Role of Non-pharmacological Pain Treatments in Safe and Effective Opioid Tapering in Chronic Pain

Background: Evidence of risks for serious adverse outcomes and limited benefit of long-term opioid therapy
(LTOT) have driven VA recommendations for LTOT tapering or discontinuation when benefits no longer
outweigh harms. However, LTOT tapering may also pose risks of harm. Significance: The study addresses a
critical need for clear demonstration of LTOT tapering risks and a specific VA call for evaluation of
nonpharmacological pain treatments including complementary and integrative health services (NPM/CIH). The
goals of this project are to assess the role of NPM/CIH use in effecting safe and clinically meaningful
reductions in LTOT regimens for Veterans with chronic pain. Changes in outcomes associated with two major
periods -- the implementation of the Whole Health System of care (WHS) and COVID-19 – will be assessed.
Innovation and Impact: In ongoing partnership with the Office of Patient-Centered Care and Cultural
Transformation (OPCC&CT), the study will broaden the scope of ongoing NPM/CIH evaluation to include
outcomes related to substance dependence and addiction. Partnering with Pharmacy Benefits Management
Services’ VA Center for Medication Safety (MedSAFE), informed by new pilot data, our team will be one of the
first to apply a novel method to optimize determination of LTOT tapering to improve analyses of tapering-
related outcomes. The study will inform clinical guidelines addressing multimodal approaches to tapering.
Specific Aims are to (1) Characterize NPM/CIH access and utilization among Veterans with LTOT,
considering the impact of implementation of the VHA Whole Health System of Care and COVID-19; (2)
Compare the effectiveness and safety of opioid tapering for Veterans with LTOT with and without NPM/CIH; (3)
Assess the moderating effect of buprenorphine on NPM/CIH effects on outcomes. We hypothesize that use of
NPM/CIH will be associated with higher rates of effectiveness and safety, and that use of buprenorphine will be
associated with more positive effects of NPM/CIH on these outcomes.
Methodology: The project will identify a retrospective cohort between 2016-2020 of approximately 200,000
Veterans receiving LTOT at ≥ 30 mg morphine equivalent daily dose (MEDD) across 54 VA facilities.
Leveraging Veterans Health Administration (VHA) electronic health record data, Veterans’ utilization of
NPM/CIH within VHA and in the community will be assessed. Applying a novel method developed by VA
MedSAFE using VHA electronic pharmacy data within the Corporate Data Warehouse, we will develop models
of opioid tapering within the target period. Using quasi-experimental methods, Veterans will be “assigned” to
NPM/CIH treatment or no treatment based on their observed service utilization. Propensity score matching will
balance baseline differences due to nonrandom assignment. In multilevel models, opioid tapering outcomes
will be modeled as a function of NPM/CIH use. The primary tapering effectiveness outcome will be the
proportion of Veterans achieving a reduction in prescribed opioid dose of ≥50% of baseline mg MEDD,
maintained over six months in the absence of worsened pain intensity. Tapering safety will be measured as the
proportion of Veterans experiencing any serious adverse event (SAE), allowing tapering to take all values,
including no taper and dose increases. SAE will include hospitalization, emergency department visit, opioid
overdose, new mental health disorder, new opioid or other substance use disorder, suicide attempt, and all-
cause mortality. Models will assess moderation of NPM/CIH effects by buprenorphine treatment for opioid
tapering and for chronic pain. Secondary models will assess the effect of NPM/CIH on LTOT-related side
effects and differences in NPM/CIH effect by age, race/ethnicity and gender. Next Steps/Implementation:
Operational partners and a Veteran engagement panel will guide interpretation of results and promote
dissemination and translation to practice. Results will inform an implementation study to support the scale-up
and sustainment of effective practices for pain management and facilitating safe and effective opioid reduction.

Grant Number: 5I01HX003412-04
NIH Institute/Center: VA
Principal Investigator: Anne Black