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Mild traumatic brain injury (TBI) is associated with persistent sleep-wake dysfunction, including insomnia and circadian rhythm disruption, which can exacerbate functional outcomes including mood, pain, and quality of life. Present therapies to treat sleep-wake disturbances in those with TBI (e.g., cognitive behavioral therapy for insomnia) are limited by marginal efficacy, poor patient acceptability, and/or high patient/provider burden. Thus, this study aimed to assess the feasibility and preliminary efficacy of morning bright light therapy, to improve sleep in Veterans with TBI (NCT03578003). Thirty-three Veterans with history of TBI were prospectively enrolled in a single-arm, open-label intervention using a lightbox (~10,000 lux at the eye) for 60-minutes every morning for 4-weeks. Pre- and post-intervention outcomes included questionnaires related to sleep, mood, TBI, post-traumatic stress disorder (PTSD), and pain; wrist actigraphy as a proxy for objective sleep; and blood-based biomarkers related to TBI/sleep. The protocol was rated favorably by ~75% of participants, with adherence to the lightbox and actigraphy being ~87% and 97%, respectively. Post-intervention improvements were observed in self-reported symptoms related to insomnia, mood, and pain; actigraphy-derived measures of sleep; and blood-based biomarkers related to peripheral inflammatory balance. The severity of comorbid PTSD was a significant positive predictor of response to treatment. Morning bright light therapy is a feasible and acceptable intervention that shows preliminary efficacy to treat disrupted sleep in Veterans with TBI. A full-scale randomized, placebo-controlled study with longitudinal follow-up is warranted to assess the efficacy of morning bright light therapy to improve sleep, biomarkers, and other TBI related symptoms.

For patients with opioid use disorder (OUD), medications for OUD (MOUD) reduce morbidity, mortality, and return to use. Nevertheless, a minority of patients receive MOUD, and underutilization is pronounced among rural patients. While Veterans Health Administration (VHA) initiatives have improved MOUD access overall, it is unknown whether access has improved in rural VA health systems specifically. How \"Community Care,\" healthcare paid for by VHA but received from non-VA providers, has affected rural access is also unknown. Data for this observational study were drawn from the VHA Corporate Data Warehouse. Facility rurality was defined by rural-urban commuting area code of the primary medical center. International Classification of Diseases codes identified patients with OUD within each year, 2015-2020. We included MOUD (buprenorphine, methadone, extended-release naltrexone) received from VHA or paid for by VHA but received at non-VA facilities through Community Care. We calculated average yearly MOUD receipt; linear regression of outcomes on study years identified trends; an interaction between year and rural status evaluated trend differences over time. All 129 VHA Health Systems, a designation that encompasses one or more medical centers and their affiliated community-based outpatient clinics MAIN MEASURES: The average proportion of patients diagnosed with OUD that receive MOUD within rural versus urban VHA health care systems. From 2015 to 2020, MOUD access increased substantially: the average proportion of patients receiving MOUD increased from 34.6 to 48.9%, with a similar proportion of patients treated with MOUD in rural and urban systems in all years. Overall, a small proportion (1.8%) of MOUD was provided via Community Care, and Community Care did not disproportionately benefit rural health systems. Strategies utilized by VHA could inform other health care systems seeking to ensure that, regardless of geographic location, all patients are able to access MOUD.

Background Rheumatoid arthritis (RA) impacts quality of life causing disability and increased mortality. Treatment decisions are complex and require individualization. Shared decision making (SDM) is the first principle of RA treat-to-target guidelines, but uptake is suboptimal. We aim to evaluate the effectiveness of a multicomponent SDM intervention on RA disease activity and explore the early implementation of the intervention within three geographically diverse rheumatology services. Methods The RAiSeD trial uses a stepped-wedge, cluster-randomized trial design at three U.S. Veterans Health Administration rheumatology clinics, targeted to enroll more than 400 patients and over 45 clinicians. The multicomponent SDM intervention consists of three parts: (1) rheumatology clinician training and a pocket card on SDM and fostering choice awareness (“acknowledging when there is more than one sensible option available to address a patient’s situation”), (2) RA patient activation using the AskShareKnow questions, and (3) a point-of-care decision aid (RA Choice) and medication summary guide. We will conduct a mixed-methods outcomes and process evaluation. Outcomes will be evaluated during a pre-intervention (usual care) and intervention period. The primary outcome is disease activity as measured by the validated Clinical Disease Activity Index (CDAI), with secondary outcomes of RA knowledge and medication adherence. SDM will be measured by two brief, validated patient-reported measures. A subgroup of clinic visits will be audio-recorded and clinicians’ efforts to involve patients in SDM will be assessed. The implementation process will be evaluated using stakeholder interviews and field notes at each of the three sites. Discussion This study is the first multi-site trial of a multicomponent intervention to facilitate SDM among veterans with RA. We expect to improve uptake of SDM across geographically distinct rheumatology clinics and hypothesize that patients exposed to the interventions will have a greater decrease in disease activity and an increase in knowledge of RA medications compared to usual care. Insights gained from this study will inform broader dissemination and implementation of SDM across VA rheumatology clinics and beyond, with the goal of improving quality of care for all persons with RA. Trial registration ClinicalTrials.gov NCT05530694. Registered on September 7, 2022.

Sleep-wake disturbances frequently present in Veterans with mild traumatic brain injury (mTBI). These TBI-related sleep impairments confer significant burden and commonly exacerbate other functional impairments. Therapies to improve sleep following mTBI are limited and studies in Veterans are even more scarce. In our previous pilot work, morning bright light therapy (MBLT) was found to be a feasible behavioral sleep intervention in Veterans with a history of mTBI; however, this was single-arm, open-label, and non-randomized, and therefore was not intended to establish efficacy. The present study, LION (light vs ion therapy) extends this preliminary work as a fully powered, sham-controlled, participant-masked randomized controlled trial (NCT03968874), implemented as fully remote within the VA (target n = 120 complete). Randomization at 2:1 allocation ratio to: 1) active: MBLT (n = 80), and 2) sham: deactivated negative ion generator (n = 40); each with identical engagement parameters (60-min duration; within 2-hrs of waking; daily over 28-day duration). Participant masking via deception balanced expectancy assumptions across arms. Outcome measures were assessed following a 14-day baseline (pre-intervention), following 28-days of device engagement (post-intervention), and 28-days after the post-intervention assessment (follow-up). Primary outcomes were sleep measures, including continuous wrist-based actigraphy, self-report, and daily sleep dairy entries. Secondary/exploratory outcomes included cognition, mood, quality of life, circadian rhythm via dim light melatonin onset, and biofluid-based biomarkers. Participant drop out occurred in <10% of those enrolled, incomplete/missing data was present in <15% of key outcome variables, and overall fidelity adherence to the intervention was >85%, collectively establishing feasibility and acceptability for MBLT in Veterans with mTBI.

Background Despite demonstrated efficacy, medication treatment for opioid use disorder (MOUD) remain inaccessible to many patients, with barriers identified at the individual, clinic and system level. A wide array of implementation strategies have guided efforts to expand access to MOUD, with most centered around externally-facilitated approaches to practice change. While effective, such approaches may be inaccessible to those clinics and systems that lack the resources necessary to partner with an external team, suggesting a need to identify and describe change-processes that are internally developed and promoted. Methods Guided by the Consolidated Framework for Implementation Research (CFIR), we utilized qualitative interviews and ethnographic observation to investigate the planning, design and implementation of a locally-initiated process to expand access to MOUD within one health care system. All study documents were coded by a primary coder and secondary reviewer using a codebook designed for use with the CFIR. To analyze data, we reviewed text tagged by key codes, compared these textual excerpts both across and within documents, and organized findings into themes. Processes identified were mapped to established implementation science constructs and strategies. Results Interviews with clinicians and administrators (n = 9) and ethnographic observation of planning meetings (n = 3) revealed how a self-appointed local team developed, established broad support for, and successfully implemented a Primary Care-based Buprenorphine Clinic and E-Consult Service to expand access to MOUD to patients across the health care system. First, national and local policy changes—including altered clinical practice guidelines, performance pay incentives regarding opioid prescribing, and a directive from VA Central Office increased individual staff and administrators’ perception of the need for change and willingness to invest time and resources. Then, a self-appointed interdisciplinary team utilized cross-clinic meetings and information gathering to identify appropriate, and widely supported, models of care delivery and care consultation. Finally, the team increased staff investment in these change efforts by bringing them into the planning process and encouraging collaborative problem solving. Conclusions This study reveals how a local team developed and built widespread support for new processes of care that were tailored to local needs and well-positioned for sustainability over time.

Abstract Objective The purpose of this study is to examine the extent to which numeric rating scale (NRS) scores collected during usual care are associated with more robust and validated measures of pain, disability, mental health, and health-related quality of life (HRQOL). Design We conducted a secondary analysis of data from a prospective cohort study. Subjects We included 186 patients with musculoskeletal pain who were prescribed long-term opioid therapy. Setting VA Portland Health Care System outpatient clinic. Methods All patients had been screened with the 0–10 NRS during routine outpatient visits. They also completed research visits that assessed pain, mental health and HRQOL every 6 months for 2 years. Accounting for nonindependence of repeated measures data, we examined associations of NRS data obtained from the medical record with scores on standardized measures of pain and its related outcomes. Results NRS scores obtained in clinical practice were moderately associated with pain intensity scores (B’s = 0.53–0.59) and modestly associated with pain disability scores (B’s = 0.33–0.36) obtained by researchers. Associations between pain NRS scores and validated measures of depression, anxiety, and health related HRQOL were low (B’s = 0.09–0.26, with the preponderance of B’s < .20). Conclusions Standardized assessments of pain during usual care are moderately associated with research-administered measures of pain intensity and would be improved from the inclusion of more robust measures of pain-related function, mental health, and HRQOL.

BackgroundBiofeedback is increasingly used to treat clinical conditions in a wide range of settings; however, evidence supporting its use remains unclear. The purpose of this evidence map is to illustrate the conditions supported by controlled trials, those that are not, and those in need of more research.MethodsWe searched multiple data sources (MEDLINE, PsycINFO, CINAHL, Epistemonikos, and EBM Reviews through September 2018) for good-quality systematic reviews examining biofeedback for clinical conditions. We included the highest quality, most recent review representing each condition and included only controlled trials from those reviews. We relied on quality ratings reported in included reviews. Outcomes of interest were condition-specific, secondary, and global health outcomes, and harms. For each review, we computed confidence ratings and categorized reported findings as no effect, unclear, or insufficient; evidence of a potential positive effect; or evidence of a positive effect. We present our findings in the form of evidence maps.ResultsWe included 16 good-quality systematic reviews examining biofeedback alone or as an adjunctive intervention. We found clear, consistent evidence across a large number of trials that biofeedback can reduce headache pain and can provide benefit as adjunctive therapy to men experiencing urinary incontinence after a prostatectomy. Consistent evidence across fewer trials suggests biofeedback may improve fecal incontinence and stroke recovery. There is insufficient evidence to draw conclusions about effects for most conditions including bruxism, labor pain, and Raynaud’s. Biofeedback was not beneficial for urinary incontinence in women, nor for hypertension management, but these conclusions are limited by small sample sizes and methodologic limitations of these studies.DiscussionAvailable evidence suggests that biofeedback is effective for improving urinary incontinence after prostatectomy and headache, and may provide benefit for fecal incontinence and balance and stroke recovery. Further controlled trials across a wide range of conditions are indicated.

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.

This study examined the association between gambling level and psychiatric and medical disorders in a nationally representative sample of older adults. Data on 10,563 U.S. older adults (age 60 or older) were analyzed from the National Epidemiologic Survey on Alcohol and Related Conditions. A total 28.74% of older adults were lifetime recreational gamblers and 0.85% were lifetime disordered gamblers. Compared with older adults without a history of regular gambling, recreational gamblers had significantly elevated rates of alcohol (30.1% versus 12.8%), nicotine (16.9% versus 8.0%), mood (12.6% versus 11.0%), anxiety (15.0% versus 11.6%), and personality disorders (11.3% versus 7.3%) and obesity (25.6% versus 20.8%), but were less likely to have past-year diagnoses of arteriosclerosis (4.7% versus 6.0%) or cirrhosis (0.2% versus 0.4%). Disordered gamblers were significantly more likely than older adults without a history of regular gambling to have alcohol (53.2% versus 12.8%), nicotine (43.2% versus 8.0%), drug (4.6% versus 0.7%), mood (39.5% versus 11.0%), anxiety (34.5% versus 11.6%), and personality (43.0% versus 7.3%) disorders, and to have past-year diagnoses of arthritis (60.2% versus 44.3%) or angina (22.7% versus 8.8%). These results remained significant even after controlling for demographic, psychiatric, and behavioral risk factors. Lifetime recreational gamblers were more likely than nonregular gamblers to have psychiatric disorders but were less likely to have some medical conditions. Lifetime disordered gamblers had a range of lifetime psychiatric disorders and were more likely than nonregular gamblers to have past-year diagnoses of angina and arthritis.

Background Patient-provider shared decision-making is associated with better treatment adherence and pain outcomes in opioid-specific pain management. One possible mechanism through which shared decision-making may impact pain management outcomes is trust in one’s prescribing provider. Elucidating relationships between factors that enhance the patient-provider relationship, such as shared decision-making and trust, may reduce risks associated with opioid treatment, such as opioid misuse. Objective The purpose of this study was to investigate the mediating effect of trust in one’s prescribing provider on the relationship between shared decision-making and current opioid misuse. Design A secondary analysis of data from a prospective cohort study of US Veterans ( N  = 1273) prescribed long-term opioid therapy (LTOT) for chronic non-cancer pain. Participants Eligibility criteria included being prescribed LTOT, ability to speak and read English, and access to a telephone. Veterans were excluded if they had a cancer diagnosis, received opioid agonist therapy for opioid use disorder, or evidence of pending discontinuation of LTOT. Stratified random sampling was employed to oversample racial and ethnic minorities and women veterans. Main Measures Physician Participatory Decision-Making assessed level of patient involvement in medical decision-making, the Trust in Provider Scale assessed interpersonal trust in patient-provider relationships, and the Current Opioid Misuse Measure assessed opioid misuse. Key Results Patient-provider shared decision-making had a total significant effect on opioid misuse, in the absence of the mediator ( c  =  − 0.243, p  < 0.001), such that higher levels of shared decision-making were associated with lower levels of reported opioid misuse. When trust in provider was added to the mediation model, the indirect effect of shared decision-making on opioid misuse through trust in provider remained significant ( c ′ =  − 0.147, p  = 0.007). Conclusions Shared decision-making is associated with less prescription opioid misuse through the trust that is fostered between patients and providers.