Maternal depression, parenting, and child psychological outcomes in the context of maternal pain.

Parental chronic pain is associated with adverse outcomes in children, but the mechanisms of transmission are largely untested. Mothers with chronic pain (N = 400, Mage = 40.3 years, 90.5% White) and their children (Mage = 10.33 years, 83.3% White, 50.2% female) were recruited in 2016-2018 to test longitudinal pathways of risk transmission from maternal chronic pain to children's psychological symptoms, examining roles of parenting, maternal depression, and child distress tolerance. Maternal pain was associated with positive (ß = .28) and pain-specific (ß = .10) parenting behaviors. Maternal depression was associated with lower child distress tolerance (ß = -.03), which was associated with greater child psychological symptoms (ß = -.62). Parenting and maternal pain were not prospectively associated with child outcomes. When considering the dual-generational impacts of chronic pain, physical and psychological functioning should be examined.

Parent Anxiety, Depression, Protective Responses, and Parenting Stress in the Context of Parent and Child Chronic Pain: A Daily Diary Study of Parent Variability.

Parents with (vs without) chronic pain report poorer psychosocial functioning (eg, worse mental health, parenting difficulties), which has been linked to poorer child outcomes (eg, child pain). However, emerging research suggests that individuals vary in their functioning from day-to-day, particularly those with chronic pain. This study used daily diaries to compare parents with (versus without) chronic pain on variability in their anxiety, mood, protective responses, and parenting stress. We also examined parent chronic pain status as a moderator of the associations between parent variability and youth daily pain and interference. Participants were 76 youth with chronic pain (Mage = 14.26; 71.1% female) and one of their parents (89.5% mothers; n = 38 or 50.0% endorsing chronic pain). Parents and youth completed self-report questionnaires and 7 days of diaries. Parent variability was calculated to reflect the frequency and size of day-to-day changes. Multilevel models revealed that parents with (vs without) chronic pain were significantly more variable in their parenting stress, but not in their anxiety, mood, or protective responses. Contrary to hypotheses, parent variability was not significantly related to youth daily pain intensity or interference and parent chronic pain did not moderate any associations. Instead, mean levels of parent anxiety, protective responses, and parenting stress across the week significantly predicted youth daily pain interference. Findings suggest that while variability was observed among parents (with and without chronic pain) of youth with chronic pain, it did not significantly predict youth's daily pain-related functioning. Further research is needed to confirm these initial findings. PERSPECTIVE: Parents with chronic pain have expressed concerns that the variable nature of their pain negatively impacts their children. Our results found that parents (with and without chronic pain) were variable in their anxiety, mood, protective responses, and parenting stress, but this variability did not significantly predict youth's chronic pain-related functioning.

Prescription Opioid Decision-making and Use Behaviors in Adolescents With Acute Pain: A Qualitative Study.

OBJECTIVES: Understanding adolescent perspectives on prescribed opioids in the context of medical care for acute pain is needed to prevent opioid-related adverse outcomes. We explored factors that may influence opioid decision-making and use behaviors among adolescents prescribed opioids for acute pain. METHODS: We conducted semistructured interviews with 19 adolescents (63% females, ages 12 to 17) prescribed opioids upon discharge from surgery or intensive care unit admission. Interview transcripts were coded using inductive thematic analysis. RESULTS: Five themes were identified: "Opioid use to reduce extreme pain and facilitate acute recovery"; "Familiarity with risks and negative effects of opioids"; "Assessment of opioid risk based on individual characteristics and use behaviors"; "Careful balance of risks, benefits, and symptoms when taking opioids"; "Importance of trusted adults for adolescent opioid management". Adolescents commonly believe opioids are only appropriate for severe pain that cannot be managed with other strategies. Most (but not all) adolescents were aware of addiction and other potential opioid harms and generally disapproved of misuse. However, a few adolescents would consider taking unprescribed opioids for severe pain. Adolescents wanted to be well informed for opioid decision-making, considering guidance from trusted adults. DISCUSSION: Adolescents often demonstrated active and sound participation in shared opioid decision-making, influenced by complex integration of inputs and self-reflection. Conversely, potential factors that could contribute to risky behaviors included low personal risk perceptions, uncertainty about what constitutes opioid misuse, and avoidance of prescribed opioids despite extreme pain. Future studies may explore associations of adolescents' opioid decision-making with longer-term pain and opioid-related outcomes.

Examining the acceptability and feasibility of the Compassionate Mindful Resilience (CMR) programme in adults living with chronic kidney disease: the COSMIC study findings.

BACKGROUND: Individuals with chronic kidney disease experience difficult physical and psychological symptoms, that impact quality of life, and are at increased risk of anxiety and depression. Access to specialist psychological support is limited. This study aimed to support a new service development project, in collaboration with Kidney Care UK, to implement the Compassionate Mindful Resilience (CMR) programme, developed by MindfulnessUK, which provides accessible mindfulness techniques and practices to enhance compassion and resilience, and explore its feasibility for people living with stage 4 or 5 kidney disease and transplant. METHODS: A multi-method feasibility design was utilised. Participants over 18 years, from the UK, with stage 4 or 5 kidney disease or post-transplant, and who were not currently undergoing psychotherapy, were recruited to the four-week CMR programme. Data was collected at baseline, post-intervention and three-months post to measure anxiety, depression, self-compassion, mental wellbeing, resilience, and mindfulness. The acceptability of the intervention for a kidney disease population was explored through qualitative interviews with participants, and the Mindfulness Teacher. RESULTS: In total, 75 participants were recruited to the study, with 65 completing the CMR programme. The majority were female (66.2%) and post-transplant (63.1%). Analysis of completed outcome measures at baseline and post-intervention timepoints (n = 61), and three-months post intervention (n = 45) revealed significant improvements in participant's levels of anxiety (p < .001) and depression (p < .001), self-compassion (p = .005), mental wellbeing (p < .001), resilience (p.001), and mindfulness (p < .001). Thematic analysis of interviews with participants (n = 19) and Mindfulness Teacher (n = 1) generated three themes (and nine-subthemes); experiences of the CMR programme that facilitated subjective benefit, participants lived and shared experiences, and practicalities of programme participation. All participants interviewed reported that they found programme participation to be beneficial. CONCLUSION: The findings suggest that the CMR programme has the potential to improve psychological outcomes among people with chronic kidney disease. Future randomized controlled trials are required to further test its effectiveness.

COVID-19-Related Outcomes Among Group Home Residents with Serious Mental Illness in Massachusetts in the First Year of the Pandemic.

This study examined COVID-19 infection and hospitalizations among people with serious mental illness who resided in residential care group homes in Massachusetts during the first year of the COVID-19 pandemic. The authors analyzed data on 2261 group home residents and COVID-19 data from the Massachusetts Department of Public Health. Outcomes included positive COVID-19 tests and COVID-19 hospitalizations March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2). Associations between hazard of outcomes and resident and group home characteristics were estimated using multi-level Cox frailty models including home- and city-level frailties. Between March 2020 and March 2021, 182 (8%) residents tested positive for COVID-19, and 51 (2%) had a COVID-19 hospitalization. Compared with the Massachusetts population, group home residents had age-adjusted rate ratios of 3.0 (4.86 vs. 1.60 per 100) for COVID infection and 13.5 (1.99 vs. 0.15 per 100) for COVID hospitalizations during wave 1; during wave 2, the rate ratios were 0.5 (4.55 vs. 8.48 per 100) and 1.7 (0.69 vs. 0.40 per 100). In Cox models, residents in homes with more beds, higher staff-to-resident ratios, recent infections among staff and other residents, and in cities with high community transmission risk had greater hazard of COVID-19 infection. Policies and interventions that target group home-specific risks are needed to mitigate adverse communicable disease outcomes in this population.Clinical Trial Registration Number This study provides baseline (i.e., pre-randomization) data from a clinical trial study NCT04726371.

Meaning and Purpose (MaP) therapy in advanced cancer patients: a randomised controlled trial.

PURPOSE: We aimed to examine the efficacy of Meaning and Purpose (MaP) Therapy in promoting posttraumatic growth and meaningful life attitudes (choices and goal seeking) in people living with advanced cancer. METHODS: Patients with a prognosis ≥ 1 year were stratified across two sites and randomised to receive MaP therapy and regular oncology/palliative care (Intervention) or usual care (Control). They completed measures at baseline (t0), post-intervention (12 weeks, t1) and 12 weeks later (t2). Our primary outcome was posttraumatic growth (PTGI); secondary outcome measures included life attitudes (LAPR), spiritual wellbeing (FACIT-Sp), anxiety, demoralization and depression. TRIAL REGISTRATION NUMBER: ACTRN12618001751268, 7 January 2019. RESULTS: We consented 107 from 404 eligible patients (26.5%) and randomised 55 to MaP Invention (35 completing t1, 25 t2) and 52 to Control (32 completing t1, 25 t2). Fidelity of the intervention was sustained. PTGI mean scores were significantly higher post-intervention on analysis by covariance (Cohen's d = 0.7 at t1 & d = 0.5 at t2). Secondary measures were significant, including LAPR (d = 0.4) and FACIT-Sp (meaning subscale d = 0.4; total d = 0.4). Participants completing six sessions achieved more noteworthy effect sizes. CONCLUSION: This brief, structured individual intervention shows promise for sustaining sense of coherence, meaning and choices in life despite living with advanced cancer.

Multimodal analysis of disinformation and misinformation.

The use of disinformation and misinformation campaigns in the media has attracted much attention from academics and policy-makers. Multimodal analysis or the analysis of two or more semiotic systems-language, gestures, images, sounds, among others-in their interrelation and interaction is essential to understanding dis-/misinformation efforts because most human communication goes beyond just words. There is a confluence of many disciplines (e.g. computer science, linguistics, political science, communication studies) that are developing methods and analytical models of multimodal communication. This literature review brings research strands from these disciplines together, providing a map of the multi- and interdisciplinary landscape for multimodal analysis of dis-/misinformation. It records the substantial growth starting from the second quarter of 2020-the start of the COVID-19 epidemic in Western Europe-in the number of studies on multimodal dis-/misinformation coming from the field of computer science. The review examines that category of studies in more detail. Finally, the review identifies gaps in multimodal research on dis-/misinformation and suggests ways to bridge these gaps including future cross-disciplinary research directions. Our review provides scholars from different disciplines working on dis-/misinformation with a much needed bird's-eye view of the rapidly emerging research of multimodal dis-/misinformation.

Experiences of People with Kidney Disease Following the Implementation of the Compassionate Mindful Resilience Programme: Qualitative Findings from the COSMIC Study.

BACKGROUND: Kidney disease is a progressive, debilitating condition. Patients experience challenging physical and psychological symptoms and are at increased risk of anxiety, depression, and poor mental wellbeing. Access to specialist psychological or social support is limited, with inadequate provision of psychosocial support available across UK renal units. The COSMIC study (examining the acceptability and feasibility of the Compassionate Mindful Resilience programme for adult patients with chronic kidney disease) aimed to support a new service development project, in partnership with Kidney Care UK, by implementing the Compassionate Mindful Resilience (CMR) programme, developed by MindfulnessUK, and explore its feasibility for patients with stage 4 or 5 kidney disease and kidney transplant recipients. This paper reports on the qualitative exploratory work which examined the experiences of study participants, their adherence to practice, and the acceptability of the intervention. METHOD: Participants (n = 19) took part in semi-structured interviews, which were transcribed, coded, and thematically analysed. RESULTS: Three themes (and nine subthemes) were reported: experiences of the CMR programme that facilitated subjective benefit, participants' lived and shared experiences, and the practicalities of CMR programme participation. All participants reported that they found taking part in the CMR programme to be a beneficial experience. CONCLUSION: The CMR programme was found to be an acceptable intervention for people living with kidney disease and provided tools and techniques that support the mental health and wellbeing of this patient group. Further qualitative exploration into participant experience should be integrated within future trials of this intervention.

Topical Review: Acute and Chronic Pain Experiences in Transgender and Gender-Diverse Youth.

OBJECTIVE: To provide an overview of the existing literature on gender diversity in pediatric acute and chronic pain, propose an ecological systems model of understanding pain in transgender and gender-diverse (TGD) youth, and identify a direction for future work that will address the key knowledge gaps identified. METHODS: Relevant literature on pain and gender diversity was reviewed, drawing from adult literature where there was insufficient evidence in pediatric populations. Existing relevant models for understanding minority stress, gender and pain, and pain experiences within marginalized groups were considered with the reviewed literature to develop a pain model in TGD youth. RESULTS: While there is an abundance of literature pointing to increased risk for pain experiences amongst TGD youth, there is comparably little empirical evidence of the rates of pain amongst TGD youth, prevalence of TGD identities in pain care settings, effective pain treatments for TGD youth and unique considerations for their care, and the role intersectional factors in understanding TGD youth identities and pain. CONCLUSION: Pediatric psychologists are well-positioned to advance the research on acute and chronic pain in TGD youth, make evidence-based adaptations to clinical care for TGD youth with pain, including pain related to gender affirmation, and support colleagues within the medical system to provide more inclusive care.

Transient absorption spectroscopy reveals that slow bimolecular recombination in SrTiO3 underpins its efficient photocatalytic performance.

The charge carrier dynamics of SrTiO3 are measured by ultrafast transient absorption spectroscopy, revealing bimolecular recombination kinetics that are at least two magnitudes slower than alternative metal oxides. This slow recombination is associated with its high dielectric constant, and suggested to be central to SrTiO3's high performance in photocatalytic systems.

A common single nucleotide variant in the cytokine receptor-like factor-3 (CRLF3) gene causes neuronal deficits in human and mouse cells.

Single nucleotide variants in the general population are common genomic alterations, where the majority are presumed to be silent polymorphisms without known clinical significance. Using human induced pluripotent stem cell (hiPSC) cerebral organoid modeling of the 1.4 megabase Neurofibromatosis type 1 (NF1) deletion syndrome, we previously discovered that the cytokine receptor-like factor-3 (CRLF3) gene, which is co-deleted with the NF1 gene, functions as a major regulator of neuronal maturation. Moreover, children with NF1 and the CRLF3L389P variant have greater autism burden, suggesting that this gene might be important for neurologic function. To explore the functional consequences of this variant, we generated CRLF3L389P-mutant hiPSC lines and Crlf3L389P-mutant genetically engineered mice. While this variant does not impair protein expression, brain structure, or mouse behavior, CRLF3L389P-mutant human cerebral organoids and mouse brains exhibit impaired neuronal maturation and dendrite formation. In addition, Crlf3L389P-mutant mouse neurons have reduced dendrite lengths and branching, without any axonal deficits. Moreover, Crlf3L389P-mutant mouse hippocampal neurons have decreased firing rates and synaptic current amplitudes relative to wild type controls. Taken together, these findings establish the CRLF3L389P variant as functionally deleterious and suggest that it may be a neurodevelopmental disease modifier.

A Review of the Scoring and Assessment of Keratosis Pilaris.

Disease severity assessment tools play a large part in evaluating skin conditions in dermatology. Currently, there is no existing validated assessment tool for keratosis pilaris (KP), a benign yet highly prevalent follicular disorder. A range of proposed scoring tools have been used in different clinical trials for the assessment of potential treatments for KP. A literature review of the current scoring systems used for KP shows that there is a lack of consistency with most studies using varying versions of unvalidated investigator global assessment (IGA) scores and quartile grading systems. A review of these studies shows that current methods of evaluating KP in clinical trials are subjective, unreliable, and inconsistent. A standardised and validated scoring system would be significant as it could be used in clinical trials to advance the current knowledge of KP.

Fertility preservation, its effectiveness and its impact on disease status in pre-menopausal women with breast cancer: A systematic review and meta-analysis.

INTRODUCTION: Preservation of reproductive function is a key concern for many premenopausal women with breast cancer, given the known gonadotoxic effects of treatments. The present systematic review aimed to investigate the effectiveness and safety of fertility preservation strategies in pre-menopausal women with breast cancer. METHODS: Primary research assessing fertility preservation strategies of any type was identified. Markers of preservation of fertility including return of menstrual function, clinical pregnancy rates and live birth rates were selected as main outcome measures. An additional analysis of safety data was also performed. RESULTS: Fertility preservation interventions were overall associated with higher fertility outcomes: with a pooled odds ratio 4.14 (95% CI 3.59-4.77) for any kind of fertility preservation intervention. This was seen both for return of menstruation and for clinical pregnancy rate, but not for live birth rates. Fertility preservation was associated with a reduced rate of disease recurrence (OR 0.63 (95% CI 0.49-0.81)), while there was no significant difference in disease free survival (OR 0.88 (95% CI 0.74-1.05)) or in overall survival (OR 0.9 (95% CI 0.74-1.10)) between the fertility preservation group and those who had not undergone fertility preservation. CONCLUSION: Fertility preservation is both effective in preserving reproductive function, and safe with regard to disease recurrence, disease free survival and overall survival in premenopausal women with breast cancer.

Long-term Pain Symptomatology in PICU Survivors Aged 8-18 Years.

BACKGROUND AND OBJECTIVES: Children discharged from the PICU often experience long-term physical, psychological, social and cognitive challenges, described as postintensive care syndrome. This study fills a critical gap by describing the long-term pain symptoms many children experience using child self-report. METHODS: Participants in this cross-sectional study were children aged 8 to 18 years (and 1 parent, n = 64 dyads) who were 8 to 24 months post-PICU discharge. Participants completed measures assessing pain, psychosocial function, and treatment utilization. Health information relevant to the PICU admission was obtained from the electronic medical record. RESULTS: Children were an average age of 14.3 years and 50% female. Average pain intensity in the past month was 3.65 (0-10 numeric rating scale), with 36% of children reporting pain ≥2 to 3 days a week. Youth with higher intensity (≥4) and more frequent pain (≥2-3 days a week) had greater pain catastrophizing, pain-related fear, anxiety, and sleep disturbance than those with less frequent and intense pain. Higher pain frequency was also associated with greater pain-related disability and depressive symptoms. Pain was not associated with any PICU-related variables abstracted from the electronic medical record. Parents reported children frequently accessed pain treatment services postdischarge; however, 37.5% reported the coronavirus disease 2019 pandemic impacted access to recommended services. CONCLUSIONS: A significant portion of children experience pain post-PICU discharge. For many of these children, pain is frequent and is associated with impairments in psychosocial function. Future prospective research studies can be used to identify risk factors of poor pain outcomes so children can receive targeted interventions.

Advancing leadership in surgery: a realist review of interventions and strategies to promote evidence-based leadership in healthcare.

BACKGROUND: Healthcare systems invest in leadership development of surgeons, surgical trainees, and teams. However, there is no agreement on how interventions should be designed, or what components they must contain to be successful. The objective of this realist review was to generate a programme theory explaining in which context and for whom surgical leadership interventions work and why. METHODS: Five databases were systematically searched, and articles screened against inclusion considering their relevance. Context-mechanism-outcome configurations (CMOCs) and fragments of CMOCs were identified. Gaps in the CMOCs were filled through deliberation with the research team and stakeholder feedback. We identified patterns between CMOCs and causal relationships to create a programme theory. RESULTS: Thirty-three studies were included and 19 CMOCs were developed. Findings suggests that interventions for surgeons and surgical teams improve leadership if timely feedback is delivered on multiple occasions and by trusted and respected people. Negative feedback is best provided privately. Feedback from senior-to-junior or peer-to-peer should be delivered directly, whereas feedback from junior-to-senior is preferred when delivered anonymously. Leadership interventions were shown to be most effective for those with awareness of the importance of leadership, those with confidence in their technical surgical skills, and those with identified leadership deficits. For interventions to improve leadership in surgery, they need to be delivered in an intimate learning environment, consider implementing a speak-up culture, provide a variety of interactive learning activities, show a genuine investment in the intervention, and be customised to the needs of surgeons. Leadership of surgical teams can be best developed by enabling surgical teams to train together. CONCLUSIONS: The programme theory provides evidence-based guidance for those who are designing, developing and implementing leadership interventions in surgery. Adopting the recommendations will help to ensure interventions are acceptable to the surgical community and successful in improving surgical leadership. TRIAL REGISTRATION: The review protocol is registered with PROSPERO (CRD42021230709).

Group Home Staff Experiences With Work and Health in the COVID-19 Pandemic in Massachusetts.

Importance: Direct reports of the experiences of staff working in group homes for people with serious mental illness (SMI) and/or intellectual or developmental disabilities (ID/DD) are rarely reported. Hearing from workers about their experiences in the COVID-19 pandemic may inform future workforce and public policy. Objective: To gather baseline data on worker experience with the perceived effects of COVID-19 on health and work in the pandemic prior to initiating an intervention to mitigate the spread of COVID-19 and to measure differences in worker experience by gender, race, ethnicity, education, and resident population served (persons with SMI and/or IDD/DD). Design, Setting, and Participants: This mixed-mode, cross-sectional survey study was conducted using online then paper-based self-administration from May to September 2021 at the end of the first year of the pandemic. Staff working in 415 group homes that provided care within 6 Massachusetts organizations serving adults aged 18 years or older with SMI and/or ID/DD were surveyed. The eligible survey population included a census of staff who were currently employed in participating group homes during the study period. A total of 1468 staff completed or partially completed surveys. The overall survey response rate was 44% (range by organization, 20% to 52%). Main Outcomes and Measures: Self-reported experiential outcomes were measured in work, health, and vaccine completion. Bivariate and multivariate analyses explore experiences by gender, race, ethnicity, education, trust in experts and employers, and population served. Results: The study population included 1468 group home staff (864 [58.9%] women; 818 [55.7%] non-Hispanic Black; 98 [6.7%] Hispanic or Latino). A total of 331 (22.5%) group home staff members reported very serious perceived effects on health; 438 (29.8%) reported very serious perceived effects on mental health; 471 (32.1%) reported very serious perceived effects on health of family and friends; and 414 reported very serious perceived effects (28.2%) on access to health services, with statistically significant differences observed by race and ethnicity. Vaccine acceptance was higher among persons with higher educational attainment and trust in scientific expertise and lower among persons who self-reported as Black or Hispanic/Latino. A total of 392 (26.7%) respondents reported needing support for health needs, and 290 (19.8%) respondents reported needing support for loneliness or isolation. Conclusions and Relevance: In this survey study, approximately one-third of group home workers reported serious personal health and access to health care barriers during the first year of the COVID-19 pandemic in Massachusetts. Addressing unmet health needs and access to health and mental health services, including inequities and disparities by race, ethnicity, and education, should benefit staff health and safety, as well as that of the individuals with disabilities who rely on them for support and care.

Associations between Chronic Pain and Attention-Deficit Hyperactivity Disorder (ADHD) in Youth: A Scoping Review.

Background: Chronic pain and ADHD are common conditions among youth that negatively impact functioning. This review fills a critical gap by summarizing current research on chronic pain and ADHD comorbidity, and it proposes a conceptual model of shared associations and underlying mechanisms. Objective: The aims of the current study were to: (1) review the extant literature and present estimates of the prevalence of comorbid non-headache chronic pain and ADHD in youth and (2) describe potential shared mechanisms for ADHD and chronic non-headache pain in youth. We also outline future directions to inform future research and interventions directed to youth with comorbid pain and ADHD. Design: A scoping review of the literature was performed in MEDLINE, PsycInfo, and Cochrane Database of Systematic Reviews using a wide range of search terms related to pain, Attention Deficit-Hyperactivity Disorder, childhood, adolescence, and young adulthood. Results: Eleven published studies were included in the review. These studies examined the prevalence of chronic pain among youth with ADHD, the prevalence of ADHD in chronic pain samples, and the association between chronic pain and ADHD among youth. Findings revealed results from studies indicating a higher prevalence of ADHD among youth with chronic pain and a higher prevalence of chronic pain in samples of youth with ADHD. Conclusions: Findings from this scoping review suggest an association between chronic pain and ADHD among youth. Little research was found to examine the etiology of this association. Future studies should examine underlying mechanisms of comorbid chronic pain and ADHD.

Best practices to reduce COVID-19 in group homes for individuals with serious mental illness and intellectual and developmental disabilities: Protocol for a hybrid type 1 effectiveness-implementation cluster randomized trial.

BACKGROUND: People with serious mental illness (SMI) and intellectual disabilities and/or developmental disabilities (ID/DD) living in group homes (GHs) and residential staff are at higher risk for COVID-19 infection, hospitalization, and death compared with the general population. METHODS: We describe a hybrid type 1 effectiveness-implementation cluster randomized trial to assess evidence-based infection prevention practices to prevent COVID-19 for residents with SMI or ID/DD and the staff in GHs. The trial will use a cluster randomized design in 400 state-funded GHs in Massachusetts for adults with SMI or ID/DD to compare effectiveness and implementation of "Tailored Best Practices" (TBP) consisting of evidence-based COVID-19 infection prevention practices adapted for residents with SMI and ID/DD and GH staff; to "General Best Practices" (GBP), consisting of required standard of care reflecting state and federal standard general guidelines for COVID-19 prevention in GHs. External (i.e., community-based research staff) and internal (i.e., GH staff leadership) personnel will facilitate implementation of TBP. The primary effectiveness outcome is incident SARS-CoV-2 infection and secondary effectiveness outcomes include COVID-19-related hospitalizations and mortality in GHs. The primary implementation outcomes are fidelity to TBP and rates of COVID-19 vaccination. Secondary implementation outcomes are adoption, adaptation, reach, and maintenance. Outcomes will be assessed at baseline, 3-, 6-, 9-, 12-, and 15-months post-randomization. CONCLUSIONS: This study will advance knowledge on comparative effectiveness and implementation of two different strategies to prevent COVID-19-related infection, morbidity, and mortality and promote fidelity and adoption of these interventions in high-risk GHs for residents with SMI or ID/DD and staff. CLINICAL TRIAL REGISTRATION NUMBER: NCT04726371.