Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US.

Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled data sharing; or broad consent and open data sharing. Of 82,328 eligible individuals, exactly 13,000 (15.8%) completed the survey. Overall, 66% (95% CI: 63%-69%) of population-weighted respondents stated they would be willing to participate in a biobank; willingness and attitudes did not differ between respondents in the three scenarios. Willingness to participate was associated with self-identified white race, higher educational attainment, lower religiosity, perceiving more research benefits, fewer concerns, and fewer information needs. Most (86%, CI: 84%-87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%-55%) would worry about their privacy. The concern that the use of broad consent and open data sharing could adversely affect participant recruitment is not supported by these findings. Addressing potential participants' concerns and information needs and building trust and relationships with communities may increase acceptance of broad consent and wide data sharing in biobank research.

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.

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.

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.

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.

Barriers to and Facilitators of Alcohol Use Disorder Pharmacotherapy in Primary Care: A Qualitative Study in Five VA Clinics.

BACKGROUND: Three medications are FDA-approved and recommended for treating alcohol use disorders (AUD) but they are not offered to most patients with AUD. Primary care (PC) may be an optimal setting in which to offer and prescribe AUD medications, but multiple barriers are likely. OBJECTIVE: This qualitative study used social marketing theory, a behavior change approach that employs business marketing techniques including "segmenting the market," to describe (1) barriers and facilitators to prescribing AUD medications in PC, and (2) beliefs of PC providers after they were segmented into groups more and less willing to prescribe AUD medications. DESIGN: Qualitative, interview-based study. PARTICIPANTS: Twenty-four providers from five VA PC clinics. APPROACH: Providers completed in-person semi-structured interviews, which were recorded, transcribed, and analyzed using social marketing theory and thematic analysis. Providers were divided into two groups based on consensus review. KEY RESULTS: Barriers included lack of knowledge and experience, beliefs that medications cannot replace specialty addiction treatment, and alcohol-related stigma. Facilitators included training, support for prescribing, and behavioral staff to support follow-up. Providers more willing to prescribe viewed prescribing for AUD as part of their role as a PC provider, framed medications as a potentially effective "tool" or "foot in the door" for treating AUD, and believed that providing AUD medications in PC might catalyze change while reducing stigma and addressing other barriers to specialty treatment. Those less willing believed that medications could not effectively treat AUD, and that treating AUD was the role of specialty addiction treatment providers, not PC providers, and would require time and expertise they do not have. CONCLUSIONS: We identified barriers to and facilitators of prescribing AUD medications in PC, which, if addressed and/or capitalized on, may increase provision of AUD medications. Providers more willing to prescribe may be the optimal target of a customized implementation intervention to promote changes in prescribing.

Impact of Opioid Dose Reduction and Risk Mitigation Initiatives on Chronic Opioid Therapy Patients at Higher Risk for Opioid-Related Adverse Outcomes.

Objective: We aimed to determine if opioid risk reduction initiatives including dose reduction and risk mitigation strategies for chronic noncancer pain patients receiving chronic opioid therapy (COT) had a differential impact on average daily opioid doses of COT patients at higher risk for opioid-related adverse outcomes compared with lower-risk patients. Design: Interrupted time series. Setting: Group Health Cooperative (GH), a health care delivery system and insurance within Washington State, between 2006 and 2014. Population: GH enrollees on COT defined as receiving a supply of 70 or more days of opioids within 90 days using electronic pharmacy data for filled prescriptions. Methods: We compared the average daily morphine equivalent doses (MED) of COT patients with and without each of the following higher-risk characteristics: mental disorders, substance use disorders, sedative use, and male gender. Results: In all four pairwise comparisons, the higher-risk subgroup had a higher average daily MED than the lower-risk subgroup across the study period. Adjusted for covariates, modest differences in the annual rate of reduction in average daily MED were noted between higher- and lower-risk subgroups in three pairwise comparisons: those with mental disorders vs without (-8.2 mg/y vs -5.2 mg/y, P = 0.005), with sedative use vs without (-9.2 mg/y vs -5.8 mg/y, P = 0.004); mg), in men vs women (-8.8 mg/y vs -5.9 mg/y, P = 0.01). Conclusion: Using clinical policy initiatives in a health care system, dose reductions were achieved among COT patients at higher risk for opioid-related adverse outcomes that were at least as large as those among lower-risk patients.

Understanding What Is Most Important to Individuals with Multiple Chronic Conditions: A Qualitative Study of Patients' Perspectives.

BACKGROUND: To improve care for individuals living with multiple chronic conditions, patients and providers must align care planning with what is most important to patients in their daily lives. We have a limited understanding of how to effectively encourage communication about patients' personal values during clinical care. OBJECTIVE: To identify what patients with multiple chronic conditions describe as most important to their well-being and health. DESIGN: We interviewed individuals with multiple chronic conditions in their homes and analyzed results qualitatively, guided by grounded theory. PARTICIPANTS: A total of 31 patients (mean age 68.7 years) participated in the study, 19 of which included the participation of family members. Participants were from Kaiser Permanente Washington, an integrated health care system in Washington state. APPROACH: Qualitative analysis of home visits, which consisted of semi-structured interviews aided by photo elicitation. KEY RESULTS: Analysis revealed six domains of what patients described as most important for their well-being and health: principles, relationships, emotions, activities, abilities, and possessions. Personal values were interrelated and rarely expressed as individual values in isolation. CONCLUSIONS: The domains describe the range and types of personal values multimorbid older adults deem important to well-being and health. Understanding patients' personal values across these domains may be useful for providers when developing, sharing, and following up on care plans.

Impact of an opioid risk reduction initiative on motor vehicle crash risk among chronic opioid therapy patients.

PURPOSE: Although prescription opioids have been associated with higher motor vehicle crash (MVC) risk, it is unknown whether health system initiatives to better manage chronic opioid therapy (COT) can reduce MVC risk at the population level. METHODS: We conducted an interrupted time series population-level cohort study at Group Health (GH), between January 2006 and September 2014, comparing MVC risk among COT patients who were GH members receiving care in either group practice or contracted care settings. Group practice COT risk reduction initiatives were implemented in two phases: (1) altered prescribing expectations and (2) multifaceted initiatives. These initiatives did not exist in the contracted care network. We compared the adjusted quarterly rate of MVC between group practice and contracted care patients over time using a modified Poisson regression model for a binary outcome. RESULTS: A total of 32 691 COT patients (27.4% from contracted care) met eligibility criteria and experienced a total of 1956 MVCs during study follow-up (mean, 8.1 quarters per person), of which 810 were serious injury crashes. Crash rates were not significantly different between the patient groups within any of the time periods. Analyses stratified by concurrent prescription of a sedative hypnotic or benzodiazepine found no significant difference between the group practice and contracted care patients. There was a modest elevation of MVC risk for high-dose patients relative to former COT patients who stopped receiving opioids. CONCLUSIONS: The risk of MVC was not mitigated in a large cohort of COT patients exposed to a health plan policy initiative that substantially lowered mean opioid dose. Copyright © 2016 John Wiley & Sons, Ltd.

The Relations of Cognitive, Behavioral, and Physical Activity Variables to Depression Severity in Traumatic Brain Injury: Reanalysis of Data From a Randomized Controlled Trial.

OBJECTIVE: To explore the relations of cognitive, behavioral, and physical activity variables to depression severity among people with traumatic brain injury (TBI) undergoing a depression treatment trial. SETTING: Community. PARTICIPANTS: Adults (N = 88) who sustained complicated mild to severe TBI within the past 10 years, met criteria for major depressive disorder, and completed study measures. DESIGN: Randomized controlled trial. METHODS: Participants were randomized to cognitive-behavioral therapy (n = 58) or usual care (n = 42). Outcomes were measured at baseline and 16 weeks. We combined the groups and used regressions to explore the relations among theoretical variables and depression outcomes. MAIN MEASURES: Depression severity was measured with the Hamilton Depression Rating Scale and Symptom Checklist-20. Theory-based measures were the Dysfunctional Attitudes Scale (DAS), Automatic Thoughts Questionnaire (ATQ), Environmental Rewards Observation Scale (EROS), and the International Physical Activity Questionnaire (IPAQ). RESULTS: Compared with non-TBI norms, baseline DAS and ATQ scores were high and EROS and IPAQ scores were low. All outcomes improved from baseline to 16 weeks except the DAS. The ATQ was an independent predictor of baseline depression. An increase in EROS scores was correlated with decreased depression. CONCLUSIONS: Increasing participation in meaningful roles and pleasant activities may be a promising approach to treating depression after TBI.

Conducting a large, multi-site survey about patients' views on broad consent: challenges and solutions.

BACKGROUND: As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants' views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or "broad" fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic. METHODS: A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients' views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. RESULTS: Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee's output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers. CONCLUSIONS: Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.

Factors Underlying Quality Problems with Alcohol Screening Prompted by a Clinical Reminder in Primary Care: A Multi-site Qualitative Study.

BACKGROUND: Population-based alcohol screening is recommended in primary care, and increasingly incentivized by policies, yet is challenging to implement. The U.S. Veterans Health Administration (VA) achieved high rates of screening using a national performance measure and associated electronic clinical reminder to prompt and facilitate screening and document results. However, the sensitivity of alcohol screening for identifying unhealthy alcohol use is low in VA clinics. OBJECTIVE: We aimed to understand factors that might contribute to low sensitivity of alcohol screening. DESIGN: This was an observational, qualitative study. PARTICIPANTS: Participants included clinical staff responsible for conducting alcohol screening and nine independently managed primary care clinics of a single VA medical center in the Northwestern U.S. APPROACH: Four researchers observed clinical staff as they conducted alcohol screening. Observers took handwritten notes, which were transcribed and coded iteratively. Template analysis identified a priori and emergent themes. KEY RESULTS: We observed 72 instances of alcohol screening conducted by 31 participating staff. Observations confirmed known challenges to implementation of care using clinical reminders, including workflow and flexibility limitations. Three themes specific to alcohol screening emerged. First, most observed screening was conducted verbally, guided by the clinical reminder, although some variability in approaches to screening (e.g., paper-based or laminate-based screening) was observed. Second, specific verbal screening practices that might contribute to low sensitivity of clinical screening were identified, including conducting non-verbatim screening and making inferences, assumptions, and/or suggestions to input responses. Third, staff introduced and adapted screening questions to enhance patient comfort. CONCLUSIONS: This qualitative study in nine clinics found that implementation of alcohol screening facilitated by a clinical reminder resulted primarily in verbal screening in which questions were not asked vertbatim and were otherwise adapted. Non-verbal approaches to screening, or patient self-administration, may enhance validity and standardization of screening while simultaneously addressing limitations of the clinical reminder and issues related to perceived discomfort.

Community dissemination and genetic research: moving beyond results reporting.

The community-based participatory research (CBPR) literature notes that researchers should share study results with communities. In the case of human genetic research, results may be scientifically interesting but lack clinical relevance. The goals of this study were to learn what kinds of information community members want to receive about genetic research and how such information should be conveyed. We conducted eight focus group discussions with Yup'ik Alaska Native people in southwest Alaska (N = 60) and 6 (N = 61) with members of a large health maintenance organization in Seattle, Washington. Participants wanted to receive genetic information they "could do something about" and wanted clinically actionable information to be shared with their healthcare providers; they also wanted researchers to share knowledge about other topics of importance to the community. Although Alaska Native participants were generally less familiar with western scientific terms and less interested in web-based information sources, the main findings were the same in Alaska and Seattle: participants wished for ongoing dialogue, including opportunities for informal, small-group conversations, and receiving information that had local relevance. Effective community dissemination is more than a matter of presenting study results in lay language. Community members should be involved in both defining culturally appropriate communication strategies and in determining which information should be shared. Reframing dissemination as a two-way dialogue, rather than a one-way broadcast, supports the twin aims of advancing scientific knowledge and achieving community benefit.

Medical comorbidity and psychotropic medication fills in older adults with breast or prostate cancer.

BACKGROUND: Previous research has shown that as people age, distress decreases despite an increase in prevalence of medical comorbidity. This could be due to increased use of psychotropic medications with comorbidity. We tested this hypothesis in older adults. METHODS: Information from medical records of older adults (65 to 99 years of age) in the following groups was collected: women with breast cancer (n = 2359), women without any cancer diagnosis (n = 27,161), men with prostate cancer (n = 2686), and men without any cancer diagnosis (n = 21,014). We collected fills of antidepressant or sedative medications, diagnosis of depression in the year of cancer diagnosis, and Charlson Comorbidity Index from the year before cancer. RESULTS: Women with breast cancer were more likely to fill psychotropic prescriptions (both ps < 0.02) or be diagnosed with depression (p < 0.001) than women without cancer. Men with prostate cancer were more likely to fill these prescriptions or receive a diagnosis of depression than men without cancer (ps < 0.05). Charlson was related to increased odds of filling both types of medication in women with breast cancer and men with prostate cancer (ps < 0.001). Comorbidity was related to greater odds of receiving a depression diagnosis in men with prostate cancer (p < 0.001) but not women with breast cancer (p > 0.15). CONCLUSIONS: Older adults with breast or prostate cancer are more likely to fill psychotropic medication prescriptions and receive a depression diagnosis than those without cancer. Comorbidity increased the likelihood of medication fills in older adults with cancer. As this population experiences polypharmacy, nonpharmacologic treatments for depression may need to be considered.

Effectiveness of the Engagement and Counseling for Latinos (ECLA) intervention in low-income Latinos.

BACKGROUND: Persistent disparities in access and quality of mental health care for Latinos indicate a need for evidence-based, culturally adapted, and outside-the-clinic-walls treatments. OBJECTIVE: Evaluate treatment effectiveness of telephone (ECLA-T) or face-to-face (ECLA-F) delivery of a 6-8 session cognitive behavioral therapy and care management intervention for low-income Latinos, as compared to usual care for depression. DESIGN: Multisite randomized controlled trial. SETTING: Eight community health clinics in Boston, Massachusetts and San Juan, Puerto Rico. PARTICIPANTS: 257 Latino patients recruited from primary care between May 2011 and September 2012. MAIN OUTCOME MEASURES: The primary outcome was severity of depression, assessed with the Patient Health Questionnaire-9 and the Hopkins Symptom Checklist-20. The secondary outcome was functioning over the previous 30 days, measured using the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). RESULTS: Both telephone and face-to-face versions of the Engagement and Counseling for Latinos (ECLA) were more effective than usual care. The effect sizes of both intervention conditions on Patient Health Questionnaire-9 were moderate when combined data from both sites are analyzed (0.56 and 0.64 for face-to-face and telephone, respectively). Similarly, effect sizes of ECLA-F and ECLA-T on the Hopkins Symptom Checklist were quite large in the Boston site (0.64 and 0.73. respectively) but not in Puerto Rico (0.10 and 0.03). CONCLUSIONS AND RELEVANCE: The intervention appears to help Latino patients reduce depressive symptoms and improve functioning. Of particular importance is the higher treatment initiation for the telephone versus face-to-face intervention (89.7% vs. 78.8%), which suggests that telephone-based care may improve access and quality of care.

Designing messaging to engage patients in an online suicide prevention intervention: survey results from patients with current suicidal ideation.

BACKGROUND: Computerized, Internet-delivered interventions can be efficacious; however, uptake and maintaining sustained client engagement are still big challenges. We see the development of effective engagement strategies as the next frontier in online health interventions, an area where much creative research has begun. We also argue that for engagement strategies to accomplish their purpose with novel targeted populations, they need to be tailored to such populations (ie, content is designed with the target population in mind). User-centered design frameworks provide a theoretical foundation for increasing user engagement and uptake by including users in development. However, deciding how to implement this approach to engage users in mental health intervention development is challenging. OBJECTIVE: The aim of this study was to get user input and feedback on acceptability of messaging content intended to engage suicidal individuals. METHODS: In March 2013, clinic intake staff distributed flyers announcing the study, "Your Feedback Counts" to potential participants (individuals waiting to be seen for a mental health appointment) together with the Patient Health Questionnaire. The flyer explained that a score of two or three ("more than half the days" or "nearly every day" respectively) on the suicide ideation question made them eligible to provide feedback on components of a suicide prevention intervention under development. The patient could access an anonymous online survey by following a link. After providing consent online, participants completed the anonymous survey. RESULTS: Thirty-four individuals provided data on past demographic information. Participants reported that they would be most drawn to an intervention where they knew that they were cared about, that was personalized, that others like them had found it helpful, and that included examples with real people. Participants preferred email invitations with subject lines expressing concern and availability of extra resources. Participants also provided feedback about a media prototype including a brand design and advertisement video for introducing the intervention. CONCLUSIONS: This paper provides one model (including development of an engagement survey, audience for an engagement survey, methods for presenting results of an engagement survey) for including target users in the development of uptake strategies for online mental health interventions.

Collaborative care for adolescents with depression in primary care: a randomized clinical trial.

IMPORTANCE: Up to 20% of adolescents experience an episode of major depression by age 18 years yet few receive evidence-based treatments for their depression. OBJECTIVE: To determine whether a collaborative care intervention for adolescents with depression improves depressive outcomes compared with usual care. DESIGN: Randomized trial with blinded outcome assessment conducted between April 2010 and April 2013. SETTING: Nine primary care clinics in the Group Health system in Washington State. PARTICIPANTS: Adolescents (aged 13-17 years) who screened positive for depression (Patient Health Questionnaire 9-item [PHQ-9] score ≥10) on 2 occasions or who screened positive and met criteria for major depression, spoke English, and had telephone access were recruited. Exclusions included alcohol/drug misuse, suicidal plan or recent attempt, bipolar disorder, developmental delay, and seeing a psychiatrist. INTERVENTIONS: Twelve-month collaborative care intervention including an initial in-person engagement session and regular follow-up by master's-level clinicians. Usual care control youth received depression screening results and could access mental health services through Group Health. MAIN OUTCOMES AND MEASURES: The primary outcome was change in depressive symptoms on a modified version of the Child Depression Rating Scale-Revised (CDRS-R; score range, 14-94) from baseline to 12 months. Secondary outcomes included change in Columbia Impairment Scale score (CIS), depression response (≥50% decrease on the CDRS-R), and remission (PHQ-9 score <5). RESULTS: Intervention youth (n = 50), compared with those randomized to receive usual care (n = 51), had greater decreases in CDRS-R scores such that by 12 months intervention youth had a mean score of 27.5 (95% CI, 23.8-31.1) compared with 34.6 (95% CI, 30.6-38.6) in control youth (overall intervention effect: F2,747.3 = 7.24, P < .001). Both intervention and control youth experienced improvement on the CIS with no significant differences between groups. At 12 months, intervention youth were more likely than control youth to achieve depression response (67.6% vs 38.6%, OR = 3.3, 95% CI, 1.4-8.2; P = .009) and remission (50.4% vs 20.7%, OR = 3.9, 95% CI, 1.5-10.6; P = .007). CONCLUSIONS AND RELEVANCE: Among adolescents with depression seen in primary care, a collaborative care intervention resulted in greater improvement in depressive symptoms at 12 months than usual care. These findings suggest that mental health services for adolescents with depression can be integrated into primary care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01140464.

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.