, pain, nursing, pharmacy). We met monthly with regional stakeholders to address implementation barriers. We also convened an advisory board to ensure alignment with national priorities. RESULTS: Pre-implementation interviews indicated facility-level and provider-level barriers to prescribing buprenorphine, including strong primary care provider resistance. Both facilities developed action plans. They both conducted educational meetings (e.g., Grand Rounds, MOUD waiver trainings). Facility A also offered clinical preceptorships for newly trained primary care prescribers. Facility B used mass media and mailings to educate patients about MOUD and CIH options and dashboards to identify potential candidates for MOUD. After 15 months, both facilities increased their OUD treatment rates to the ≥ 90th percentile of VHA medical centers nationally. Exit interviews indicated an attitudinal shift in MOUD delivery in primary care. Stakeholders valued the EBQI process, particularly cross-site collaboration. IMPLICATIONS: Despite initial implementation barriers, we effectively engaged stakeholders using EBQI strategies. Local QI teams used an assortment of QI interventions and developed tools to catapult their facilities to among the highest performers in VHA OUD treatment. IMPACTS: EBQI is an effective strategy to partner with stakeholders to implement MOUD and CIH therapies.

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.

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain.

BACKGROUND: Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain. However, the predominant MBI, mindfulness-based stress reduction, has features that pose significant implementation barriers. OBJECTIVES: This study will test two approaches to delivering MBIs for improving Veterans' chronic pain and mental health comorbidities. These two approaches address key implementation barriers. METHODS: We will conduct a four-site, three-arm pragmatic randomized controlled trial, Learning to Apply Mindfulness to Pain (LAMP), to test the effectiveness of two MBIs at improving pain and mental health comorbidities. Mobile+Group LAMP consists of prerecorded modules presented by a mindfulness instructor that are viewed in an online group setting and interspersed with discussions led by a facilitator. Mobile LAMP consists of the same prerecorded modules but does not include a group component. We will test whether either of these MBIs will be more effective than usual care at improving chronic pain and whether the Mobile+Group LAMP will be more effective than Mobile LAMP at improving chronic pain. Comparisons for the primary hypotheses will be conducted with continuous outcomes (Brief Pain Inventory interference score) repeated at 10 weeks, 6 months, and 12 months. The secondary hypotheses are that Mobile+Group LAMP and Mobile LAMP will be more effective than usual care at improving secondary outcomes (e.g., post-traumatic stress disorder, depression). We will also confirm the comparisons for the primary and secondary hypotheses in gender-specific strata. IMPLICATIONS: This trial is expected to result in two approaches for delivering MBIs that will optimize engagement, adherence, and sustainability and be able to reach large numbers of Veterans.

The APPROACH trial: Assessing pain, patient-reported outcomes, and complementary and integrative health.

Electronic health record data can be used in multiple ways to facilitate real-world pragmatic studies. Electronic health record data can provide detailed information about utilization of treatment options to help identify appropriate comparison groups, access historical clinical characteristics of participants, and facilitate measuring longitudinal outcomes for the treatments being studied. An additional novel use of electronic health record data is to assess and understand referral pathways and other business practices that encourage or discourage patients from using different types of care. We describe an ongoing study utilizing access to real-time electronic health record data about changing patterns of complementary and integrative health services to demonstrate how electronic health record data can provide the foundation for a pragmatic study when randomization is not feasible. Conducting explanatory trials of the value of emerging therapies within a healthcare system poses ethical and pragmatic challenges, such as withholding access to specific services that are becoming widely available to patients. We describe how prospective examination of real-time electronic health record data can be used to construct and understand business practices as potential surrogates for direct randomization through an instrumental variables analytic approach. In this context, an example of a business practice is the internal hiring of acupuncturists who also provide yoga or Tai Chi classes and can offer these classes without additional cost compared to community acupuncturists. Here, the business practice of hiring internal acupuncturists is likely to encourage much higher rates of combined complementary and integrative health use compared to community referrals. We highlight the tradeoff in efficiency of this pragmatic approach and describe use of simulations to estimate the potential sample sizes needed for a variety of instrument strengths. While real-time monitoring of business practices from electronic health records provides insights into the validity of key independence assumptions associated with the instrumental variable approaches, we note that there may be some residual confounding by indication or selection bias and describe how alternative sources of electronic health record data can be used to assess the robustness of instrumental variable assumptions to address these challenges. Finally, we also highlight that while some clinical outcomes can be obtained directly from the electronic health record, such as longitudinal opioid utilization and pain intensity levels for the study of the value of complementary and integrative health, it is often critical to supplement clinical electronic health record-based measures with patient-reported outcomes. The experience of this example in evaluating complementary and integrative health demonstrates the use of electronic health record data in several novel ways that may be of use for designing future pragmatic trials.

Complementary and Integrated Health Approaches: What Do Veterans Use and Want.

OBJECTIVES: Non-pharmacological treatment options for common conditions such as chronic pain, anxiety, and depression are being given increased consideration in healthcare, especially given the recent emphasis to address the opioid crisis. One set of non-pharmacological treatment options are evidence-based complementary and integrative health (CIH) approaches, such as yoga, acupuncture, and meditation. The Veterans Health Administration (VHA), the nation's largest healthcare system, has been at the forefront of implementing CIH approaches, given their patients' high prevalence of pain, anxiety, and depression. We aimed to conduct the first national survey of veterans' interest in and use of CIH approaches. METHODS: Using a large national convenience sample of veterans who regularly use the VHA, we conducted the first national survey of veterans' interest in, frequency of and reasons for use of, and satisfaction with 26 CIH approaches (n = 3346, 37% response rate) in July 2017. RESULTS: In the past year, 52% used any CIH approach, with 44% using massage therapy, 37% using chiropractic, 34% using mindfulness, 24% using other meditation, and 25% using yoga. For nine CIH approaches, pain and stress reduction/relaxation were the two most frequent reasons veterans gave for using them. Overall, 84% said they were interested in trying/learning more about at least one CIH approach, with about half being interested in six individual CIH approaches (e.g., massage therapy, chiropractic, acupuncture, acupressure, reflexology, and progressive relaxation). Veterans appeared to be much more likely to use each CIH approach outside the VHA vs. within the VHA. CONCLUSIONS: Veterans report relatively high past-year use of CIH approaches and many more report interest in CIH approaches. To address this gap between patients' level of interest in and use of CIH approaches, primary care providers might want to discuss evidence-based CIH options to their patients for relevant health conditions, given most CIH approaches are safe.

Synthesizing the Strength of the Evidence of Complementary and Integrative Health Therapies for Pain.

OBJECTIVE: Pain and opioid use are highly prevalent, leading for calls to include nonpharmacological options in pain management, including complementary and integrative health (CIH) therapies. More than 2,000 randomized controlled trials (RCTs) and many systematic reviews have been conducted on CIH therapies, making it difficult to easily understand what type of CIH therapy might be effective for what type of pain. Here we synthesize the strength of the evidence for four types of CIH therapies on pain: acupuncture, therapeutic massage, mindfulness techniques, and tai chi. DESIGN: We conducted searches of English-language systematic reviews and RCTs in 11 electronic databases and previously published reviews for each type of CIH. To synthesize that large body of literature, we then created an "evidence map," or a visual display, of the literature size and broad estimates of effectiveness for pain. RESULTS: Many systematic reviews met our inclusion criteria: acupuncture (86), massage (38), mindfulness techniques (11), and tai chi (21). The evidence for acupuncture was strongest, and largest for headache and chronic pain. Mindfulness, massage, and tai chi have statistically significant positive effects on some types of pain. However, firm conclusions cannot be drawn for many types of pain due to methodological limitations or lack of RCTs. CONCLUSIONS: There is sufficient strength of evidence for acupuncture for various types of pain. Individual studies indicate that tai chi, mindfulness, and massage may be promising for multiple types of chronic pain. Additional sufficiently powered RCTs are warranted to indicate tai chi, mindfulness, and massage for other types of pain.

Standardized text messages improve 30-day patient follow-up for ACS pediatric NSQIP cases.

PURPOSE: Thirty-day follow-up is a critical and challenging component of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP). We hypothesized the simplicity and immediacy of text messaging would increase response rates while reducing workload. METHODS: For 6 months, text messages were the primary form of contact for first and second follow-up attempts. If no response, a phone call was made. Results of this protocol were compared to the previous 6 months when phone calls were the primary method. RESULTS: The text message (TM) group had 298 cases and phone call (PC) group had 354. The first contact was successful in 63.8% of the TM group compared to 47.5% of the PC group. The second contact was successful in 15.4% (TM) and 16.9% (PC). In the third attempt, 3.0% answered the call in the TM group versus 9.3% in the PC group. Some families remained unreachable: 17.8% in TM group and 26.3% in PC group (p = 0.01). When totaled, time spent to obtain caregivers' responses was over five times higher in the PC group (910 min) than the TM group (173 min) (p = 0.005). CONCLUSION: Patient follow-up using text messaging has improved our follow-up rate while decreasing workload.