Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol

Darnall, Beth D.; Mackey, Sean; Lorig, Kate; Kao, Ming-Chih J.; Mardian, Aram S.; Stieg, Richard L.; Porter, Joel; DeBruyne, Korina; Murphy, Jennifer L.; Perez, Luzmercy; Okvat, Heather A.; Tian, Lu; Flood, Pamela; McGovern, Mark P.; Colloca, Luana; King, Heather A.; Dorsten, Brent Van; Pun, Ting-Chung; Cheung, Matthias

doi:10.1093/pm/pnz285

Cited by 34 publications

(44 citation statements)

References 22 publications

(20 reference statements)

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“…EMPOWER is a four-state, eleven-clinic pragmatic comparative effectiveness study of two evidence-based behavioral pain treatments applied within the context of a voluntary patient-centered opioid tapering program 11 . The study sites include academic and private pain clinics, primary care clinics, and a Veterans Health Administration site.…”

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confidence: 99%

Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success

et al. 2021

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Patients with chronic pain experience stigma within the healthcare system. This stigma is compounded for those taking long-term prescription opioids. Often, public messaging and organizational policies have telegraphed that opioid treatment is a problem to be solved by focusing only on medication reduction efforts. Lack of data has contributed to misperceptions and poor opioid policies. In part, data collection remains poor because patients feel fractured from systems of care and are often not interested in engaging with opioid reduction mandates and research. Similarly, clinicians may fail to engage with opioid stewardship and research due to complexities that exceed their training or capacities. The EMPOWER study applies a coproduction model that engages researchers, patients, clinicians, managers, and other health system users. Key stakeholders shaped the design of the study to best ensure acceptability and engagement of the “end users”—patients who enroll in the study and the clinicians who implement the opioid tapers. Targeting the needs of any stakeholder group in isolation is suboptimal. Accordingly, we detail the EMPOWER patient-centered opioid tapering clinical research framework and specific strategies to address stakeholder concerns. We also discuss how this framework may be applied to enhance engagement in healthcare research broadly.

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Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success

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“… 38 One of the most effective treatment strategies for chronic pain is psychobehavioral therapy to help patient's cognitive, behavioral, and emotional processes that provoke and reinforce centralized pain symptoms. 39–41 One of the mechanisms by which VR may be used as a tool to treat chronic pain is the recontextualization of the association between sensorimotor processing of motor behavior. 42 , 43 In virtual embodiment, the visual feedback of movement does not come from the patient’s own body but from their virtual avatar.…”

Section: Discussionmentioning

confidence: 99%

<p>Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series</p>

Trujillo¹,

Alvarez²,

Nguyen³

et al. 2020

JPR

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Purpose: We describe two case studies that use embodiment in virtual reality as a treatment for chronic low back pain. The purpose of this case series was to determine the feasibility of a novel virtual reality-based digital therapeutic for the treatment of chronic pain. Patients and Methods: Two patients with chronic low back pain received seven sessions, two sessions per week, of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises using an off-the-shelf virtual reality system. Pain intensity was measured using a visual analog scale before and after each session to get an indication whether individual sessions of virtual embodiment training decrease pain intensity. Pain catastrophizing scale was assessed before the first session and after the seventh session to determine the extent to which virtual embodiment training can improve psychological symptoms of chronic low back pain. Results: In both patients, pain intensity was improved after individual sessions of virtual embodiment training as measured by a paired t-test: (Patient A: t = 2.890, P < 0.05) and (Patient B: t = 5.346, P < 0.005). This indicates that individual sessions of virtual embodiment training decrease pain intensity. In both patients, improvements were observed in three subscales of the pain catastrophizing scale (rumination, magnification, and helplessness). This indicates that virtual embodiment training may have benefits for chronic pain symptoms such as pain intensity, pain-related mobility impairment, and disability. Conclusion: This case series provides evidence that embodiment in virtual reality improves symptoms of persistent chronic low back pain. We propose a mechanism by which virtual embodiment may improve chronic pain symptoms by recontextualizing sensory feedback from the body as patients engage in functional rehabilitation exercises while in virtual reality.

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“…The EMPOWER study team first searched for a screening tool to identify OUD by severity categories when preparing to launch a study to investigate the effectiveness of behavioral medicine strategies within the context of patient-centered opioid tapering in outpatient settings ( 23 ). Our search yielded several self-report instruments that were validated and widely used to assess prescription opioid misuse and aberrant drug-taking behaviors such as the Current Opioid Misuse Measure ( 24 ), Pain Medication Questionnaire ( 25 ), and Prescription Opioid Misuse Index ( 26 ).…”

Section: Development Of the Empower Study Expert Consensus Protocol Fmentioning

confidence: 99%

“…In the absence of existing validated methods, we provide our consensus screening protocol in response to the urgent societal need for such tools so that (a) clinicians may offer appropriate treatments to a heterogeneous patient population receiving long-term opioid therapy for chronic pain ( Table 1 , Step 3), and (b) researchers can study characteristics and treatment outcomes of patients with appropriate opioid use and across the spectrum of OUD severity. Our screening protocol can also facilitate efficient evaluation of eligibility for our multi-site pragmatic study of patient-centered opioid tapering ( 23 ). We are currently investigating the validity and reliability of administrating our protocol in an electronic format using an open-source learning healthcare system ( https://choir.stanford.edu/ ).…”

Section: Strength and Limitations Of The Empower Study Expert Consensmentioning

confidence: 99%

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol

et al. 2021

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Growing concerns about the safety of long-term opioid therapy and its uncertain efficacy for non-cancer pain have led to relatively rapid opioid deprescribing in chronic pain patients who have been taking opioid for years. To date, empirically supported processes for safe and effective opioid tapering are lacking. Opioid tapering programs have shown high rates of dropouts and increases in patient distress and suicidal ideation. Therefore, safe strategies for opioid deprescribing that are more likely to succeed are urgently needed. In response to this demand, the EMPOWER study has been launched to examine the effectiveness of behavioral medicine strategies within the context of patient-centered opioid tapering in outpatient settings (https://empower.stanford.edu/). The EMPOWER protocol requires an efficient process for ensuring that collaborative opioid tapering would be offered to the most appropriate patients while identifying patients who should be offered alternate treatment pathways. As a first step, clinicians need a screening tool to identify patients with Opioid Use Disorder (OUD) and to assess for OUD severity. Because such a tool is not available, the study team composed of eight chronic pain and/or addiction experts has extended a validated screening instrument to develop a brief and novel consensus screening tool to identify OUD and assess for OUD severity for treatment stratification. Our screening tool has the potential to assist busy outpatient clinicians to assess OUD among patients receiving long-term opioid therapy for chronic pain.

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Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol

Cited by 34 publications

References 22 publications

Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success

Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success

<p>Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series</p>

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol

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