Optimizing evidence-based practice implementation: a case study on simulated patient protocols in long-term opioid therapy.

BACKGROUND: Substantial work has been done to update or create evidence-based practices (EBPs) in the changing health care landscape. However, the success of these EBPs is limited by low levels of clinician implementation. OBJECTIVE: The goal of this study is to describe the use of standardized/simulated patient/person (SP) methodology as a framework to develop implementation bundles to increase the effectiveness, sustainability, and reproducibility of EBPs across health care clinicians. DESIGN: We observed 12 clinicians' first-time experiences with six unique decision-making algorithms, developed previously using rigorous Delphi methods, for use with patients exhibiting concerning behaviors associated with long-term opioid therapy (LTOT) for chronic pain. Clinicians were paired with two SPs trained to portray individuals with one of the concerning behaviors addressed by the algorithms in a telehealth environment. The SP evaluations were followed by individual interviews, guided by the Consolidated Framework for Implementation Research (CFIR), with each of the clinician participants. PARTICIPANTS: Twelve primary care clinicians and 24 SPs in Western Pennsylvania. MAIN MEASUREMENT: The primary outcome was identifying likely facilitators for the successful implementation of the EBP using the SP methodology. Our secondary outcome was to assess the feasibility of using SPs to illuminate likely implementation barriers and facilitators. RESULTS: The SP portrayal illuminated factors that were pertinent to address in the implementation bundle. SPs were realistic in their portrayal of patients with concerning behaviors associated with LTOT for chronic pain, but clinicians also noted that their patients in practice may have been more aggressive about their treatment plan. CONCLUSIONS: SP simulation provides unique opportunities for obtaining crucial feedback to identify best practices in the adoption of new EBPs for high-risk patients. SETTING: Zoom simulated patient evaluations.

"To prescribe or not to prescribe, that is the question": Perspectives on opioid prescribing for chronic, cancer-related pain from clinicians who treat pain in survivorship.

BACKGROUND: Opioid pain management in cancer survivorship is a complex and understudied topic. METHODS: The authors conducted in-depth, qualitative interviews to understand clinician approaches to opioid pain management in chronic cancer pain and to generate ideas for improvement. They used a rigorous, inductive, qualitative, descriptive approach to examine clinician (n = 20) perspectives about opioid pain management in survivorship, including oncologists (n = 5), palliative care clinicians (n = 8), primary care clinicians (n = 5), and pain management specialists (n = 2). RESULTS: The findings indicated that no consistent medical home exists for chronic pain management in cancer survivors and that there are fundamental differences in how each subspecialty approaches chronic pain management in survivorship (e.g., "Do we think of this as noncancer pain or cancer pain?… This is in this limbo zone-this gray zone-because it's cancer-related pain, right?"). Simultaneously, clinicians are influenced by their peers' perceptions of their opioid prescribing decisions, sparking intraprofessional tension when disagreement occurs. In these instances, clinicians described overthinking and doubting their clinical decision-making as well as a sense of judgment, pressure, and/or shame. Finally, clinicians acknowledged a fear of consequences for opioid prescribing decisions. Specifically, participants cited conflict with patients, sometimes escalating to aggression and threats of violence, as well as potential disciplinary actions and/or legal consequences. CONCLUSIONS: Participants suggested that opportunities to improve chronic cancer pain care include developing clear, systematic guidance for chronic cancer pain management, facilitating clinician communication and consultation, creating tailored survivorship care plans in partnership with patients, and developing accessible, evidence-based, complementary pain treatments.

Buprenorphine dispensing before and after the April 2021 X-Waiver exemptions: An interrupted time series analysis.

BACKGROUND: Until the end of 2022, a special registration, known as the X-waiver, was required to prescribe buprenorphine in the US. Before its removal, US federal regulations trialed an X-waiver exemption, initiated on April 28, 2021, which permitted buprenorphine prescribing for up to 30 patients without additional training. We aimed to understand if these regulatory changes impacted buprenorphine dispensing. METHODS: We conducted an interrupted time series analysis to understand changes in buprenorphine dispensing during the 26 weeks after the X-waiver exemption compared to the expected baseline trend established in the 26 weeks before using the IQVIA Longitudinal Prescription claims database. The primary outcome was number of new buprenorphine prescribers nationwide (defined as no prior buprenorphine prescription dispensed in the last 26 weeks). Segmented regression estimated relative changes in buprenorphine dispensing at 1, 13, and 26 weeks post-X-waiver change. RESULTS: A total of 15,517,525 prescriptions filled for 1,328,172 patients (43.4 % female) ordered by 62,312 providers were included for analysis. At 26 weeks post-X-waiver change, there was no change in the number of new prescribers compared to the expected baseline trend (-2.7 % [95 % CI:-8.3,2.9]). The number of new (15.2 % [4.6,25.8]) and existing (1.7 % [0.9,2.4]) patients and patients per prescriber (4.3 % [3,5.6]) increased. Buprenorphine prescriptions reimbursed by Medicaid increased (7.5 % [6.6,8.4]) while commercial fills decreased (-3.4 % [-5.3,-1.5]). CONCLUSIONS: The number of new prescribers did not increase six months post-X-waiver exemption while new patients continued to enter treatment at higher-than-expected rates. These findings suggest that additional interventions beyond the recent X-waiver removal may be needed to increase access to buprenorphine.

Stakeholder-Driven Intervention Development for Dialysis Trials Using a Design Sprint Methodology.

Rationale & Objective: Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly with buprenorphine pain treatment. To address stigma, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype. Study Design: Adapted Design Sprint which clarified the problem to be solved, proposed solutions, and created a blueprint for the selected solution. Settings & Participants: Five individuals with pain and kidney disease receiving dialysis, 5 physicians (nephrology, palliative care, and addiction medicine) and 4 large dialysis organization leaders recruited for specific expertise or experience. Conducted through online platform (Zoom) and virtual white board (Miro board). Analytical Approach: Descriptions of the Design Sprint adaptations and processes. Results: To facilitate patient comfort, a patient-only phase included four 90-minute sessions over 2-weeks, during which patient participants used a mapping process to define the critical problem and sketch out solutions. In a physician-only phase, consisting of two 120-minute sessions, participants accomplished the same tasks. During a combined phase of two 120-minute sessions, patients, physicians, and large dialysis organization representatives vetted and developed solutions from earlier phases, leading to an intervention blueprint. Videoconferencing technology allowed for geographically diverse representation and facilitated participation from patients experiencing medical illness. The electronic whiteboard permitted interactive written contributions and voting on priorities instead of only verbal discussion, which may privilege physician participants. A skilled qualitative researcher facilitated the sessions. Limitations: Challenges included the time commitment of the sessions, absences owing to illness or emergencies, and technical difficulties. Conclusions: An adapted Design Sprint is a novel method of efficiently and rapidly incorporating multiple stakeholders to develop solutions for clinical challenges in kidney disease. Plain Language Summary: Stigma contributes to ineffective treatment for pain among individuals with kidney failure on dialysis, particularly when using buprenorphine, an opioid pain medicine with a lower risk of sedation used to treat addiction. To develop a stigma intervention, we adapted a Design Sprint, an industry-developed structured exercise where an interdisciplinary group works over 5 days to clarify the problem, identify and choose a solution, and build and test a prototype. We conducted 3 sprints with (1) patients alone, (2) physicians alone, and (3) combined patients, physicians, and dialysis organization representatives. This paper describes the adaptations and products of sprints as a method for gathering diverse stakeholder voices to create an intervention blueprint efficiently and rapidly.

A Simulated Patient Protocol for Implementing Evidence-Based Practices in Health Care Delivery.

Background: Substantial work has been done to update or create evidence-based practices (EBPs) in the changing health care landscape. However, the success of these EBPs is limited by low levels of clinician implementation. The goal of this study is to describe the use of simulated patient (SP) methodology as a framework to develop implementation bundles to increase the effectiveness, sustainability, and reproducibility of EBPs across health care clinicians. The primary outcome was identifying likely facilitators for the successful implementation of EBP. Our secondary outcome was the assess the feasibility of using SPs to illuminate likely implementation barriers and facilitators. Methods: We observed 12 primary care clinicians' first-time experiences with six unique decision-making algorithms for use with patients exhibiting concerning behaviors associated with long-term opioid therapy (LTOT) for chronic pain over Zoom. Each clinician was paired with two simulated patients trained to portray individuals with one of the concerning behaviors addressed by the algorithms. The Standardized Patient-evaluations were followed by CFIR guided one-on-one interviews with the clinicians. Results: The SP portrayal illuminated factors that were pertinent to address in the implementation bundle. SPs were realistic in their portrayal of patients with concerning behaviors associated with LTOT for chronic pain, but clinicians also noted that their patients in practice may have been more aggressive about their treatment plan. Conclusions: SP simulation provides unique opportunities for obtaining crucial feedback to identify best practices in the adoption of new EBPs for high-risk patients.

Influence of patient trust in provider and health literacy on receipt of guideline-concordant chronic opioid therapy in HIV care settings.

OBJECTIVE: Persons with HIV (PWH) frequently receive opioids for pain. Health literacy and trust in provider may impact patient-provider communication, and thus receipt of guideline-concordant opioid monitoring. We analyzed baseline data of HIV-positive patients on chronic opioid therapy (COT) in a trial to improve guideline-concordant COT in HIV clinics. DESIGN: Retrospective cohort study. SETTING: Two hospital-based safetynet HIV clinics in Boston and Atlanta. PATIENTS AND PARTICIPANTS: A cohort of patients who were ≥18 years, HIV-positive, had received ≥ 3 opioid prescriptions from a study site ≥21 days apart within a 6-month period during the prior year and had ≥1 visit at the HIV clinic in the prior 18 months. MAIN OUTCOME MEASURES: Adjusted logistic regression models examined whether health literacy and trust in provider (scale scored 11-55, higher indicates more trust) were associated with: (1) ≥ 2 urine drug tests (UDTs) and (2) presence of an opioid treatment agreement. RESULTS: Among 166 PWH, mean trust in provider was 47.4 (SD 6.6); 117 (70 percent) had adequate health literacy. Fifty patients (30 percent) had ≥ 2 UDTs and 20 (12 percent) had a treatment agreement. The adjusted odds ratio (aOR) for a one-point increase in trust in provider was 0.97 for having ≥ 2 UDTs (95 percent CI 0.92-1.02) and 1.03 for opioid treatment agreement (95 percent CI 0.95-1.12). The aOR for adequate health literacy was 0.89 for having ≥ 2 UDTs (95 percent CI 0.42-1.88) and 1.66 for an opioid treatment agreement (95 percent CI 0.52-5.31). CONCLUSIONS: Health literacy and trust in provider were not associated with chronic opioid therapy quality outcomes.

Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.

BACKGROUND: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. METHODS: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

Implementing harm reduction kits in an office-based addiction treatment program.

BACKGROUND: The rising rates of drug use-related complications call for a paradigm shift in the care for people who use drugs. While addiction treatment and harm reduction have historically been siloed in the US, co-location of these services in office-based addiction treatment (OBAT) settings offers a more realistic and patient-centered approach. We describe a quality improvement program on integrating harm reduction kits into an urban OBAT clinic. METHODS: After engaging appropriate stakeholders and delivering clinician and staff trainings on safer use best practices, we developed a clinical workflow for universal offering and distribution of pre-packaged kits coupled with patient-facing educational handouts. We assessed: (1) kit uptake with kit number and types distributed; and (2) implementation outcomes of feasibility, acceptability, appropriateness, and patient perceptions. RESULTS: One-month post-implementation, 28% (40/141) of completed in-person visits had at least one kit request, and a total of 121 kits were distributed. Staff and clinicians found the program to be highly feasible, acceptable, and appropriate, and patient perceptions were positive. CONCLUSIONS: Incorporating kits in OBAT settings is an important step toward increasing patient access and utilization of life-saving services. Our program uncovered a significant unmet need among our patients, suggesting that kit integration within addiction treatment can improve the standard of care for people who use drugs.

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial.

OBJECTIVES: Patients with opioid use disorder (OUD) are increasingly being hospitalized for acute medical illnesses. Despite initiation of medications for OUD (MOUDs), many discontinue treatment after discharge. To evaluate whether a psychosocial intervention can improve MOUD retention after hospitalization, we conducted a pilot randomized controlled trial of a peer recovery coach intervention. METHODS: An existing peer recovery coach intervention was adapted for this trial. Hospitalized adults with OUD receiving MOUD treatment were randomized to receive either a recovery coach intervention or treatment-as-usual. For those in the intervention arm, the coach guided the participant to complete a relapse prevention plan, maintained contact throughout the 6-month follow-up period, encouraged MOUD continuation, and helped to identify community resources. Those receiving treatment-as-usual were discharged with a referral to outpatient treatment. Primary outcome was retention in MOUD treatment at 6 months. Secondary outcomes were the proportion of participants readmitted to the hospital and the number of days until treatment discontinuation and to hospital readmission. RESULTS: Twenty-five individuals who provided consent and randomized to the recovery coach intervention (n = 13) or treatment-as-usual (n = 12) were included in the analysis. No significant differences were found in the proportion of participants retained in MOUD treatment at 6 months (38.5% vs 41.7%, P = 0.87), proportion of participants readmitted at 6 months (46.2% vs 41.2%, P = 0.82), or the time to treatment discontinuation (log-rank P = 0.92) or readmission (log-rank P = 0.85). CONCLUSIONS: This pilot trial failed to demonstrate that a recovery coach intervention improved MOUD treatment retention compared with treatment-as-usual among hospitalized individuals with OUD.

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after. Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Expert consensus-based guidance on approaches to opioid management in individuals with advanced cancer-related pain and nonmedical stimulant use.

BACKGROUND: Clinicians treating cancer-related pain with opioids regularly encounter nonmedical stimulant use (i.e., methamphetamine, cocaine), yet there is little evidence-based management guidance. The aim of the study is to identify expert consensus on opioid management strategies for an individual with advanced cancer and cancer-related pain with nonmedical stimulant use according to prognosis. METHODS: The authors conducted two modified Delphi panels with palliative care and addiction experts. In Panel A, the patient's prognosis was weeks to months and in Panel B the prognosis was months to years. Experts reviewed, rated, and commented on the case using a 9-point Likert scale from 1 (very inappropriate) to 9 (very appropriate) and explained their responses. The authors applied the three-step analytical approach outlined in the RAND/UCLA to determine consensus and level of clinical appropriateness of management strategies. To better conceptualize the quantitative results, they thematically analyzed and coded participant comments. RESULTS: Consensus was achieved for all management strategies. The 120 Experts were mostly women (47 [62%]), White (94 [78%]), and physicians (115 [96%]). For a patient with cancer-related and nonmedical stimulant use, regardless of prognosis, it was deemed appropriate to continue opioids, increase monitoring, and avoid opioid tapering. Buprenorphine/naloxone transition was inappropriate for a patient with a short prognosis and of uncertain appropriateness for a patient with a longer prognosis. CONCLUSION: Study findings provide urgently needed consensus-based guidance for clinicians managing cancer-related pain in the context of stimulant use and highlight a critical need to develop management strategies to address stimulant use disorder in people with cancer. PLAIN LANGUAGE SUMMARY: Among palliative care and addiction experts, regardless of prognosis, it was deemed appropriate to continue opioids, increase monitoring, and avoid opioid tapering in the context of cancer-related pain and nonmedical stimulant use. Buprenorphine/naloxone transition as a harm reduction measure was inappropriate for a patient with a short prognosis and of uncertain appropriateness for a patient with a longer prognosis.

Dispensary Staff Perceptions About the Benefits, Risks, and Safety of Cannabis for Medical Purposes.

BACKGROUND: Therapeutic use of cannabis is common in the United States (up to 18.7% of Americans aged ≥12), and dispensaries in the US are proliferating rapidly. However, the efficacy profile of medical cannabis is unclear, and customers often rely on dispensary staff for purchasing decisions. The objective was to describe cannabis dispensary staff perceptions of medical cannabis benefits and risks, as well as its safety in high-risk populations. METHODS: Online Survey study conducted using Qualtrics from February 13, 2020 to October 2, 2020 with a national sample of dispensary staff who reportedinteracting with customers in a cannabis dispensary selling tetrahydrocannabinol-containing products. Participants were queried about benefits ("helpfulness") and risks ("worry") about cannabis for a variety of medical conditions, and safety in older adults and pregnant women on a five-point Likert scale. These results were then collapsed into three categories including "neutral" (3/5). "I don't know" (uncertainty) was a response option for helpfulness and safety. RESULTS: Participants (n = 434) were from 29 states and included patient-facing dispensary staff (40%); managers (32%); pharmacists (13%); and physicians, nurse practitioners, or physician assistants (5%). Over 80% of participants perceived cannabis as helpful for post-traumatic stress disorder (88.7%), epilepsy (85.3%) and cancer (83.4%). Generally, participants were not concerned about potential cannabis risks, including increased use of illicit drugs (76.3%), decreases in intelligence (74.4%), disrupted sleep (71.7%), and new/worsening health problems from medical cannabis use (70.7%). Cannabis was considered safe in older adults by 81.3% of participants, though there was much less consensus on safety in pregnancy. CONCLUSIONS: Cannabis dispensary staff generally view medical cannabis as beneficial and low-risk. However, improvements in dispensary staff training, an increased role for certifying clinicians, and interventions to reduce dispensary staff concerns (e.g., cost, judgment) may improve evidence-based staff recommendations to patients seeking medical cannabis.

Cannabis dispensary staff approaches to counseling on potential contraindications to cannabis use: insights from a national self-report survey.

BACKGROUND: Legal cannabis is available in more than half of the United States. Health care professionals (HCPs) rarely give recommendations on dosing or safety of cannabis due to limits imposed by policy and lack of knowledge. Customer-facing cannabis dispensary staff, including clinicians (pharmacists, nurses, physician's assistants), communicate these recommendations in the absence of HCP recommendations. Little is known about how dispensary staff approach individuals with complex medical and psychiatric comorbidities. Using responses from a national survey, we describe how cannabis dispensary staff counsel customers with medical and psychiatric comorbidities on cannabis use and examine whether state-specific cannabis policy is associated with advice given to customers. METHODS: National, cross-sectional online survey study from February 13, 2020 to October 2, 2020 of dispensary staff at dispensaries that sell delta-9-tetrahydrocannabinol containing products. Measures include responses to survey questions about how they approach customers with medical and psychiatric comorbidities; state medicalization score (scale 0-100; higher score indicates more similarity to regulation of traditional pharmacies); legalized adult-use cannabis (yes/no). We conducted multiple mixed effects multivariable logistic regression analyses to understand relationships between state medicalization and dispensary employees' perspectives. RESULTS: Of 434 eligible respondents, most were budtenders (40%) or managers (32%), and a minority were clinicians (18%). State medicalization score was not associated with responses to most survey questions. It was associated with increased odds of encouraging customers with medical comorbidities to inform their traditional HCP of cannabis use (Odds ratio [OR]=1.2, 95% confidence interval [CI] 1.0-1.4, p=0.03) and reduced odds of recommending cannabis for individuals with cannabis use disorder (CUD) (OR=0.8, 95% CI 0.7-1.0, p=0.04). Working in a state with legalized adult-use cannabis was associated with recommending traditional health care instead of cannabis in those with serious mental illness (OR 2.2, 95% CI 1.1-4.7, p=0.04). Less than half of respondents believed they had encountered CUD (49%), and over a quarter did not believe cannabis is addictive (26%). CONCLUSIONS: When managing cannabis dosing and safety in customers with medical and psychiatric comorbidity, dispensary staff preferred involving individuals' traditional HCPs. Dispensary staff were skeptical of cannabis being addictive. While state regulations of dispensaries may impact the products individuals have access to, they were not associated with recommendations that dispensary staff gave to customers. Alternative explanations for dispensary recommendations may include regional or store-level variation not captured in this analysis.

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.

"I Refused to Get Addicted to Opioids": Exploring Attitudes About Opioid Use Disorder in Patients With Advanced Cancer Pain and Their Support People.

Patients with advanced cancer are commonly prescribed opioids, yet patient attitudes about opioid risks (eg, opioid use disorder, or OUD) are understudied. Our objective was to use in-depth qualitative interviews to understand perceptions of opioid prescribing and OUD in patients with advanced, solid-tumor cancers and their support people. We conducted a qualitative study using a rigorous inductive, qualitative descriptive approach to examine attitudes about OUD in patients with advanced cancer (n = 20) and support providers (n = 11). Patients with cancer hold 2 seemingly distinct views: prescription opioids are addictive, yet OUD cannot happen to me or my loved one. Participants described general concerns about the addictive nature of prescription opioids ("My biggest concern… would just be the risk of getting addicted to the medication or even like, overdosing it"), while separating cancer pain management from OUD when considering prescription opioid risks and benefits ("They need to make sure they get the right ones, when they're taking it away from you."). Finally, participants identified personal characteristics and behaviors that they felt were protective against developing OUD (commonly control, willpower, and responsibility). This rigorous qualitative study demonstrates that patients with advanced cancer and their support people simultaneously hold concerns about the addictive nature of prescription opioids, while distancing from perceptions of OUD risks when using opioids for cancer pain management. Given high rates of opioid exposure during advanced cancer treatment, it is important to explore opportunities to promote a balanced understanding of prescription opioid use and OUD risks in this population. PERSPECTIVE: Though prescription opioids carry risk of OUD, there is little data to help guide patients with advanced cancer. Findings suggest that there is a need to develop new, innovative strategies to promote effective pain management and minimize opioid risks in this complex population.

Impact of COVID-19-related regulatory changes on nationwide access to buprenorphine: An interrupted time series design.

Background: The impact of COVID-19-related healthcare changes on access to buprenorphine (BUP) nationwide in the US is unknown. Methods: We conducted an interrupted time series with the IQVIA LRx database. The study timeline included BUP prescriptions from 52 weeks before (2/23/19-2/21/20) to 52 weeks after (4/4/20-4/2/21) the initial pandemic period (2/22/20-4/3/20). Segmented regression estimated relative changes in total milligrams (MG) of BUP available per week nationwide at 1, 26, and 52 weeks post-initial-pandemic. We evaluated treatment disruptions in previously stable patients, defined as ≥6 months of BUP prescriptions. Results: A total of 31 617 849 prescriptions were included. Total MG BUP dispensed increased at 1 and 26 weeks and then returned to baseline trends at 52 weeks post-initial pandemic period (4.1% [95% CI: 3.7,4.5], 2.1% [1.5,2.6], 0.1% [-0.6,0.9]). Stably-treated patients saw a decrease in 7-, 14-, and 28-day treatment disruptions at 52 weeks post-initial-pandemic period (-21.6% [-25.6,-17.7]; -10.8% [-16.3,-5.3]; -27.3% [-33.0,-21.6]). Men retained an increase in MG BUP compared to women at 52 weeks (0.7% [0.01,1.4] versus -0.6% [-1.5,0.2]). Younger age groups (18-29 years and 30-39 years) had a decrease in MG BUP at 52 weeks compared to expected baseline trend (-16.6 [-24.2, -9.0]; -1.6 [-3.0, -0.1). Patients with Medicaid demonstrated an increase in MG BUP at 52 weeks (8.3% [6.3,10.3]). MG BUP prescribed by APP prescribing increased by over 140 000 mg per week prior to the pandemic and continued to increase. Conclusions: Regulatory changes around buprenorphine prescribing facilitated patient access to buprenorphine during the pandemic.

Evidence-Based Interventions to Improve Opioid Prescribing in Primary Care: a Qualitative Assessment of Implementation in Two Studies.

BACKGROUND: The TOPCARE and TEACH randomized controlled trials demonstrated the efficacy of a multi-faceted intervention to promote guideline-adherent long-term opioid therapy (LTOT) in primary care settings. Intervention components included a full-time Nurse Care Manager (NCM), an electronic registry, and academic detailing sessions. OBJECTIVE: This study sought to identify barriers, facilitators, and other issues germane to the wider implementation of this intervention. DESIGN: We conducted a nested, qualitative study at 4 primary care clinics (TOPCARE) and 2 HIV primary care clinics (TEACH), where the trials had been conducted. APPROACH: We purposively sampled primary care physicians and advanced practice providers (hereafter: PCPs) who had received the intervention. Semi-structured interviews explored perceptions of the intervention to identify unanticipated barriers to and facilitators of implementation. Interview transcripts were analyzed through iterative deductive and inductive coding exercises. KEY RESULTS: We interviewed 32 intervention participants, 30 physicians and 2 advanced practice providers, who were majority White (66%) and female (63%). Acceptability of the intervention was high, with most PCPs valuing didactic and team-based intervention elements, especially co-management of LTOT patients with the NCM. Adoption of new prescribing practices was facilitated by proximity to expertise, available behavioral health care, and the NCM's support. Most participants were enthusiastic about the intervention, though a minority voiced concerns about the appropriateness in their particular clinical environments, threats to the patient-provider relationship, or long-term sustainability. CONCLUSION: TOPCARE/TEACH participants found the intervention generally acceptable, appropriate, and easy to adopt in a variety of primary care environments, though some challenges were identified. Careful attention to the practical challenges of implementation and the professional relationships affected by the intervention may facilitate implementation and sustainability.

Post-traumatic stress disorder and risky opioid use among persons living with HIV and chronic pain.

Persons with HIV (PWH) experience chronic pain and Post-Traumatic Stress Disorder (PTSD) at higher rates than the general population, and more often receive opioid medications to treat chronic pain. A known association exists between PTSD and substance use disorders, but less is known about the relationship between PTSD and risky opioid use among PWH taking prescribed opioid medications. In this observational study of PWH on long-term opioid medications for pain we examined associations between PTSD symptom severity based on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5, response range 0-80) and the following outcomes: 1) risk for opioid misuse (COMM score ≥13); 2) risky alcohol use (AUDIT score ≥8); 3) concurrent benzodiazepine prescription; and 4) morphine equivalent dose. Among 166 patients, 38 (23%) had a PCL-5 score over 38, indicating high PTSD symptom burden. Higher PCL-5 score (per 10 point difference) was associated with increased odds of opioid misuse (aOR 1.55; 95%CI: 1.31-1.83) and risky drinking (aOR: 1.28;1.07-1.52). No significant association was observed between PCL-5 score and benzodiazepine prescriptions or morphine equivalent dose. These findings suggest that when addressing alcohol and opioid use in PWH on long term opioid therapy, attention to PTSD symptoms is especially important given the higher risk for risky alcohol and opioid use among patients with this common comorbid condition.

Manifestations of Opioid Stigma in Patients With Advanced Cancer: Perspectives From Patients and Their Support Providers.

PURPOSE: Stigma surrounding prescription opioids, or opioid stigma, is increasingly recognized as a barrier to effective and guideline-concordant cancer pain management. Patients with advanced cancer report high rates of pain and prescription opioid exposure, yet little is known about how opioid stigma may manifest in this population. METHODS: We conducted in-depth qualitative interviews with 20 patients with advanced cancer and 11 support providers between March 2020, and May 2021. We took a rigorous inductive, qualitative descriptive approach to characterize how opioid stigma manifests in the lives of patients with advanced cancer. RESULTS: Patients and their support providers described three primary manifestations of opioid stigma: (1) direct experiences with opioid stigma and discrimination in health care settings (eg, negative, stigmatizing interactions in pharmacies or a pain clinic); (2) concerns about opioid stigma affecting patient care in the future, or anticipated stigma; and (3) opioid-restricting attitudes and behaviors that may reflect internalized stigma and fear of addiction (eg, feelings of guilt). CONCLUSION: This qualitative study advances our understanding of opioid stigma manifestations in patients with advanced cancer, as well as coping strategies that patients may use to alleviate their unease (eg, minimizing prescription opioid use, changing clinicians, and distancing from perceptions of addiction). In recognition of the costs of undermanaged cancer pain, it is important to consider innovative treatment strategies to address opioid stigma and improve pain management for patients with advanced cancer. Future research should examine opportunities to build an effective, multilevel opioid stigma intervention targeting patients, clinicians, and health care systems.