Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial.

BACKGROUND: Severe hypoglycemia is a common and feared complication of medications used to lower blood glucose levels in individuals with diabetes. Psychoeducational interventions can prevent severe hypoglycemia in individuals with type 1 diabetes (T1D). We aim to determine the effectiveness of this approach among adults with type 2 diabetes (T2D) at elevated risk for severe hypoglycemia. METHODS: Preventing Hypoglycemia in Type 2 diabetes (PHT2) is a two-arm, parallel, randomized controlled trial. Participants are eligible if they are adults with T2D receiving care at an integrated group practice in Washington state and have experienced one or more episodes of severe hypoglycemia in the prior 12 months or have impaired awareness of hypoglycemia (Gold score ≥ 4). Participants are randomized to proactive nurse care management with or without my hypo compass, an evidence-based, psychoeducational intervention combining group and individual self-management training. For this study, my hypo compass was adapted to be suitable for adults with T2D and from an in-person to a virtual intervention over videoconference and telephone. The primary outcome is any self-reported severe hypoglycemia in the 12 months following the start of the intervention. Secondary outcomes include biochemical measures of hypoglycemia, self-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. The study includes a process evaluation to assess implementation fidelity and clarify the causal pathway. CONCLUSION: The PHT2 trial will compare the effectiveness of two approaches for reducing severe hypoglycemia in adults with T2D. TRIAL REGISTRATION: clinicaltrials.gov, # NCT04863872.

A Randomized Controlled Trial of Animal-assisted Activities for Pediatric Oncology Patients: Psychosocial and Microbial Outcomes.

INTRODUCTION: Evidence about the effectiveness and safety of dog visits in pediatric oncology is limited. METHOD: We conducted a randomized controlled trial (n=26) of dog visits versus usual care among pediatric oncology inpatients. Psychological functioning and microbial load from hand wash samples were evaluated. Parental anxiety was a secondary outcome. RESULTS: We did not observe a difference in the adjusted mean present functioning score (-3.0; 95% confidence interval [CI], -12.4 to 6.4). The difference in microbial load on intervention versus control hands was -0.04 (95% CI, -0.60 to 0.52) log10 CFU/mL, with an upper 95% CI limit below the prespecified noninferiority margin. Anxiety was lower in parents of intervention versus control patients. DISCUSSION: We did not detect an effect of dog visits on functioning; however, our study was underpowered by low recruitment. Visits improved parental anxiety. With hand sanitization, visits did not increase hand microbial levels. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT03471221.

Integrating Alcohol-Related Prevention and Treatment Into Primary Care: A Cluster Randomized Implementation Trial.

Importance: Unhealthy alcohol use is common and affects morbidity and mortality but is often neglected in medical settings, despite guidelines for both prevention and treatment. Objective: To test an implementation intervention to increase (1) population-based alcohol-related prevention with brief interventions and (2) treatment of alcohol use disorder (AUD) in primary care implemented with a broader program of behavioral health integration. Design, Setting, and Participants: The Sustained Patient-Centered Alcohol-Related Care (SPARC) trial was a stepped-wedge cluster randomized implementation trial, including 22 primary care practices in an integrated health system in Washington state. Participants consisted of all adult patients (aged ≥18 years) with primary care visits from January 2015 to July 2018. Data were analyzed from August 2018 to March 2021. Interventions: The implementation intervention included 3 strategies: practice facilitation; electronic health record decision support; and performance feedback. Practices were randomly assigned launch dates, which placed them in 1 of 7 waves and defined the start of the practice's intervention period. Main Outcomes and Measures: Coprimary outcomes for prevention and AUD treatment were (1) the proportion of patients who had unhealthy alcohol use and brief intervention documented in the electronic health record (brief intervention) for prevention and (2) the proportion of patients who had newly diagnosed AUD and engaged in AUD treatment (AUD treatment engagement). Analyses compared monthly rates of primary and intermediate outcomes (eg, screening, diagnosis, treatment initiation) among all patients who visited primary care during usual care and intervention periods using mixed-effects regression. Results: A total of 333 596 patients visited primary care (mean [SD] age, 48 [18] years; 193 583 [58%] female; 234 764 [70%] White individuals). The proportion with brief intervention was higher during SPARC intervention than usual care periods (57 vs 11 per 10 000 patients per month; P < .001). The proportion with AUD treatment engagement did not differ during intervention and usual care (1.4 vs 1.8 per 10 000 patients; P = .30). The intervention increased intermediate outcomes: screening (83.2% vs 20.8%; P < .001), new AUD diagnosis (33.8 vs 28.8 per 10 000; P = .003), and treatment initiation (7.8 vs 6.2 per 10 000; P = .04). Conclusions and Relevance: In this stepped-wedge cluster randomized implementation trial, the SPARC intervention resulted in modest increases in prevention (brief intervention) but not AUD treatment engagement in primary care, despite important increases in screening, new diagnoses, and treatment initiation. Trial Registration: ClinicalTrials.gov Identifier: NCT02675777.

Measuring Attitudes About Alcohol Misuse and Dependence Among Alaska Native People Within a Tribal Health Care System.

OBJECTIVES: Attitudes about alcohol misuse and dependence influence alcohol use and help-seeking behavior. Alaska Native and American Indian (AN/AI) people have higher rates of alcohol-related morbidity and mortality but engage in treatment at lower rates than the general population. No validated instruments exist to assess attitudes of AN/AI people about alcohol misuse and dependence to inform treatment and prevention efforts. This study aimed to develop an instrument to assess public attitudes among AN/AI people of alcohol misuse and dependence. METHODS: This multiphase, mixed-methods study was conducted at Southcentral Foundation, a tribally owned health system serving 65,000 AN/AI people in Alaska. We conducted focus groups and interviews with health system users, providers, and leaders to adapt the Public Attitudes About Addiction Survey. The adapted instrument was piloted with 200 people. Cognitive interviews and exploratory and confirmatory factor analyses were used to refine the instrument, which were then administered to 777 AN/AI people. RESULTS: Initial exploratory factor analysis identified 5 factors, including 3 from the original Public Attitudes About Addiction Survey (moral, disease, nature), a combined psychology and sociology factor (psychosocial), and a new factor (environment). A final 4-factor model (psychosocial, moral, disease, nature) with 14 items had good fit with root mean square error of approximation (0.035; comparative fit index = 0.977; Tucker-Lewis index = 0.970; standardized root mean residual = 0.040) and loadings ranging from 0.41 to 0.80. CONCLUSIONS: This study developed the first instrument to assess AN/AI attitudes about alcohol misuse and dependence. This instrument has potential to inform alcohol-related treatment in AN/AI communities. Future research is warranted to adequately measure place-based contributors salient to AN/AI people.

"What Will Happen If I Say Yes?" Perspectives on a Standardized Firearm Access Question Among Adults With Depressive Symptoms.

OBJECTIVE: Addressing firearm access is recommended when patients are identified as being at risk of suicide. However, the practice of assessing firearm access is controversial, and no national guidelines exist to inform practice. This study qualitatively explored patient perspectives on a routine question about firearm access to optimize the patient centeredness of this practice in the context of suicide risk. METHODS: Electronic health record data were used to identify primary care patients reporting depressive symptoms, including suicidal thoughts, within 2 weeks of sampling. Participants completed a semistructured telephone interview (recorded and transcribed), which focused broadly on the experience of being screened for suicidality and included specific questions to elicit beliefs and opinions about being asked a standard firearm access question. Directive (deductive) and conventional (inductive) content analysis was used to analyze responses to the portion of the interview focused on firearm assessment and disclosure. RESULTS: Thirty-seven patients in Washington State ages 20-95 completed the qualitative interview by phone. Organizing themes included apprehensions about disclosing access to firearms related to privacy, autonomy, and firearm ownership rights; perceptions regarding relevance of the firearm question, informed by experiences with suicidality and common beliefs and misconceptions about the inevitability of suicide; and suggestions for connecting questions about firearms and other lethal means to suicide risk. CONCLUSIONS: Clarifying the purpose and use of routine firearm access assessment, contextualizing firearm questions within injury prevention broadly, and addressing misconceptions about suicide prevention may help encourage disclosure of firearm access and increase the patient centeredness of this practice.

Mechanisms for the testing effect on patient-reported outcomes.

The testing effect is when patient-reported outcomes (PRO) improve with repeated administration without intervention. The testing effect can confound interpretation of clinical trials using PROs as endpoints. This study investigated potential mechanisms. The parent study (n = 302) investigated a self-management intervention for depression. We qualitatively analyzed exit interview feedback from the 89 control group participants completing the last assessment. Participants reported several perceived benefits from control group participation including novel mechanisms (study participation was meaningful, emotional support, appreciating outreach), a possible negative testing effect and mechanisms previously identified (behavioral change).

The impact of primary care behavioral health services on patient behaviors: A randomized controlled trial.

INTRODUCTION: Greater understanding of the impact of low intensity psychosocial interventions delivered by behavioral health clinicians (BHCs) working in an integrated care program (ICP) may promote better depression care. METHOD: In a randomized controlled trial, 153 participants identified as depressed by their primary care provider (PCP) were assigned to ICP or usual care (UC, management by PCP, including specialty referral). In the ICP condition, BHCs worked collaboratively with PCPs and liaison psychiatrists. RESULTS: ICP participants with lower and higher severity symptoms reported significantly greater use of coping strategies than UC participants at the 1-month follow up (lower: p = .002; higher: p = .016). ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups. ICP participants were more likely to be following relapse preventions plans at the 4-month follow up (lower: 89.5% vs. 50%, p = .0.000; higher 74.1% vs. 33%, p = .0001). ICP participants also reported use of antidepressant medications on more days than UC participants at the 4-month follow up (lower: 21.27 vs. 14.49 days, p = .049; higher: 24.61 vs. 17.08 days, p = .035). Patient retention in the ICP was high, and ICP participants were significantly more satisfied with depression care than UC participants at follow-up assessments. DISCUSSION: Delivery of low intensity psychosocial interventions by BHCs was associated with improvements to behavior charge targets. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

"You Actually View Us as the Experts in Our Own System": Indigenous-Academic Community Partnership.

BACKGROUND: The literature on community-engaged research provides important principles to guide research partnerships, but concrete descriptions of the complexities involved in developing, navigating, and maintaining such partnerships are lacking. OBJECTIVES: To describe and assess a longstanding, complex research partnership between Indigenous and academic pharmacogenetic research partners, with attention to co-learning and capacity building lessons learned. METHODS: Descriptive thematic analysis of 11 semistructured interviews with interdisciplinary research partners situated at Indigenous and academic settings. RESULTS: Lessons learned included the need for explicit negotiation around mentoring expectations, and discussion on advisory and staff roles. Partners need to be aware not only of the structures, policies, and hierarchies within each partner institution, but also the tacit value commitments and understandings entailed in their different missions. CONCLUSIONS: This study highlights that the concept of "bidirectional" learning as it is usually presented in the literature fails to capture the complexity of how partnerships work.

Perceptions of alcohol misuse among Alaska native health care system stakeholders: A qualitative exploration.

Although alcohol misuse is a priority for health care systems serving Alaska Native and American Indian (ANAI) people, stakeholders' perceptions of misuse are understudied. Patients (n = 34), providers (n = 20), and leaders (n = 16) at a Tribally owned and operated health care system reported that alcohol misuse results from the interaction of factors, including colonization, structural factors, social alienation, social norms about overdrinking introduced at the time of colonizing contact, coping with emotions, and beliefs about ANAI people and alcohol. Childhood exposure to alcohol misuse leads some ANAI people to avoid alcohol altogether, shedding light on the high levels of abstinence observed in ANAI communities.

Mixed method evaluation of Relational Team Development (RELATED) to improve team-based care for complex patients with mental illness in primary care.

BACKGROUND: Patients with mental illness are frequently treated in primary care, where Primary Care Providers (PCPs) report feeling ill-equipped to manage their care. Team-based models of care improve outcomes for patients with mental illness, but multiple barriers limit adoption. Barriers include practical issues and psychosocial factors associated with the reorganization of care. Practice facilitation can improve implementation, but does not directly address the psychosocial factors or gaps in PCP skills in managing mental illness. To address these gaps, we developed Relational Team Development (RELATED). METHODS: RELATED is an implementation strategy combining practice facilitation and psychology clinical supervision methodologies to improve implementation of team-based care. It includes PCP-level clinical coaching and a team-level practice change activity. We performed a preliminary assessment of RELATED with a convergent parallel mixed method study in 2 primary care clinics in an urban Federally Qualified Health Center in Southwest, USA, 2017-2018. Study participants included PCPs, clinic staff, and patient representatives. Clinic staff and patients were recruited for the practice change activity only. Primary outcomes were feasibility and acceptability. Feasibility was assessed as ease of recruitment and implementation. Acceptability was measured in surveys of PCPs and staff and focus groups. We conducted semi-structured focus groups with 3 participant groups in each clinic: PCPs; staff and patients; and leadership. Secondary outcomes were change in pre- post- intervention PCP self-efficacy in mental illness management and team-based care. We conducted qualitative observations to better understand clinic climate. RESULTS: We recruited 18 PCPs, 17 staff members, and 3 patient representatives. We ended recruitment early due to over recruitment. Both clinics developed and implemented practice change activities. The mean acceptability score was 3.7 (SD=0.3) on a 4-point Likert scale. PCPs had a statistically significant increase in their mental illness management self-efficacy [change = 0.9, p-value= <.01]. Focus group comments were largely positive, with PCPs requesting additional coaching. CONCLUSIONS: RELATED was feasible and highly acceptable. It led to positive changes in PCP self-efficacy in Mental Illness Management. If confirmed as an effective implementation strategy, RELATED has the potential to significantly impact implementation of evidence-based interventions for patients with mental illness in primary care.

Designing the relational team development intervention to improve management of mental health in primary care using iterative stakeholder engagement.

BACKGROUND: Team-based models of care are efficacious in improving outcomes for patients with mental and physical illnesses. However, primary care clinics have been slow to adopt these models. We used iterative stakeholder engagement to develop an intervention to improve the implementation of team-based care for this complex population. METHODS: We developed the initial framework for Relational Team Development (RELATED) from a qualitative study of Primary Care Providers' (PCPs') experiences treating mental illness and a literature review of practice facilitation and psychology clinical supervision. Subsequently, we surveyed 900 Colorado PCPs to identify factors associated with PCP self-efficacy in management of mental illness and team-based care. We then conducted two focus groups for feedback on RELATED. Lastly, we convened an expert panel to refine the intervention. RESULTS: We developed RELATED, a two-part intervention delivered by a practice facilitator with a background in clinical psychology. The facilitator observes PCPs during patient visits and provides individualized coaching. Next, the facilitator guides the primary care team through a practice change activity with a focus on relational team dynamics. CONCLUSION: The iterative development of RELATED using stakeholder engagement offers a model for the development of interventions tailored to the needs of these stakeholders. TRIAL REGISTRATION: Not applicable.

Effect of a Care Management Intervention on 12-Month Drinking Outcomes Among Patients With and Without DSM-IV Alcohol Dependence at Baseline.

BACKGROUND: The CHOICE care management intervention did not improve drinking relative to usual care (UC) for patients with frequent heavy drinking at high risk of alcohol use disorders. Patients with alcohol dependence were hypothesized to benefit most. We conducted preplanned secondary analyses to test whether the CHOICE intervention improved drinking relative to UC among patients with and without baseline DSM-IV alcohol dependence. METHODS: A total of 304 patients reporting frequent heavy drinking from 3 VA primary care clinics were randomized (stratified by DSM-IV alcohol dependence, sex, and site) to UC or the patient-centered, nurse-delivered, 12-month CHOICE care management intervention. Primary outcomes included percent heavy drinking days (%HDD) using 28-day timeline follow-back and a "good drinking outcome" (GDO)-abstaining or drinking below recommended limits and no alcohol-related symptoms on the Short Inventory of Problems at 12 months. Generalized estimating equation binomial regression models (clustered on provider) with interaction terms between dependence and intervention group were fit. RESULTS: At baseline, 59% of intervention and UC patients had DSM-IV alcohol dependence. Mean drinking outcomes improved for all subgroups. For participants with dependence, 12-month outcomes did not differ for intervention versus UC patients (%HDD 37% versus 38%, p = 0.76 and GDO 16% versus 16%, p = 0.77). For participants without dependence, %HDD did not differ between intervention (41%) and UC (31%) patients (p = 0.12), but the proportion with GDO was significantly higher among UC participants (26% versus 13%, p = 0.046). Neither outcome was significantly modified by dependence (interaction p values 0.19 for %HDD and 0.10 for GDO). CONCLUSIONS: Among participants with frequent heavy drinking, care management had no benefit relative to UC for patients with dependence, but UC may have had benefits for those without dependence. TRIAL REGISTRATION: ClinicalTrials.gov NCT01400581.

If You Listen, I Will Talk: the Experience of Being Asked About Suicidality During Routine Primary Care.

BACKGROUND: Routine population-based screening for depression is an essential part of evolving health care models integrating care for mental health in primary care. Depression instruments often include questions about suicidal thoughts, but how patients experience these questions in primary care is not known and may have implications for accurate identification of patients at risk. OBJECTIVES: To explore the patient experience of routine population-based depression screening/assessment followed, for some, by suicide risk assessment and discussions with providers. DESIGN: Qualitative, interview-based study. PARTICIPANTS: Thirty-seven patients from Kaiser Permanente Washington who had recently screened positive for depression on the 2-item Patient Health Questionnaire [PHQ] and completed the full PHQ-9. APPROACH: Criterion sampling identified patients who had recently completed the PHQ-9 ninth question which asks about the frequency of thoughts about self-harm. Patients completed semi-structured interviews by phone, which were recorded and transcribed. Directive and conventional content analyses were used to apply knowledge from prior research and elucidate new information from interviews; thematic analysis was used to organize key content overall and across groups based on endorsement of suicide ideation. KEY RESULTS: Four main organizing themes emerged from analyses: (1) Participants believed being asked about suicidality was contextually appropriate and valuable, (2) some participants described a mismatch between their lived experience and the PHQ-9 ninth question, (3) suicidality disclosures involved weighing hope for help against fears of negative consequences, and (4) provider relationships and acts of listening and caring facilitated discussions about suicidality. CONCLUSIONS: All participants believed being asked questions about suicidal thoughts was appropriate, though some who disclosed suicidal thoughts described experiencing stigma and sometimes distanced themselves from suicidality. Direct communication with trusted providers, who listened and expressed empathy, bolstered comfort with disclosure. Future research should consider strategies for reducing stigma and encouraging fearless disclosure among primary care patients experiencing suicidality.

Integration of screening, assessment, and treatment for cannabis and other drug use disorders in primary care: An evaluation in three pilot sites.

BACKGROUND: This pilot study evaluated whether use of evidence-based implementation strategies to integrate care for cannabis and other drug use into primary care (PC) as part of Behavioral Health Integration (BHI) increased diagnosis and treatment of substance use disorders (SUDs). METHODS: Patients who visited the three pilot PC sites were eligible. Implementation strategies included practice coaching, electronic health record decision support, and performance feedback (3/2015-4/2016). BHI introduced annual screening for past-year cannabis and other drug use, a Symptom Checklist for DSM-5 SUDs, and shared decision-making about treatment options. Main analyses tested whether the proportions of PC patients diagnosed with, and treated for, new cannabis or other drug use disorders (CUDs and DUDs, respectively), differed significantly pre- and post-implementation. RESULTS: Of 39,599 eligible patients, 57% and 59% were screened for cannabis and other drug use, respectively. Among PC patients reporting daily cannabis use (2%) or any drug use (1%), 51% and 37%, respectively, completed an SUD Symptom Checklist. The proportion of PC patients with newly diagnosed CUD increased significantly post-implementation (5 v 17 per 10,000 patients, p < 0.0001), but not other DUDs (10 vs 13 per 10,000, p = 0.24). The proportion treated for newly diagnosed CUDs did not increase post-implementation (1 vs 1 per 10,000, p = 0.80), but did for those treated for newly diagnosed other DUDs (1 vs 3 per 10,000, p = 0.038). CONCLUSIONS: A pilot implementation of BHI to increase routine screening and assessment for SUDs was associated with increased new CUD diagnoses and a small increase in treatment of new other DUDs.

Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT): Study Protocol.

This article describes the protocol for the Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT), a single-blind randomized pilot trial to test a personalized, pragmatic, multi-domain Alzheimer's disease (AD) risk reduction intervention in a US integrated healthcare delivery system. Study participants will be 200 higher-risk older adults (age 70-89 years with subjective cognitive complaints, low normal performance on cognitive screen, and ≥ two modifiable risk factors targeted by our intervention) who will be recruited from selected primary care clinics of Kaiser Permanente Washington, oversampling people with non-white race or Hispanic ethnicity. Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control. Randomization will be stratified by clinic, race/ethnicity (non-Hispanic white versus non-white or Hispanic), and age (70-79, 80-89). Participants randomized to the SMARRT group will work with a behavioral coach and nurse to develop a personalized plan related to their risk factors (poorly controlled hypertension, diabetes with evidence of hyper or hypoglycemia, depressive symptoms, poor sleep quality, contraindicated medications, physical inactivity, low cognitive stimulation, social isolation, poor diet, smoking). Participants in the HE control group will be mailed general health education information about these risk factors for AD. The primary outcome is two-year cognitive change on a cognitive test composite score. Secondary outcomes include: 1) improvement in targeted risk factors, 2) individual cognitive domain composite scores, 3) physical performance, 4) functional ability, 5) quality of life, and 6) incidence of mild cognitive impairment, AD, and dementia. Primary and secondary outcomes will be assessed in both groups at baseline and 6, 12, 18, and 24 months.

Understanding Why Patients May Not Report Suicidal Ideation at a Health Care Visit Prior to a Suicide Attempt: A Qualitative Study.

OBJECTIVE: The authors sought to understand why patients may not report suicidal ideation at a health care visit prior to a suicide attempt. METHODS: Electronic health record data from Kaiser Permanente Washington were used to identify patients who reported having no suicidal ideation on question 9 of the nine-item Patient Health Questionnaire and who subsequently made a suicide attempt (≤60 days). Semistructured interviews were audio-recorded, transcribed, and analyzed by using a combination of directed (deductive) and conventional (inductive) content analysis to validate and further explore reasons why patients may not report suicidal ideation prior to a suicide attempt. RESULTS: Of 42 adults sampled, 26 agreed to be interviewed, of whom about half were women (N=15) and a majority was white (N=20), with ages ranging from 18 to 63. Key themes were that patients who attempted suicide after having reported no thoughts of self-harm were either not experiencing suicidal ideation at the time of screening or feared the outcome of disclosure, including stigma, overreaction, and loss of autonomy. An additional theme that emerged from the interviews included reports of heavy episodic drinking at the time of the suicide attempt, particularly when suicide was completely unplanned. Patients also identified important aspects of interactions with health care system providers that may facilitate disclosure about suicidal ideation. CONCLUSIONS: Nonjudgmental listening and expressions of caring without overreaction among providers may help patients overcome fear of reporting suicidal ideation. Screening for heavy episodic drinking may help identify individuals who make unplanned suicide attempts.

Impact of Chronic Opioid Therapy Risk Reduction Initiatives on Opioid Overdose.

We assessed the effects of opioid dose and risk reduction initiatives on opioid overdose rates among patients on chronic opioid therapy (COT). Using an interrupted time series design, we compared trends in overdose rates. We compared patients on COT in settings that implemented a COT dose reduction initiative and then a COT risk stratification/monitoring initiative to similar patients on COT from control settings. From 2006 to 2014, 31,142 patients on COT (22,673 intervention, 8,469 control) experienced 311 fatal or nonfatal opioid overdoses. In primary analyses, changes in opioid overdose rates among patients on COT did not differ significantly between intervention and control settings with the implementation of either dose reduction or risk stratification/monitoring. In planned secondary analyses, overdose rates decreased significantly (17% per year) during the dose reduction initiative among patients on COT in intervention settings (relative annual change, 0.83; 95% confidence interval, 0.70-0.99), but not in control settings (0.98. 95% confidence interval, 0.70-1.39). We conclude that overdose rates among patients on COT were not decreased by risk stratification and monitoring initiatives. Results were inconsistent for COT dose reduction, with no significant difference between intervention and control settings (primary hypothesis test), but a significant decrease in overdose rates within the intervention setting during dose reduction (secondary hypothesis test). PERSPECTIVE: Risk stratification/monitoring interventions among patients on COT did not decrease opioid overdose rates. The effects of COT dose reduction on opioid overdose rates were inconsistent. Greater decreases in COT dose, a larger control group, or both may have been needed to identify conclusive reductions in opioid overdose rates.

Impact of initiatives to reduce prescription opioid risks on medically attended injuries in people using chronic opioid therapy.

PURPOSE: The purpose of the study is to determine whether initiatives to improve the safety of opioid prescribing decreased injuries in people using chronic opioid therapy (COT). METHODS: We conducted an interrupted time series analysis using data from Group Health (GH), an integrated health care delivery system in the United States. In 2007, GH implemented initiatives which substantially reduced daily opioid dose and increased patient monitoring. Among GH members age 18 or older receiving COT between 2006 and 2014, we compared injury rates for patients in GH's integrated group practice (IGP; exposed to the initiatives) vs patients cared for by contracted providers (not exposed). Injuries were identified using a validated algorithm. We calculated injury incidence during the baseline (preintervention) period from 2006 to 2007; the dose reduction period, 2008 to 2010; and the risk stratification and monitoring period, 2010 to 2014. Using modified Poisson regression, we estimated adjusted relative risks (RRs) representing the relative change per year in injury rates. RESULTS: Among 21 853 people receiving COT in the IGP and 8260 in contracted care, there were 2679 injuries during follow-up. The baseline injury rate was 1.0% per calendar quarter in the IGP and 0.9% in contracted care. Risk reduction initiatives did not decrease injury rates: Within the IGP, the RR in the dose reduction period was 1.01 (95% CI, 0.95-1.07) and in the risk stratification and monitoring period, 0.99 (95% CI, 0.95-1.04). Injury trends did not differ between the two care settings. CONCLUSIONS: Risk reduction initiatives did not decrease injuries in people using COT.

Parents' attitudes toward consent and data sharing in biobanks: A multisite experimental survey.

BACKGROUND: The factors influencing parents' willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents' willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data-sharing scenarios, and to identify factors associated with willingness. METHODS: This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups. Participants were randomized to receive one of three consent and data-sharing scenarios. RESULTS: In total, 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate). 5737 respondents were parents of minor children. Overall, 55% (95% confidence interval 50-59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios. Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs were independently associated with less willingness to allow their child to participate. Of parents who were willing to participate themselves, 25% were not willing to allow their child to participate. Being willing to participate but not willing to allow one's child to participate was independently associated with multiple factors, including race, lower educational attainment, lower annual household income, public health care insurance, and higher religiosity. CONCLUSIONS: Fifty-five percent of parents were willing to allow their youngest minor child to participate in a hypothetical biobank. Building trust, protecting privacy, and addressing attitudes may increase enrollment and diversity in pediatric biobanks.

Balancing Hope and Risk Among Adolescent and Young Adult Cancer Patients with Late-Stage Cancer: A Qualitative Interview Study.

PURPOSE: Previous studies have called for further research to explore adolescent and young adult (AYA) decision-making in the context of advanced cancer to understand the perspectives of this understudied population. We conducted a qualitative study with patients and providers to better understand the decision-making experience of AYA patients with advanced stages of cancer. METHODS: Semistructured qualitative telephone interviews were conducted from April 2016 to October 2016. English-speaking AYAs and healthcare providers were recruited through the social media sites Twitter and Facebook. AYAs were eligible if they were aged 18-39 years at diagnosis and self-reported having metastatic cancer; any provider who worked with AYAs with metastatic cancer was eligible. Researchers with expertise in qualitative methods conducted inductive thematic content analysis of transcribed interviews. The analyzed data were used to formulate recommendations for clinicians. RESULTS: Twelve AYA patients with self-reported stage IV cancer and five clinicians who care for AYAs with advanced stages of cancer were enrolled and shared their experience about AYA medical decision-making. Four primary themes emerged: (1) AYAs describe receiving unclear prognosis, (2) AYAs balance concepts of hope and risk, (3) AYAs choose aggressive treatment options, and (4) AYAs want support facing mortality. Recommendations for clinicians include clear communication about prognosis and side effects and concerted efforts to elicit patient values. CONCLUSION: AYA patients and clinicians provided insights into the experiences and decision-making processes of AYA patients choosing to continue or discontinue treatment and into the areas for improvement in patient-centered oncology care. Taken together, these data provide important suggestions for clinicians caring for this vulnerable population.