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BackgroundBehavioral and psychological symptoms of dementia (BPSD) are associated with increased stress, burden, and depression among family caregivers of people with dementia. STAR-Caregivers Virtual Training and Follow-up (STAR-VTF) is adapted from an evidence-based, in-person program that trains family caregivers to manage BPSD. We used a human-centered design approach to obtain feedback from family caregivers about STAR-VTF. The program will be evaluated using a pragmatic randomized trial. ObjectiveThe objective of the study was to understand the needs of family caregivers for improving BPSD management and the extent to which caregivers perceived that STAR-VTF could address those needs. MethodsBetween July and September 2019, we conducted 15 semistructured interviews with family caregivers of people with dementia who receive care at Kaiser Permanente Washington in the Seattle metropolitan area. We identified participants from electronic health records, primarily based on a prescription for antipsychotic medication for the person with dementia (a proxy for caregivers dealing with BPSD). We showed caregivers low-fidelity prototypes of STAR-VTF online self-directed materials and verbally described potential design elements. We obtained caregiver feedback on these elements, focusing on their needs and preferences and perceived barriers to using STAR-VTF. We used a hybrid approach of inductive and deductive coding and aggregated codes to develop themes. ResultsThe idea of a virtual training program for learning to manage BPSD appealed to caregivers. They said health care providers did not provide adequate education in the early disease stages about the personality and behavior symptoms that can affect people with dementia. Caregivers found it unexpected and frustrating when the person with dementia began experiencing BPSD, symptoms they felt unprepared to manage. Accordingly, caregivers expressed a strong desire for the health care organization to offer programs such as STAR-VTF much sooner. Caregivers had already put considerable effort into problem solving challenging behaviors. They anticipated deriving less value from STAR-VTF at that point. Nonetheless, many were interested in the virtual aspect of the training due to the convenience of receiving help from home and the perception that help from a virtual program would be timelier than traditional service modalities (eg, face to face). Given caregivers’ limited time, they suggested dividing the STAR-VTF content into chunks to review as time permitted. Caregivers were interested in having a STAR-VTF provider for additional support in managing challenging behaviors. Caregivers reported a preference for having the same coach for the program duration. ConclusionsCaregivers we interviewed would likely accept a virtual training program such as STAR-VTF to obtain information about BPSD and receive help managing it. Family caregivers anticipated deriving more value if STAR-VTF was offered earlier in the disease course.

Purpose: The US Food and Drug Administration's Sentinel Innovation Center aimed to establish a query‐ready, quality‐checked distributed data network containing electronic health records (EHRs) linked with insurance claims data for at least 10 million individuals to expand the utility of real‐world data for regulatory decision‐making. Methods: In this report, we describe the resulting network, the Real‐World Evidence Data Enterprise (RWE‐DE), including data from two commercial EHR‐claims linked assets collectively termed the Commercial Network covering 21 million lives, and four academic partner institutions collectively termed the Development Network covering 4.5 million lives. Results: We discuss provenance and completeness of the data converted in the Sentinel Common Data Model (SCDM), describe patient populations, and report on EHR‐claims linkage characterization for all contributing data sources. Further, we introduce a standardized process to store free‐text notes in the Development Network for efficient retrieval as needed. Conclusions: Finally, we outline typical use cases for the RWE‐DE where it can broaden the reach of the types of questions that can be addressed by the Sentinel system. [ABSTRACT FROM AUTHOR]

This cohort study investigates the characteristics of adolescents with a history of depression who do not endorse risk on the Patient Health Questionnaire before self-harm or suicide. Key Points: Question: What are characteristics of adolescents with a history of depression who do not endorse risk via the Patient Health Questionnaire (PHQ) item 9 before self-harm or suicide? Findings: This cohort study including 691 and 1024 adolescents in 30- and 90-day cohorts, respectively, found that being screened in primary care or having a history of an inpatient encounter with a mental health diagnosis were associated with significantly greater odds of not endorsing risk before self-harm or suicide. Meaning: At-risk adolescents with depression screened in primary care or those with prior inpatient mental health encounters have an increased likelihood of not endorsing risk via the PHQ item 9. Importance: Given that the Patient Health Questionnaire (PHQ) item 9 is commonly used to screen for risk of self-harm and suicide, it is important that clinicians recognize circumstances when at-risk adolescents may go undetected. Objective: To understand characteristics of adolescents with a history of depression who do not endorse the PHQ item 9 before a near-term intentional self-harm event or suicide. Design, Setting, and Participants: This was a retrospective cohort study design using electronic health record and claims data from January 2009 through September 2017. Settings included primary care and mental health specialty clinics across 7 integrated US health care systems. Included in the study were adolescents aged 13 to 17 years with history of depression who completed the PHQ item 9 within 30 or 90 days before self-harm or suicide. Study data were analyzed September 2022 to April 2023. Exposures: Demographic, diagnostic, treatment, and health care utilization characteristics. Main Outcome(s) and Measure(s): Responded "not at all" (score = 0) to PHQ item 9 regarding thoughts of death or self-harm within 30 or 90 days before self-harm or suicide. Results: The study included 691 adolescents (mean [SD] age, 15.3 [1.3] years; 541 female [78.3%]) in the 30-day cohort and 1024 adolescents (mean [SD] age, 15.3 [1.3] years; 791 female [77.2%]) in the 90-day cohort. A total of 197 of 691 adolescents (29%) and 330 of 1024 adolescents (32%), respectively, scored 0 before self-harm or suicide on the PHQ item 9 in the 30- and 90-day cohorts. Adolescents seen in primary care (odds ratio [OR], 1.5; 95% CI, 1.0-2.1; P =.03) and older adolescents (OR, 1.2; 95% CI, 1.0-1.3; P =.02) had increased odds of scoring 0 within 90 days of a self-harm event or suicide, and adolescents with a history of inpatient hospitalization and a mental health diagnosis had twice the odds (OR, 2.0; 95% CI, 1.3-3.0; P =.001) of scoring 0 within 30 days. Conversely, adolescents with diagnoses of eating disorders were significantly less likely to score 0 on item 9 (OR, 0.4; 95% CI, 0.2-0.8; P =.007) within 90 days. Conclusions and Relevance: Study results suggest that older age, history of an inpatient mental health encounter, or being screened in primary care were associated with at-risk adolescents being less likely to endorse having thoughts of death and self-harm on the PHQ item 9 before a self-harm event or suicide death. As use of the PHQ becomes more widespread in practice, additional research is needed for understanding reasons why many at-risk adolescents do not endorse thoughts of death and self-harm. [ABSTRACT FROM AUTHOR]

Background: Given the low usage of virtual health care prior to the COVID‐19 pandemic, it was unclear whether those living in rural locations would benefit from increased availability of virtual mental health care. The rapid transition to virtual services during the COVID‐19 pandemic allowed for a unique opportunity to examine how the transition to virtual mental health care impacted psychotherapy disruption (i.e., 45+ days between appointments) among individuals living in rural locations compared with those living in nonrural locations. Methods: Electronic health record and insurance claims data were collected from three health care systems in the United States including rurality status and psychotherapy disruption. Psychotherapy disruption was measured before and after the COVID‐19 pandemic onset. Results: Both the nonrural and rural cohorts had significant decreases in the rates of psychotherapy disruption from pre‐ to post‐COVID‐19 onset (32.5–16.0% and 44.7–24.8%, respectively, p < 0.001). The nonrural cohort had a greater reduction of in‐person visits compared with the rural cohort (96.6–45.0 vs. 98.0–66.2%, respectively, p < 0.001). Among the rural cohort, those who were younger and those with lower education had greater reductions in psychotherapy disruption rates from pre‐ to post‐COVID‐19 onset. Several mental health disorders were associated with experiencing psychotherapy disruption. Conclusions: Though the rapid transition to virtual mental health care decreased the rate of psychotherapy disruption for those living in rural locations, the reduction was less compared with nonrural locations. Other strategies are needed to improve psychotherapy disruption, especially among rural locations (i.e., telephone visits). [ABSTRACT FROM AUTHOR]

PURPOSE We conducted a randomized controlled trial to compare the effectiveness of adding various forms of enhanced external support to practice facilitation on primary care practices' clinical quality measure (CQM) performance. METHODS Primary care practices across Washington, Oregon, and Idaho were eligible if they had fewer than 10 full-time clinicians. Practices were randomized to practice facilitation only, practice facilitation and shared learning, practice facilitation and educational outreach visits, or practice facilitation and both shared learning and educational outreach visits. All practices received up to 15 months of support. The primary outcome was the CQM for blood pressure control. Secondary outcomes were CQMs for appropriate aspirin therapy and smoking screening and cessation. Analyses followed an intention-to-treat approach. RESULTS Of 259 practices recruited, 209 agreed to be randomized. Only 42% of those offered educational outreach visits and 27% offered shared learning participated in these enhanced supports. CQM performance improved within each study arm for all 3 cardiovascular disease CQMs. After adjusting for differences between study arms, CQM improvements in the 3 enhanced practice support arms of the study did not differ significantly from those seen in practices that received practice facilitation alone (omnibus P = .40 for blood pressure CQM). Practices randomized to receive both educational outreach visits and shared learning, however, were more likely to achieve a blood pressure performance goal in 70% of patients compared with those randomized to practice facilitation alone (relative risk = 2.09; 95% CI, 1.16-3.76). CONCLUSIONS Although we found no significant differences in CQM performance across study arms, the ability of a practice to reach a target level of performance may be enhanced by adding both educational outreach visits and shared learning to practice facilitation. Key words: primary health care; cardiovascular disease; quality improvement; chronic illness; prevention; health promotion; quantitative methods; health services; organizational change; practice-based research, INTRODUCTION Past efforts to transform primary care have included practice redesign based on medical home principles and adoption of electronic health records. (1-4) More recently, primary care practices face increasing [...]

PURPOSE Six key elements of opioid medication management redesign in primary care have been previously identified. Here, we examine the effect of implementing these Six Building Blocks on opioid-prescribing practices. METHODS Six rural-serving organizations with 20 clinic locations received support for 15 months during the period October 2015 to May 2017 to implement the Six Building Blocks. Patients undergoing long-term opioid therapy (LtOT) at these study sites were compared with patients undergoing LtOT enrolled in a regional health plan who did not receive care at the study sites but who resided in the same primary care service areas (control group). Outcomes were monthly trend in the proportion of patients undergoing LtOT prescribed a >100 morphine equivalent dose (MED) of opioids daily and the total number of patients receiving an opioid prescription. An interrupted time series using difference- indifference analysis was used for tests of significance. RESULTS The proportion of patients prescribed a >100 MED of opioids daily decreased 2.2% (11.8% to 9.6%) among patients at the intervention clinics and 1.3% (14.0% to 12.7%) among patients in the control group. The rate of decrease was significantly greater among study patients than among patients in the control group (P = .018). The rate of decrease in the number of patients on LtOT at intervention clinics increased during the intervention period compared with the preintervention period (P CONCLUSIONS Efforts to redesign opioid medication management in primary care resulted in a significant decrease in opioid prescribing. Future research is needed to determine if these results are generalizable to other settings and to assess implications for patient-reported outcomes., INTRODUCTION Use of opioid medication long term for chronic pain has contributed to an epidemic of opioid overdose and addiction. (1) Although rates of opioid prescribing have moderated in recent [...]

INTRODUCTION: People enrolled in Medicaid managed care who struggle with diabetes control often have complex medical, behavioral, and social needs. Here the authors report the results of a program designed to partner with primary care teams to address those needs. METHODS: A nonprofit organization partnered with a Medicaid managed care plan and a Federally Qualified Health Center in California to enroll people with A1cs >9% in a 12-month program. The program team included a community health worker, certified diabetes care and education specialist/registered dietitian, behavioral health counselor, and registered nurse. They developed patient-led action plans, connected patients to community resources, and supported behavior changes to improve diabetes control. Baseline assessments of behavioral health conditions and social needs were collected. Monthly A1c values were tracked for participants and a comparison group. RESULTS: Of the 51 people enrolled, 83% had at least 1 behavioral health condition. More than 90% reported at least 1 unmet social need. The average monthly A1c among program participants was 0.699 lower than the comparison group post-enrollment (P = .0008), and the disparity in A1c between Hispanic and non-Hispanic White participants at enrollment declined. DISCUSSION: Participants had high levels of unmet medical, behavioral, and social needs. Addressing these needs resulted in a rapid and sustained improvement in A1c control compared to non-enrollees and a reduction in disparity of control among Hispanic participants. CONCLUSION: By partnering with a primary care team, a program external to Federally Qualified Health Center primary care can improve clinical outcomes for people with complex needs living with diabetes. [ABSTRACT FROM AUTHOR]

This study aimed to examine population-level disruption in psychotherapy before and after the rapid shift to virtual mental health care induced by the onset of the COVID-19 pandemic in the United States. This retrospective study used electronic health record and insurance claims data from three U.S. health systems. The sample included 110,089 patients with mental health conditions who were members of the health systems' affiliated health plans and attended at least two psychotherapy visits from June 14, 2019, through December 15, 2020. Data were subdivided into two 9-month periods (before vs. after COVID-19 onset, defined in this study as March 14, 2020). Psychotherapy visits were measured via health records and categorized as in person or virtual. Disruption was defined as a gap of >45 days between visits. Visits in the preonset period were almost exclusively in person (97%), whereas over half of visits in the postonset period were virtual (52%). Approximately 35% of psychotherapy visits were followed by a disruption in the preonset period, compared with 18% in the postonset period. Disruption continued to be less common (adjusted OR=0.45) during the postonset period after adjustment for visit, mental health, and sociodemographic factors. The magnitude of the difference in disruption between periods was homogeneous across sociodemographic characteristics but heterogeneous across psychiatric diagnoses. This study found fewer population-level disruptions in psychotherapy receipt after rapid transition to virtual mental health care following COVID-19 onset. These data support the continued availability of virtual psychotherapy. [ABSTRACT FROM AUTHOR]

Purpose: Observational studies assessing effects of medical products on suicidal behavior often rely on health record data to account for pre‐existing risk. We assess whether high‐dimensional models predicting suicide risk using data derived from insurance claims and electronic health records (EHRs) are superior to models using data from insurance claims alone. Methods: Data were from seven large health systems identified outpatient mental health visits by patients aged 11 or older between 1/1/2009 and 9/30/2017. Data for the 5 years prior to each visit identified potential predictors of suicidal behavior typically available from insurance claims (e.g., mental health diagnoses, procedure codes, medication dispensings) and additional potential predictors available from EHRs (self‐reported race and ethnicity, responses to Patient Health Questionnaire or PHQ‐9 depression questionnaires). Nonfatal self‐harm events following each visit were identified from insurance claims data and fatal self‐harm events were identified by linkage to state mortality records. Random forest models predicting nonfatal or fatal self‐harm over 90 days following each visit were developed in a 70% random sample of visits and validated in a held‐out sample of 30%. Performance of models using linked claims and EHR data was compared to models using claims data only. Results: Among 15 845 047 encounters by 1 574 612 patients, 99 098 (0.6%) were followed by a self‐harm event within 90 days. Overall classification performance did not differ between the best‐fitting model using all data (area under the receiver operating curve or AUC = 0.846, 95% CI 0.839–0.854) and the best‐fitting model limited to data available from insurance claims (AUC = 0.846, 95% CI 0.838–0.853). Competing models showed similar classification performance across a range of cut‐points and similar calibration performance across a range of risk strata. Results were similar when the sample was limited to health systems and time periods where PHQ‐9 depression questionnaires were recorded more frequently. Conclusion: Investigators using health record data to account for pre‐existing risk in observational studies of suicidal behavior need not limit that research to databases including linked EHR data. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions Antipsychotic medications (AP) are inappropriately prescribed to young people. The goal of this pragmatic trial was to test a four‐component approach to improved targeting of antipsychotic prescribing to people aged ≥3 and <18 years.Clinicians in four health systems were cluster randomized by the number of previous AP orders and service line – specialty mental health and all others. Intervention arm clinicians received a best practice alert and child psychiatrist consultation and feedback. Families received system navigation and expedited access to psychotherapy. Primary outcomes were total days' supply of AP medication and proportion of youth with any AP supply at 6 months. We estimated the log‐odds of AP use at 6 months and the relative rate of AP over 6 months. The Safer and Targeted Use of Antipsychotics in Youth (SUAY) trial took place between 3/2018 and 12/2020.The trial enrolled 733 patients. The odds ratio (OR) comparing use at 6 months was 0.75 (95% CI: 0.52, 1.09). The mean number of days using AP was 118.5 for intervention patients and 128.2 for control patients (relative risk [RR] = 0.92; 95% CI: 0.81–1.04). Exploratory heterogeneity of treatment effects (HTE) was not detected in groups defined by age, gender, provider specialty, and insurance type. HTE by race/ethnicity was present: among youth of color, mean days' supply was 103.2 for intervention arm and 131.2 for the control arm (RR 0.79, 95% CI: 0.67–0.93). Among secondary outcomes, only new psychotherapy referrals differed with 44.3% (n = 154) of intervention participants having a new order for psychotherapy compared to 33.5% (n = 129) in the control arm (OR 1.47: 95% CI: 1.01–2.14).This intervention did not result in less AP use at 6 months or a reduction in the days' supply of AP medication, although psychotherapy orders increased. The intervention may be effective for some subgroups. [ABSTRACT FROM AUTHOR]