Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement.

ABSTRACT: Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

Telehealth Engaged Music for Pain Outcomes: A Music and Imagery Proof-of-concept Study with Veterans.

Music therapy interventions target biopsychosocial outcomes and are a non-pharmacological option for integrated pain management. To date, most music and pain studies have focused on acute pain, passive music experiences, and in-person delivery. The purpose of this study was to examine feasibility and acceptability and determine proof-of-concept for a newly developed telehealth music imagery (MI) intervention for Veterans with chronic pain. A single-group proof-of-concept pilot study was conducted with Veterans with chronic pain (n = 8). Feasibility was assessed through examination of recruitment, retention, and session/measure completion rates; acceptability through participant interviews; and whether the intervention resulted in clinically meaningful change scores (pre- to post-intervention) on measures of pain, anxiety, and depression at the individual level. For Veterans who passed eligibility screening, we had an enrollment rate of 89%, with good retention (75%). Overall, participating Veterans found the intervention acceptable, identified specific challenges with technology, and recommended an increased number of sessions. Preliminary outcome data for pain, anxiety, and depression were mixed, with some Veterans reporting clinically meaningful improvements and others reporting no change or worsening symptoms. Findings informed modifications to the telehealth MI intervention and the design of a larger pilot randomized controlled trial to assess feasibility and acceptability of the modified intervention in a larger population of Veterans with chronic pain using additional measures and a control condition.

Communication and activation in pain to enhance relationships and treat pain with equity (COOPERATE): a randomized clinical trial.

ABSTRACT: Racialized disparities in chronic pain care are well-documented and persist despite national priorities focused on health equity. Similar disparities have been observed in patient activation (ie, having the knowledge, confidence, and skills to manage one's health). As such, interventions targeting patient activation represent a novel approach to addressing and reducing disparities in pain care. Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity is a randomized controlled trial of a 6-session telephone-delivered intervention to increase patient activation for Black patients with chronic pain. Two hundred fifty Black patients from a Midwestern Veterans Affairs medical center were randomized to the intervention or attention control. The primary outcome was patient activation; secondary outcomes included communication self-efficacy, pain, and psychological functioning. Outcomes were assessed at baseline and at 3 (primary endpoint), 6, and 9 months (sustained effects). Analyses used an intent-to-treat approach. Compared with baseline, patient activation increased 4.6 points at 3 months (versus +0.13 in control group, 95% CI: 0.48, 7.34; P = 0.03). These improvements in the intervention group were sustained, with +7 from baseline at 6 months and +5.77 at 9 months, and remained statistically significant from the control group. Communication self-efficacy increased significantly relative to the control group from baseline to 3 months. Pain intensity and interference improved at 3 months, but differences were not significant after adjusting for multiple comparisons. Most other secondary outcomes improved, but group differences were not statistically significant after controlling for multiple comparisons. Results suggest that increasing patient activation is a potentially fruitful path toward improving pain management and achieving health equity.

Patterns of Opioid Prescriptions in the Veterans Health Administration for Patients With Chronic Low-Back Pain After the Onset of the COVID-19 Pandemic: A Retrospective Cohort Analysis.

The COVID-19 pandemic led to severe disruptions in health care and a relaxation of rules surrounding opioid prescribing-changes which led to concerns about increased reliance on opioids for chronic pain and a resurgence of opioid-related harms. Although some studies found that opioid prescriptions increased in the first 6 months of the pandemic, we know little about the longer-term effects of the pandemic on opioid prescriptions. Further, despite the prevalence of pain in veterans, we know little about patterns of opioid prescriptions in the Veterans Health Administration (VA) associated with the pandemic. Using a retrospective cohort of VA patients with chronic low-back pain, we examined the proportion of patients with an opioid prescription and mean morphine milligram equivalents over a 3-year period-1 year prior to and 2 years after the pandemic's onset. Analyses revealed that both measures fell during the entire observation period. The largest decrease in the odds of filling an opioid prescription occurred in the first quarter of the pandemic, but this downward trend continued throughout the observation period, albeit at a slower pace. Clinically meaningful differences in opioid prescriptions and dose over time did not emerge based on patient race or rurality; however, differences emerged between female and male veterans, with decreases in opioid prescriptions slowing more markedly for women after the pandemic onset. These findings suggest that the pandemic was not associated with short- or long-term increases in opioid prescriptions or doses in the VA. PERSPECTIVE: This article examines opioid prescribing over a 3-year period-1 year prior to and 2 years after the onset of the COVID-19 pandemic-for VA patients with chronic low-back pain. Results indicate that, despite disruptions to health care, opioid prescriptions and doses decreased over the entire observation period.

Rapid implementation of Veterans Health Administration telehealth creative arts therapies: survey evaluation of adoption and adaptation.

BACKGROUND: Creative arts therapies (CAT) are employed throughout the Veterans Health Administration (VHA) and are predominantly delivered in-person. Though telehealth delivery of CAT was used at several VHA facilities to increase services to rural Veterans, due to guidance from the Center for Disease Control and VHA that temporarily suspended or reduced in-person services, there was a large increase of CAT therapists enterprise-wide who adopted telehealth delivery. The aims of this study were to evaluate adoption and adaptation of CAT telehealth delivery and identify related barriers and facilitators. METHODS: We deployed a survey guided by the Consolidated Framework for Implementation Research and administered it via email to all VHA CAT therapists (N = 120). Descriptive statistics were used to summarize data and responses were compared based on therapists' age, years of experience and CAT discipline. Open survey field responses were summarized, qualitatively coded, and analyzed thematically. RESULTS: Most therapists (76%) reported adopting telehealth with 74% each delivering > 50 CAT sessions in the prior year. Therapists adapted interventions or created new ones to be delivered through telehealth. Barriers included: technical challenges, control of the virtual space, and building rapport. Facilitators included added equipment, software, and infrastructure. CAT therapists adapted their session preparation, session content, outcome expectations, and equipment. CAT therapists reported being able to reach more patients and improved access to care with telehealth compared to in person visits. Additional benefits were patient therapeutic effects from attending sessions from home, therapist convenience, and clinician growth. CONCLUSIONS: VHA CAT therapists used their inherent creativity to problem solve difficulties and make adaptations for CAT telehealth adoption. Future studies may explore CAT telehealth sustainment and its effectiveness on clinical processes and outcomes.

Outcomes of a peer-led navigation program, PARTNER-MH, for racially minoritized Veterans receiving mental health services: a pilot randomized controlled trial to assess feasibility and acceptability.

This pilot study explored the feasibility and acceptability of PARTNER-MH, which aimed to engage racially diverse Veterans in mental health services, facilitate their active participation in care, and improve their communication with providers. Fifty participants were randomized to the intervention or a waitlist control group. For primary outcomes, we assessed the feasibility of the study design and PARTNER-MH's feasibility and acceptability. For secondary outcomes, we explored preliminary effects on patient engagement, patient activation, shared decision-making, and health-related outcomes. The study had a recruitment rate of 68%, enrollment rate of 91%, and a follow-up retention rate of 72%. For intervention feasibility and acceptability, fidelity scores were satisfactory and improved over time, session attendance was modest with 33% of participants completing ≥6 sessions, and 89% of participants were satisfied with the intervention. For secondary outcomes, patients in the intervention arm showed significant improvement on self-reported mental health and depression, compared with those in the control group at both 6- and 9-month follow-ups. However, there were no significant differences between study arms on the other measures. Pilot results provide support for future testing of PARTNER-MH in a larger trial, although modifications are needed to increase session attendance and follow-up retention rate. CLINICAL TRIAL INFORMATION: The study was preregistered at Clinical Trials.gov. The study Trial registration number is ClinicalTrials.gov NCT04515771.

This study tested whether a peer-led navigation program, PARTNER-MH, can be delivered effectively by peer specialists in the Veterans Health Administration (VHA) healthcare system to racially minoritized Veterans who are receiving mental healthcare. The study evaluated our ability to recruit and retain participants, deliver the intervention, and examined satisfaction with the program. We also explored preliminary effects of the program. Participants were successfully recruited for the study and peers were able to deliver the program effectively. Participants reported high satisfaction with the program and significant improvements in mental health outcomes, although completion rate of the program was low. Results provide support for future testing of PARTNER-MH in a larger trial, with modifications to increase program session attendance and retention.

Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement.

ABSTRACT: Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions.

Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol.

BACKGROUND: Behavioral interventions for chronic pain among people with HIV (PWH) are understudied, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. However, to date, there are few effective and scalable interventions for chronic pain in PWH. OBJECTIVE: This manuscript outlines the protocol for a randomized control trial of a novel theory-based pain self-management intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PWH versus enhanced usual care controls. STOMP is a 12-week intervention developed from prior work on pain self-management in PWH and rigorous intervention mapping. The STOMP intervention has three major components: group sessions, one-on-one pain self-management sessions, and peer leaders. METHODS: STOMP is a 2-arm randomized trial conducted with PWH with chronic pain. The trial compares STOMP, a theory-based intervention tailored to improving chronic pain in PWH, with a comparison group receiving enhanced usual care effectiveness on pain and HIV proximal outcome measures. The proposed sample size is 280 PWH recruited from two high-volume Center for AIDS Research Network of Integrated Clinical Systems clinical sites. RESULTS: Study procedures are ongoing, and results will be recorded in future manuscripts. CONCLUSION: The study will generate evidence on the effectiveness of STOMP with the potential to dramatically change chronic pain treatment for PWH. TRIAL REGISTRATION: clinicialtrials.gov, Clinical Trials Registration # NCT03692611https://clinicaltrials.gov/ct2/show/NCT03692611?term=STOMP&cond=Hiv&draw=2&rank=1.

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for conservative chronic low back pain treatment.

BACKGROUND: Chronic low back pain (cLBP) is a common and highly disabling problem world-wide. Although many treatment options exist, it is unclear how to best sequence the multitude of care options to provide the greatest benefit to patients. METHODS: The Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER) trial uses a pragmatic, randomized, stepped design. Enrollment targets 2529 participants from 20 Veterans Affairs (VA) medical centers. Participants with chronic low back pain will first be randomized to one of three options: 1) an internet-based self-management program (Pain EASE); 2) a tailored physical therapy program (Enhanced PT); or 3) continued care with active monitoring (CCAM), a form of usual care. Participants not achieving a 30% or 2-point reduction on the study's primary outcome (Brief Pain Inventory Pain Interference (BPI-PI) subscale), 3 months after beginning treatment may undergo re-randomization in a second step to cognitive behavioral therapy for chronic pain, spinal manipulation therapy, or yoga. Secondary outcomes include pain intensity, back pain-related disability, depression, and others. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Companion economic and implementation analyses are also planned. RESULTS: The SCEPTER trial is currently recruiting and enrolling participants. CONCLUSIONS: Trial results will inform treatment decisions for the stepped management of chronic low back pain - a common and disabling condition. Additional analyses will help tailor treatment selection to individual patient characteristics, promote efficient resource use, and identify implementation barriers of interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT04142177.

Association between prescribed opioid dose and risk of motor vehicle crashes.

ABSTRACT: Opioid-involved motor vehicle traffic fatalities have increased over the past 2 decades. However, the extent to which prescribed opioids increase the risk of motor vehicle crashes remains uncertain. This study used real-world healthcare claims data to examine the association between prescription opioid dose and motor vehicle crash risk. Using nationwide US commercial insurance claims data for 2010 to 2018, we identified 772,404 adults who received incident, noncancer opioid therapy. We examined associations between daily prescription opioid dose, calculated in morphine milligram equivalents (MME) from filled prescription claims, and risk of motor vehicle crashes, assessed as diagnoses of motor vehicle injuries in claims for emergency visits, inpatient hospitalizations, and ambulance transportation. We estimated associations using a within-individual design, which ruled out all time-stable confounding. We complemented the design with time-varying statistical adjustment for other pharmacotherapies and a negative control pain pharmacotherapy analysis (with incident cyclic antidepressant prescriptions). During 2,150,009 person-years of follow-up, there were 12,123 motor vehicle crashes (5.64 crashes per 1000 person-years). In within-individual comparisons, crash risk was greater during opioid prescription periods involving doses ≤60 MME/day (odds ratio [OR], 3.86; 95% confidence interval [CI], 3.54, 4.21), >60 to 120 MME/day (OR, 5.46; 95% CI, 4.44, 6.73), and >120 MME/day (OR, 3.45; 95% CI, 2.31, 5.15) than during off-treatment periods. The negative control analysis supported the specificity of the results to opioids rather than to other processes associated with pharmacologic pain management. These findings suggest that the receipt of prescription opioids, even at doses ≤60 MME/day, is associated with an increased risk of motor vehicle crashes.

Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial.

Importance: Medication management and cognitive behavioral therapy (CBT) are commonly used treatments for chronic low back pain (CLBP). However, little evidence is available comparing the effectiveness of these approaches. Objective: To compare collaborative care medication optimization vs CBT on pain intensity, interference, and other pain-related outcomes. Design, Setting, and Participants: The Care Management for the Effective Use of Opioids (CAMEO) trial was a 12-month, comparative effectiveness randomized clinical trial with blinded outcome assessment. Recruitment of veterans with CLBP prescribed long-term opioids occurred at 7 Veterans Affairs primary care clinics from September 1, 2011, to December 31, 2014, and follow-up was completed December 31, 2015. Analyses were based on intention to treat in all randomized participants and were performed from March 22, 2015, to November 1, 2021. Interventions: Patients were randomized to receive either collaborative care with nurse care manager-delivered medication optimization (MED group) (n = 131) or psychologist-delivered CBT (CBT group) (n = 130) for 6 months, with check-in visits at 9 months and final outcome assessment at 12 months. Main Outcomes and Measures: The primary outcome was change in Brief Pain Inventory (BPI) total score, a composite of the pain intensity and interference subscales at 6 (treatment completion) and 12 (follow-up completion) months. Scores on the BPI range from 0 to 10, with higher scores representing greater pain impact and a 30% improvement considered a clinically meaningful treatment response. Secondary outcomes included pain-related disability, pain catastrophizing, self-reported substance misuse, health-related quality of life, depression, and anxiety. Results: A total of 261 patients (241 [92.3%] men; mean [SD] age, 57.9 [9.5] years) were randomized and included in the analysis. Baseline mean (SD) BPI scores in the MED and CBT groups were 6.45 (1.79) and 6.49 (1.67), respectively. Improvements in BPI scores were significantly greater in the MED group at 12 months (between-group difference, -0.54 [95% CI, -1.18 to -0.31]; P = .04) but not at 6 months (between-group difference, -0.46 [95% CI, -0.94 to 0.11]; P = .07). Secondary outcomes did not differ significantly between treatment groups. Conclusions and Relevance: In this randomized clinical trial among US veterans with CLBP who were prescribed long-term opioid therapy, collaborative care medication optimization was modestly more effective than CBT in reducing pain impact during the 12-month study. However, this difference may not be clinically meaningful or generalize to nonveteran populations. Trial Registration: ClinicalTrials.gov Identifier: NCT01236521.

Therapist-Delivered Versus Care Ally-Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic neck pain (CNP) is prevalent, and it reduces functional status and quality of life and is associated with deleterious psychological outcomes in affected individuals. Despite the desirability of massage and its demonstrated effectiveness in CNP treatment, multiple accessibility barriers exist. Caregiver-applied massage has demonstrated feasibility in various populations but has not been examined in Veterans with CNP or compared in parallel to therapist-delivered massage. OBJECTIVE: This manuscript described the original study design, lessons learned, and resultant design modifications for the Trial Outcomes for Massage: Care Ally-Assisted Versus Therapist-Treated (TOMCATT) study. METHODS: TOMCATT began as a 3-arm, randomized controlled trial of 2 massage delivery approaches for Veterans with CNP with measures collected at baseline, 1 and 3 months after intervention, and 6 months (follow-up). Arm I, care ally-assisted massage, consisted of an in-person, 3.5-hour training workshop, an instructional DVD, a printed treatment manual, and three 30-minute at-home care ally-assisted massage sessions weekly for 3 months. Arm II, therapist-treated massage, consisted of two 60-minute sessions tailored to individual pain experiences and treatments per week for 3 months. The treatments followed a standardized Swedish massage approach. Arm III consisted of wait-list control. RESULTS: Retention and engagement challenges in the first 30 months were significant in the care ally-assisted massage study arm (63% attrition between randomization and treatment initiation) and prompted modification to a 2-arm trial, that is, removing arm I. CONCLUSIONS: The modified TOMCATT study successfully launched and exceeded recruitment goals 2.5 months before the necessary COVID-19 pause and is expected to be completed by early 2023. TRIAL REGISTRATION: ClinicalTrials.gov NCT03100539; https://clinicaltrials.gov/ct2/show/NCT03100539. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38950.

Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH), a Peer-Led Patient Navigation Intervention for Racially and Ethnically Minoritized Veterans in Veterans Health Administration Mental Health Services: Protocol for a Mixed Methods Randomized Controlled Feasibility Study.

BACKGROUND: Mental health care disparities are persistent and have increased in recent years. Compared with their White counterparts, members of racially and ethnically minoritized groups have less access to mental health care. Minoritized groups also have lower engagement in mental health treatment and are more likely to experience ineffective patient-provider communication, which contribute to negative mental health care experiences and poor mental health outcomes. Interventions that embrace recovery-oriented practices to support patient engagement and empower patients to participate in their mental health care and treatment decisions may help reduce mental health care disparities. Designed to achieve this goal, the Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH) is a peer-led patient navigation intervention that aims to engage minoritized patients in mental health treatment, support them to play a greater role in their care, and facilitate their participation in shared treatment decision-making. OBJECTIVE: The primary aim of this study is to assess the feasibility and acceptability of PARTNER-MH delivered to patients over 6 months. The second aim is to evaluate the preliminary effects of PARTNER-MH on patient activation, patient engagement, and shared decision-making. The third aim is to examine patient-perceived barriers to and facilitators of engagement in PARTNER-MH as well as contextual factors that may inhibit or promote the integration, sustainability, and scalability of PARTNER-MH using the Consolidated Framework for Implementation Research. METHODS: This pilot study evaluates the feasibility and acceptability of PARTNER-MH in a Veterans Health Administration (VHA) mental health setting using a mixed methods, randomized controlled trial study design. PARTNER-MH is tested under real-world conditions using certified VHA peer specialists (peers) selected through usual VHA hiring practices and assigned to the mental health service line. Peers provide PARTNER-MH and usual peer support services. The study compares the impact of PARTNER-MH versus a wait-list control group on patient activation, patient engagement, and shared decision-making as well as other patient-level outcomes. PARTNER-MH also examines organizational factors that could impact its future implementation in VHA settings. RESULTS: Participants (N=50) were Veterans who were mostly male (n=31, 62%) and self-identified as non-Hispanic (n=44, 88%) and Black (n=35, 70%) with a median age of 45 to 54 years. Most had at least some college education, and 32% (16/50) had completed ≥4 years of college. Randomization produced comparable groups in terms of characteristics and outcome measures at baseline, except for sex. CONCLUSIONS: Rather than simply documenting health disparities among vulnerable populations, PARTNER-MH offers opportunities to evaluate a tailored, culturally sensitive, system-based intervention to improve patient engagement and patient-provider communication in mental health care for racially and ethnically minoritized individuals. TRIAL REGISTRATION: ClinicalTrials.gov NCT04515771; https://clinicaltrials.gov/ct2/show/NCT04515771. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37712.

Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic pain and access to care are identified as critical needs of the Veterans Health Administration. Music imagery and music listening interventions have shown promise as effective nonpharmacological options for pain management. However, most studies have focused on acute pain, passive music experiences, and in-person delivery. OBJECTIVE: In this study, we aimed to examine the feasibility and acceptability of 2 music interventions delivered through telehealth for chronic musculoskeletal pain, trial design, and theoretical model before conducting a fully powered efficacy or comparative effectiveness trial. METHODS: FAMILIA (Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia) is a 3-arm, parallel group, pilot trial. A total of 60 veterans will be randomized to one of the three conditions: music imagery, music listening, or usual care. Aim 1 is to test the feasibility and acceptability of a multicomponent, interactive music imagery intervention (8-weekly, individual sessions) and a single-component, minimally interactive music learning intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of the treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of music imagery and music listening versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes. RESULTS: Recruitment for FAMILIA began in March 2022, and as of July 2022, 16 participants have been enrolled. We anticipate that enrollment will be completed by May 2023. We expect that music imagery and music listening will prove acceptable to veterans and that feasibility benchmarks will be reached. We hypothesize that music imagery and music listening will be more effective than usual care on pain and related outcomes. CONCLUSIONS: FAMILIA addresses four limitations in music intervention research for chronic pain: limited studies in veterans, evaluation of a multicomponent music intervention, methodological rigor, and internet-based delivery. Findings from FAMILIA will inform a fully powered trial to identify putative mechanisms and test efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05426941; https://tinyurl.com/3jdhx28u. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38788.

The Pain Outcomes Comparing Yoga vs. Structured Exercise (POYSE) Trial in Veterans With Fibromyalgia: Study Design and Methods.

Background: Fibromyalgia is a common pain condition that often leads to significant disability. Unfortunately, the effectiveness of most medications for fibromyalgia is limited, and there is a need for alternative, non-pharmacological therapies. Yoga and aerobic exercise are both evidence-based non-pharmacological treatments for fibromyalgia. However, no prior studies have directly compared the effectiveness of yoga vs. exercise. Objective: This article describes the study design and recruitment outcomes of the Pain Outcomes comparing Yoga vs. Structured Exercise (POYSE) Trial, a two-arm randomized comparative effectiveness trial. Methods: Veterans with fibromyalgia, defined by the 2010 American College of Rheumatology diagnostic criteria, who also experienced at least moderate pain severity were enrolled. The participants were randomized to a 12-week yoga-based or a structured exercise program (SEP) and will undergo comprehensive outcome assessments at baseline, 1, 3, 6, and 9 months by interviewers blinded to treatment assignment. The primary outcome will be the overall severity of fibromyalgia as measured by the total Fibromyalgia Impact Questionnaire-Revised. Secondary outcomes included depression, anxiety, health-related quality of life, pain beliefs, fatigue, sleep, and self-efficacy. Results: A total of 2,671 recruitment letters were sent to potential participants with fibromyalgia. Of the potential participants, 623 (23.3%) were able to be contacted by telephone and had their eligibility assessed. Three hundred seventy-one of those interviewed were found to be eligible (59.6%) and 256 (69.0%) agreed to participate and were randomized to the YOGA (n = 129) or the SEP (n = 127) arm of the trial. Conclusions: Clinicians are faced with numerous challenges in treating patients with fibromyalgia. The interventions being tested in the POYSE trial have the potential to provide primary care and other care settings with new treatment options for clinicians while simultaneously providing a much needed relief for patients suffering from fibromyalgia. Trial Registration: Funded by VA Rehabilitation Research and Development (D1100-R); Trial registration: ClinicalTrials.gov, NCT01797263.

Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics.

BACKGROUND: Chronic pain is associated with profound negative effects, and racial disparities are well-documented in chronic pain treatment. In addition, Black patients report poorer communication with providers and exhibit lower levels of patient activation (self-management self-efficacy) than White patients. Although the causes of healthcare disparities are complex and require intervention at multiple levels, empowering patients is one critical path to achieving health equity. The current study is a coaching intervention focused on increasing patient activation and building communication skills for Black patients with chronic pain. METHODS: In this randomized controlled trial, 250 Black patients with chronic pain were randomized to either the coaching intervention or an attention control arm. Intervention patients attended 6 telephone-delivered individual coaching sessions over 12 weeks. Coaching focused on clarifying and prioritizing goals and on communication skills, such as agenda setting. The primary outcome is patient activation. Secondary outcomes include communication self-efficacy, pain intensity and interference, and psychological functioning. DISCUSSION: Having the knowledge and confidence to participate in one's pain care, coupled with the skills needed to effectively communicate with providers, is essential to optimize chronic pain care. This is particularly important for Black patients who often experience lower quality pain care. Interventions such as COOPERATE hold promise for helping patients to acquire the requisite tools to take greater control of their chronic pain care. TRIAL REGISTRATION: clinicaltrials.gov, # NCT03562793.

If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program.

Little is known about how individuals with chronic pain use tailored internet-based interventions. This study is the first to compare self-reported skill module use to observed module access and to examine each of these in relationship to tailored recommendations to access specific content. Participants (N = 58) enrolled in a 10-week trial of the Pain EASE program, a tailored internet-based intervention that includes 10 pain self-management skill modules. Participants completed a "Self-Assessment," which was used to provide a "Personalized Plan" that encouraged accessing specific modules. Participants self-reported module use during weekly data collection telephone calls. Program log data were extracted to capture "observed" module use during the trial period. Findings indicated significantly greater self-reported use of the Pain EASE modules compared to observed access with log data. Further, log data revealed that participants accessed less than half of the modules recommended to them via tailoring.

Prioritization and surgical wait lists: A cross-sectional survey of patient's health-related quality of life.

INTRODUCTION: In many countries, there are waits for elective (planned) surgery. In these settings, processes for triaging patients are applied to determine how long patients wait for their surgery. There are very few instances that evaluate the effectiveness of surgical triage processes. METHODS: A sample of patients from four acute care hospitals in Vancouver, Canada, completed a number of patient-reported outcomes shortly after being registered on the surgical wait list. Patients' diagnosis was used to triage and determine their expected wait for surgery. The associations between patient-reported outcomes with surgical triage were measured. RESULTS: The mean wait times for participants were similar across wait times categories. Participants whose expected waits for surgery were the longest reported successively lower levels of self-rated health (p < 0.01) and successively higher levels of pain (p < 0.01.) There was no difference in symptoms of anxiety among participants expected to wait the longest. DISCUSSION: The diagnosis-based system for prioritizing patients found higher levels of pain and lower health status among those expected to wait the longest for their surgery. Screening waiting patients for treatable mental health conditions should be implemented and the process of surgical triage could be redesigned to allow for a broader set of attributes of health to determine how long a patient waits for their elective surgery.

Associations of opioid prescription dose and discontinuation with risk of substance-related morbidity in long-term opioid therapy.

ABSTRACT: Efforts to reduce opioid-related harms have decreased opioid prescription but have provoked concerns about unintended consequences, particularly for long-term opioid therapy (LtOT) recipients. Research is needed to address the knowledge gap regarding how risk of substance-related morbidity changes across LtOT and its discontinuation. This study used nationwide commercial insurance claims data and a within-individual design to examine associations of LtOT dose and discontinuation with substance-related morbidity. We identified 194,839 adolescents and adults who initiated opioid prescription in 2010 to 2018 and subsequently received LtOT. The cohort was followed for a median of 965 days (interquartile range, 525-1550), of which a median of 176 days (119-332) were covered by opioid prescription. During follow-up, there were 17,582 acute substance-related morbidity events, defined as claims for emergency visits, inpatient hospitalizations, and ambulance transportation with substance use disorder or overdose diagnoses. Relative to initial treatment, risk was greater within individual during subsequent periods of >60 to 120 (adjusted odds ratio [OR], 1.29; 95% CI, 1.12 to 1.49) and >120 (OR, 1.48; 95% CI, 1.24-1.76) daily morphine milligram equivalents. Risk was also greater during days 1 to 30 after discontinuations than during initial treatment (OR, 1.19; 95% CI, 1.05-1.35). However, it was no greater than during the 30 days before discontinuations, indicating that the risk may not be wholly attributable to discontinuation itself. Results were supported by a negative control pharmacotherapy analysis and additional sensitivity analyses. They suggest that LtOT recipients may experience increased substance-related morbidity risk during treatment subsequent to initial opioid prescription, particularly in periods involving higher doses.