OBJECTIVES:Cervical cancer screening reduces cancer morbidity and mortality, but ineffective communication of test results and inadequate follow-up undermines these benefits. Variable knowledge about human papillomavirus (HPV), and the stigma, anxiety, and confusion associated with sexual transmission of HPV complicate communication about results. Our objective was to adapt and integrate evidence-based messages into a conversation guide to help clinicians discuss HPV-based cervical cancer screening results with patients. METHODS:Iterative co-production process included patient engagement panels, semi-structured individual interviews with healthcare system users, preceded by an online questionnaire, and clinician engagement. Interview participants (n = 21) were female healthcare system users aged 21-65, with a cervical cancer screening test in the past 5 years. We consulted with a patient engagement panel to develop the study design and provide feedback on results. We invited interview participants to complete a questionnaire rating the helpfulness of 13 evidence-based messages, followed by a qualitative interview to better understand responses to the messages. Using results from rapid qualitative analysis, we refined messages and incorporated them into a draft conversation guide, reviewed with the patient engagement panel and women's health clinicians, and revised. RESULTS:Principal recommendations for conversations about test results were: (1) Recognize and respond to patient fear and anxiety, particularly fear of cancer; (2) Empower patients to navigate next steps in the screening continuum; and (3) Avoid using a sexually transmitted infection (STI) framework for HPV, which may focus patient reactions and concerns unhelpfully. Based on these recommendations, the conversation guide includes five primary messages, frequently asked questions with responses tailored to individual situations, and guidance for offering personalized follow-up instructions. CONCLUSIONS:Engaging with stakeholders and integrating end-user perspectives throughout the design process may lead to an increased ability to fulfill users' needs. PRACTICE IMPLICATIONS:As HPV-testing becomes the primary modality for cervical cancer screening, a conversation guide may help facilitate more effective communication about screening results.

INTRODUCTION:Little is known whether cannabis and tobacco use are indicators of suicide-related risks. This longitudinal study examined the associations of cannabis and tobacco use with risks of suicide attempt/death and overdose death over a 2-year follow-up in a cohort of veterans prescribed opioids. METHODS:This study analyzed data in 2024 using a national cohort of 923,291 veterans receiving opioid analgesics in Veterans Health Administration clinics collected during 2014-2019. Cannabis and tobacco use were assessed at cohort entry. Outcomes (suicide attempts, suicide death, overdose death) were obtained at follow-up through 2021. Cause-specific hazard models were used to examine the associations of cannabis and tobacco use with each outcome, adjusting for well-established risk factors for suicide/overdose (e.g., substance use disorders, mental health, sociodemographics). RESULTS:At baseline, 5.4% of the cohort used cannabis, and 39.4% used tobacco. At the end of follow-up (median follow-up time of 6.7-6.8 years), 2.2% of the sample had attempted suicide, 0.4% had died by suicide, and 0.5% had died by overdose. In adjusted models, cannabis use was associated with a higher rate of suicide attempt (hazard ratio=1.11, 95% CI=1.06, 1.15). Current use of tobacco at baseline (versus never use) was associated with a higher rate of suicide attempts (hazard ratio=1.18, 95% CI=1.13, 1.22), suicide deaths (hazard ratio=1.19, 95% CI=1.07, 1.32), and overdose deaths (hazard ratio=1.67, 95% CI=1.51, 1.83). CONCLUSIONS:Cannabis and tobacco use were associated with suicide attempts/deaths and overdose deaths among veterans prescribed opioid analgesics, underscoring a need for monitoring patients who use tobacco and cannabis in this population.

Veterans are at high risk for pain-related disability, medication overdose, and opioid-related deaths. In response, Veterans Affairs (VA) healthcare systems are working to implement innovative, multimodal pain care. Recently, the Veterans’ Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study compared two interventions that provide individualized pain care and opioid tapering—an interdisciplinary integrated pain team (IPT) and pharmacist collaborative management (PCM). Informed by VOICE qualitative interview data, this paper examines patient experiences with IPT and PCM and identifies factors that affected patient satisfaction across both interventions. We conducted qualitative, semi-structured interviews with 63 veteran patients who participated in VOICE. The first set of interviews (n = 32) examined patients’ experience with the VOICE interventions and solicited suggestions for improvement. The second set (n = 31) examined patients’ experiences with telehealth in VOICE and inquired about changes to pain-care access and delivery associated with the COVID-19 pandemic. We used rapid analysis procedures to identify themes across both sets of interviews. Veterans enrolled in both VOICE interventions described how they learned to better live with and self-manage pain. Across interventions, key factors that facilitated a positive patient experience included the opportunity to develop a long-term relationship with the clinician or care team, meaningful patient involvement in treatment planning and decision-making, adequate variety and accessibility of options for treatment and self-management, and ease of communication and care coordination. Although IPT and PCM are unique interventions with significant differences from one another, the fundamental factors that influenced patients’ satisfaction were common to both interventions, including the opportunity to develop a therapeutic patient–clinician relationship, engagement in shared decision-making, adequate care access, and support for care coordination. These factors, which are relevant across different pain care interventions and contexts, should be key considerations as healthcare organizations design and implement pain care interventions.

Importance:Guidelines recommend dose reduction or discontinuation of long-term opioid therapy when harm outweighs benefit, but strategies to help patients do so are limited. Objective:To test optionally switching to buprenorphine as a strategy for improving pain and reducing opioids among patients prescribed high-dose, full agonist long-term opioid therapy. Design, Setting, and Participants:In this pragmatic, multisite, 12-month randomized clinical trial with masked outcome assessment, patients treated at Veterans Affairs primary care clinics were recruited from October 2017 to March 2021, with follow-up completed June 2022. Eligible patients had moderate to severe chronic pain despite high-dose opioid therapy (≥70 mg/d for at least 3 months). Patients were randomized to having the option to switch to buprenorphine or not having the option to switch. Interventions:The buprenorphine option was discussed with eligible patients as part of a larger trial of collaborative pain care interventions. Those who switched had structured follow-up to optimize dosing and address adverse effects. Main Outcomes and Measures:The primary outcome was Brief Pain Inventory total score at 12 months. The main secondary outcome was opioid dose in morphine milligram equivalents at 12 months. Results:Of 207 included participants, 185 (89.4%) were male, and the mean (SD) age was 60.9 (10.2) years. A total of 104 were randomized to the buprenorphine option and 103 to the no buprenorphine option. In the buprenorphine option arm, 27 participants (26.0%) switched. Over 12 months, the mean (SD) Brief Pain Inventory score improved from 6.8 (1.5) to 6.1 (1.9; adjusted mean difference [AMD], -0.59; 95% CI, -0.89 to -0.29) in the buprenorphine option arm and from 6.8 (1.6) to 6.3 (1.7; AMD, -0.50; 95% CI, -0.81 to 0.20) in the no option arm (between-group AMD, -0.09; 95% CI, -0.52 to 0.34). Over 12 months, mean (SD) opioid dosage decreased from 157 (75) mg/d to 94 (98) mg/d in the buprenorphine option arm (AMD, -61.0 mg/d; 95% CI, -74.1 to -47.9) and from 165 (88) mg/d to 107 (89) mg/d (AMD, -58.5 mg/d; 95% CI, -71.6 to -45.4) in the no option arm (between-group AMD, -2.5 mg/d; 95% CI, -21.1 to 16.0). Conclusions and Relevance:In this trial, outcomes did not differ between groups; both had small improvements in pain and substantial reductions in opioid dosage, but the proportion of participants who switched to buprenorphine was low. Trial Registration:ClinicalTrials.gov Identifier: NCT03026790.

Importance:Chronic pain is common among individuals with dialysis-dependent kidney failure. Objective:To evaluate the effectiveness of pain coping skills training (PCST), a cognitive behavioral intervention, on pain interference. Design, Setting, and Participants:This multicenter randomized clinical trial of PCST vs usual care was conducted across 16 academic centers and 103 outpatient dialysis facilities in the US. Adults undergoing maintenance hemodialysis and experiencing chronic pain were randomly assigned to PCST or usual care in a 1:1 ratio. Participants were followed in the trial for 36 weeks. Enrollment began on January 4, 2021, and follow-up ended on December 21, 2023. Interventions:PCST consisting of 12 weekly coach-led sessions via video or telephone conferencing, followed by 12 weeks of daily interactive voice response sessions. Usual care had no trial-driven pain intervention. Main Outcomes:The primary outcome was pain interference measured with the Brief Pain Inventory (BPI) Interference subscale (score range of 0-10, with higher scores indicating more pain interference). Secondary outcomes included pain intensity, pain catastrophizing, quality of life, depression, and anxiety. Results:A total of 643 participants (mean [SD] age, 60.3 [12.6] years; 288 [44.8%] female) were randomized, with 319 assigned to PCST and 324 assigned to usual care. At week 12 (primary end point), the PCST group had a larger reduction in the BPI Interference score than the usual care group (between-group difference, -0.49; 95% CI, -0.85 to -0.12; P = .009). The effect persisted at week 24 (between-group difference in BPI Interference score, -0.48; 95% CI, -0.86 to -0.11) but was diminished at week 36 (between-group difference in BPI Interference score, -0.34; 95% CI, -0.72 to 0.04). A decrease in BPI Interference score greater than 1 point (minimal clinically important difference) occurred in 143 of 281 participants (50.9%) in the PCST group vs 108 of 295 participants (36.6%) in the usual care group at 12 weeks (odds ratio, 1.79; 95% CI, 1.28-2.49) and 142 of 258 participants (55.0%) in the PCST group vs 113 of 264 participants (42.8%) in the usual care group at 24 weeks (odds ratio, 1.59; 95% CI, 1.13-2.24). Favorable changes with PCST were also apparent for secondary outcomes of pain intensity, quality of life, depression, and anxiety at weeks 12 and/or 24, as well as for pain catastrophizing at weeks 24 and 36. Conclusions and Relevance:In this randomized clinical trial of patients undergoing maintenance hemodialysis, PCST had benefits on pain interference and other pain-associated outcomes. While the effect on the overall cohort was of modest magnitude, the intervention resulted in a clinically meaningful improvement in pain interference for a substantial proportion of participants. Trial Registration:ClinicalTrials.gov Identifier: NCT04571619.

ImportanceGuidelines recommend dose reduction or discontinuation of long-term opioid therapy when harm outweighs benefit, but strategies to help patients do so are limited.ObjectiveTo test optionally switching to buprenorphine as a strategy for improving pain and reducing opioids among patients prescribed high-dose, full agonist long-term opioid therapy.Design, Setting, and ParticipantsIn this pragmatic, multisite, 12-month randomized clinical trial with masked outcome assessment, patients treated at Veterans Affairs primary care clinics were recruited from October 2017 to March 2021, with follow-up completed June 2022. Eligible patients had moderate to severe chronic pain despite high-dose opioid therapy (≥70 mg/d for at least 3 months). Patients were randomized to having the option to switch to buprenorphine or not having the option to switch.InterventionsThe buprenorphine option was discussed with eligible patients as part of a larger trial of collaborative pain care interventions. Those who switched had structured follow-up to optimize dosing and address adverse effects.Main Outcomes and MeasuresThe primary outcome was Brief Pain Inventory total score at 12 months. The main secondary outcome was opioid dose in morphine milligram equivalents at 12 months.ResultsOf 207 included participants, 185 (89.4%) were male, and the mean (SD) age was 60.9 (10.2) years. A total of 104 were randomized to the buprenorphine option and 103 to the no buprenorphine option. In the buprenorphine option arm, 27 participants (26.0%) switched. Over 12 months, the mean (SD) Brief Pain Inventory score improved from 6.8 (1.5) to 6.1 (1.9; adjusted mean difference [AMD], −0.59; 95% CI, −0.89 to −0.29) in the buprenorphine option arm and from 6.8 (1.6) to 6.3 (1.7; AMD, −0.50; 95% CI, −0.81 to 0.20) in the no option arm (between-group AMD, −0.09; 95% CI, −0.52 to 0.34). Over 12 months, mean (SD) opioid dosage decreased from 157 (75) mg/d to 94 (98) mg/d in the buprenorphine option arm (AMD, −61.0 mg/d; 95% CI, −74.1 to −47.9) and from 165 (88) mg/d to 107 (89) mg/d (AMD, −58.5 mg/d; 95% CI, −71.6 to −45.4) in the no option arm (between-group AMD, −2.5 mg/d; 95% CI, −21.1 to 16.0).Conclusions and RelevanceIn this trial, outcomes did not differ between groups; both had small improvements in pain and substantial reductions in opioid dosage, but the proportion of participants who switched to buprenorphine was low.Trial RegistrationClinicalTrials.gov Identifier: NCT03026790

BackgroundMeaningful engagement of patients in the research process is a growing component of learning health systems; however, few studies have examined efforts to facilitate or foster patient-engaged research among large healthcare organizations.ObjectiveTo describe patient engagement activities and infrastructure among the seven national research networks funded by US Veterans Affairs (VA) Health Systems Research (HSR).DesignWe conducted an environmental scan comprised of (1) structured searches of peer-reviewed publications and other publicly available documents and (2) qualitative, semi-structured group interviews with VA HSR research network representatives.ParticipantsStaff and leaders with knowledge of their research network's engagement-related activities.ApproachWe used principles of thematic analysis and content analysis to code and categorize networks' engagement activities and key considerations identified through the environmental scan.Key ResultsWe identified 129 discrete engagement-related activities across the seven VA HSR research networks in three domains of (1) facilitating patient-engaged research, (2) network engagement infrastructure, and (3) building and maintaining relationships with partners. The number and types of reported activities varied across the networks. All five networks with a current or planned patient engagement group budgeted for staff effort and patient compensation, and offered patient engagement services that spanned research and care implementation projects. We identified five themes essential to engagement infrastructure (supportive network environment; team environment and relationship building; patient engagement group characteristics; flexibility and adaptability; and efficiency).ConclusionsThis work documents patient engagement activities and infrastructure among seven VA-funded national research networks within VA's integrated learning health system. Network representatives' experiences highlight important considerations for developing and sustaining patient engagement infrastructure. Future research is needed to examine quality, outcomes, and costs of patient engagement services within different contexts, and how this infrastructure could best be deployed to meaningfully incorporate patient perspectives across learning health system improvement cycles.

BACKGROUND:Clinicians and healthcare systems have little evidence available to guide effective strategies to manage pain while reducing opioid use. The Veterans Pain Care Organizational Improvement Comparative Effectiveness (VOICE) trial tested two strategies to manage pain and reduce opioid use in primary care settings: interdisciplinary pain team (IPT) and pharmacist collaborative management (PCM). OBJECTIVES:This qualitative process evaluation was conducted parallel to the effectiveness trial to inform future implementation efforts. DESIGN:Ethnographic observations and semi-structured interviews. PARTICIPANTS:Study staff (n=19), facility clinicians (n=37), facility clinical champions (n=4), and patients (n=32) from 10 Veterans Health Administration (VHA) facilities. APPROACH:Guided by the Practical Implementation Sustainability Model (PRISM), we used rapid analysis procedures to identify and categorize themes relevant to implementation. Key themes were identified for the PRISM constructs of implementation and sustainability infrastructure, organizational characteristics, organizational perspectives of the interventions, patient perspectives of the interventions, patient characteristics, and the external environment. To facilitate the development of recommendations for successful and sustainable implementation, identified themes were also mapped to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) outcomes, which are part of the PRISM framework. KEY RESULTS:Successful adoption required leadership support and scanning the environment for existing similar programs and interested, knowledgeable clinical champions. Implementation was supported by training in core features of the interventions, which included meaningful patient involvement in decision-making, responsiveness of the clinical team, and the longevity and intensity of the interventions. Maintenance was supported through sustained leadership support for dedicated clinical team positions and standardized roles and procedures. CONCLUSION:This process evaluation identified strategies to support the successful implementation and sustainment of both interventions. Implementation considerations are particularly important as sites determine which intervention(s) to adopt, given that the VOICE trial found the interventions to be similarly effective at improving pain and reducing opioid dosage.

ImportanceChronic pain is common among individuals with dialysis-dependent kidney failure.ObjectiveTo evaluate the effectiveness of pain coping skills training (PCST), a cognitive behavioral intervention, on pain interference.Design, Setting, and ParticipantsThis multicenter randomized clinical trial of PCST vs usual care was conducted across 16 academic centers and 103 outpatient dialysis facilities in the US. Adults undergoing maintenance hemodialysis and experiencing chronic pain were randomly assigned to PCST or usual care in a 1:1 ratio. Participants were followed in the trial for 36 weeks. Enrollment began on January 4, 2021, and follow-up ended on December 21, 2023.InterventionsPCST consisting of 12 weekly coach-led sessions via video or telephone conferencing, followed by 12 weeks of daily interactive voice response sessions. Usual care had no trial-driven pain intervention.Main OutcomesThe primary outcome was pain interference measured with the Brief Pain Inventory (BPI) Interference subscale (score range of 0-10, with higher scores indicating more pain interference). Secondary outcomes included pain intensity, pain catastrophizing, quality of life, depression, and anxiety.ResultsA total of 643 participants (mean [SD] age, 60.3 [12.6] years; 288 [44.8%] female) were randomized, with 319 assigned to PCST and 324 assigned to usual care. At week 12 (primary end point), the PCST group had a larger reduction in the BPI Interference score than the usual care group (between-group difference, −0.49; 95% CI, −0.85 to −0.12; P = .009). The effect persisted at week 24 (between-group difference in BPI Interference score, −0.48; 95% CI, −0.86 to −0.11) but was diminished at week 36 (between-group difference in BPI Interference score, −0.34; 95% CI, −0.72 to 0.04). A decrease in BPI Interference score greater than 1 point (minimal clinically important difference) occurred in 143 of 281 participants (50.9%) in the PCST group vs 108 of 295 participants (36.6%) in the usual care group at 12 weeks (odds ratio, 1.79; 95% CI, 1.28-2.49) and 142 of 258 participants (55.0%) in the PCST group vs 113 of 264 participants (42.8%) in the usual care group at 24 weeks (odds ratio, 1.59; 95% CI, 1.13-2.24). Favorable changes with PCST were also apparent for secondary outcomes of pain intensity, quality of life, depression, and anxiety at weeks 12 and/or 24, as well as for pain catastrophizing at weeks 24 and 36.Conclusions and RelevanceIn this randomized clinical trial of patients undergoing maintenance hemodialysis, PCST had benefits on pain interference and other pain-associated outcomes. While the effect on the overall cohort was of modest magnitude, the intervention resulted in a clinically meaningful improvement in pain interference for a substantial proportion of participants.Trial RegistrationClinicalTrials.gov Identifier: NCT04571619

Importance:Patients prescribed long-term opioid therapy for chronic pain often experience unrelieved pain, poor quality of life, and serious adverse events. Objective:To compare the effects of integrated pain team (IPT) vs pharmacist collaborative management (PCM) on pain and opioid dosage. Design, Setting, and Participants:This study was a pragmatic multisite 12-month randomized comparative effectiveness trial with masked outcome assessment. Patients were recruited from October 2017 to March 2021; follow-up was completed June 2022. The study sites were Veterans Affairs primary care clinics. Eligible patients had moderate to severe chronic pain despite long-term opioid therapy (≥20 mg/d for at least 3 months). Interventions:IPT involved interdisciplinary pain care planning, visits throughout 12 months with medical and mental health clinicians, and emphasis on nondrug therapies and motivational interviewing. PCM was a collaborative care intervention involving visits throughout 12 months with a clinical pharmacist care manager who conducted structured monitoring and medication optimization. Both interventions provided individualized pain care and opioid tapering recommendations to patients. Main Outcomes and Measures:The primary outcome was pain response (≥30% decrease in Brief Pain Inventory total score) at 12 months. The main secondary outcome was 50% or greater reduction in opioid daily dosage at 12 months. Results:A total of 820 patients were randomized to IPT (n = 411) or PCM (n = 409). Participants' mean (SD) age was 62.2 (10.6) years, and 709 (86.5%) were male. A pain response was achieved in 58/350 patients in the IPT group (16.4%) vs 54/362 patients in the PCM group (14.9%) (odds ratio, 1.11 [95% CI, 0.74-1.67]; P = .61). A 50% opioid dose reduction was achieved in 102/403 patients in the IPT group (25.3%) vs 98/399 patients in the PCM group (24.6%) (odds ratio, 1.03 [95% CI, 0.75-1.42]; P = .85). Over 12 months, the mean (SD) Brief Pain Inventory total score improved from 6.7 (1.5) points to 6.1 (1.8) points (P < .001) in IPT and from 6.6 (1.6) points to 6.0 (1.9) points (P < .001) in PCM (between-group P = .82). Over 12 months, mean (SD) opioid daily dosage decreased from 80.8 (74.2) mg/d to 54.2 (65.0) mg/d in IPT (P < .001) and from 74.5 (56.9) mg/d to 52.8 (51.9) mg/d (P < .001) in PCM (between-group P = .22). Conclusions and Relevance:Outcomes in this randomized clinical trial did not differ between groups; both had small improvements in pain and substantial reductions in opioid dosage. Trial Registration:ClinicalTrials.gov Identifier: NCT03026790.

BACKGROUND:Chronic pain is more prevalent among Veterans than in the general population, and greater social support is linked to better pain outcomes and emotional well-being. For Veterans with chronic pain, social connections can enhance treatment effectiveness, while for those on long-term opioid therapy (LTOT), support may also facilitate pain management and opioid tapering. OBJECTIVE:To explore the relationship between self-reported companionship and changes in pain and opioid dosage among Veterans with chronic pain prescribed LTOT. DESIGN:Prospective observational cohort study of primary care patients prescribed LTOT in the Veterans Health Administration PARTICIPANTS: A total of 290 Veterans prescribed LTOT MAIN MEASURES: Self-reported companionship was assessed using the 4-item PROMIS Companionship measure at 18-month follow-up, and cohorts were dichotomized into high (N=156) and low (N=134) companionship groups. We assessed pain severity and pain interference with the 3-item PEG scale along with multiple secondary measures, with up to 18 months of follow-up. RESULTS:PEG scores were significantly lower in the high companionship group (6.5, 6.5, 6.3 at baseline, 12 months, and 18 months, respectively) compared to the low companionship group (7.3, 7.4, 7.1 at baseline, 12 months, and 18 months, respectively, p<0.001 in each case). High and low companionship groups did not differ significantly in mean opioid dose at any time point, nor did they differ in opioid daily dose change over time or whether dose tapering was voluntary or involuntary. High companionship was associated with significantly better general health status, less depression/anxiety, less fatigue, and better pain self-efficacy, but was not associated with sleep. CONCLUSIONS:We found that high perceived companionship was associated with lower pain severity in Veterans with chronic pain on LTOT. However, changes in opioid medication dosage were not related to companionship levels. Findings suggest that approaches to enhancing companionship could be an important strategy in management of chronic pain.

Veterans living in rural areas with chronic pain often utilize multiple systems of care, including the VA and community care. The Tele-Collaborative Outreach to Rural Patients with Chronic Pain (CORPs) is a pragmatic effectiveness trial testing the utility of collaborative care for rural veterans with high impact chronic pain. This presentation highlights results of formative implementation efforts made to adapt CORPs to diverse VA healthcare systems covering rural catchments from eight different states. Between 12/2022-04/2023 we conducted listening sessions with 5 regional patient engagement boards that comprise veteran patients, including veterans residing in rural areas or who are living with pain (35 veterans). Additionally, we interviewed VA clinicians and administrators from our participating sites (24 interviewees). The focus of these activities was to ascertain ways to optimize implementation of CORPs at the participating sites. Findings highlight lack of communication and trust between the VA and community care clinicians when coordinating care for rural veterans. Engagement partners noted clinicians’ lack of understanding of rural culture as barriers to adequate care. In addition, they perceived clinicians to have poor understanding of system complexities, hampering their ability to help patients navigate between and within VA and community care systems. Clinicians voiced concern over what they perceived to be suboptimal care within the community and challenges obtaining community care records. In response to these data, the CORPs intervention will leverage nurse care managers who will serve as patient navigators and care coordinators to optimize patient experiences and clinical outcomes. Funding: UG3AT012257.

The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619.

OBJECTIVES/GOALS: Our aims are to 1) describe changes in thumb Carpometacarpal (CMC1) joint stability following an 8-week clinic-based dynamic stability exercise program using computerized tomography (CAT) and 2) to evaluate the agreement between ultrasound and CAT (reference standard) when quantifying thumb CMC stability. METHODS/STUDY POPULATION: Aim 1: We have enrolled 13/49 participants in a prospective pre-post interventional study of an 8-week clinic-based occupational therapy dynamic stability program. The primary outcome will be change in stability (thumb metacarpal subluxation in mm) when forcefully loading the thumb as per CAT from pre-treatment to post-treatment at 9 weeks. Aim 2: Same 49 participants are undergoing a one-time ultrasound during baseline assessment. Agreement of ultrasound and CAT measurements (thumb metacarpal subluxation in mm) will be assessed by the Bland-Altman method. RESULTS/ANTICIPATED RESULTS: Exercise is a first-line treatment of CMC1 OA yet there is insufficient evidence to support this. Progression of CMC1 OA is characterized by altered joint mechanics. Joint replacement surgery may reduce pain but often worsens thumb mechanics and overall hand function. This study is the first to test the sustained biomechanical effects of non-invasive thumb exercises. Should these benefits exist, this will further support exercise as a first-tier intervention. Should ultrasound be a suitable proxy for CAT, therapists/physicians could monitor thumb CMC mechanics in response to treatment without risk of radiation exposure. We anticipate 1) a statistically significant reduction in thumb CMC subluxation at 9 weeks follow up and 2) high agreement between sonographic and CAT measures of thumb stability. DISCUSSION/SIGNIFICANCE: This study will lay the foundation for future work and may offer critical support for the use of a non-pharmacological and non-surgical approach as first-line treatment of a highly disabling disease. Future study should include controlled trials where hand function, activity limitation, disease progression, and costs are the outcomes in interest.

Background The Veterans Health Administration tracks urine drug tests (UDTs) among patients on long-term opioid therapy (LTOT) and recommends discussing the health effects of cannabis use. Objective To determine the occurrence of cannabis-related discussions between providers and patients on LTOT during six months following UDT positive for cannabis, and examine factors associated with documenting cannabis use. Design We identified patients prescribed LTOT with a UDT positive for cannabis in 2019. We developed a text-processing tool to extract discussions around cannabis use from their charts. Subjects Twelve thousand seventy patients were included. Chart review was conducted on a random sample of 1,946 patients. Main measures The presence of a cannabis term in the chart suggesting documented cannabis use or cannabis-related discussions. Content of those discussions was extracted in a subset of patients. Logistic regression was used to examine the association between patient factors, including state of residence legal status, with documentation of cannabis use. Key Results Among the 12,070 patients, 65.8% ( N = 7,948) had a cannabis term, whereas 34.1% ( N = 4,122) of patients lacked a cannabis term, suggesting that no documentation of cannabis use or discussion between provider and patient took place. Among the subset of patients who had a discussion documented, 47% related to cannabis use for medical reasons, 35% related to a discussion of VA policy or legal issues, and 17% related to a discussion specific to medical risks or harm reduction strategies. In adjusted analyses, residents of states with legalized recreational cannabis were less likely to have any cannabis-related discussion compared to patients in non-legal states [OR 0.73, 95% CI 0.64–0.82]. Conclusions One-third of LTOT patients did not have documentation of cannabis use in the chart in the 6 months following a positive UDT for cannabis. Discussions related to the medical risks of cannabis use or harm reduction strategies were uncommon.