Opioid analgesic use after ambulatory surgery: a descriptive prospective cohort study of factors associated with quantities prescribed and consumed.

OBJECTIVES: To prospectively characterise: (1) postoperative opioid analgesic prescribing practices; (2) experience of patients undergoing elective ambulatory surgeries and (3) impact of patient risk for medication misuse on postoperative pain management. DESIGN: Longitudinal survey of patients 7 days before and 7-14 days after surgery. SETTING: Academic urban safety-net hospital. PARTICIPANTS: 181 participants recruited, 18 surgeons, follow-up data from 149 participants (82% retention); 54% women; mean age: 49 years. INTERVENTIONS: None. PRIMARY AND SECONDARY OUTCOME MEASURES: Total morphine equivalent dose (MED) prescribed and consumed, percentage of unused opioids. RESULTS: Surgeons postoperatively prescribed a mean of 242 total MED per patient, equivalent to 32 oxycodone (5 mg) pills. Participants used a mean of 116 MEDs (48%), equivalent to 18 oxycodone (5 mg) pills (~145 mg of oxycodone remaining per patient). A 10-year increase in patient age was associated with 12 (95% CI (-2.05 to -0.35)) total MED fewer prescribed opioids. Each one-point increase in the preoperative Graded Chronic Pain Scale was associated with an 18 (6.84 to 29.60) total MED increase in opioid consumption, and 5% (-0.09% to -0.005%) fewer unused opioids. Prior opioid prescription was associated with a 55 (5.38 to -104.82) total MED increase in opioid consumption, and 19% (-0.35% to -0.02%) fewer unused opioids. High-risk drug use was associated with 9% (-0.19% to 0.002%) fewer unused opioids. Pain severity in previous 3 months, high-risk alcohol, use and prior opioid prescription were not associated with postoperative prescribing practices. CONCLUSIONS: Participants with a preoperative history of chronic pain, prior opioid prescription, and high-risk drug use were more likely to consume higher amounts of opioid medications postoperatively. Additionally, surgeons did not incorporate key patient-level factors (eg, substance use, preoperative pain) into opioid prescribing practices. Opportunities to improve postoperative opioid prescribing include system changes among surgical specialties, and patient education and monitoring.

Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial.

AIMS: To test the hypothesis that among hospitalized people who inject drugs (PWID), a brief intervention in skin-cleaning would result in greater reductions in follow-up emergency department (ED) or hospitalization rates compared with a usual care condition. DESIGN: Randomized, two-group (intervention, n = 128; usual care, n = 124), single-site clinical trial with12-month follow-up. SETTING: Hospital inpatient services in Boston, Massachusetts, United States. PARTICIPANTS: People who injected drugs on at least 3 days each week prior to hospital admission (n = 252). Participants averaged 37.9 (± 10.7) years of age; 58.5% were male, 59.3% were white and 61.1% had a diagnosis related to skin infection at enrollment. INTERVENTION AND COMPARATOR: Intervention was a skin hygiene education and skills-training behavioral intervention [short-term efficacy data on a behavioral intervention (SKIN)] consisting of two education- and skills-based skin-cleaning sessions, one during hospitalization and another 4 weeks later. The comparator was treatment as usual: an informational brochure about substance use treatment options and needle exchange programs in the area and follow-up clinical appointments as arranged by the inpatient medical staff. MEASUREMENTS: Electronic medical records were reviewed and discharge diagnoses for each ED visit and hospital admission were categorized into injection-related bacterial events (e.g. cellulitis) and non-injection-related events. Negative binomial regression was used to test the intervention effects for the primary outcome and total ED visits, as well as the secondary outcomes, total number of hospitalizations, injection drug use-related (IDU-related) ED visits and IDU-related hospitalizations. We also tested whether the outcomes were moderated by whether the initial hospitalization was IDU-related. FINDINGS: Of people assigned to SKIN, 66 completed two sessions, 55 completed one session and seven completed zero sessions. Adjusting for baseline covariates, the mean rate of total ED visits in the next 12 months was non-significantly higher [incidence rate ratio (IRR) = 1.13, 95% confidence interval (CI) = 0.96, 1.33, P = 0.152] compared with usual treatment. The intervention did not significantly reduce total hospitalizations or IDU-related hospitalizations. Adjusting for baseline covariates, the mean rate of injection drug use-related ED visits in the next 12 months was lower (IRR = 0.57, 95% CI = 0.35, 0.91, P = 0.019) compared with treatment as usual. CONCLUSIONS: A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization. There was some evidence that it may have reduced injection drug use-related emergency department visits.

Perceived Behavioral Control and Barriers to Cleaning Skin Before Injecting Drugs.

OBJECTIVES: Skin and soft-tissue infections (SSTI) among people who inject drugs (PWID) are common and represent a significant public health burden. In the current study, we examined the relationship between perceived behavioral control and perceived barriers to cleaning skin before injecting drugs. METHODS: Participants (n = 248; 37.9 [±10.7] years of age, 58.5% male, 59.3% white, 16.1% Hispanic) were patients seeking medical care at a large urban hospital in the northeastern United States. We used ordinary least squares regression to estimate the associations between perceived barriers to skin cleaning with background characteristics and perceived behavioral control. RESULTS: Controlling for background and other study variables, greater number of past-year skin abscesses was associated with greater level of perceived barriers to skin cleaning (P < 0.001), whereas higher level of education and higher perceived behavioral control were associated with lower levels of perceived barriers to skin cleaning (P < 0.001). CONCLUSIONS: Interventions aiming to reduce the likelihood for SSTI among people who inject drugs may benefit from strengthening individual's behavioral control and providing skin cleaning skills training.

Self-treatment of skin infections by people who inject drugs.

BACKGROUND AND AIMS: Persons who inject drugs (PWID) experience high rates of skin and soft tissue infections (SSTI) and often access emergency or inpatient treatment. However, many PWID do not seek care and self-treat some or all of their infections. The goal of the current study was to examine predictors of self-treatment of SSTI in a sample of hospitalized PWID, and describe methods of and reasons for self-treatment. METHODS: PWID (N = 252) were recruited from inpatient medical units at an urban safety-net hospital to join a behavioral intervention trial. The baseline interview focused on past-year SSTI incidence and related treatment, including reasons for not accessing medical care and methods of self-treatment. RESULTS: Of study participants, 162 (64%) reported having at least one SSTI in the past year. This subset was 59.9% White/Caucasian with a mean age of 38.0 (SD + 10.5). One-third of these participants (32.3%) reported ever self-treating SSTI in the past year. In a logistic regression model, number of past-year infections (OR = 1.81, p < .001) and positive outlook (OR = 2.46, p < .001) were associated with self-treatment of SSTI. Common methods of self-treatment included mechanically draining sores, applying heat/warm compress, and cleaning affected areas. Continued drug use and belief that infections were not serious and could be self-treated were two main reasons for not seeking professional medical care. CONCLUSIONS: Interventions targeting SSTI among PWID should include education on when to seek medical care and the risks of serious infection, and could be implemented at local clinics or harm reduction programs to increase access.

Blood Lead Levels of Children Using Traditional Indian Medicine and Cosmetics: A Feasibility Study.

BACKGROUND: Traditional Indian cosmetics and Ayurvedic medicines may contain lead. Previous studies have shown a relationship between eye cosmetic use (kohl) in children and elevated blood lead levels (BLLs) > 10 µg/dL. However, an association between Ayurvedic use and elevated BLLs in children is unknown and understudied. METHODS: We assessed the feasibility of collecting BLLs in children attending Ayurvedic outpatient settings in India. Our pilot study took place over 3 days in the summer of 2010 at a large public Ayurveda hospital and a small pediatric clinic in southern India. Using a trained interpreter, we administered a standardized questionnaire in Malayalam, assessing sociodemographics, Ayurvedic medicine use, kohl use, and other potential risk factors for lead exposure, to parents of pediatric outpatients. We also analyzed BLLs using a portable lead analyzer. RESULTS: The study enrolled 29 children (mean age, 3.8 years). The mean BLL was 6.7 µg/dL (SD = 3.5; range, 3.5-20.2). Seventy-two percent of the children used Ayurvedic medicine in the past 2 years and 55% reported kohl use. Mean BLL of Ayurvedic users and nonusers was 6.2 µg/dL and 8.5 µg/dL, respectively (P = .08). Kohl users had a statistically significant higher BLL than nonusers (8.0 µg/dL vs 5.3 µg/dL, P = .03). CONCLUSIONS: It is feasible to collect BLLs in pediatric Ayurvedic outpatient clinics in southern India. Collaborative relationships with community members and hospital staff were essential. Further research is needed to investigate Ayurveda and kohl use as risk factors for elevated lead burden among Indian children.

Homelessness, Personal Hygiene, and MRSA Nasal Colonization among Persons Who Inject Drugs.

Methicillin-resistant Staphylococcus aureus (MRSA) infection is a leading cause of hospitalization and medical visits among individuals experiencing homelessness and also among persons who inject drugs (PWID), populations with significant overlap in urban centers in the USA. While injection drug use is a risk factor for MRSA skin infections, MRSA is also known to transmit easily in crowded, public locations in which individuals have reduced personal hygiene. Individuals in urban centers who experience homelessness or drug addiction may spend significant amounts of time in environments where MRSA can be easily transmitted, and may also experience reduced access to facilities to maintain personal hygiene. We assessed the relationship between homelessness, personal hygiene, and MRSA nasal colonization, a proxy for MRSA infection risk, in a study of PWID in Boston, MA (n = 78). Sleeping in a homeless shelter for at least one night in the last 3 months was significantly associated with MRSA nasal colonization (OR 3.0; p = 0.02; 95% CI 1.2, 7.6). Sleeping at more than one place during the last week (considered a metric of elevated housing instability) was also associated with a threefold increase in odds of MRSA nasal colonization (OR 3.1; p = 0.01; 95% CI 1.3, 7.6). MRSA nasal colonization was strongly associated with use of public showers (OR 13.7; p = 0.02; 95% CI 1.4, 132.8), although few people in this study (4 of 78) reported using these public facilities. Sharing bedding with other people was also associated with increased risk of MRSA colonization (OR 2.2; p = 0.05; 95% CI 1.0-4.7). No associations between hand hygiene, frequency of bathing or clothes laundering, or street sleeping were observed. Use of public facilities supporting persons experiencing homelessness and housing instability, including shelters and public showers, is associated with an increased risk of MRSA nasal colonization in this study. Personal hygiene behaviors appear less associated with MRSA nasal colonization. Environmental assessments of MRSA contamination in homeless shelters and public sanitation facilities are warranted so as to inform appropriate intervention activities.

Reasons for Opioid Discontinuation and Unintended Consequences Following Opioid Discontinuation Within the TOPCARE Trial.

OBJECTIVE: To identify reasons for opioid discontinuation and post-discontinuation outcomes among patients in the Transforming Opioid Prescribing in Primary Care (TOPCARE) study. DESIGN: In TOPCARE, an intervention to improve adherence to opioid prescribing guidelines, randomized intervention primary care providers (PCPs) received nurse care manager support, an electronic registry, academic detailing, and electronic tools, and control PCPs received electronic tools only. SETTING: Four Boston safety net primary care practices. SUBJECTS: Patients in both TOPCARE study arms who discontinued opioid therapy during the trial. METHODS: Through chart review, we examined the reason for discontinuation and post-discontinuation outcomes: one or more PCP visits, one or more pain-related emergency department (ED) visits, evidence of opioid use disorder (OUD), and referral for OUD treatment. RESULTS: Opioid discontinuations occurred in 83/586 (14.2%) intervention and 42/399 (10.5%) control patients (P = 0.09). Among patients who discontinued opioids, 81 (65%) discontinued for misuse, with no difference by group (P = 0.38). Aberrancy in monitoring (e.g., discordant urine drug test results) was the most common type of misuse prompting discontinuation (occurring in (51/83 [61%] of intervention patients vs 19/42 [45%, P = 0.08] of control patients). Intervention patients who discontinued opioids had less PCP follow-up (65% vs 88%, P < 0.01) compared with control patients. We found no differences between groups for pain-related ED visits, evidence of OUD, or OUD treatment referral following discontinuation. CONCLUSIONS: The decreased follow-up among TOPCARE intervention patients who discontinued opioids highlights the need to understand unintended consequences of involuntary opioid discontinuations resulting from interventions to reduce opioid risk.

The provision of cell phones as a recruitment and retention strategy for people who inject drugs enrolling in a randomized trial.

BACKGROUND: Studies of drug-using populations often restrict enrollment by limiting participation to those with a working telephone. It is unknown whether supplying phones could broaden recruitment and sustain retention among an urban population of people who inject drugs (PWID). We compare the feasibility of offering pay-by-month phones to gift card compensation as part of an ongoing randomized controlled trial of hospitalized PWID. METHODS: Participants were recruited from inpatient services at an urban hospital in Boston, MA to participate in an ongoing randomized trial testing a motivational interviewing (MI) intervention. Participants who did not have their own phone at the time of enrollment were offered a pay-by-month phones as compensation for study participation. RESULTS: Eighty-one participants met study criteria, were enrolled, and completed the study at the time of analysis. We used a generalized estimating equation to compare the overall likelihood of attending interviews during the 12-month follow-up period. Participants receiving phones tended to have lower mean educational attainment (11.4 years vs. 12.1 years), were significantly (Fisher's exact p < 0.001) more likely to report homelessness during the past 90 days (86.7% vs. 37.3%), and were significantly less likely (Fisher's exact p = .044) to be employed (3.3% vs. 20.4%) compared to those receiving gift cards. Participants in each group were equally likely to attend follow-up interviews during the study (83.3% vs. 88.3%, p = 0.53). CONCLUSION: Offering phones as a compensation method allows recruitment of a more disenfranchised population without impacting study retention and therefore may improve generalizability of study results.

Improving Adherence to Long-term Opioid Therapy Guidelines to Reduce Opioid Misuse in Primary Care: A Cluster-Randomized Clinical Trial.

Importance: Prescription opioid misuse is a national crisis. Few interventions have improved adherence to opioid-prescribing guidelines. Objective: To determine whether a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE; http://mytopcare.org/), improves guideline adherence while decreasing opioid misuse risk. Design, Setting, and Participants: Cluster-randomized clinical trial among 53 primary care clinicians (PCCs) and their 985 patients receiving long-term opioid therapy for pain. The study was conducted from January 2014 to March 2016 in 4 safety-net primary care practices. Interventions: Intervention PCCs received nurse care management, an electronic registry, 1-on-1 academic detailing, and electronic decision tools for safe opioid prescribing. Control PCCs received electronic decision tools only. Main Outcomes and Measures: Primary outcomes included documentation of guideline-concordant care (both a patient-PCC agreement in the electronic health record and at least 1 urine drug test [UDT]) over 12 months and 2 or more early opioid refills. Secondary outcomes included opioid dose reduction (ie, 10% decrease in morphine-equivalent daily dose [MEDD] at trial end) and opioid treatment discontinuation. Adjusted outcomes controlled for differing baseline patient characteristics: substance use diagnosis, mental health diagnoses, and language. Results: Of the 985 participating patients, 519 were men, and 466 were women (mean [SD] patient age, 54.7 [11.5] years). Patients received a mean (SD) MEDD of 57.8 (78.5) mg. At 1 year, intervention patients were more likely than controls to receive guideline-concordant care (65.9% vs 37.8%; P < .001; adjusted odds ratio [AOR], 6.0; 95% CI, 3.6-10.2), to have a patient-PCC agreement (of the 376 without an agreement at baseline, 53.8% vs 6.0%; P < .001; AOR, 11.9; 95% CI, 4.4-32.2), and to undergo at least 1 UDT (74.6% vs 57.9%; P < .001; AOR, 3.0; 95% CI, 1.8-5.0). There was no difference in odds of early refill receipt between groups (20.7% vs 20.1%; AOR, 1.1; 95% CI, 0.7-1.8). Intervention patients were more likely than controls to have either a 10% dose reduction or opioid treatment discontinuation (AOR, 1.6; 95% CI, 1.3-2.1; P < .001). In adjusted analyses, intervention patients had a mean (SE) MEDD 6.8 (1.6) mg lower than controls (P < .001). Conclusions and Relevance: A multicomponent intervention improved guideline-concordant care but did not decrease early opioid refills. Trial Registration: clinicaltrials.gov Identifier: NCT01909076.

Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.

BACKGROUND: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. OBJECTIVE: To determine whether yoga is noninferior to PT for cLBP. DESIGN: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: 320 predominantly low-income, racially diverse adults with nonspecific cLBP. INTERVENTION: Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. MEASUREMENTS: Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. RESULTS: One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. LIMITATIONS: Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. CONCLUSION: A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. PRIMARY FUNDING SOURCE: National Center for Complementary and Integrative Health of the National Institutes of Health.

"We're all in this together": A qualitative study of predominantly low income minority participants in a yoga trial for chronic low back pain.

OBJECTIVE: To explore the experiences of low-income minority adults taking part in a yoga dosing trial for chronic low back pain. DESIGN: Individual semi-structured interviews were conducted with nineteen participants recruited from a randomized yoga dosing trial for predominantly low-income minority adults with chronic low back pain. Interviews discussed the impact of yoga on low back pain and emotions; other perceived advantages or disadvantages of the intervention; and facilitators and barriers to practicing yoga. Interviews were audio taped and transcribed, coded using ATLAS.ti software, and analyzed with inductive and deductive thematic analysis methods. SETTING: Boston Medical Center, Boston, MA, USA. RESULTS: Participants viewed yoga as a means of pain relief and attributed improved mood, greater ability to manage stress, and enhanced relaxation to yoga. Overall, participants felt empowered to self-manage their pain. Some found yoga to be helpful in being mindful of their emotions and accepting of their pain. Trust in the yoga instructors was a commonly cited facilitator for yoga class attendance. Lack of time, motivation, and fear of injury were reported barriers to yoga practice. CONCLUSIONS: Yoga is a multidimensional treatment for low back pain that has the potential to favorably impact health in a predominantly low-income minority population.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. METHODS/DESIGN: This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial.

Background. Previous studies have demonstrated that once-weekly yoga classes are effective for chronic low back pain (cLBP) in white adults with high socioeconomic status. The comparative effectiveness of twice-weekly classes and generalizability to racially diverse low income populations are unknown. Methods. We conducted a 12-week randomized, parallel-group, dosing trial for 95 adults recruited from an urban safety-net hospital and five community health centers comparing once-weekly (n = 49) versus twice-weekly (n = 46) standardized yoga classes supplemented by home practice. Primary outcomes were change from baseline to 12 weeks in pain (11-point scale) and back-related function (23-point modified Roland-Morris Disability Questionnaire). Results. 82% of participants were nonwhite; 77% had annual household incomes <$40,000. The sample's baseline mean pain intensity [6.9 (SD 1.6)] and function [13.7 (SD 5.0)] reflected moderate to severe back pain and impairment. Pain and back-related function improved within both groups (P < 0.001). However, there were no differences between once-weekly and twice-weekly groups for pain reduction [-2.1 (95% CI -2.9, -1.3) versus -2.4 (95% CI -3.1, -1.8), P = 0.62] or back-related function [-5.1 (95% CI -7.0, -3.2) versus -4.9 (95% CI -6.5, -3.3), P = 0.83]. Conclusions. Twelve weeks of once-weekly or twice-weekly yoga classes were similarly effective for predominantly low income minority adults with moderate to severe chronic low back pain. This trial is registered with ClinicalTrials.gov NCT01761617.