Randomized trial of the leadership and organizational change for implementation (LOCI) strategy in substance use treatment clinics.

INTRODUCTION: Evidence-based practice (EBP) implementation represents a strategic change that requires alignment of leadership and support throughout organizations. Leadership and Organizational Change for Implementation (LOCI) is a multifaceted implementation strategy that aims to improve implementation leadership and climate within organizations through iterative cycles of leadership and climate assessment and feedback, leadership training and coaching, and strategic planning with upper-level leaders. This study tested the effects of LOCI on transformational and implementation leadership, implementation climate, implementation citizenship behavior, and EBP reach. METHODS: A multiple cohort, cluster randomized trial tests the effect of LOCI in 60 clinics across nine behavioral health organizations in California and Arizona, USA. The study randomized clinics within organizations to either LOCI or a leadership training webinar control condition in three consecutive cohorts. Repeated web-based surveys of direct service providers (nLOCI = 201, nControl = 179) assessed leadership, implementation climate, and implementation citizenship over time. Multilevel autoregressive modeling was the primary statistical analysis such that providers (level-1) were nested within clinics (level-2). The study predicted between-condition differences at 4-, 8-, and 12-month follow-up assessments. Provider engagement in a fidelity monitoring process assessed reach of motivational interviewing (i.e., number of sessions recorded/submitted for fidelity coding). An independent sample t-test explored between condition differences in motivational interviewing reach. RESULTS: Results indicated between condition differences at 4 months for implementation leadership, implementation climate, and implementation citizenship behavior such that greater improvements were evidenced in the LOCI condition compared to the control condition. Reach of MI was significantly greater in the LOCI vs control condition such that LOCI providers were significantly more likely to engage in the fidelity monitoring process (chi-square (1, n = 370) = 5.59, p = .018). CONCLUSIONS: LOCI was developed based on organizational theories of strategic leadership and climate to affect organizational change processes that communicate that innovation implementation is expected, supported, and recognized as a value of the organization. The LOCI implementation strategy resulted in more positive hypothesized outcomes compared to the control condition. Organizational change strategies have utility for implementing health innovations in complex, multilevel contexts and for greater sustainment of facilitative leader behaviors, strategic implementation climate, and improved implementation outcomes. TRIAL REGISTRATION: This study is registered with Clinicaltrials.gov gov (NCT03042832, 2 February 2017; retrospectively registered).

Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.

OBJECTIVE: This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance-based health system (Scripps Health). RESEARCH DESIGN AND METHODS: A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). RESULTS: All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. CONCLUSIONS: This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.

A pragmatic randomized trial of mailed fecal immunochemical testing to increase colorectal cancer screening among low-income and minoritized populations.

BACKGROUND: Colorectal cancer (CRC) screening is underused, particularly among low-income and minoritized populations, for whom the coronavirus disease 2019 (COVID-19) pandemic has challenged progress in achieving equity. METHODS: A hub-and-spoke model was used. The hub was a nonacademic organization and the spokes were three community health center (CHC) systems overseeing numerous clinic sites. Via a cluster-randomized trial design, nine clinic sites were randomized to intervention and 16 clinic sites were randomized to usual care. Patient-level interventions included invitation letters, mailed fecal immunochemical tests (FITs), and call/text-based reminders. Year 1 intervention impact, which took place during the COVID-19 pandemic, was assessed as the proportion completing screening among individuals not up to date at baseline, which compared intervention and nonintervention clinics accounting for intraclinic cluster variation; confidence intervals (CIs) around differences not including 0 were interpreted as statistically significant. RESULTS: Among 26,736 patients who met eligibility criteria, approximately 58% were female, 55% were Hispanic individuals, and 44% were Spanish speaking. The proportion completing screening was 11.5 percentage points (ppts) (95% CI, 6.1-16.9 ppts) higher in intervention versus usual care clinics. Variation in differences between intervention and usual care clinics was observed by sex (12.6 ppts [95% CI, 7.2-18.0 ppts] for females; 8.8 ppts [95% CI, 4.7-13.9 ppts] for males) and by racial and ethnic group (13.8 ppts [95% CI, 7.0-20.6 ppts] for Hispanic individuals; 13.0 ppts [95% CI, 3.6-22.4 ppts] for Asian individuals; 11.3 ppts [95% CI, 5.8-16.8 ppts] for non-Hispanic White individuals; 6.1 ppts [95% CI, 0.8-10.4 ppts] for Black individuals). CONCLUSIONS: A regional mailed FIT intervention was effective for increasing CRC screening rates across CHC systems serving diverse, low-income populations.

Psychometric Properties of the Weight Loss Readiness Test in Active Duty Military Personnel Enrolled in a Weight Management Trial.

INTRODUCTION: The Weight Loss Readiness Test (WLRT) was developed to encourage consideration of factors influencing readiness to engage in weight loss. The WLRT is used clinically, most notably to assess motivation before initiating Navy weight management programs, yet little is known about its psychometric properties. MATERIALS AND METHODS: This study examined the reliability, convergent and predictive validity, and factor structure of the WLRT in a sample of active duty service members enrolling in a Navy-based weight management program (N = 178, identified as female = 61%, mean age = 29.7 years, mean baseline body mass index = 33.1 kg/m2). All procedures were approved by the respective Institutional Review Boards and research committees. RESULTS: Exploratory factor analysis revealed a 5-factor structure explaining 52% of the variance that best fit the data with low to moderate correlations between factors: (1) Motivation, (2) Exercise-Related Confidence, (3) Non-Exercise Confidence, (4) Cues, and (5) Anticipated Satisfaction. Internal reliability of subscales was acceptable to good (α = 0.755-0.903). Generally, convergent validity was found between the identified subscales and other measures of motivation, confidence, and disinhibited eating in expected directions. No relationships were found between the subscales and predictive validity outcomes (weight change, program attendance). CONCLUSIONS: Results indicate adequate structural and convergent validity in the WLRT, but that weight loss readiness, as measured by the WLRT, does not provide predictive validity regarding weight loss or attendance outcomes in this sample. Nonetheless, this measure offers clinical utility in fostering thoughtful conversations about weight loss. The WLRT uniquely focuses on long-term maintenance of behavior change and differentiates between exercise-related and non-exercise confidence. Future studies should further probe the utility of this measure in other populations and the contexts in which it is being used.

The latent structure of the Delis-Kaplan system for autism.

A core feature of autism is deficits in executive functioning (EF), including difficulty with planning, cognitive flexibility, and working memory. Despite a growing need for evidence-based assessments of EF for autism populations, statistical models of many commonly used measures of EF, including the Delis-Kaplan Executive Function System (D-KEFS), have not been investigated for a sample of autistic participants. The purpose of this study was to address a gap in the literature regarding the latent structure of the D-KEFS in a sample of autistic individuals. The D-KEFS is one of the most widely used clinical assessments of executive function, but its factor structure has not been examined in a sample of autistic participants. Reliability analyses were performed for sample subgroups based on participants' clinical and demographic characteristics, including IQ, autism severity, age, and race/ethnicity. Verbal Fluency (VF) was found to consistently decrease or not affect the overall reliability score. Additionally, one- and two-factor structure models were tested for the D-KEFS with a sample of autistic participants. The one-factor model was not found to be a good fit for the data. However, the two-factor model, with Cognitive Flexibility and Abstraction latent factors, was found to fit the data relatively well. This two-factor model was reexamined excluding the VF observed variable, resulting in a better overall model fit. Communication deficits are a common feature of autism, which explains why the VF task, that requires participants to produce novel words, may not be an adequate measure of executive function for autism populations.

Skin cancer risk behaviors in sexual minority men: A mixed methods approach.

OBJECTIVE: Sexual minority men experience disproportionately elevated rates of skin cancers, likely driven by excess ultraviolet radiation exposure-namely through tanning behaviors. However, limited integrated theoretical models exist to explain sexual minority men's elevated skin cancer risk. The aim of the current study is to further test and refine an integrated theory of skin cancer risk behaviors among sexual minority men by incorporating minority stress into the integrated health behavior model of tanning. METHOD: The study employed a parallel mixed methods design, with a Phase 1 qualitative stage (N = 30) and a Phase 2 quantitative stage (Model 1: N = 320; Model 2: N = 319). In both phases, participants were sexual minority men, equally stratified as those with versus without recent tanning exposure and were recruited from across the United States. RESULTS: Qualitative and quantitative data supported the overall integrated model, with some quantitative paths varying depending on the tanning behavior outcome. Overall, appearance-related motives to tan and beliefs that tanning regulates affect emerged as the most consistent proximal predictors. Minority stress significantly predicted holding more positive attitudes toward tanning as an effective affect regulation strategy. CONCLUSIONS: The results from this mixed methods study support the inclusion of minority stressors into the adapted integrative health behavior model of tanning. Replication within prospective designs would strengthen the evidence for this model, which may be helpful in guiding future skin cancer prevention programs tailored to sexual minority men. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Randomized Feasibility Pilot of an Executive Functioning Intervention Adapted for Children's Mental Health Settings.

The critical role of executive functioning in autism as well as the co-occurring mental health challenges common among autistic youth support to the immense value of interventions targeting executive functioning for enhancing mental health services for autistic children. The goal of the present study was to conduct a randomized feasibility trial of Unstuck and On Target, an executive functioning intervention, adapted for delivery in children's community mental health setting. Mental health therapists (n = 26) enrolled with participating autistic clients (n = 32) were randomized to receive training in and deliver the adapted Unstuck intervention or to deliver care as usual. We completed masked observational measures of Unstuck strategy use (fidelity) during recorded sessions of participating therapist-client dyads and collected measures of acceptability from participating clients and their caregivers. We also collected measures of pre-post changes in executive functioning and mental health symptoms. Therapists trained in Unstuck demonstrated significantly higher use of Unstuck strategies compared to usual care therapists. Caregivers and autistic clients perceive adapted Unstuck as highly acceptability and helpful. Autistic clients whose therapists were trained in adapted Unstuck demonstrated larger pre-post changes in executive functioning compared to usual care. Across all participating clients, changes in executive functioning were significantly related to changes in mental health symptoms. Finally, clients of therapists trained in adapted Unstuck demonstrated moderate improvements in overall mental health symptoms. The current study provides preliminary evidence of the feasibility and impact of Unstuck and On Target for children's community mental health settings.

An ecological momentary cognitive assessment study of over-attribution of threat and suicide risk factors in people with serious mental illness.

INTRODUCTION: People with serious mental illness (SMI; schizophrenia, schizoaffective disorder, bipolar disorder) are at increased risk of suicidal ideation (SI). Over-attribution of social threat, or attributing threatening emotions to neutral faces, may contribute to social isolation through increased social avoidance and decreased social approach motivation. These factors are related to suicide, as well as perceived burdensomeness (PB) and thwarted belongingness (TB). This study examined how over-attribution of threat relates to PB, TB, and social motivations. METHOD: N = 273 participants with SMI were assessed for current SI and behavior, and were stratified into SI (N = 130) vs. non-SI (N = 143) groups. Participants completed smartphone surveys (via ecological momentary assessments [EMA]) 3×/day for 10 days. They also completed the Mobile Ecological Test of Emotion Recognition (METER) 1×/day. Linear mixed models and multi-level mediation tested the relationships between over-attribution of threat, METER performance, PB/TB, and social motivations. RESULTS: Participants with and without SI did not significantly differ in over-attribution of threat or METER performance. In separate models, there was a relationship of over-attribution of threat with increased PB (B = 1.00, SE = 0.21, t = 4.72, p < .001), reduced social approach motivation (B = -0.74, SE = 0.22, t = -3.33, p < .001), and increased social avoidance (B = 0.90, SE = 0.24, t = 3.70, p < .001), all significant when adjusting for facial affect recognition ability. A model examining social motivations as a mediator between over-attribution of threat and PB/TB was not significant. CONCLUSION: These results suggest that over-attribution of threat relates to interpersonal constructs related to SI irrespective of facial affect abilities. This study may inform understanding of social cognitive processes related to suicide in SMI.

Randomized trial of an integrated care intervention among Latino adults: Sustained effects on diabetes management.

We examined the 12-month maintenance effects of a previously successful integrated model of diabetes care at improving glycemic management and psychological well-being among Latino adults with type 2 diabetes (T2D). A randomized controlled trial (2015-19) compared an integrated care intervention (ICI) with usual care among 456 adults with T2D. The ICI included integrated medical and behavioral care and health education over 6 months. Assessments were completed at baseline, 3, 6, 9, and 12 months. Most participants were female (63.7%) with a mean age of 55.7 years. In multilevel models, significant Group × Time (quadratic) interaction effects were found for HbA1c [Bint = 0.10, 95% confidence interval (CI) 0.02, 0.17, P < .01] and anxiety symptoms (Bint = 0.20, 95% CI 0.05, 0.35, P < .009), but not depression symptoms (Bint = 0.15, 95% CI -0.01, 0.31, P < .07). Analyses of instantaneous rate of change in the ICI group showed significant decreases at 3 and 6 months for both HbAc1 (B = -0.31 at 3 months; B = -0.12 at 6 months) and anxiety symptoms (B = -0.92 at 3 months; B = -0.46 at 6 months), and no significant instantaneous changes at 9 or 12 months, suggesting that initial improvements were largely maintained. The usual care group showed a small decrease in anxiety symptoms at 6 months (B = -0.17), but no other significant changes at any time-point for anxiety or HbA1c (all Ps > .05). This culturally tailored integrated care model shows potential in producing and sustaining positive effects on clinical and psychological outcomes above standard care.

Our previous studies found that a culturally adapted, enhanced service (integrated care intervention) that we developed improved glycemic management and decreased depression and anxiety symptoms over the 6 months that the service was offered. In this study, we examined whether those improvements in diabetes management and depression and anxiety symptoms were maintained up to 6 months after the conclusion of the intervention. The integrated care intervention involved providing medical and behavioral healthcare on the same day and at the same location as well as health education for 6 months. The study participants were 456 Latino adults (aged 23­80 years) who had type 2 diabetes and were not taking insulin. Participants were randomly assigned to one of two groups: the integrated care intervention or usual care. In this study, we found that the improvements in glycemic management and in anxiety and depression symptoms previously shown were largely maintained. These findings suggest that culturally adapted health services that include both medical and behavioral care and health education programs may benefit Latino patients with type 2 diabetes.

Moderators of Loneliness Trajectories in People with Systemic Sclerosis During the COVID-19 Pandemic: A SPIN COVID-19 Cohort Longitudinal Study.

BACKGROUND: Many individuals with systemic sclerosis (SSc) are at heightened risk for COVID-19 related morbidity and isolation due to interstitial lung disease, frailty, and immunosuppressant use. Minimal research has explored loneliness predictors in individuals with chronic illnesses during COVID-19. This study evaluated moderators of loneliness trajectories in individuals with SSc during COVID-19. METHODS: Longitudinal data were analyzed across 30 timepoints from April 2020 to May 2022 from 775 adults in the Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Cohort. Hierarchical linear modeling evaluated cross-level moderators of loneliness trajectories, including marital status, baseline number of household members, number of virtual or telephone one-on-one or virtual group conversations, number of hours spent enjoying in-person household conversations or activities, and satisfaction with quality of in-person household conversations (all in the past week). Level-1 moderation analyses assessed effects of conversation, activity, and satisfaction means and slopes over time. RESULTS: Baseline values were not statistically significant moderators of loneliness trajectories. Higher mean (averaged over time) virtual or telephone one-on-one and in-person household conversations, in-person household activity, and in-person household conversation satisfaction were associated with lower loneliness trajectories (ps < .05). The relationship between in-person household conversation satisfaction and loneliness trajectory was statistically significantly but minimally attenuated over time (p < .001). CONCLUSIONS: For people with SSc, higher mean conversation, activity, and satisfaction variables were associated with lower levels of loneliness during the pandemic, but changes in these social variables were generally not predictive of changes in loneliness.

Measurement equivalence of the English and French versions of the self-efficacy to manage chronic disease scale: a Scleroderma Patient-Centered Intervention Network (SPIN) study.

PURPOSE: The Self-Efficacy to Manage Chronic Disease (SEMCD) scale is widely used, including in systemic sclerosis (SSc). The SEMCD has been validated in SSc, but the metric equivalence of the English and French versions has not been assessed (i.e., whether psychometric properties are equivalent across English and French). METHODS: Participants were adults from the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort (N = 2159) who completed baseline measures in English (n = 1473) or French (n = 686) between May 2014 to July 2020. Analyses assessed internal consistency reliability via Cronbach's alpha and McDonald's omega, convergent validity via Pearson's correlations, structural validity via confirmatory factor analysis (CFA), and differential item functioning via the Multiple-Indicator Multiple-Cause (MIMIC) model. RESULTS: Internal consistency reliability was high in English (α = .93, ω = .93) and French (α = .92, ω = .93). All correlations between the SEMCD and measures of health outcomes were moderate to large, statistically significant, and in the hypothesized direction in both languages. The CFA demonstrated that the one-factor model of self-efficacy, overall, fit reasonably well (CFI = .96, TLI = .93, SRMR = .03, RMSEA = .14). Standardized factor loadings were large (.76 to .88). Three items displayed statistically significant uniform DIF and all six displayed nonuniform DIF; all DIF was of minimal magnitude. Comparison of unadjusted and DIF-adjusted models indicated that DIF did not meaningfully impact total score (ICC = 0.999, r = 0.999). CONCLUSION: Scores from English- and French-speaking adults with SSc can be combined for analysis or compared.

A Call to Validate the Stress Continuum Model.

INTRODUCTION: Since the start of the Global War on Terrorism, exponential demands have been put on military personnel, their families, and the military health care system. In response to a Department of Defense Task Force on Mental Health, the U.S. military began developing and fielding programs to promote the psychological health of its personnel. As part of these initiatives, the Navy and Marine Corps developed the Stress Continuum model. The Stress Continuum is a stress classification system ("ready," "reacting," "injured," and "ill") that provides a common language for identifying, engaging, and intervening when stress reactions or stress injuries are present in military personnel. It is the foundation for resilience and prevention efforts across the Navy and Marine Corps. Although the Stress Continuum has strong face validity, is consistent with current theory, and has been agreed up by expert consensus, it has yet to be empirically validated. The goal of the current article is to begin to empirically validate the Stress Continuum using validated measures of psychological stress. MATERIALS AND METHODS: We conducted a retrospective analysis of Stress Continuum data (n = 2,049) collected as part of a program evaluation of two Navy operational stress control programs. Receiver operating characteristic (ROC) curves and analyses were conducted to determine the classification quality of the Stress Continuum using a validated measure of stress (a brief version of the Perceived Stress Scale [PSS-4]). RESULTS: For the first ROC curve, we used the "ill" category (vs. the other three categories) to identify the cut point on the PSS-4. PSS-4 cut point values of 9 and 10, respectively, maximized sensitivity and 1-specificity values. Using the chi-square test, we further found that a more accurate prediction for those in the "ill" category was using the cut point of 9 (79%) relative to 10 (71.8%). For the second and the third ROC curves, we used the "ill" and "injured" categories (vs. the other two categories) and "ill," "injured," and "reacting" categories (vs. the "ready" category), respectively. No optimal cut points on the PSS-4 were identified for these models, indicating that the PSS-4 could not reliably differentiate true-positive and false-positive rates. CONCLUSIONS: We found that the "ill" category of the Stress Continuum was predictive of higher levels of stress on the validated measure of perceived stress. Thus, our findings strongly suggest that the individuals in the "ill" zone likely warrant some type of intervention by a trained professional. FUTURE RESEARCH: The Navy has recently leveraged the Stress Continuum to create the Stress-o-Meter to support the fundamental principles of early recognition, peer intervention, and connection to services at the unit level. The Stress-o-Meter serves as a prevention tool that has the capability to collect information about stress levels throughout the entire unit at any time. Continued work on validating the Stress Continuum model and making it easily accessible to military units will ensure service members get the support they need and leaders are able to address the psychological health of their units.

Social and built neighborhood environments and sleep health: The Hispanic Community Health Study/Study of Latinos Community and Surrounding Areas and Sueño Ancillary Studies.

STUDY OBJECTIVES: To test associations between neighborhood social, built, and ambient environment characteristics and multidimensional sleep health in Hispanic/Latino adults. METHODS: Data were from San Diego-based Hispanic/Latino adults mostly of Mexican heritage enrolled in the Hispanic Community Health Study/Study of Latinos (N = 342). Home addresses were geocoded to ascertain neighborhood characteristics of greenness, walkability (density of intersections, retail spaces, and residences), socioeconomic deprivation (e.g. lower income, lower education), social disorder (e.g. vacant buildings, crime), traffic density, and air pollution (PM 2.5) in the Study of Latinos Communities and Surrounding Areas Study. Sleep dimensions of regularity, satisfaction, alertness, timing, efficiency, and duration were measured by self-report or actigraphy approximately 2 years later. Multivariable regression models accounting for study design (stratification and clustering) were used to examine associations of neighborhood variables with individual sleep dimensions and a multidimensional sleep health composite score. RESULTS: Neighborhood characteristics were not significantly associated with the multidimensional sleep health composite, and there were few significant associations with individual sleep dimensions. Greater levels of air pollution (B = 9.03, 95% CI: 1.16, 16.91) were associated with later sleep midpoint, while greater social disorder (B = -6.90, 95% CI: -13.12, -0.67) was associated with earlier sleep midpoint. Lower walkability was associated with more wake after sleep onset (B = -3.58, 95% CI: -7.07, -0.09). CONCLUSIONS: Living in neighborhoods with lower walkability and greater air pollution was associated with worse sleep health, but otherwise findings were largely null. Future research should test these hypotheses in settings with greater variability and investigate mechanisms of these associations.

Greater subjective cognitive decline severity is associated with worse memory performance and lower entorhinal cerebral blood flow in healthy older adults.

OBJECTIVE: Subjective cognitive decline (SCD) is a potential early risk marker for Alzheimer's disease (AD), but its utility may vary across individuals. We investigated the relationship of SCD severity with memory function and cerebral blood flow (CBF) in areas of the middle temporal lobe (MTL) in a cognitively normal and overall healthy sample of older adults. Exploratory analyses examined if the association of SCD severity with memory and MTL CBF was different in those with lower and higher cardiovascular disease (CVD) risk status. METHODS: Fifty-two community-dwelling older adults underwent magnetic resonance imaging, neuropsychological testing, and were administered the Everyday Cognition Scale (ECog) to measure SCD. Regression models investigated whether ECog scores were associated with memory performance and MTL CBF, followed by similar exploratory regressions stratified by CVD risk status (i.e., lower vs higher stroke risk). RESULTS: Higher ECog scores were associated with lower objective memory performance and lower entorhinal cortex CBF after adjusting for demographics and mood. In exploratory stratified analyses, these associations remained significant in the higher stroke risk group only. CONCLUSIONS: Our preliminary findings suggest that SCD severity is associated with cognition and brain markers of preclinical AD in otherwise healthy older adults with overall low CVD burden and that this relationship may be stronger for individuals with higher stroke risk, although larger studies with more diverse samples are needed to confirm these findings. Our results shed light on individual characteristics that may increase the utility of SCD as an early risk marker of cognitive decline.

Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol.

BACKGROUND: Guidelines recommend screening for colorectal cancer (CRC), but participation and abnormal test follow up rates are suboptimal, with disparities by demography. Evidence-based interventions exist to promote screening, but community adoption and implementation are limited. METHODS: The San Diego Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) program is an academic-community partnership testing regional implementation of a Hub-and-Spoke model for increasing CRC screening and follow-up. The "hub" is a non-academic, non-profit organization that includes 17 community health center (CHC) systems, serving over 190 rural and urban clinic sites. The "spokes" are 3 CHC systems that oversee 11-28 clinics each, totaling over 60 clinics. Using a cluster-randomized trial design, 9 clinics were randomized to intervention and 16 to usual care. Within intervention clinics, approximately 5000 eligible patients not up-to-date with CRC screening per year were identified for intervention. Interventions include an invitation primer, a mailed fecal immunochemical test with completion instructions, and phone and text-based reminders (hub) and patient navigation protocol to promote colonoscopy completion after abnormal FIT (spoke). Outcomes include: 1) proportion of patients up-to-date with screening after three years in intervention versus non-intervention clinics; 2) proportion of patients with abnormal FIT completing colonoscopy within six months of the abnormal result. Implementation science measures are collected to assess acceptability, intervention and usual care adaptations, and sustainability of the intervention strategies. CONCLUSION: This large-scale, regional cluster randomized trial among CHCs serving diverse populations is anticipated to accelerate progress in CRC prevention in underserved populations. TRIAL REGISTRATION: NCT04941300.

Rationale and design of a pilot randomized controlled trial to increase moderate-to-vigorous physical activity in preadolescent Latina girls and their mothers.

Background: Hispanic/Latina girls have a low prevalence of moderate-intensity physical activity (PA) compared to their male counterparts and non-Hispanic White girls. Mothers influence their children's activity levels by creating and supporting PA opportunities, modeling PA, and reinforcing children's efforts to be physically active. The Conmigo trial will evaluate a mother-daughter intervention to promote PA and examine potential mechanisms of change including mothers' PA, parenting regarding PA, and mother-daughter communication. Method: This randomized controlled trial examines the feasibility, acceptability, and impact of a 12-week intervention promoting PA in preadolescent Latina girls in San Diego County, CA. Participants (n = 90 dyads) are randomized to the Conmigo PA intervention or to a control group that receive an abbreviated version of the intervention. The intervention was informed by Social Cognitive Theory and Family Systems Theory and emphasize family-level factors to promote PA using an actor-partner model. Mothers and daughters attend weekly 90-min sessions in English or in Spanish via Zoom video conferencing, supported by facilitator follow-ups and WhatsApp supportive chat group for mothers. Objective (accelerometer) and self-report measures at baseline, 3 months, and 6 months capture the frequency and intensity of PA and correlates and predictors of PA. We also examine the impact of the intervention on the bidirectional influence of mother-daughter PA. Implications: The findings from the Conmigo trial will form the basis of a randomized controlled community trial and will move the field forward in identifying targets of change in preventing chronic disease risk in Hispanic/Latino communities.

Pain-Related Anxiety in Spanish-Speaking Mexican Americans Who Report Chronic Pain: Psychometric Evaluation of a New Spanish Adaptation of the 20-Item Pain Anxiety Symptom Scale (PASS-20).

The 20-item Pain Anxiety Symptom Scale (PASS-20) was adapted for Spanish-speaking Mexican Americans who report chronic pain (SSMACP). The instrument measures pain-related anxiety with fear, physiological, avoidance/escape, and cognitive anxiety as subtypes. In SSMACP, the Spanish PASS-20's psychometric properties were evaluated while exploring relationships between pain-related anxiety with other variables. Using convenience sampling, 188 SSMACP (women = 108, men = 77; mean age = 37.20 years, standard deviation = 9.87) were recruited across the United States. Confirmatory factor analyses examined the structural validity of the hierarchical factor structure. Hierarchical multiple regression examined incremental validity. Correlational analyses examined convergent validity. Cronbach's coefficient alphas and McDonald's omegas examined internal consistency. Pearson's r, t-tests, and analysis of variance tests examined relationships between demographic variables and PASS-20 scores. Confirmatory factor analyses supported the hierarchical factor structure (root mean square error of approximation = .061, standardized root mean residual = .038, comparative fit index = .940). Total and subscale PASS-20 scores had acceptable convergent validity and internal consistency (range = .75-.93). Hierarchical multiple regression found that total and subscale PASS-20 scores have adequate incremental validity, considering that they contributed uniquely to the prediction of generalized anxiety scores above and beyond other pain-related scores. Demographic variables were significantly related to total and subscale PASS-20 scores. Evidence supports the use of Spanish total and subscale PASS-20 scores in SSMACP. Exploratory evidence also informed on the possible consequences and predictors of their pain-related anxiety. The results also encourage pain research in specific populations from Latin America (eg, Mexican Americans). PERSPECTIVE: The Spanish PASS-20 has adequate psychometric properties in SSMACP. This instrument can help catalyze pain research in SSMACP by informing on their pain-related anxiety and by helping evaluate other pain-related instruments. Evidence also informed on pain-related anxiety in SSMACP.

Evaluation of Measurement Properties and Differential Item Functioning in the English and French Versions of the University of California, Los Angeles, Loneliness Scale-6: A Scleroderma Patient-Centered Intervention Network (SPIN) Study.

OBJECTIVE: Loneliness has been associated with poorer health-related quality of life but has not been studied in patients with systemic sclerosis (SSc). The current study was undertaken to examine and compare the psychometric properties of the English and French versions of the University of California, Los Angeles, Loneliness Scale-6 (ULS-6) in patients with SSc during the COVID-19 pandemic. METHODS: This study used baseline cross-sectional data from 775 adults enrolled in the Scleroderma Patient-Centered Intervention Network (SPIN) COVID-19 Cohort. Reliability and validity of ULS-6 scores overall and between languages were evaluated using confirmatory factor analysis (CFA), differential item functioning (DIF) through the multiple-indicator multiple-cause (MIMIC) model, omega/alpha calculation, and correlations of hypothesized convergent relationships. RESULTS: CFA for the total sample supported the single-factor structure (comparative fit index [CFI] 0.96, standardized root mean residual [SRMR] 0.03), and all standardized factor loadings for items were large (0.60-0.86). The overall MIMIC model with language as a covariate fit well (CFI 0.94, SRMR 0.04, root mean square error of approximation 0.11). Statistically significant DIF was found for 3 items across language (ßitem2  = 0.14, P < 0.001; ßitem4  = -0.07, P = 0.01; ßitem6  = 0.13, P < 0.001), but these small differences were without practical measurement implications. Analyses demonstrated high internal consistency with no language-based convergent validity differences. CONCLUSION: Analyses demonstrated evidence of acceptable reliability and validity of ULS-6 scores in English- and French-speaking adults with SSc. DIF analysis supported use of the ULS-6 to examine comparative experiences of loneliness without adjusting for language.

Tailoring dissemination strategies to increase evidence-informed policymaking for opioid use disorder treatment: study protocol.

BACKGROUND: Policy is a powerful tool for systematically altering healthcare access and quality, but the research to policy gap impedes translating evidence-based practices into public policy and limits widespread improvements in service and population health outcomes. The US opioid epidemic disproportionately impacts Medicaid members who rely on publicly funded benefits to access evidence-based treatment including medications for opioid use disorder (MOUD). A myriad of misaligned policies and evidence-use behaviors by policymakers across federal agencies, state Medicaid agencies, and managed care organizations limit coverage of and access to MOUD for Medicaid members. Dissemination strategies that improve policymakers' use of current evidence are critical to improving MOUD benefits and reducing health disparities. However, no research describes key determinants of Medicaid policymakers' evidence use behaviors or preferences, and few studies have examined data-driven approaches to developing dissemination strategies to enhance evidence-informed policymaking. This study aims to identify determinants and intermediaries that influence policymakers' evidence use behaviors, then develop and test data-driven tailored dissemination strategies that promote MOUD coverage in benefit arrays. METHODS: Guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, we will conduct a national survey of state Medicaid agency and managed care organization policymakers to identify determinants and intermediaries that influence how they seek, receive, and use research in their decision-making processes. We will use latent class methods to empirically identify subgroups of agencies with distinct evidence use behaviors. A 10-step dissemination strategy development and specification process will be used to tailor strategies to significant predictors identified for each latent class. Tailored dissemination strategies will be deployed to each class of policymakers and assessed for their acceptability, appropriateness, and feasibility for delivering evidence about MOUD benefit design. DISCUSSION: This study will illuminate key determinants and intermediaries that influence policymakers' evidence use behaviors when designing benefits for MOUD. This study will produce a critically needed set of data-driven, tailored policy dissemination strategies. Study results will inform a subsequent multi-site trial measuring the effectiveness of tailored dissemination strategies on MOUD benefit design and implementation. Lessons from dissemination strategy development will inform future research about policymakers' evidence use preferences and offer a replicable process for tailoring dissemination strategies.