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SDR 21-108 – HSR Study

SDR 21-108
Role of Non-pharmacological Pain Treatments in Safe and Effective Opioid Tapering in Chronic Pain
Anne C Black, PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, CT
Funding Period: May 2022 - April 2026


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.

External Links for this Project

NIH Reporter

Grant Number: I01HX003412-01A1

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None at this time.

DRA: Mental, Cognitive and Behavioral Disorders, Substance Use Disorders
DRE: TRL - Applied/Translational
Keywords: Pain, Symptom Management, Telemedicine/Telehealth
MeSH Terms: None at this time.

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