Use of electronic health record data to examine administrations of pro re nata analgesics during hip fracture post-acute care.

PURPOSE: Medications prescribed to older adults in US skilled nursing facilities (SNF) and administrations of pro re nata (PRN) "as needed" medications are unobservable in Medicare insurance claims. There is an ongoing deficit in our understanding of medication use during post-acute care. Using SNF electronic health record (EHR) datasets, including medication orders and barcode medication administration records, we described patterns of PRN analgesic prescribing and administrations among SNF residents with hip fracture. METHODS: Eligible participants resided in SNFs owned by 11 chains, had a diagnosis of hip fracture between January 1, 2018 to August 2, 2021, and received at least one administration of an analgesic medication in the 100 days after the hip fracture. We described the scheduling of analgesics, the proportion of available PRN doses administered, and the proportion of days with at least one PRN analgesic administration. RESULTS: Among 24 038 residents, 57.3% had orders for PRN acetaminophen, 67.4% PRN opioids, 4.2% PRN non-steroidal anti-inflammatory drugs, and 18.6% PRN combination products. The median proportion of available PRN doses administered per drug was 3%-50% and the median proportion of days where one or more doses of an ordered PRN analgesic was administered was 25%-75%. Results differed by analgesic class and the number of administrations ordered per day. CONCLUSIONS: EHRs can be leveraged to ascertain precise analgesic exposures during SNF stays. Future pharmacoepidemiology studies should consider linking SNF EHRs to insurance claims to construct a longitudinal history of medication use and healthcare utilization prior to and during episodes of SNF care.

Intensive longitudinal assessment following index trauma to predict development of PTSD using machine learning.

There are significant challenges to identifying which individuals require intervention following exposure to trauma, and a need for strategies to identify and provide individuals at risk for developing PTSD with timely interventions. The present study seeks to identify a minimal set of trauma-related symptoms, assessed during the weeks following traumatic exposure, that can accurately predict PTSD. Participants were 2185 adults (Mean age=36.4 years; 64% women; 50% Black) presenting for emergency care following traumatic exposure. Participants received a 'flash survey' with 6-8 varying symptoms (from a pool of 26 trauma symptoms) several times per week for eight weeks following the trauma exposure (each symptom assessed ∼6 times). Features (mean, sd, last, worst, peak-end scores) from the repeatedly assessed symptoms were included as candidate variables in a CART machine learning analysis to develop a pragmatic predictive algorithm. PTSD (PCL-5 ≥38) was present for 669 (31%) participants at the 8-week follow-up. A classification tree with three splits, based on mean scores of nervousness, rehashing, and fatigue, predicted PTSD with an Area Under the Curve of 0.836. Findings suggest feasibility for a 3-item assessment protocol, delivered once per week, following traumatic exposure to assess and potentially facilitate follow-up care for those at risk.

Comparative safety of tramadol and other opioids following total hip and knee arthroplasty.

BACKGROUND: Tramadol is increasingly used to treat acute postoperative pain among older adults following total hip and knee arthroplasty (THA/TKA). However, tramadol has a complex pharmacology and may be no safer than full opioid agonists. We compared the safety of tramadol, oxycodone, and hydrocodone among opioid-naïve older adults following elective THA/TKA. METHODS: This retrospective cohort included Medicare Fee-for-Service beneficiaries ≥ 65 years with elective THA/TKA between January 1, 2010 and September 30, 2015, 12 months of continuous Parts A and B enrollment, 6 months of continuous Part D enrollment, and no opioid use in the 6 months prior to THA/TKA. Participants initiated single-opioid therapy with tramadol, oxycodone, or hydrocodone within 7 days of discharge from THA/TKA hospitalization, regardless of concurrently administered nonopioid analgesics. Outcomes of interest included all-cause hospitalizations or emergency department visits (serious adverse events (SAEs)) and a composite of 10 surgical- and opioid-related SAEs within 90-days of THA/TKA. The intention-to-treat (ITT) and per-protocol (PP) hazard ratios (HRs) for tramadol versus other opioids were estimated using inverse-probability-of-treatment-weighted pooled logistic regression models. RESULTS: The study population included 2,697 tramadol, 11,407 oxycodone, and 14,665 hydrocodone initiators. Compared to oxycodone, tramadol increased the rate of all-cause SAEs in ITT analyses only (ITT HR 1.19, 95%CLs, 1.02, 1.41; PP HR 1.05, 95%CLs, 0.86, 1.29). Rates of composite SAEs were not significant across comparisons. Compared to hydrocodone, tramadol increased the rate of all-cause SAEs in the ITT and PP analyses (ITT HR 1.40, 95%CLs, 1.10, 1.76; PP HR 1.34, 95%CLs, 1.03, 1.75), but rates of composite SAEs were not significant across comparisons. CONCLUSIONS: Postoperative tramadol was associated with increased rates of all-cause SAEs, but not composite SAEs, compared to oxycodone and hydrocodone. Tramadol does not appear to have a superior safety profile and should not be preferentially prescribed to opioid-naïve older adults following THA/TKA.

Long-Term Care Pharmacy Market Shares and Differences in Skilled Nursing Facilities Served.

Medications and pharmacy services are critical to post-acute care (PAC) in skilled nursing facilities (SNFs), yet little is known about the long-term care (LTC) pharmacies that provide them. We estimated the market shares of LTC pharmacies and how SNFs differed between pharmacies. This cross-sectional study used data from SNFs that provided PAC services in Rhode Island (RI) in 2019. We applied the parametric g-formula to compare SNF pharmacy-related deficiencies and medication use measures between LTC pharmacies while standardizing for SNF membership in a chain and number of beds. Among 75 SNFs, 68 (91%) were served by either Omnicare (n = 32, 43%) or PharMerica (n = 36, 48%), and 7 (9%) by other LTC pharmacies. After covariate adjustment, PharMerica SNFs had the lowest prevalences of any pharmacy-related deficiency (PharMerica, 63.2%; Omnicare, 80.2%; other LTC pharmacy, 69.1%) and antianxiety medication use (PharMerica, 9.7%; Omnicare, 13.6%; other LTC pharmacy, 13.5%), but estimates were imprecise. The RI market is highly concentrated between LTC pharmacies. If similarly high LTC pharmacy market concentration exists nationally, there is enormous promise for efficiently delivering interventions to improve medication management in SNFs. However, it may also present a risk of harm if policies do not maintain sufficient competition and innovation is stifled.

Little is known about long-term care pharmacies serving skilled nursing facilitiesThese pharmacies may have a strong influence on quality of care and outcomesTwo pharmacies dominate 91% of the Rhode Island skilled nursing facility marketSkilled beds, pharmacy deficiencies, and medication use may differ by pharmacyPharmacy market concentration creates opportunities for both big benefits and harms.

Long-term health care costs following COVID-19: implications for pandemic preparedness.

OBJECTIVES: To estimate excess health care costs in the 12 months following COVID-19 diagnosis. STUDY DESIGN: Retrospective cohort study using Blue Cross Blue Shield of Rhode Island claims incurred from January 1, 2019, to March 31, 2022, among commercial and Medicare Advantage members. METHODS: Difference-in-differences analyses were used to compare changes in health care spend between the 12 months before (baseline period) and the 12 months after (post period) COVID-19 diagnosis for COVID-19 cases and contemporaneous matched controls without COVID-19. RESULTS: Overall, there were 7224 commercial and 1630 Medicare Advantage members with a COVID-19 diagnosis on/before March 31, 2021, each with a matched control, yielding a sample of 14,448 commercial and 3260 Medicare Advantage members. Among commercial members, 51.9% were aged 25 to 54 years and 54.0% were female. Among Medicare Advantage members, 94.2% were 65 years or older and 62.0% were female. Among commercial members, from the baseline period to the post period, total health care spend increased $41.61 (7.7%) per member per month (PMPM) more among COVID-19 cases compared with their matched controls. Among Medicare Advantage members, the difference-in-differences was greater, with spend increasing $97.30 (13.1%) PMPM more among cases compared with controls. The difference-in-differences was greatest for outpatient and professional services (both populations) and prescription services (Medicare Advantage only). CONCLUSIONS: COVID-19 diagnosis was associated with excess health care spend PMPM over the subsequent 12 months, highlighting the importance of societal preparations to support individuals' long-term health care needs following COVID-19 and as a part of future pandemic preparedness.

Gene therapies for sickle cell disease: Effectiveness and value.

DISCLOSURES: Drs. Nikitin, McKenna, Rind, Nhan, and Pearson report grants from Arnold Ventures, grants from Blue Cross Blue Shield of MA, grants from California Healthcare Foundation, grants from The Commonwealth Fund, grants from The Patrick and Catherine Weldon Donaghue Medical Research Foundation, during the conduct of the study; other from America's Health Insurance Plans, other from Anthem, other from AbbVie, other from Alnylam, other from AstraZeneca, other from Biogen, other from Blue Shield of CA, other from CVS, other from Editas, other from Express Scripts, other from Genentech/Roche, other from GlaxoSmithKline, other from Harvard Pilgrim, other from Health Care Service Corporation, other from Kaiser Permanente, other from LEO Pharma, other from Mallinckrodt, other from Merck, other from Novartis, other from National Pharmaceutical Council, other from Premera, other from Prime Therapeutics, other from Regeneron, other from Sanofi, other from United Healthcare, other from HealthFirst, other from Pfizer, other from Boehringer-Ingelheim, other from uniQure, other from Envolve Pharmacy Solutions, other from Humana, other from Sunlife, outside the submitted work.

Evaluation of post-acute care and one-year outcomes among Medicare beneficiaries with hip fractures: a retrospective cohort study.

BACKGROUND: Post-acute care (PAC) services after hospitalization for hip fracture are typically provided in skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), or at home via home health care (HHC). Little is known about the clinical course following PAC for hip fracture. We examined the nationwide burden of adverse outcomes by PAC setting in the year following discharge from PAC for hip fracture. METHODS: This retrospective cohort included Medicare Fee-for-Service beneficiaries > 65 years who received PAC services in U.S. SNFs, IRFs, or HHC following hip fracture hospitalization between 2012 and 2018. Individuals who had a fall-related injury (FRI) during PAC or received PAC services in multiple settings were excluded. Primary outcomes included FRIs, all-cause hospital readmissions, and death in the year following discharge from PAC. Cumulative incidences and incidence rates for adverse outcomes were reported by PAC setting. Exploratory analyses examined risk ratios and hazard ratios between settings before and after inverse-probability-of-treatment-weighting, which accounted for 43 covariates. RESULTS: Among 624,631 participants (SNF, 67.78%; IRF, 16.08%; HHC, 16.15%), the mean (standard deviation) age was 82.70 (8.26) years, 74.96% were female, and 91.30% were non-Hispanic White. Crude incidence rates (95%CLs) per 1000 person-years were highest among individuals receiving SNF care for FRIs (SNF, 123 [121, 123]; IRF, 105 [102, 107]; HHC, 89 [87, 91]), hospital readmission (SNF, 623 [619, 626]; IRF, 538 [532, 544]; HHC, 418 [414, 423]), and death (SNF, 167 [165, 169]; IRF, 47 [46, 49]; HHC, 55 [53, 56]). Overall, rates of adverse outcomes generally remained higher among SNF care recipients after covariate adjustment. However, inferences about the group with greater adverse outcomes differed for FRIs and hospital readmissions based on risk ratio or hazard ratio estimates. CONCLUSIONS: In this retrospective cohort study of individuals hospitalized for hip fracture, rates of adverse outcomes in the year following PAC were common, especially among SNF care recipients. Understanding risks and rates of adverse events can inform future efforts to improve outcomes for older adults receiving PAC for hip fracture. Future work should consider calculating risk and rate measures to assess the influence of differential time under observation across PAC groups.

Post-Acute Care Setting After Hip Fracture Hospitalization and Subsequent Opioid Use in Older Adults.

OBJECTIVE: Pain management in post-acute care (PAC) requires careful balance, with both opioid use and inadequate pain treatment linked to poor outcomes. We describe opioid use among older adults following discharge from PAC for hip fracture in skilled nursing facilities (SNFs) and inpatient rehabilitation facilities (IRFs). DESIGN: Retrospective cohort. SETTING AND PARTICIPANTS: Medicare beneficiaries with Medicare Provider Analysis (MedPAR) claims, aged 66 years and older with a hip fracture hospitalization between 2012 and 2018 followed by PAC in SNFs or IRFs and then discharge to the community. METHODS: Individuals were followed from PAC discharge for up to 1 year to assess opioid use. Covariate-standardized risk ratios (RR) and risk differences (RD) for opioid use within 7 days of PAC discharge were estimated via parametric g-formula with modified Poisson regression, and hazard ratios (HRs) for any post-PAC opioid use and long-term opioid use via Fine-Gray sub-distribution hazards regression. RESULTS: Of 101,021 individuals, 80% (n = 80,495) were discharged from SNFs and 20% (n = 20,526) from IRFs. Opioids were dispensed to 50,433 patients (50%) overall and the 1-year cumulative incidence was notably higher in IRF (68%) than SNF (46%) patients. The adjusted risk of discharge from PAC with an opioid was 41% lower after SNFs versus IRFs [RR: 0.59; 95% confidence limits (CLs): 0.57-0.61; and RD: -0.16; 95% CLs: -0.17 to -0.15]. The adjusted rate of any opioid use in the year after PAC discharge was 44% lower (HR: 0.56; 95% CLs: 0.54-0.57) and of long-term opioid use was 17% lower (HR: 0.83; 95% CLs: 0.80-0.87) after SNFs versus IRFs. CONCLUSIONS AND IMPLICATIONS: Opioid use is highly prevalent upon discharge from PAC after hip fracture, with lower use after SNF versus IRF care. Future research should assess the benefits and harms of post-PAC opioid prescribing and whether care practices during PAC can be improved to optimize long-term opioid use.

Utility of Wrist-Wearable Data for Assessing Pain, Sleep, and Anxiety Outcomes After Traumatic Stress Exposure.

Importance: Adverse posttraumatic neuropsychiatric sequelae after traumatic stress exposure are common and have higher incidence among socioeconomically disadvantaged populations. Pain, depression, avoidance of trauma reminders, reexperiencing trauma, anxiety, hyperarousal, sleep disruption, and nightmares have been reported. Wrist-wearable devices with accelerometers capable of assessing 24-hour rest-activity characteristics are prevalent and may have utility in measuring these outcomes. Objective: To evaluate whether wrist-wearable devices can provide useful biomarkers for recovery after traumatic stress exposure. Design, Setting, and Participants: Data were analyzed from a diverse cohort of individuals seen in the emergency department after experiencing a traumatic stress exposure, as part of the Advancing Understanding of Recovery After Trauma (AURORA) study. Participants recruited from 27 emergency departments wore wrist-wearable devices for 8 weeks, beginning in the emergency department, and completed serial assessments of neuropsychiatric symptoms. A total of 19 019 patients were screened. Of these, 3040 patients met study criteria, provided informed consent, and completed baseline assessments. A total of 2021 provided data from wrist-wearable devices, completed the 8-week assessment, and were included in this analysis. The data were randomly divided into 2 equal parts (n = 1010) for biomarker identification and validation. Data were collected from September 2017 to January 2020, and data were analyzed from May 2020 to November 2022. Exposures: Participants were recruited for the study after experiencing a traumatic stress exposure (most commonly motor vehicle collision). Main Outcomes and Measures: Rest-activity characteristics were derived and validated from wrist-wearable devices associated with specific self-reported symptom domains at a point in time and changes in symptom severity over time. Results: Of 2021 included patients, 1257 (62.2%) were female, and the mean (SD) age was 35.8 (13.0) years. Eight wrist-wearable device biomarkers for symptoms of adverse posttraumatic neuropsychiatric sequelae exceeded significance thresholds in the derivation cohort. One of these, reduced 24-hour activity variance, was associated with greater pain severity (r = -0.14; 95% CI, -0.20 to -0.07). Changes in 6 rest-activity measures were associated with changes in pain over time, and changes in the number of transitions between sleep and wake over time were associated with changes in pain, sleep, and anxiety. Simple cutoffs for these biomarkers identified individuals with good recovery for pain (positive predictive value [PPV], 0.85; 95% CI, 0.82-0.88), sleep (PPV, 0.63; 95% CI, 0.59-0.67, and anxiety (PPV, 0.76; 95% CI, 0.72-0.80) with high predictive value. Conclusions and Relevance: These findings suggest that wrist-wearable device biomarkers may have utility as screening tools for pain, sleep, and anxiety symptom outcomes after trauma exposure in high-risk populations.

The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography.

BACKGROUND: Psychosocial interventions are needed to enhance patient engagement and retention in medication treatment within opioid treatment programs. Measurement-based care (MBC), an evidence-based intervention structure that involves ongoing monitoring of treatment progress over time to assess the need for treatment modifications, has been recommended as a flexible and low-cost intervention for opioid treatment program use. The MBC2OTP Project is a two-phase pilot hybrid type 1 effectiveness-implementation trial that has three specific aims: (1) to employ Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) to collect mixed methods data to inform MBC implementation; (2) to use RAPICE data to adapt an MBC protocol; and (3) to conduct a hybrid type 1 trial to evaluate MBC's preliminary effectiveness and implementation potential in opioid treatment programs. METHODS: This study will be conducted in two phases. Phase 1 will include RAPICE site visits, qualitative interviews (N = 32-48 total), and quantitative surveys (N = 64-80 total) with staff at eight programs to build community partnerships and evaluate contextual factors impacting MBC implementation. Mixed methods data will be analyzed using immersion/crystallization and thematic analysis to inform MBC adaptation and site selection. Four programs selected for Phase 2 will participate in MBC electronic medical record integration, training, and ongoing support. Chart reviews will be completed in the 6 months prior-to and following MBC integration (N = 160 charts, 80 pre and post) to evaluate effectiveness (patient opioid abstinence and treatment engagement) and implementation outcomes (counselor MBC exposure and fidelity). DISCUSSION: This study is among the first to take forward recommendations to implement and evaluate MBC in opioid treatment programs. It will also employ an innovative RAPICE approach to enhance the quality and rigor of data collection and inform the development of an MBC protocol best matched to opioid treatment programs. Overall, this work seeks to enhance treatment provision and clinical outcomes for patients with opioid use disorder. Trial registration This study will be registered with Clinicaltrials.gov within 21 days of first participant enrollment in Phase 2. Study Phase 1 (RAPICE) does not qualify as a clinical trial, therefore Phase 2 clinical trial registration has not yet been pursued because all elements of Phase 2 will be dependent on Phase 1 outcomes.

Comparing Treatment Response Between Older and Younger Patients with Chronic Hepatitis C Virus Infection on Direct-acting Antiviral Agents.

OBJECTIVE: To compare sustained virologic response 12 weeks post-treatment completion (SVR12) and patient characteristics for older versus younger patients with chronic hepatitis C virus infection (HCV) receiving direct-acting antiviral (DAA) agent therapy. METHODS: This retrospective cohort study included patients with chronic HCV who received DAA therapy, between 2015 and 2018, in the largest health system in Rhode Island (N=154). Patient characteristics, comorbid diagnoses, and SVR12 status were compared between older (aged ≥60 years) and younger (<60 years) adults using chi-squared tests. RESULTS: Overall, 94.1% (95% CI: 90.4-97.8) achieved SVR12; response rates were 91.8% (95% CI: 84.9-98.6) for older adults and 95.6% (95% CI: 91.5-99.8) for younger adults (p=0.51). CONCLUSIONS: Our findings refute the historical notion that older adults were a "difficult-to-treat" subpopulation for whom clinicians should expect less treatment success. This is no longer the case with DAA therapy.

Pain Treatments After Hip Fracture Among Older Nursing Home Residents.

OBJECTIVES: To examine the association between use of opioids versus other analgesics with death and functioning after hip fracture in older nursing home (NH) residents. DESIGN: Retrospective cohort using national Medicare fee-for-service claims linked to the Minimum Data Set. SETTING: US NHs. PARTICIPANTS: NH residents aged ≥65 years who became a long-stay resident (>100 days in the NH) between January 2008 and December 2009, had a hospitalized hip fracture, and returned to the NH. EXPOSURE: New use of opioid versus nonopioid analgesics (acetaminophen or nonsteroidal anti-inflammatory drugs) within 14 days post hip fracture. MEASUREMENTS: Follow-up began on the index date and continued until the first occurrence of death, significant functional decline (3-point increase on MDS Activities of Daily Living scale), or 120 days of follow-up. Odds ratios (ORs) with 95% confidence intervals (CIs) for outcomes were estimated using inverse probability of treatment-weighted multinomial logistic regression models. RESULTS: Among the 2755 NH residents with a hip fracture included in our study, 1155 (41.9%) were opioid users, and 1600 (58.1%) were nonopioid analgesic users. The mean age was 86.3 years, 73.8% were female, and 86.0% were white. Opioid use was associated with a significantly lower likelihood of death (OR = 0.47, 95% CI 0.39-0.56) and a nonsignificant decrease in functional decline (OR = 0.77, 95% CI 0.58-1.03). CONCLUSION: A rigorous study that addresses the limitations of this study is critical to validate our preliminary findings and provide evidence about the effect of using opioid versus nonopioid analgesics to optimize acute pain in NH residents with a hip fracture.

State-level and system-level opioid prescribing policies: The impact on provider practices and overdose deaths, a systematic review.

OBJECTIVE: In response to persistent public health concerns regarding prescription opioids, many states and healthcare systems have implemented legislation and policies intended to regulate or guide opioid prescribing. The overall impact of these policies is still uncertain. The aim of this systematic review was to examine the existing evidence of provider-level and patient-level outcomes preimplementation and postimplementation of policies and legislation constructed to impact provider prescribing practices around opioid analgesics. DESIGN: A systematic search of MEDLINE, EMBASE, the Web of Science, and the Cochrane Database of Systematic Reviews was conducted to identify studies evaluating the impact of opioid prescribing policies on provider-level and patient-level outcomes. The systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Eleven studies were included in the review. A meta-analysis was not possible due to between-study heterogeneity. Six of the studies assessed state-level policies, and five were at the level of the healthcare system or hospital. Studies showed temporal associations between policy implementation and reductions in opioid prescribing, as well as opioid-related overdoses. Results were mixed regarding the impact of policies on misuse. The majority of the studies were judged to be of low quality based on the GRADE criteria. CONCLUSIONS: There is low to moderate quality evidence suggesting that the presence of opioid prescribing policy will reduce the amount and strength of opioid prescribed. The presence of these policies may impact the number of overdoses, but there is no clear evidence to suggest that it reduces opioid misuse.

A research agenda for gender and substance use disorders in the emergency department.

For many years, gender differences have been recognized as important factors in the etiology, pathophysiology, comorbidities, and treatment needs and outcomes associated with the use of alcohol, drugs, and tobacco. However, little is known about how these gender-specific differences affect ED utilization; responses to ED-based interventions; needs for substance use treatment and barriers to accessing care among patients in the ED; or outcomes after an alcohol-, drug-, or tobacco-related visit. As part of the 2014 Academic Emergency Medicine consensus conference on "Gender-Specific Research in Emergency Care: Investigate, Understand and Translate How Gender Affects Patient Outcomes," a breakout group convened to generate a research agenda on priority questions related to substance use disorders.