Search

Whereas effective treatments exist for adults with recurrent binge eating, developmental factors specific to adolescents point to the need for a modified treatment approach for youth. We adapted an existing cognitive behavioral therapy treatment manual for adults with bulimia nervosa and binge eating disorder (Fairburn, 2008) for use with adolescents. This paper presents a number of clinical case vignettes, drawn directly from interactions with teen participants, that illustrate some of the developmental factors common to adolescents--as well as the importance of our adaptations to address for these factors.

There is a need for treatment interventions to address the high prevalence of disordered eating throughout adolescence and early adulthood. We developed an adolescent-specific manualized CBT protocol to treat female adolescents with recurrent binge eating and tested its efficacy in a small, pilot randomized controlled trial. We present lessons learned in recruiting adolescents, a description of our treatment approach, acceptability of the treatment for teens and parents, as well as results from the pilot trial. Participants in the CBT group had significantly fewer posttreatment eating binges than those in a treatment as usual/delayed treatment (TAU-DT) control group; 100% of CBT participants were abstinent at follow-up. Our results provide preliminary support for the efficacy of this adolescent adaptation of evidence-based CBT for recurrent binge eating. The large, robust effect size estimate observed for the main outcome (NNT = 2) places this among the larger effects observed for any mental health intervention. (Contains 4 tables and 2 figures.)

Objective: Cognitive behavioral therapy for chronic pain (CBT‐CP) is an evidence‐based treatment for improving functioning and pain intensity for people with chronic pain with extensive evidence of effectiveness. However, there has been relatively little investigation of the factors associated with successful implementation and uptake of CBT‐CP, particularly clinician and system level factors. This formative evaluation examined barriers and facilitators to the successful implementation and uptake of CBT‐CP from the perspective of CBT‐CP clinicians and referring primary care clinicians. Methods: Qualitative interviews guided by the Consolidated Framework for Implementation Research were conducted at nine geographically diverse Veterans Affairs sites as part of a pragmatic clinical trial comparing synchronous, clinician‐delivered CBT‐CP and remotely delivered, technology‐assisted CBT‐CP. Analysis was informed by a grounded theory approach. Results: Twenty‐six clinicians (CBT‐CP clinicians = 17, primary care clinicians = 9) from nine VA medical centers participated in individual qualitative interviews conducted by telephone from April 2019 to August 2020. Four themes emerged in the qualitative interviews: (1) the complexity and variability of referral pathways across sites, (2) referring clinician's lack of knowledge about CBT‐CP, (3) referring clinician's difficulty identifying suitable candidates for CBT‐CP, and (4) preference for interventions that can be completed from home. Conclusions: This formative evaluation identified clinician and system barriers to widespread implementation of CBT‐CP and allowed for refinement of the subsequent implementation of two forms of CBT‐CP in an ongoing pragmatic trial. Identification of relative difference in barriers and facilitators in the two forms of CBT‐CP may emerge more clearly in a pragmatic trial that evaluates how treatments perform in real‐world settings and may provide important information to guide future system‐wide implementation efforts. [ABSTRACT FROM AUTHOR]

Background: Opioid tapering has been identified as an effective strategy to prevent the dangers associated with long-term opioid therapy for patients with chronic pain. However, many patients are resistant to tapering, and conversations about tapering can be challenging for health care providers. Pharmacists can play a role in supporting both providers and patients with the process of opioid tapering. Objective: Qualitatively describe patient experiences with a unique phone-based and pharmacy-led opioid tapering program implemented within an integrated health care system. Methods: In-depth telephone interviews with patients who completed the programwere recorded, transcribed, and analyzed. Themeswere identified through a constant comparative approach. Results: We completed 25 interviews; 80% of patients were women (20), with a mean age of 58 years, and 72% (18) had been using opioids for pain management for 10 or moreyears. Most (60%) described a positive and satisfying experience with the tapering program. Strengths of the program reported by patients included a patient-centered and compassionate taper approach, flexible taper pace, easy access to knowledgeable pharmacist advocates, and resultant improvements in quality of life (e.g., increased energy). Challenges reported included: unhelpful or difficult-to-access nonpharmacological pain management options, negative quality of life impacts (e.g., inability to exercise), and lack of choice in the taper process. At the end of tapering, most patients (72%) described their pain as reduced or manageable rather than worse and expressed willingness to use the program in the future if a need should arise. Conclusions: Patients in a pharmacist-led opioid tapering program appreciated the program’s individualized approach to care and access to pharmacist’ expertise. Most interviewed patients successfully reduced their opioid use and recommended that the program should continue as an offered service. To improve the program, patients suggested increased personalization of the taper process and additional support for withdrawal symptoms and nonpharmacological pain management. [ABSTRACT FROM AUTHOR]

A study was conducted to evaluate the efficacy of a group cognitive behavioral (CB) prevention program in preventing the occurrence of depression in adolescents. Results indicated that the CB prevention program was quite effective in controlling the onset of depression, but was found to be less effective in cases where one parent was also suffering from depression.

Background: In 1979, Marvin Zelen proposed a new design for randomized clinical trials intended to facilitate clinicians' and patients' participation. The defining innovation of Zelen's proposal was random assignment of treatment prior to patient or participant consent. Following randomization, a participant would receive information and asked to consent to the assigned treatment.Methods: This narrative review examined recent examples of Zelen design trials evaluating clinical and public health interventions.Results: Zelen designs have often been applied to questions regarding real-world treatment or intervention effects under conditions of incomplete adherence. Examples include evaluating outreach or engagement interventions (especially for stigmatized conditions), evaluating treatments for which benefit may vary according to participant motivation, and situations when assignment to a control or usual care condition might prompt a disappointment effect. Specific practical considerations determine whether a Zelen design is scientifically appropriate or practicable. Zelen design trials usually depend on identifying participants automatically from existing records rather than by advertising, referral, or active recruitment. Assessments of baseline or prognostic characteristics usually depend on available records data rather than research-specific assessments. Because investigators must consider how exposure to treatments or interventions might bias ascertainment of outcomes, assessment of outcomes from routinely created records is often necessary. A Zelen design requires a waiver of the usual requirement for informed consent prior to random assignment of treatment. The Revised Common Rule includes specific criteria for such a waiver, and those criteria are most often met for evaluation of a low-risk and potentially beneficial intervention added to usual care. Investigators and Institutional Review Boards must also consider whether the scientific or public health benefit of a Zelen design trial outweighs the autonomy interests of potential participants. Analysis of Zelen trials compares outcomes according to original assignment, regardless of any refusal to accept or participate in the assigned treatment.Conclusions: A Zelen design trial assesses the real-world consequences of a specific strategy to prompt or promote uptake of a specific treatment. While such trials are poorly suited to address explanatory or efficacy questions, they are often preferred for addressing pragmatic or policy questions. [ABSTRACT FROM AUTHOR]

Objective To identify factors that influence or interfere with referrals by primary care providers (PCPs) to a pharmacist-led telephone-based program to assist patients undergoing opioid tapering. The Support Team Onsite Resource for Management of Pain (STORM) program provides individualized patient care and supports PCPs in managing opioid tapers. Design Qualitative interviews were conducted with referring PCPs and STORM staff. Interview guides addressed concepts from the RE-AIM framework, focusing on issues affecting referral to the STORM program. Setting An integrated healthcare system (HCS) in the Northwest United States. Subjects Thirty-five interviews were conducted with 20 PCPs and 15 STORM staff. Methods Constant comparative analysis was used to identify key themes from interviews. A codebook was developed based on interview data and a qualitative software program was used for coding, iterative review, and content analysis. Representative quotes illustrate identified themes. Results Use of the STORM opioid tapering program was influenced by PCP, patient, and HCS considerations. Factors motivating use of STORM included lack of PCP time to support chronic pain patients requiring opioid tapering and the perception that STORM is a valued partner in patient care. Impediments to referral included PCP confidence in managing opioid tapering, patient resistance to tapering, forgetting about program availability, and PCP resistance to evolving guidelines regarding opioid tapering goals. Conclusions PCPs recognized that STORM supported patient safety and reduced clinician burden. Utilization of the program could be improved through ongoing PCP education about the service and consistent co-location of STORM pharmacists within primary care clinics. [ABSTRACT FROM AUTHOR]

Abstract Background Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. Methods Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. Results Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. Conclusions The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research. Trial Registration ClinicalTrials.gov: NCT00526565

Abstract Background Substantial recent research examines the efficacy of many types of complementary and alternative (CAM) therapies. However, outcomes associated with the "real-world" use of CAM has been largely overlooked, despite calls for CAM therapies to be studied in the manner in which they are practiced. Americans seek CAM treatments far more often for chronic musculoskeletal pain (CMP) than for any other condition. Among CAM treatments for CMP, acupuncture and chiropractic (A/C) care are among those with the highest acceptance by physician groups and the best evidence to support their use. Further, recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain--despite their high costs, potential adverse effects, and modest efficacy--suggests the need to evaluate real world outcomes associated with promising non-pharmacological/non-surgical CAM treatments for CMP, which are often well accepted by patients and increasingly used in the community. Methods/Design This multi-phase, mixed methods study will: (1) conduct a retrospective study using information from electronic medical records (EMRs) of a large HMO to identify unique clusters of patients with CMP (e.g., those with differing demographics, histories of pain condition, use of allopathic and CAM health services, and comorbidity profiles) that may be associated with different propensities for A/C utilization and/or differential outcomes associated with such care; (2) use qualitative interviews to explore allopathic providers' recommendations for A/C and patients' decisions to pursue and retain CAM care; and (3) prospectively evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services. Sensitivity analyses will compare methods relying solely on EMR-derived data versus analyses supplementing EMR data with conventionally collected patient and clinician data. Discussion Successful completion of these aggregate aims will provide an evaluation of outcomes associated with the real-world use of A/C services. The trio of retrospective, qualitative, and prospective study will also provide a clearer understanding of the decision-making processes behind the use of A/C for CMP and a transportable methodology that can be applied to other health care settings, CAM treatments, and clinical populations. Trial registration ClinicalTrials.gov: NCT01345409

Abstract Background As concern about youth obesity continues to mount, there is increasing consideration of widespread policy changes to support improved nutritional and enhanced physical activity offerings in schools. A critical element in the success of such programs may be to involve students as spokespeople for the program. Making such a public commitment to healthy lifestyle program targets (improved nutrition and enhanced physical activity) may potentiate healthy behavior changes among such students and provide a model for their peers. This paper examines whether student's "public commitment"--voluntary participation as a peer communicator or in student-generated media opportunities--in a school-based intervention to prevent diabetes and reduce obesity predicted improved study outcomes including reduced obesity and improved health behaviors. Methods Secondary analysis of data from a 3-year randomized controlled trial conducted in 42 middle schools examining the impact of a multi-component school-based program on body mass index (BMI) and student health behaviors. A total of 4603 students were assessed at the beginning of sixth grade and the end of eighth grade. Process evaluation data were collected throughout the course of the intervention. All analyses were adjusted for students' baseline values. For this paper, the students in the schools randomized to receive the intervention were further divided into two groups: those who participated in public commitment activities and those who did not. Students from comparable schools randomized to the assessment condition constituted the control group. Results We found a lower percentage of obesity (greater than or equal to the 95th percentile for BMI) at the end of the study among the group participating in public commitment activities compared to the control group (21.5% vs. 26.6%, p = 0.02). The difference in obesity rates at the end of the study was even greater among the subgroup of students who were overweight or obese at baseline; 44.6% for the "public commitment" group, versus 53.2% for the control group (p = 0.01). There was no difference in obesity rates between the group not participating in public commitment activities and the control group (26.4% vs. 26.6%). Conclusions Participating in public commitment activities during the HEALTHY study may have potentiated the changes promoted by the behavioral, nutrition, and physical activity intervention components. Trial Registration ClinicalTrials.gov number, NCT00458029

Background Multisite chronic pain (MSCP) is associated with increased chronic pain impact, but methods for identifying MSCP for epidemiological research have not been evaluated. Objective We assessed the validity of identifying MSCP using electronic health care data compared with survey questionnaires. Methods Stratified random samples of adults served by Kaiser Permanente Northwest and Washington (N = 2,059) were drawn for a survey, oversampling persons with frequent use of health care for pain. MSCP and single-site chronic pain were identified by two methods, with electronic health care data and with self-report of common chronic pain conditions by survey questionnaire. Analyses were weighted to adjust for stratified sampling. Results MSCP was somewhat less common when ascertained by electronic health records (14.7% weighted prevalence) than by survey questionnaire (25.9% weighted prevalence). Agreement of the two MSCP classifications was low (kappa agreement statistic of 0.21). Ascertainment of MSCP with electronic health records was 30.9% sensitive, 91.0% specific, and had a positive predictive value of 54.5% relative to MSCP identified by self-report as the standard. After adjusting for age and gender, patients with MSCP identified by either electronic health records or self-report showed higher levels of pain-related disability, pain severity, depressive symptoms, and long-term opioid use than persons with single-site chronic pain identified by the same method. Conclusions Identification of MSCP with electronic health care data was insufficiently accurate to be used as a surrogate or screener for MSCP identified by self-report, but both methods identified persons with heightened chronic pain impact. [ABSTRACT FROM AUTHOR]

Introduction: Primary care practitioners (PCPs) are concerned about adverse effects and poor outcomes of opioid use but may find opioid tapering difficult because of a lack of pain management training or time constraints limiting patient counseling. In 2010, Kaiser Permanente Northwest implemented a pharmacistled opioid tapering program--Support Team Onsite Resource for Management of Pain (STORM)--to address high rates of opioid use, alleviate PCPs' workload demands, and improve patient outcomes. Objective: To describe the rationale, structure, and delivery of this unique pharmacist-led program, which partners with PCPs and provides individualized care to help patients reduce opioid use, and the Facilitating Lower Opioid Amounts through Tapering study, which examines the program's effectiveness, cost-effectiveness, and implementation. Results: The STORM program includes a pain medicine physician, a social worker or nurse, and pharmacists who have received specialized clinical and communications training. The program has a 2-fold role: 1) to provide PCP education about pain management and opioid use and 2) to offer clinician and patient support with opioid tapering and pain management. After program training, PCPs are equipped to discuss the need for tapering with a patient and to refer to the program. Program pharmacists provide a range of services, including opioid taper plans, nonopioid pain management recommendations, and taper-support outreach to patients. Discussion: The STORM program provides individualized care to assist patients with opioid tapering while reducing the burden on PCPs. Conclusion: The STORM program may be a valuable addition to health care systems and settings seeking options to address their patients' opioid tapering needs. [ABSTRACT FROM AUTHOR]

Drawing on advances in chronic pain metrics, a simplified Graded Chronic Pain Scale-Revised was developed to differentiate mild, bothersome, and high-impact chronic pain. Graded Chronic Pain Scale-Revised was validated among adult enrollees of 2 health plans (N = 2021). In this population, the prevalence of chronic pain (pain present most or every day, prior 3 months) was 40.5%: 15.4% with mild chronic pain (lower pain intensity and interference); 10.1% bothersome chronic pain (moderate to severe pain intensity with lower interference with life activities); and 15.0% high-impact chronic pain (sustained pain-related activity limitations). Persons with mild chronic pain vs those without chronic pain showed small differences on 10 health status indicators (unfavorable health perceptions, activity limitations, and receiving long-term opioid therapy), with nonsignificant differences for 7 of 10 indicators. Persons with bothersome vs mild chronic pain differed significantly on 6 of 10 indicators (eg, negative pain coping beliefs, psychological distress, unfavorable health perceptions, and pain-related interference with overall activities). Persons with high-impact chronic pain differed significantly from those with mild chronic pain on all 10 indicators. Persons with high-impact chronic pain, relative to those with bothersome chronic pain, were more likely to have substantial activity limitations (significant differences for 4 of 5 disability indicators) and more often received long-term opioid therapy. Graded Chronic Pain Scale-Revised strongly predicted 5 activity-limitation indicators with area under receiver operating characteristic curve coefficients of 0.76 to 0.89. We conclude that the 5-item Graded Chronic Pain Scale-Revised and its scoring rules provide a brief, simple, and valid method for assessing chronic pain. [ABSTRACT FROM AUTHOR]

Effective management of patients with pain requires accurate information about the prevalence, outcomes, and co-occurrence of common pain conditions. However, the transition from ICD-9-CM to ICD-10-CM diagnostic coding in 2015 left researchers without methods for comparing the prevalence of pain conditions before and after the transition. In this study, we developed and assessed a diagnostic framework to serve as a crosswalk between ICD-9-CM and ICD-10-CM diagnosis codes for common pain-related health conditions. We refined existing ICD-9-CM definitions for diagnostic clusters of common pain conditions consistent with the US National Pain Strategy and developed corresponding ICD-10-CM definitions. We then assessed the stability of prevalence estimates and associated patient socio-demographic features of each diagnostic cluster during 1-year periods before and after the transition to ICD-10-CM in 3 US health care systems using electronic health records data for in-person encounters. Prevalence estimates and socio-demographic characteristics were similar before and after the transition. The Pain Condition ICD-9-CM to ICD-10-CM Crosswalk includes a full spectrum of common pain conditions to enable prevalence estimates of multiple and chronic overlapping pain conditions. This allows the tool to serve as a foundation for a broad array of pain-related health services research utilizing electronic databases. PERSPECTIVE: This article details the development and assessment of the Pain Condition ICD-9-CM to ICD-10-CM Crosswalk, a diagnostic framework for assessing pain condition prevalence across the ICD-9-CM to ICD-10-CM transition. This framework can serve as a standardized tool for research on pain conditions, including health services and epidemiologic research. [ABSTRACT FROM AUTHOR]

Aims: Despite many reports about complementary and alternative medicine (CAM) use in the general population, little information exists about specific CAM therapies used for particular health conditions. This study examines the use of CAM therapies among patients with temporomandibular disorders (TMD). Methods: We surveyed 192 patients with documented TMD as part of a larger project on the effectiveness of various CAM modalities for TMD patients. The survey asked about use of and attitudes toward specific CAM therapies for treating TMD and other patient-identified health conditions. The survey also measured physical health, health behavior, and psychosocial functioning. Results: Nearly two thirds of the respondents (62.5%; n = 120) reported using CAM therapies for TMD or a related condition. Of all the therapies reported, massage was rated as the most frequent and among the most satisfactory and helpful. In general, respondents who used CAM for their TMD reported being most satisfied with the "hands on" CAM therapies (massage, acupuncture, and chiropractic care). The vast majority of respondents reported using CAM approaches for TMD simultaneously with conventional care (95.6%; 66 of 69). Those using CAM for TMD tended to be older, had a history of multiple medical problems, and reported more positive psychologic functioning. Respondents who most often reported CAM treatment as "very helpful" for their TMD were likely to be healthier (ie, reporting higher levels of exercise and fewer sleep disturbances). Conclusion: Given the frequent use of CAM treatments by our respondents, allopathic providers should inquire about the adjunctive use of CAM among their TMD patients. [ABSTRACT FROM AUTHOR]

Importance: Few studies have examined the relationship between nonmalignant chronic pain (NMCP) and suicide death, and even fewer have specifically explored what role sleep disturbance might play in the association between NMCP and suicide death. Objective: To assess whether sleep disturbance mediates the relationship between NMCP and suicide death. Design: This case‐control study included 2,674 individuals who died by suicide between 2000 and 2013 (cases) and 267,400 matched individuals (controls). Setting: Eight Mental Health Research Network (MHRN)‐affiliated healthcare systems. Participants: All cases and matched controls were health plan members for at least 10 months during the year prior to the index date. Main Outcomes and Measures: Sociodemographic data and diagnosis codes for NMCP and sleep disorders were extracted from the MHRN's Virtual Data Warehouse. Suicide mortality was identified using International Statistical Classification of Diseases and Related Health Problems (ICD)‐10 codes from official government mortality records matched to health system records. Results: After accounting for covariates, there was a significant relationship between NMCP and sleep disturbance; those who were diagnosed with NMCP were more likely to develop subsequent sleep disturbance. Similarly, sleep disturbance was significantly associated with suicide death. Finally, a significant indirect effect of NMCP on suicide death, through sleep disturbance, and a nonsignificant direct effect of NMCP on suicide death provide support for a fully mediated model. Conclusions and Relevance: There is a need for clinicians to screen for both sleep disturbance and suicidal ideation in NMCP patients and for health systems to implement more widespread behavioral treatments that address comorbid sleep problems and NMCP. [ABSTRACT FROM AUTHOR]

Objective: Youth depression can be prevented, yet few programs are offered. Decision makers lack cost information. This study evaluated the cost-effectiveness of a cognitive-behavioral prevention program (CBP) versus usual care.Methods: A cost-effectiveness analysis was conducted with data from a randomized controlled trial of 316 youths, ages 13-17, randomly assigned to CBP or usual care. Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder. Outcomes included depression-free days (DFDs), quality-adjusted life years (QALYs), and costs.Results: Nine months after baseline assessment, youths in CBP experienced 12 more DFDs (p=.020) and .018 more QALYs (p=.007), compared with youths in usual care, with an incremental cost-effectiveness ratio (ICER) of $24,558 per QALY. For youths whose parents were not depressed at baseline, CBP youths had 26 more DFDs (p=.001), compared with those in usual care (ICER=$10,498 per QALY). At 33 months postbaseline, youths in CBP had 40 more DFDs (p=.05) (ICER=$12,787 per QALY). At 33 months, CBP youths whose parents were not depressed at baseline had 91 more DFDs (p=.001) (ICER=$13,620 per QALY). For youths with a currently depressed parent at baseline, CBP was not significantly more effective than usual care at either 9 or 33 months, and costs were higher.Conclusions: CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline. Depression prevention programs could improve youths' health at a reasonable cost; services to treat depressed parents may also be warranted. [ABSTRACT FROM AUTHOR]

Objectives: The authors employ a Whole Systems framework to explore implementation of new guidelines for back and neck pain in Oregon's Medicaid system. Whole Systems research is useful for understanding the relationship between complementary and integrative health care (CIH) and conventional health care systems in real-world clinical and practice settings. Design: Preliminary results are from an observational study designed to evaluate state-wide implementation of CIH and other non-pharmacological treatments for neck and back pain among Oregon Medicaid patients. This natural experiment, even in early stages, provides insight into the challenges of integrating Whole Systems oriented therapies into Medicaid billing and treatment. Methods: Qualitative data are drawn from: (1) semi-structured interviews with representatives of each of the 16 coordinated care organizations (CCOs) responsible for administering the Oregon's Medicaid insurance through the Oregon Health Plan (OHP); and (2) open-ended survey responses from acupuncturists in all 16 CCO areas. Results: Implementation of the new policy guidelines poses logistical and epistemological challenges. Differences in worldview, inadequate reimbursement, and simple lack of awareness of CIH among medical providers are some of the factors that pose barriers to merging CIH therapies into conventional frameworks. Conclusions: In this article, we explore the potential for a Whole Systems perspective to better explain the complexity of integrating CIH and other non-pharmacological services into a state financed health care system. Oregon's expansion of services for back and neck pain presents an opportunity to explore challenges and successes in melding multiple approaches to health and pain management into a managed system such as the OHP. [ABSTRACT FROM AUTHOR]

Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care. Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses. MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway. Trial Registration: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021. [ABSTRACT FROM AUTHOR]

Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity. [ABSTRACT FROM AUTHOR]

Background: Supporting day-to-day self-care activities has emerged as a best practice when caring for patients with chronic pain, yet providing this support may introduce challenges for both patients and primary care physicians. It is essential to develop tools that help patients identify the issues and outcomes that are most important to them and to communicate this information to primary care physicians at the point of care. Objective: We describe our process to engage patients, primary care physicians, and other stakeholders in the context of a pilot randomized controlled trial of a patient-centered assessment process implemented in an everyday practice setting. We identify lessons on how to engage stakeholders and improve patient-centered care for those with chronic conditions within the primary care setting. Methods: A qualitative analysis of project minutes, interviews, and focus groups was conducted to evaluate stakeholder experiences. Stakeholders included patients, caregivers, clinicians, medical office support staff, health plan administrators, an information technology consultant, and a patient advocate. Results: Our stakeholders included many patients with no prior experience with research. This approach enriched the applicability of feedback but necessitated extra time for stakeholder training and meeting preparation. Types of stakeholders varied over the course of the project, and more involvement of medical assistants and Information Technology staff was required than originally anticipated. Conclusion: Meaningful engagement of patient and physician stakeholders must be solicited in a well-coordinated manner with broad health care system supports in place to ensure full execution of patient-centered processes. [ABSTRACT FROM AUTHOR]

Introduction: Self-reporting by patients though the use of electronic patient-reported outcome (PRO) measures has been shown to use increase patient satisfaction with care, and improve patient-provider communication, symptom management, and health quality. Additionally, PROs are increasingly used in research to expand understanding regarding the relative risks, benefits, and burdens of interventions. While experience embedding patient-reported outcomes (PROs) into registries and clinical workflow is growing, there is little in the literature to guide those interested in incorporating PROs into routine clinical care and for use in research. Case Descriptions: The NIH Health Care Systems Research Collaboratory PRO Core interviewed investigators from seven programs to get their first-hand experiences on the incorporation of PROs for both care and research, and the investigators have contributed to this manuscript as authors. Findings: We use these case studies to present practical approaches to initiating and implementing PROS, including instrument selection, tips for integrating PRO collection systems into clinical workflow, considerations for user experience and data collection, and the methods to assess and monitor quality. Conclusion: Because the decision to initiate and implement PRO collection impacts many different stakeholders, the solution requires collaboration among the involved parties, careful planning, and integration into clinical workflow. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVE: Health care providers have few alternatives for youth depression other than antidepressants. We examined whether brief cognitive behavioral therapy (CBT) is a viable alternative in primary care. METHODS: A total of 212 adolescents aged 12 to 18 with major depression who had recently declined or quickly discontinued new antidepressant treatment were randomized to self-selected treatment as usual (TAU) control condition or TAU plus brief individual CBT. Blinded evaluators followed youth for 2 years. The primary outcome was time to major depression diagnostic recovery. RESULTS: CBT was superior to the control condition on the primary outcome of time to diagnostic recovery from major depression, with number needed to treat from 4 to 10 across follow-up. A similar CBT advantage was found for time to depression diagnosis response, with number needed to treat of 5 to 50 across time points. We observed a significant advantage for CBT on many secondary outcomes over the first year of follow-up but not the second year. Cohen's d effect sizes for significant continuous measures ranged from 0.28 to 0.44, in the small to medium effect range. Most TAU health care services did not differ across conditions, except for psychiatric hospitalizations, which occurred at a significantly higher rate in the control condition through the first year of follow-up. CONCLUSIONS: Observed results were consistent with recent meta-analyses of CBT for youth depression. The initial year of CBT superiority imparted an important clinical benefit and may reduce the risk of future recurrent depression episodes. [ABSTRACT FROM AUTHOR]

Background: Current literature describes the limits and pitfalls of using opioid pharmacotherapy for chronic pain and the importance of identifying alternatives. The objective of this study was to identify the practical issues patients and providers face when accessing alternatives to opioids, and how multiple parties view these issues. Methods: Qualitative data were gathered to evaluate the outcomes of acupuncture and chiropractic (A/C) services for chronic musculoskeletal pain (CMP) using structured interview guides among patients with CMP (n = 90) and primary care providers (PCPs) (n = 25) purposively sampled from a managed care health care system as well as from contracted community A/C providers (n = 14). Focus groups and interviews were conducted patients with CMP with varying histories of A/C use. Plan PCPs and contracted A/C providers took part in individual interviews. All participants were asked about their experiences managing chronic pain and experience with and/or attitudes about A/C treatment. Audio recordings were transcribed and thematically coded. A summarized version of the focus group/interview guides is included in the Additional file 1. Results: We identified four themes around opioid use: (1) attitudes toward use of opioids to manage chronic pain; (2) the limited alternative options for chronic pain management; (3) the potential of A/C care as a tool to help manage pain; and (4) the complex system around chronic pain management. Despite widespread dissatisfaction with opioid medications for pain management, many practical barriers challenged access to other options. Most of the participants’ perceived A/C care as helpful for short term pain relief. We identified that problems with timing, expectations, and plan coverage limited A/C care potential for pain relief treatment. Conclusions: These results suggest that education about realistic expectations for chronic pain management and therapy options, as well as making A/C care more easily accessible, might lead to more satisfaction for patients and providers, and provide important input to policy makers. [ABSTRACT FROM AUTHOR]

Background Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources.Purpose This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone.Methods We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone.Results Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (BMI; p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06).Limitations We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations.Conclusion Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared. [ABSTRACT FROM PUBLISHER]