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Principal Investigator: WILLIAM C BECKER
Organization: VA CONNECTICUT HEALTHCARE SYSTEM
Fiscal Year: 2024
Funding agency: Veterans Affairs
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.
Terms: <Address><Adverse Experience><Adverse event><American><Articulation><Benefits and Risks><Buprenorphine><COVID-19><COVID-19 affected><COVID-19 consequence><COVID-19 effect><COVID-19 impact><COVID-19 impacted><CV-19><Caring><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Cessation of life><Characteristics><Chiropractic><Clinical><Combined Modality Therapy><Communities><Complementary Health><Coronavirus Infectious Disease 2019><Data><De-implementation><Death><Deimplementation><Dose><Dropout><ED visit><ER visit><Effectiveness><Electronic Health Record><Electronics><Emergency care visit><Emergency department visit><Emergency hospital visit><Emergency room visit><Equilibrium><Ethnic Origin><Ethnicity><Evaluation><Evaluation Reports><Event><Exercise><Face><Feeling suicidal><Formulation><Funding><Gender><Goals><Guidelines><Health Care Systems><Health Services><Healthcare Systems><Hospital Admission><Hospitalization><Institution><Integrative Medicine><Measures><Mental Health><Mental Hygiene><Mental disorders><Mental health disorders><Methodology><Methods><Modality><Modeling><Multimodal Therapy><Multimodal Treatment><Opiate Addiction><Opiate Dependence><Opiates><Opioid><Outcome><Overdose><Pain><Pain Control><Pain Therapy><Pain intensity><Pain management><Painful><Patient-Centered Care><Patients><Pattern><Perception><Personal Satisfaction><Pharmacies><Pharmacy facility><Physiologic><Physiological><Practice Management><Prevention Guidelines><Psychiatric Disease><Psychiatric Disorder><Psychological Health><Quasi-experiment><Quasi-experimental analysis><Quasi-experimental approach><Quasi-experimental design><Quasi-experimental methods><Quasi-experimental research><Quasi-experimental study><Quasi-experimental technique><Race><Races><Randomized, Controlled Trials><Recommendation><Recovery><Regimen><Research><Research Design><Retrospective cohort><Retrospective cohort study><Risk><Role><Safety><Sampling><Serious Adverse Event><Services><Severe Adverse Event><Site><Study Type><Substance Addiction><Substance Dependence><Substance Use Disorder><Suicidal thoughts><Suicide attempt><Testing><Translations><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><United States Department of Veterans Affairs><United States Veterans Administration><Veterans><Veterans Administration><Veterans Affairs><Veterans Health Administration><Veterans Health Affairs><Withdrawal Symptom><Work><Yoga><addiction><addictive disorder><adverse consequence><adverse outcome><age associated effects><age effect><age related effects><aging effect><balance><balance function><buprenorphine treatment><chiropracty><chronic pain><chronic pain control><chronic pain intervention><chronic pain management><chronic pain therapy><chronic pain treatment><co-morbid><co-morbidity><cohort><combination therapy><combined modality treatment><combined treatment><comorbidity><compare effectiveness><conference><convention><coronavirus disease 2019><coronavirus disease 2019 consequence><coronavirus disease 2019 effect><coronavirus disease 2019 impact><coronavirus disease-19><coronavirus disease-19 impact><coronavirus infectious disease-19><data warehouse><design><designing><drug safety><effective therapy><effective treatment><effectiveness outcome><effectiveness-related outcomes><electronic><electronic device><electronic health care record><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><evidence base><experience><faces><facial><impact of age><implementation study><improved><influence of age><innovate><innovation><innovative><integrative healing><integrative health><licit opioid><medication safety><mental illness><methods to study multiple-level influences><milligram><morphine equivalence><morphine equivalent><mortality><multi-level analysis><multi-level model><multi-modal therapy><multi-modal treatment><multi-modality><multidisciplinary><multilevel analysis><multilevel model><multilevel modeling><multimodality><non fatal attempt><nonfatal attempt><novel><opiate consumption><opiate deaths><opiate drug use><opiate intake><opiate medication><opiate mortality><opiate overdose><opiate related overdose><opiate therapy><opiate use><opiate use disorder><opioid addiction><opioid consumption><opioid deaths><opioid dependence><opioid dependent><opioid drug overdose><opioid drug use><opioid induced overdose><opioid intake><opioid intoxication><opioid medication><opioid medication overdose><opioid mortality><opioid overdose><opioid overdose death><opioid poisoning><opioid related death><opioid related overdose><opioid tapering><opioid therapy><opioid toxicity><opioid use><opioid use disorder><pain treatment><pharmaceutical safety><pharmacy benefit><physical conditioning><physical health><prescribed opiate><prescribed opioid><prescription opiate><prescription opioid><psychiatric illness><psychological disorder><racial><racial background><racial origin><randomized control trial><scale up><secondary analysis><serious adverse experience><serious adverse reaction><service uptake><service utilization><side effect><social role><socio-demographics><sociodemographics><study design><substance use><substance use and disorder><substance using><suicidal attempt><suicidal ideation><suicidal thinking><suicide ideation><summit><symposia><symposium><thoughts about suicide><translation><treat chronic pain><treatment effect><uptake><well-being><wellbeing><whole health><whole person health>