The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm.

BACKGROUND: About half of people living with dementia have not received a diagnosis, delaying access to treatment, education, and support. We previously developed a tool, eRADAR, which uses information in the electronic health record (EHR) to identify patients who may have undiagnosed dementia. This paper provides the protocol for an embedded, pragmatic clinical trial (ePCT) implementing eRADAR in two healthcare systems to determine whether an intervention using eRADAR increases dementia diagnosis rates and to examine the benefits and harms experienced by patients and other stakeholders. METHODS: We will conduct an ePCT within an integrated healthcare system and replicate it in an urban academic medical center. At primary care clinics serving about 27,000 patients age 65 and above, we will randomize primary care providers (PCPs) to have their patients with high eRADAR scores receive targeted outreach (intervention) or usual care. Intervention patients will be offered a "brain health" assessment visit with a clinical research interventionist mirroring existing roles within the healthcare systems. The interventionist will make follow-up recommendations to PCPs and offer support to newly-diagnosed patients. Patients with high eRADAR scores in both study arms will be followed to identify new diagnoses of dementia in the EHR (primary outcome). Secondary outcomes include healthcare utilization from the EHR and patient, family member and clinician satisfaction assessed through surveys and interviews. CONCLUSION: If this pragmatic trial is successful, the eRADAR tool and intervention could be adopted by other healthcare systems, potentially improving dementia detection, patient care and quality of life.

Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial).

BACKGROUND: Experts recommend that treatment for substance use disorder (SUD) be integrated into primary care. The Digital Therapeutics for Opioids and Other SUD (DIGITS) Trial tests strategies for implementing reSET® and reSET-O®, which are prescription digital therapeutics for SUD and opioid use disorder, respectively, that include the community reinforcement approach, contingency management, and fluency training to reinforce concept mastery. This purpose of this trial is to test whether two implementation strategies improve implementation success (Aim 1) and achieve better population-level cost effectiveness (Aim 2) over a standard implementation approach. METHODS/DESIGN: The DIGITS Trial is a hybrid type III cluster-randomized trial. It examines outcomes of implementation strategies, rather than studying clinical outcomes of a digital therapeutic. It includes 22 primary care clinics from a healthcare system in Washington State and patients with unhealthy substance use who visit clinics during an active implementation period (up to one year). Primary care clinics implemented reSET and reSET-O using a multifaceted implementation strategy previously used by clinical leaders to roll-out smartphone apps ("standard implementation" including discrete strategies such as clinician training, electronic health record tools). Clinics were randomized as 21 sites in a 2x2 factorial design to receive up to two added implementation strategies: (1) practice facilitation, and/or (2) health coaching. Outcome data are derived from electronic health records and logs of digital therapeutic usage. Aim 1's primary outcomes include reach of the digital therapeutics to patients and fidelity of patients' use of the digital therapeutics to clinical recommendations. Substance use and engagement in SUD care are additional outcomes. In Aim 2, population-level cost effectiveness analysis will inform the economic benefit of the implementation strategies compared to standard implementation. Implementation is monitored using formative evaluation, and sustainment will be studied for up to one year using qualitative and quantitative research methods. DISCUSSION: The DIGITS Trial uses an experimental design to test whether implementation strategies increase and improve the delivery of digital therapeutics for SUDs when embedded in a large healthcare system. It will provide data on the potential benefits and cost-effectiveness of alternative implementation strategies. CLINICALTRIALS: gov Identifier: NCT05160233 (Submitted 12/3/2021). https://clinicaltrials.gov/ct2/show/NCT05160233.

Assessment of a diverse panel of transmitted/founder HIV-1 infectious molecular clones in a luciferase based CD8 T-cell mediated viral inhibition assay.

Introduction: Immunological protection against human immunodeficiency virus-1 (HIV-1) infection is likely to require both humoral and cell-mediated immune responses, the latter involving cytotoxic CD8 T-cells. Characterisation of CD8 T-cell mediated direct anti-viral activity would provide understanding of potential correlates of immune protection and identification of critical epitopes associated with HIV-1 control. Methods: The present report describes a functional viral inhibition assay (VIA) to assess CD8 T-cell-mediated inhibition of replication of a large and diverse panel of 45 HIV-1 infectious molecular clones (IMC) engineered with a Renilla reniformis luciferase reporter gene (LucR), referred to as IMC-LucR. HIV-1 IMC replication in CD4 T-cells and CD8 T-cell mediated inhibition was characterised in both ART naive subjects living with HIV-1 covering a broad human leukocyte antigen (HLA) distribution and compared with uninfected subjects. Results & discussion: CD4 and CD8 T-cell lines were established from subjects vaccinated with a candidate HIV-1 vaccine and provided standard positive controls for both assay quality control and facilitating training and technology transfer. The assay was successfully established across 3 clinical research centres in Kenya, Uganda and the United Kingdom and shown to be reproducible. This IMC-LucR VIA enables characterisation of functional CD8 T-cell responses providing a tool for rational T-cell immunogen design of HIV-1 vaccine candidates and evaluation of vaccine-induced T-cell responses in HIV-1 clinical trials.

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship.

BACKGROUND: There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention. METHODS: The Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received. DISCUSSION: The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial's strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective. TRIAL REGISTRATION: ClinicalTrials.gov NCT05018000 . August 23, 2021.

Service learning: Nursing students' civic engagement with diverse populations of children with special needs.

PURPOSE: There is limited knowledge of nursing students' perspectives about engagement with special needs populations. The purpose of this study was to identify the advantages/benefits and disadvantages/challenges of nursing students' engagement experience with children with special mental and physical disabilities. Recommendations to enhance student engagement experiences were also provided. METHODS: A descriptive, qualitative design was employed. Undergraduate nursing students (N = 28) responded to open-ended questions about their civic engagement experiences at a community-based, respite care program for children with special needs. Student accounts underwent directed content analysis, with coding, category and theme development according to the Theory of Planned Behavior. The Atlas.Ti computer program was used to manage the data. RESULTS: Advantages/Benefits: Filling cognitive and experiential learning gaps, rewarding connections/relationships, positive emotions, perceptions and interactions, and fun and stress relief. Disadvantage/challenges: Managing negative/uncomfortable emotions and uncertainty, witnessing and managing disruptive behaviors, negative perceptions of program operations/expectations. CONCLUSIONS: Students experienced cognitive, emotional, interpersonal and educational advantages and/or disadvantages while engaging with this defined population. PRACTICE IMPLICATIONS: To enhance engagement faculty can provide education and anticipatory guidance, detail responsibilities and expectations, and/or utilize simulation for student preparation. Nurses and researchers can utilize community based participatory methods to guide discussions with community-based organizations to collaboratively develop strategies to institute, evaluate and enhance student engagement during service learning experiences with children who have special needs.

Eliciting Willingness and Beliefs towards Participation in Genetic Psychiatric Testing in Black/African American Mothers at Risk for Depression.

Black/African American women are at high risk for depression, yet are underrepresented in psychiatric genetic research for depression prevention and treatment. Little is known about the factors that influence participation in genetic testing for Black/African American women at risk. The purpose of this study was to elicit the beliefs that underlie participation in genetic testing for depression in Black/African American mothers, a subgroup at high risk. Willingness to participate in genetic testing procedures was also determined. A qualitative, descriptive design was employed. Exactly 19 mothers aged 21-42 completed open-ended questionnaires. Directed content and descriptive analyses of the text were conducted based on the Theory of Planned Behavior. Salient beliefs included: behavioral advantages-diagnosing/detecting depression (31.6%), finding cure/treatment (21.1%); disadvantages-not finding follow-up treatment/help (21.1%); salient referents, who approves-family members (47.4%), agencies/organizations (26.3%); who disapproves-church associates (21.1%). Control beliefs included: barriers-unpleasant/difficult testing procedures (42.1%), limited knowledge about the purpose of testing (26.3%); facilitator-a convenient location (21.1%). Most mothers (89.5%) indicated willingness to participate in testing. Interventions can target families, address barriers, emphasize future benefits, and use convenient locations and community-based participatory research methods. Policies can address social determinants of participation to increase inclusion of these mothers in psychiatric genetic research.

Communication with Physicians about Health Care Costs: Survey of an Insured Population.

CONTEXT: Health care costs have increasingly shifted to patients, and financial distress caused by medical care has increased. Patients may wish to discuss costs with their clinicians. OBJECTIVE: Describe patient preferences for communication about cost in the clinical setting. DESIGN: Cross-sectional, self-administered survey of a stratified random sample of the population insured in an integrated health care system in Washington State. Our sampling frame was the entire membership aged 21 years or older. Sampling was stratified by sex and group practice enrollment. MAIN OUTCOME MEASURES: Preference for discussing health care costs with one's physician. We conducted regression analyses to determine predictors of communication preference; potential predictors included demographic characteristics, financial burden, delay in seeking care because of cost, and socioeconomic variables. Survey responses were weighted to adjust for nonresponse and sampling. RESULTS: Of 7200 invitations sent, 2200 survey responses were returned. Ninety-two percent wished to know their out-of-pocket costs before beginning treatment. Most respondents preferred their physician talk with them about out-of-pocket costs (81.4%) and expressed comfort with discussing costs with their physician (75.6%). Overall, 43.7% reported any delay in seeking care in the previous 12 months. One in 5 respondents (21.6%) reported family medical debt. Delay in seeking care was positively and independently associated with preferring to discuss costs with one's physician; current medical financial burden was not. CONCLUSION: Patient preferences for communication about costs with physicians are high, and medical debt and delay in care-seeking are prevalent. Delay in care-seeking independently predicts cost communication preferences.

A novel running mechanic's class changes kinematics but not running economy.

A novel method of running technique instruction, Midstance to Midstance Running (MMR), was studied to determine how MMR affected kinematics and running economy (RE) of recreational runners. An experimental pre-post randomized groups design was used. Participants (n = 18) were recreational runners who ran at least 3 days a week and 5 km per run. All testing was performed on a treadmill at 2.8 m·s. The intervention group (n = 9) completed 8 weeks of instruction in MMR; the control group (n = 9) continued running without instruction. The MMR group showed significant decreases in stride length (SL) (p = 0.02) and maximum knee flexion velocity in stance (p = 0.01), and a significant increase in stride rate (SR) (p = 0.02) after 8 weeks. No significant changes were found in heart rate, rating of perceived exertion, or RE. Midstance to Midstance Running was effective in changing SR and SL, but was not effective in changing other kinematic variables such as foot contact position and maximum knee flexion during swing. Midstance to Midstance Running did not affect RE. Evidence suggests that MMR may be an appropriate instructional method for recreational runners trying to decrease SL and increase SR.

Depression, perceived family criticism, and functional status among older, primary-care patients.

OBJECTIVE: Relatively little research has examined the role of family factors in later-life depression, particularly in the broad range of depressive conditions seen in primary care. Authors tested the hypotheses that 1) perceived family criticism is independently associated with depression, 2) that family criticism and depression are independently associated with functional disability, and 3) that perceived family criticism moderates the association between depression and functional disability. METHODS: This cross-sectional study recruited 379 adults age > or =65 years from primary-care practices. Study measures included the Structured Clinical Interview for DSM-IV, the Hamilton Rating Scale for Depression, the Family Emotional Involvement and Criticism Scale, and several measures of functional disability. Multiple regression determined independent associations, and a multiplicative interaction term tested the moderator model of the third hypothesis. RESULTS: Perceived family criticism was independently associated with depression diagnosis and depressive symptoms. Depression diagnosis, depressive symptoms, and perceived family criticism were each independently associated with functional status. Perceived family criticism did not moderate the association between depressive symptoms and functional status in the overall study group, although it did moderate the association between depression diagnosis and instrumental activities of daily living when only early-onset depressed patients were included. CONCLUSIONS: Authors confirmed the first and second hypotheses; however data did not support the third hypothesis. These results provide support for clinicians to attend to quality of primary family relationships and perceived criticism in depressed older adults and for researchers to consider aspects of family functioning as covariates or potential targets for intervention studies.

The emergence of "family integrity" in later life.

In contrast to the rich and abundant literature on the early stages of the family life cycle, there are relatively few theoretical accounts of family developmental processes in the second half of life. In an effort to address this imbalance, we introduce the concept of "family integrity" to refer to the ultimate, positive outcome of an older adult's developmental striving toward meaning, connection, and continuity within his or her multigenerational family. Subjectively, for the older adult, family integrity may be experienced as a deep and abiding sense of peace and/or satisfaction with his or her multigenerational family relationships, past, present, and future. It is the result of a growing concern for relational closure that typically begins to emerge in mid-life and gains ascendance in later-life. Objectively, at the level of observable relational processes, it is manifest in three interrelated competencies of the family as a system: (a) the transformation of relationships over time in a manner that is dynamic and responsive to the changing life cycle needs of individual family members, (b) the resolution or acceptance of past losses or family conflicts, with the dead as well as the living, and (c) the shared creation of meaning by passing on individual and family legacies within and across generations. As a construct, family integrity involves processes at multiple levels of social organization. At the individual level, it refers to an older adult's inner experience of satisfaction or "completeness" in the context of his or her family relationships. At the family level, it refers to observable relational competencies and transactions that contribute directly to an elder's sense of meaning, purpose, and connection with others. Simultaneously, at the level of culture and society, there are values and rituals that influence whether individuals experience meaning and purpose within the multigenerational family.

Do over-the-counter medications for migraine hinder the physician?

The availability of many over-the-counter drugs that were formerly prescription medications enable patients with migraine to self-medicate easily and delay entry into the appropriate medical management. The potential for adverse effects, drug interactions, and analgesic rebound headaches can often be complications that hinder treatment. Over-the-counter products force the patient to employ a less effective step-care approach as opposed to evidence-based guidelines.