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.

Objective: The Department of Veterans Affairs trained primary-care providers to deliver Battlefield Acupuncture (BFA), a subset of auricular acupuncture, to patients. However, little is known about BFA effectiveness in group or individual sessions or repeated administrations versus singular use. The aim of this study was to examine the use and effectiveness of BFA for back pain and four pain-comorbid conditions in group and individual sessions at a large Veterans Affairs (VA) medical center. Materials and Methods: This cross-sectional study was conducted at the West Haven VA Medical Center, in West Haven CT. Between October 2016 and December 2017, 284 veterans with pain received BFA. The BFA was administered in group clinics or in individual encounters. The Defense and Veterans Pain Rating Scale was used to assess self-reported pain immediately before and after each BFA administration. Results: Over the study period, an average of 57 (range: 50-66) new patients per month received BFA. Of 753 total patient encounters, an immediate decrease in self-reported pain occurred in 616 (82.0%) patients, no change occurred in 73 (9.7%) patients, and an increase occurred in 62 (8.3%) patients. Decreases in pain were common in the group and individual settings, even in patients with originally high pain scores, and the effectiveness remained with repeated uses. Conclusions: BFA can be effective for immediate relief of pain-whether the BFA is administered in a group or individual setting-for the overwhelming majority of veterans and, as such, holds promise as a nonpharmacologic pain-management intervention.

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.

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.

PURPOSE: [corrected] Active surveillance has been endorsed for low-risk prostate cancer, but information about long-term outcomes and comparative effectiveness of active surveillance is lacking. The purpose of this study is to project prostate cancer mortality under active surveillance followed by radical prostatectomy versus under immediate radical prostatectomy. EXPERIMENTAL DESIGN: A simulation model was developed to combine information on time from diagnosis to treatment under active surveillance and associated disease progression from a Johns Hopkins active surveillance cohort (n = 769), time from radical prostatectomy to recurrence from cases in the CaPSURE database with T-stage ≤ T2a (n = 3,470), and time from recurrence to prostate cancer death from a T-stage ≤ T2a Johns Hopkins cohort of patients whose disease recurred after radical prostatectomy (n = 963). Results were projected for a hypothetical cohort aged 40 to 90 years with low-risk prostate cancer (T-stage ≤ T2a, Gleason score ≤ 6, and prostate-specific antigen level ≤ 10 ng/mL). RESULTS: The model projected that 2.8% of men on active surveillance and 1.6% of men with immediate radical prostatectomy would die of their disease in 20 years. Corresponding lifetime estimates were 3.4% for active surveillance and 2.0% for immediate radical prostatectomy. The average projected increase in life expectancy associated with immediate radical prostatectomy was 1.8 months. On average, the model projected that men on active surveillance would remain free of treatment for an additional 6.4 years relative to men treated immediately. CONCLUSIONS: Active surveillance is likely to produce a very modest decline in prostate cancer-specific survival among men diagnosed with low-risk prostate cancer but could lead to significant benefits in terms of quality of life.

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.

Purpose

[corrected] Active surveillance has been endorsed for low-risk prostate cancer, but information about long-term outcomes and comparative effectiveness of active surveillance is lacking. The purpose of this study is to project prostate cancer mortality under active surveillance followed by radical prostatectomy versus under immediate radical prostatectomy.

Experimental design

A simulation model was developed to combine information on time from diagnosis to treatment under active surveillance and associated disease progression from a Johns Hopkins active surveillance cohort (n = 769), time from radical prostatectomy to recurrence from cases in the CaPSURE database with T-stage ≤ T2a (n = 3,470), and time from recurrence to prostate cancer death from a T-stage ≤ T2a Johns Hopkins cohort of patients whose disease recurred after radical prostatectomy (n = 963). Results were projected for a hypothetical cohort aged 40 to 90 years with low-risk prostate cancer (T-stage ≤ T2a, Gleason score ≤ 6, and prostate-specific antigen level ≤ 10 ng/mL).

Results

The model projected that 2.8% of men on active surveillance and 1.6% of men with immediate radical prostatectomy would die of their disease in 20 years. Corresponding lifetime estimates were 3.4% for active surveillance and 2.0% for immediate radical prostatectomy. The average projected increase in life expectancy associated with immediate radical prostatectomy was 1.8 months. On average, the model projected that men on active surveillance would remain free of treatment for an additional 6.4 years relative to men treated immediately.

Conclusions

Active surveillance is likely to produce a very modest decline in prostate cancer-specific survival among men diagnosed with low-risk prostate cancer but could lead to significant benefits in terms of quality of life.

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.

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.

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.