grant

Options for Pain Management using Nonpharmacological Strategies (OPTIONS)

Organization RLR VA MEDICAL CENTERLocation INDIANAPOLIS, UNITED STATESPosted 1 Nov 2022Deadline 31 Oct 2026
VANIHUS FederalResearch GrantFY2025AddressAdherenceAffectAreaAssess implementationBehaviorBeliefChronicCognition TherapyCognitive PsychotherapyCognitive TherapyCognitive treatmentCommunitiesComplementComplement ProteinsComplementary HealthControl GroupsDecision AidDrugsEffectivenessEnsureFosteringFutureGoalsGuidelinesHybridsImplementation assessmentIndividualIntegrative MedicineInterventionIntervention StrategiesInterviewInvestmentsLifeLife StyleLifestyleLightMaintenanceMedicationMethodologyModalityMotivationNon-pharmacologic TherapyNonpharmacologic InterventionNonpharmacologic TherapyNonpharmacologic approachNonpharmacologic treatmentOpiatesOpioidOutcomePainPain ControlPain TherapyPain interferencePain managementPainfulPatient-Centered CarePatientsPharmaceutical PreparationsPhotoradiationPoliciesProviderQualitative MethodsRE-AIMRandomizedReach, Effectiveness, Adoption, Implementation, and MaintenanceRecommendationRecoveryReportingResearchResearch DesignRiskSamplingSelf EfficacySiteStudy TypeSystemTestingTimeVariantVariationVeteransWaiting ListsWorkaddictionaddictive disorderarmbarriers to implementationbehavioral healthchronic MSK painchronic musculoskeletal painchronic painchronic pain controlchronic pain interventionchronic pain managementchronic pain therapychronic pain treatmentcognitive behavior interventioncognitive behavior modificationcognitive behavior therapycognitive behavioral interventioncognitive behavioral modificationcognitive behavioral therapycognitive behavioral treatmentcomplementationdisabling paindrug/agenteffectiveness and implementation trialeffectiveness testingeffectiveness/implementation hybrid trialeffectiveness/implementation trialevaluate implementationevaluation of implementationevidence basefacilitators to implementationfuture implementationgroup interventionhealth related quality of lifehybrid type 1 studyhybrid type I studyimplementation barriersimplementation challengesimplementation evaluationimplementation facilitationimplementation facilitatorsimprovedinnovateinnovationinnovativeintegrative healingintegrative healthintervention effectlicit opioidmotivational enhancement therapymotivational interviewmulti-modalitymultimodalitynon-drug therapynon-drug treatmentnondrug therapynondrug treatmentnovelopiate medicationopioid medicationopioid taperingpain interventionpain treatmentpain-related disabilityparticipant engagementpatient barrierspatient centeredpatient engagementpatient orientedpatient-level barriersprescribed opiateprescribed opioidprescription opiateprescription opioidprimary care providerprimary end pointprimary endpointprimary outcomeproviders from primary careproviders of primary carepsychologicpsychologicalqualitative reasoningrandomisationrandomizationrandomly assignedreach, efficacy, adoption, implementation, and maintenanceresponsesecondary outcomestudy designsuccesssystem-level barrierstooltreat chronic painuptakewaitlistwhole healthwhole person health
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Full Description

Background: In response to opioid-related harms and evidence supporting nonpharmacological treatments
(NPTs) for chronic pain, VHA has prioritized multimodal pain treatment approaches that include evidence-

based NPTs. However, NPTs are persistently underutilized, and Veteran-level barriers remain largely

unaddressed. OPTIONS (Options for Pain management using Nonpharmacological Strategies) is focused on

overcoming Veteran-level barriers to NPT use and adherence with 1) a decision aid to help patients

understand and compare NPT options and find NPTs that work best with their goals and lifestyle, and 2) a

coach who uses motivational interviewing to foster self-efficacy, prepare Veterans to discuss NPTs with their

providers, and build patients’ confidence to manage their pain with NPTs.

Significance: OPTIONS is directly responsive to HSR&D’s Opioid Solicitation by focusing on behavioral health

and engagement of Veterans in non-medication treatments. OPTIONS also supports the 2016 Comprehensive

Addiction and Recovery Act and numerous VA directives focused on increasing availability of NPTs.

Innovation/Impact: Despite mounting evidence on the effectiveness of NPTs, there is a distinct lack of research

aimed at overcoming patient-level barriers to NPT use. This is a critical gap that impedes pain management

and the goal of reducing reliance on opioids. OPTIONS is the first study to use a tailored, patient-centered

approach to address patient-level barriers to uptake of and adherence to NPTs. As such, OPTIONS provides

an important complement to VA’s system-wide efforts aimed at promoting NPTs and helps ensure that VA’s

substantial investment in these initiatives leads to increased use of NPTs and improved Veteran outcomes.

Our partnership with VA Pain Management and the Office of Patient-Centered Care and Cultural

Transformation will facilitate implementation of OPTIONS by leveraging existing Whole Health coaches if it is a

positive trial—further enhancing the impact of this proposal.

Specific Aims: Aim 1: Test the OPTIONS intervention’s effects on pain interference (primary outcome) among

Veterans with chronic pain.

Aim 2: Test the OPTIONS intervention’s effects on NPT use and secondary outcomes (health-related quality of

life, psychological functioning, patient activation).

Aim 3: Identify facilitators and barriers to implementing the OPTIONS intervention.

Methodology: This Hybrid Type 1 study will test effectiveness while examining implementation facilitators and

barriers. 296 Veterans with chronic musculoskeletal pain will be randomized to the intervention (10 weeks of

coaching using motivational interviewing and the OPTIONS decision aid on NPTs) or to a waitlist control arm.

We will examine outcomes at baseline and 3, 6 and 9 months. In Aim 3, we will use qualitative methods to

understand facilitators and barriers to future implementation via interviews with a subset of intervention

Veterans and with PCPs whose patients received the OPTIONS intervention.

Implementation/Next Steps: Pending positive results, our next step will be a multi-site hybrid type 2

effectiveness-implementation trial, in which we will evaluate for implementation while continuing to test for

effectiveness. We will work with our operational partners to implement the OPTIONS intervention using

existing Whole Health Coaches, thereby helping to ensure sustainability. In addition, findings from Aim 3,

which examines barriers and facilitators to implementation, will help to guide these next steps.

Grant Number: 5I01HX003402-03
NIH Institute/Center: VA

Principal Investigator: Matthew Bair

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