Optimizing the Implementation of a Lifestyle Dementia Prevention Intervention for Older Patients in an Academic Healthcare System.

Background: Interventions that promote healthy lifestyles are critical for the prevention of Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD). However, knowledge of the best practices for implementing AD/ADRD prevention in healthcare settings remains limited. Objective: We aimed to qualitatively identify barriers and facilitators to implementing a clinical trial of a novel lifestyle intervention (My Healthy Brain) in our medical center for older patients with subjective cognitive decline who are at-risk for AD/ADRD. Methods: We conducted focus groups with 26 healthcare professionals (e.g., physicians, psychology, nursing) from 5 clinics that treat older patients (e.g., memory care, psychiatry). Our qualitative analysis integrated two implementation frameworks to systematically capture barriers and facilitators to AD/ADRD prevention (Consolidated Framework for Implementation Science Research) that impact implementation outcomes of acceptability, appropriateness, and feasibility (Proctor's framework). Results: We found widespread support for an RCT of My Healthy Brain and AD/ADRD prevention. Participants identified barriers related to patients (stigma, technological skills), providers (dismissiveness of "worried well," doubting capacity for behavior change), clinics (limited time and resources), and the larger healthcare system (underemphasis on prevention). Implementation strategies guided by Expert Recommendations for Implementing Change (ERIC) included: developing tailored materials, training staff, obtaining buy-in from leadership, addressing stigmatized language and practices, identifying "champions," and integrating with workflows and resources. Conclusions: The results will inform our recruitment, enrollment, and retention procedures to implement the first randomized clinical trial of My Healthy Brain. Our study provides a blueprint for addressing multi-level barriers to the implementation of AD/ADRD prevention for older patients in medical settings.

Predictors of COVID-19 infection and hospitalization in group homes for individuals with intellectual and/or developmental disabilities.

BACKGROUND: More than seven million people with intellectual and/or developmental disabilities (ID/DD) live in the US and may face an elevated risk for COVID-19. OBJECTIVE: To identify correlates of COVID-19 and related hospitalizations among people with ID/DD in group homes in Massachusetts. METHODS: We collected data during March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2) from the Massachusetts Department of Public Health and six organizations administering 206 group homes for 1035 residents with ID/DD. The main outcomes were COVID-19 infections and related hospitalizations. We fit multilevel Cox proportional hazards models to estimate associations with observed predictors and assess contextual home- and organizational-level effects. RESULTS: Compared with Massachusetts residents, group home residents had a higher age-adjusted rate of COVID-19 in wave 1 (incidence rate ratio [IRR], 12.06; 95 % confidence interval [CI], 10.51-13.84) and wave 2 (IRR, 2.47; 95 % CI, 2.12-2.88) and a higher age-adjusted rate of COVID-19 hospitalizations in wave 1 (IRR, 17.64; 95 % CI, 12.59-24.70) and wave 2 (IRR, 4.95; 95 % CI, 3.23-7.60). COVID-19 infections and hospitalizations were more likely among residents aged 65+ and in group homes with 6+ resident beds and recent infection among staff and residents. CONCLUSIONS: Aggressive efforts to decrease resident density, staff-to-resident ratios, and staff infections through efforts such as vaccination, in addition to ongoing access to personal protective equipment and COVID-19 testing, may reduce COVID-19 and related hospitalizations in people with ID/DD living in group homes.

Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial.

BACKGROUND: People with serious mental illness (SMI) and people with intellectual disabilities/developmental disabilities (ID/DD) are at higher risk for COVID-19 and more severe outcomes. We compare a tailored versus general best practice COVID-19 prevention program in group homes (GHs) for people with SMI or ID/DD in Massachusetts (MA). METHODS: A hybrid effectiveness-implementation cluster randomized control trial compared a four-component implementation strategy (Tailored Best Practices: TBP) to dissemination of standard prevention guidelines (General Best-Practices: GBP) in GHs across six MA behavioral health agencies. GBP consisted of standard best practices for preventing COVID-19. TBP included GBP plus four components including: (1) trusted-messenger peer testimonials on benefits of vaccination; (2) motivational interviewing; (3) interactive education on preventive practices; and (4) fidelity feedback dashboards for GHs. Primary implementation outcomes were full COVID-19 vaccination rates (baseline: 1/1/2021-3/31/2021) and fidelity scores (baseline: 5/1/21-7/30/21), at 3-month intervals to 15-month follow-up until October 2022. The primary effectiveness outcome was COVID-19 infection (baseline: 1/1/2021-3/31/2021), measured every 3 months to 15-month follow-up. Cumulative incidence of vaccinations were estimated using Kaplan-Meier curves. Cox frailty models evaluate differences in vaccination uptake and secondary outcomes. Linear mixed models (LMMs) and Poisson generalized linear mixed models (GLMMs) were used to evaluate differences in fidelity scores and incidence of COVID-19 infections. RESULTS: GHs (n=415) were randomized to TBP (n=208) and GBP (n=207) including 3,836 residents (1,041 ID/DD; 2,795 SMI) and 5,538 staff. No differences were found in fidelity scores or COVID-19 incidence rates between TBP and GBP, however TBP had greater acceptability, appropriateness, and feasibility. No overall differences in vaccination rates were found between TBP and GBP. However, among unvaccinated group home residents with mental disabilities, non-White residents achieved full vaccination status at double the rate for TBP (28.6%) compared to GBP (14.4%) at 15 months. Additionally, the impact of TBP on vaccine uptake was over two-times greater for non-White residents compared to non-Hispanic White residents (ratio of HR for TBP between non-White and non-Hispanic White: 2.28, p = 0.03). CONCLUSION: Tailored COVID-19 prevention strategies are beneficial as a feasible and acceptable implementation strategy with the potential to reduce disparities in vaccine acceptance among the subgroup of non-White individuals with mental disabilities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04726371, 27/01/2021. https://clinicaltrials.gov/study/NCT04726371 .

Using simulation modeling to inform intervention and implementation selection in a rapid stakeholder-engaged hybrid effectiveness-implementation randomized trial.

BACKGROUND: Implementation research generally assumes established evidence-based practices and prior piloting of implementation strategies, which may not be feasible during a public health emergency. We describe the use of a simulation model of the effectiveness of COVID-19 mitigation strategies to inform a stakeholder-engaged process of rapidly designing a tailored intervention and implementation strategy for individuals with serious mental illness (SMI) and intellectual/developmental disabilities (ID/DD) in group homes in a hybrid effectiveness-implementation randomized trial. METHODS: We used a validated dynamic microsimulation model of COVID-19 transmission and disease in late 2020/early 2021 to determine the most effective strategies to mitigate infections among Massachusetts group home staff and residents. Model inputs were informed by data from stakeholders, public records, and published literature. We assessed different prevention strategies, iterated over time with input from multidisciplinary stakeholders and pandemic evolution, including varying symptom screening, testing frequency, isolation, contact-time, use of personal protective equipment, and vaccination. Model outcomes included new infections in group home residents, new infections in group home staff, and resident hospital days. Sensitivity analyses were performed to account for parameter uncertainty. Results of the simulations informed a stakeholder-engaged process to select components of a tailored best practice intervention and implementation strategy. RESULTS: The largest projected decrease in infections was with initial vaccination, with minimal benefit for additional routine testing. The initial level of actual vaccination in the group homes was estimated to reduce resident infections by 72.4% and staff infections by 55.9% over the 90-day time horizon. Increasing resident and staff vaccination uptake to a target goal of 90% further decreased resident infections by 45.2% and staff infections by 51.3%. Subsequent simulated removal of masking led to a 6.5% increase in infections among residents and 3.2% among staff. The simulation model results were presented to multidisciplinary stakeholders and policymakers to inform the "Tailored Best Practice" package for the hybrid effectiveness-implementation trial. CONCLUSIONS: Vaccination and decreasing vaccine hesitancy among staff were predicted to have the greatest impact in mitigating COVID-19 risk in vulnerable populations of group home residents and staff. Simulation modeling was effective in rapidly informing the selection of the prevention and implementation strategy in a hybrid effectiveness-implementation trial. Future implementation may benefit from this approach when rapid deployment is necessary in the absence of data on tailored interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04726371.

Primary care barriers and facilitators to nonpharmacologic treatments for low back pain: A qualitative pilot study.

BACKGROUND: Clinical practice guidelines encourage primary care providers (PCPs) to recommend nonpharmacologic treatment as first-line therapy for low back pain (LBP). However, the determinants of nonpharmacologic treatment use for LBP in primary care remain unclear, particularly in low-income settings. OBJECTIVE: To pilot a framework-informed interview guide and codebook to explore determinants of nonpharmacologic treatment use in primary care. METHODS: In this qualitative interview study, we enrolled PCPs and community health workers (CHWs) from four primary care clinics at a safety net hospital. A semistructured interview guide informed by the Consolidated Framework for Implementation Research (CFIR) guided inquiry on barriers/facilitators to nonpharmacologic treatments for LBP (eg, acupuncture, chiropractic care, physical therapy). We included questions on whether current CHW roles may address barriers to nonpharmacologic treatment use. Interviews were audio-recorded, transcribed verbatim, and independently coded by four investigators. An a priori codebook composed of CFIR determinants and known CHW roles guided deductive content analysis to identify major themes. RESULTS: Eight individuals (six PCPs, two CHWs; age range: 32-51 years, five female) participated in hour-long interviews. Half had worked at the hospital for ≥15 years and all reported seeing patients with LBP (range: 2-20 patients per week). All participants identified the following CFIR factors as barriers/facilitators: nonpharmacologic treatment characteristics (perceived cost, relative advantage compared to other treatments); outer setting (patient needs/resources, limited connections with community-based nonpharmacologic treatment) and PCP characteristics (attitudes/beliefs about nonpharmacologic treatments). Although participants indicated several CHW roles could be adapted to address barriers (eg, care coordination, resource linking, case management), other roles seemed less feasible (eg, targeted health education) in our health care system. CONCLUSIONS: Preliminary insight on key determinants of nonpharmacologic treatments for LBP should be further examined in large multisite studies. Future studies may also determine whether a CHW-led strategy can improve nonpharmacologic treatment access and clinical outcomes in primary care.

Trends in Chiropractic Care and Physical Rehabilitation Use Among Adults with Low Back Pain in the United States, 2002 to 2018.

BACKGROUND: While nonpharmacologic treatments are increasingly endorsed as first-line therapy for low back pain (LBP) in clinical practice guidelines, it is unclear if use of these treatments is increasing or equitable. OBJECTIVE: Examine national trends in chiropractic care and physical rehabilitation (occupational/physical therapy (OT/PT)) use among adults with LBP. DESIGN/SETTING: Serial cross-sectional analysis of the National Health Interview Survey, 2002 to 2018. PARTICIPANTS: 146,087 adults reporting LBP in prior 3 months. METHODS: We evaluated the association of survey year with chiropractic care or OT/PT use in prior 12 months. Logistic regression with multilevel linear splines was used to determine if chiropractic care or OT/PT use increased after the introduction of clinical guidelines. We also examined trends in use by age, sex, race, and ethnicity. When trends were similar over time, we present differences by these demographic characteristics as unadjusted ORs using data from all respondents. RESULTS: Between 2002 and 2018, less than one-third of adults with LBP reported use of either chiropractic care or OT/PT. Rates did not change until 2016 when uptake increased with the introduction of clinical guidelines (2016-2018 vs 2002-2015, OR = 1.15; 95% CI: 1.10-1.19). Trends did not differ significantly by sex, race, or ethnicity (p for interactions > 0.05). Racial and ethnic disparities in chiropractic care or OT/PT use were identified and persisted over time. For example, compared to non-Hispanic adults, either chiropractic care or OT/PT use was lower among Hispanic adults (combined OR = 0.62, 95% CI: 0.65-0.73). By contrast, compared to White adults, Black adults had similar OT/PT use (OR = 0.98; 95% CI: 0.94-1.03) but lower for chiropractic care use (OR = 0.50; 95% CI: 0.47-0.53). CONCLUSIONS: Although use of chiropractic care or OT/PT for LBP increased after the introduction of clinical guidelines in 2016, only about a third of US adults with LBP reported using these services between 2016 and 2018 and disparities in use have not improved.

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.

Preferred language and disease severity predict evaluation for liver transplantation among patients admitted with alcohol-associated hepatitis.

BACKGROUND: Liver transplantation (LT) for alcohol-associated hepatitis (AH) is a relatively new practice and limited work exists surrounding the role social determinants of health may play in evaluation. This includes language that defines how patients interact with the healthcare system. We explored characteristics of patients with AH evaluated for LT within an integrated health system. METHODS: Using a system-wide registry, we identified admissions for AH from 1 January 2016 to 31 July 2021. A multivariable logistic regression model was developed to evaluate independent predictors of LT evaluation. RESULTS: Among 1723 patients with AH, 95 patients (5.5%) underwent evaluation for LT. Evaluated patients were more likely have English as their preferred language (95.8% vs 87.9%, P = 0.020), and had higher INR (2.0 vs 1.4, P < 0.001) and bilirubin (6.2 vs 2.9, P < 0.001). AH patients who underwent evaluation had a lower burden of mood and stress disorders (10.5% vs 19.2%, P < 0.05). Patients with English preferred language had a greater than three times adjusted odds of LT evaluation compared with all others when adjusting for clinical disease severity, insurance status, sex, and psychiatric comorbid conditions (OR, 3.20; 95% CI, 1.14-9.02). CONCLUSION: Patients with AH evaluated for LT were more likely to have English as their preferred language, more psychiatric comorbidities, and more severe liver disease. Despite adjustment for psychiatric comorbidities and disease severity, English preferred language remained the strongest predictor of evaluation. As programs expand LT for AH, it is vital to build equitable systems that account for the interaction between language and healthcare in transplantation.

Assessment of the Massachusetts Flexible Services Program to Address Food and Housing Insecurity in a Medicaid Accountable Care Organization.

Importance: Health systems are increasingly addressing health-related social needs. The Massachusetts Flexible Services program (Flex) is a 3-year pilot program to address food insecurity and housing insecurity by connecting Medicaid accountable care organization (ACO) enrollees to community resources. Objective: To understand barriers and facilitators of Flex implementation in 1 Medicaid ACO during the first 17 months of the program. Design, Setting, and Participants: This mixed-methods qualitative evaluation study from March 2020 to July 2021 used the Reach, Efficacy, Adoption, Implementation, Maintenance/Practical, Robust Implementation, and Sustainability Model (RE-AIM/PRISM) framework. Two Mass General Brigham (MGB) hospitals and affiliated community health centers were included in the analysis. Quantitative data included all MGB Medicaid ACO enrollees. Qualitative interviews were conducted with 15 members of ACO staff and 17 Flex enrollees. Main Outcomes and Measures: Reach was assessed by the proportion of ACO enrollees who completed annual social needs screening (eg, food insecurity and housing insecurity) and the proportion and demographics of Flex enrollees. Qualitative interviews examined other RE-AIM/PRISM constructs (eg, implementation challenges, facilitators, and perceived effectiveness). Results: Of 67 098 Medicaid ACO enrollees from March 2020 to July 2021 (mean [SD] age, 28.8 [18.7] years), 38 442 (57.3%) completed at least 1 social needs screening; 10 730 (16.0%) screened positive for food insecurity, and 7401 (11.0%) screened positive for housing insecurity. There were 658 (1.6%) adults (mean [SD] age, 46.6 [11.8] years) and 173 (0.7%) children (<21 years; mean [SD] age, 10.1 [5.5]) enrolled in Flex; of these 831 people, 613 (73.8%) were female, 444 (53.4%) were Hispanic/Latinx, and 172 (20.7%) were Black. Most Flex enrollees (584 [88.8%] adults; 143 [82.7%] children) received the intended nutrition or housing services. Implementation challenges identified by staff interviewed included administrative burden, coordination with community organizations, data-sharing and information-sharing, and COVID-19 factors (eg, reduced clinical visits). Implementation facilitators included administrative funding for enrollment staff, bidirectional communication with community partners, adaptive strategies to identify eligible patients, and raising clinician awareness of Flex. In Flex enrollee interviews, those receiving nutrition services reported increased healthy eating and food security; they also reported higher program satisfaction than Flex enrollees receiving housing services. Enrollees who received nutrition services that allowed for selecting food based on preferences reported higher satisfaction than those not able to select food. Conclusions and Relevance: This mixed-methods qualitative evaluation study found that to improve implementation, Medicaid and health system programs that address social needs may benefit from providing funding for administrative costs, developing bidirectional data-sharing platforms, and tailoring support to patient preferences.

To screen or not to screen: Are we asking the right question? In response to considering de-implementation of universal perinatal depression screening.

This Editorial is a response to the Canadian Task Force on Preventive Health Care's recent recommendation "against instrument-based depression screening using a questionnaire with cut-off score to distinguish 'screen positive' and 'screen negative' administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth)." While we acknowledge the gaps and limitations in research on perinatal mental health screening, we have concerns regarding the potential impact of a recommendation against screening and for "de-implementation" of existing perinatal depression screening practices, particularly if there is not careful attention to the specificity as well as limitations of the recommendation, or if there are not clear alternative systems put in place to support the detection of perinatal depression. In this manuscript, we highlight some of our key concerns and suggest considerations for perinatal mental health practitioners and researchers.

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.

Healthy choices, healthy changes: A randomized trial of incentives to promote healthy eating and exercise in people with schizophrenia and other serious mental illnesses.

INTRODUCTION: People with schizophrenia and other serious mental illnesses (SMI) represent a concerning health disparity population, with 10-30 fewer years of life compared to the general population, mainly from high rates of cardiovascular disease (CVD). Preventing CVD is possible with exercise and diet interventions, but only 50 % of participants in clinical trials achieve reduction in CVD risk. This study assessed whether cash incentives improved weight loss, cardiovascular endurance, and/or mortality risk when added to one of four healthy lifestyle programs (gym membership, Weight Watchers membership, the InSHAPE program, InSHAPE + Weight Watchers). METHODS: From 2012 to 2015, 1348 overweight or obese adults with SMI enrolled in a study using equipoise stratified randomization. Participants were randomly assigned to intervention, then to cash incentives, or not, for participation (gym and/or Weight Watchers), with baseline and quarterly assessments for 12 months. We examined effects of the interventions, key covariates, and incentives, using generalized linear models. RESULTS: Main effects of randomization to receive cash incentives was not significant for any outcome; whereas total amount of incentives was significantly associated with all three primary outcomes (weight loss, cardiovascular endurance, mortality risk), mainly for participants in the InSHAPE+WW group who received additional cash incentives. CONCLUSIONS: Incentives may be effective at preventing CVD and improving health outcomes for people with SMI, especially in the context of intensive support for healthy lifestyle behaviors. Policy changes are required to increase access to healthy lifestyle programming and more research is needed to establish the optimal amount of incentives for people with SMI. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02515981.

Enhancing the Capacity of Providers in Mental Health Integration (ECaP-MHI) in Rural Uganda: The Adaptation Process.

Purpose: Uganda adopted the World Health Organization (WHO) model of creating district health management teams (DHMT) comprised of public health officials and administrators to supervise health service delivery at the community level. The purpose of this study was to characterize the perspectives of the DMHT in providing support supervision to primary health-care providers implementing mental health integration using the pre-recorded material. Our aim was to identify barriers to individual uptake and contextual fit, and to solicit solutions for co-designed improvements. Methods: We conducted a qualitative exploratory study using one-on-one interviews informed by the Practical Robust Implementation and Sustainability Model. Results: Members of the DHMT identified a systemic gap in supporting mental health integration into primary care, and reported limited knowledge in how to supervise mental health integration and lacked data on mental health delivery and outcomes. They recommended training of the DHMT in supervising mental health integration supported by standard outcome reports, pre-recorded instructional material by psychiatrists, checklists to help guide and standardize the process, and use of visual aids illustrating mental disorders and treatments for low-health literacy populations. Conclusion: Implementing integrated mental health care using the WHO model of DHMTs as external facilitators and supervisors of primary health-care providers is potentially feasible and scalable, provided that substantial reforms occur such as training in how to provide supervision, standard collection of outcome reports, and practical tools to help guide and facilitate the process.

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.

Exploring Opportunities to Optimize Stress and Trauma-Focused Primary Care with Low-Income Midlife and Older Women.

Trauma and trauma-related symptoms often remain hidden in the lives of low-income midlife and older women. In primary care encounters, midlife and older women are infrequently asked about trauma histories, and symptoms of trauma are commonly misinterpreted. As stress and trauma raise risk morbidity and mortality, under-recognition of trauma is a health equity issue. This secondary qualitative analysis explores stress and trauma as factors that affect primary/preventive care engagement in low-income midlife and older women. Semi-structured interviews were completed with 22 low-income midlife and older women from December 2020-January 2021. A deductive-inductive content analysis approach was guided by the Behavioral Model for Vulnerable Populations. Three categories were identified: (1) stress and competing demands; (2) history and impact of trauma; (3) integrated trauma-related behavioral health focus. Co-designing and culturally adapting stress and trauma screening and interventions may optimize stress and trauma-focused primary care while promoting health equity with socially marginalized women.

Stakeholder and Equity Data-Driven Implementation: a Mixed Methods Pilot Feasibility Study.

We conducted a mixed methods pilot feasibility study of a Stakeholder and Equity Data-Driven Implementation (SEDDI) process to facilitate using healthcare data to identify patient groups experiencing gaps in the use of evidence-based interventions (EBIs) and rapidly adapt EBIs to achieve greater access and equitable outcomes. We evaluated the feasibility and acceptability of SEDDI in a pilot hybrid type 2 effectiveness-implementation trial of a paired colorectal cancer (CRC) and social needs screening intervention at four federally qualified community health centers (CHCs). An external facilitator partnered with CHC teams to support initial implementation, followed by the SEDDI phase focused on advancing health equity. Facilitation sessions were delivered over 8 months. Preliminary evaluation of SEDDI involved convergent mixed methods with quantitative survey and focus group data. CHCs used data to identify gaps in outreach and completion of CRC screening with respect to race/ethnicity, gender, age, and language. Adaptations to improve access and use of the intervention included cultural, linguistic, and health literacy tailoring. CHC teams reported that facilitation and systematic review of data were helpful in identifying and prioritizing gaps. None of the four CHCs completed rapid cycle testing of adaptations largely due to competing priorities during the COVID-19 response. SEDDI has the potential for advancing chronic disease prevention and management by providing a stakeholder and data-driven approach to identify and prioritize health equity targets and guide adaptations to improve health equity. ClinicalTrials.gov Identifier: NCT04585919.

Virtual Learning Collaborative Compared to Technical Assistance as a Strategy for Implementing Health Promotion in Routine Mental Health Settings: A Hybrid Type 3 Cluster Randomized Trial.

BACKGROUND: Despite widespread use of learning collaboratives, few randomized trials have evaluated their effectiveness as a strategy for implementing evidence based practices. This randomized trial evaluated the effectiveness of a virtual learning collaborative (VLC) in the implementation of a health promotion program for persons with serious mental illness (SMI) aimed at reducing cardiovascular risk reduction in routine mental health settings, compared to routine technical assistance (TA). METHODS: Fifty-five mental health provider organizations were recruited to participate in a Hybrid Type 3 cluster randomized implementation-effectiveness trial of the InSHAPE health promotion program for persons with SMI. Sites were stratified by size and randomized prior to implementation to an 18-month group-based VLC with monthly learning sessions or individual site TA with four scheduled conference calls over 18 months. Primary implementation and service outcomes were InSHAPE program fidelity, participation, and reach. Primary clinical outcomes were weight loss, cardiorespiratory fitness, and cardiovascular risk reduction (≥ 5% weight loss or > 50 m increase on the 6-Minute Walk Test). Program fidelity was assessed at 6, 12, and 24 months; program participation and participant-level outcomes were assessed at 3, 6, 9, and 12 months. RESULTS: VLC (N = 27) and TA (N = 28) sites were similar in organizational characteristics (all p > 0.05). At 12-month follow-up mean program fidelity score was higher in VLC compared to TA (90.5 vs. 79.1; p = 0.002), with over double the proportion with good fidelity (VLC = 73.9% vs. TA = 34.8%; p = 0.009). Over half of individuals in both VLC and TA achieved cardiovascular risk-reduction at 6-month follow-up (VLC: 51.0%; TA: 53.5%; p = 0.517) and at 12-month follow-up (62% VLC and TA; p = 0.912). At 12-month follow-up VLC compared to TA was associated with greater participation (VLC 69.5% vs. TA 56.4% attending at least 50% of sessions, p = 0.002); larger caseloads (VLC = 16 vs. TA = 11; p = 0.024); greater reach consisting of 45% greater number of participants receiving InSHAPE (VLC = 368 vs. TA = 253), and 58% greater number of participants achieving cardiovascular risk reduction (VLC = 150 vs. TA = 95). CONCLUSION: Virtual learning collaboratives compared to routine technical assistance as an implementation strategy for evidence-based health promotion promote greater intervention fidelity, greater levels of intervention participation, greater reach, and a greater number of participants achieving clinically significant risk reduction outcomes, while achieving similarly high levels of intervention effectiveness for participants who completed at least 6 months of the program.

Transitional Care Management Quality Improvement Methods That Reduced Readmissions in a Rural, Primary Care System.

BACKGROUND: Transitional Care Management (TCM) is a reimbursable service designed to minimize hospital readmissions. We describe a multifaceted approach to increase TCM services among 107 primary care providers in a rural catchment area of 4250 square miles. OBJECTIVE: The primary objective was to increase use of TCM phone calls, office visits, and billing codes; the secondary objective was to decrease hospital readmissions. METHODS: We utilized a learning health system model, an improvement support team (IST), and a learning collaborative that included webinars and in-person support. The process emphasized user-centered system redesign, coaching, electronic health record (EHR) improvements, and real-time feedback. Analyses included statistical process control charts, box plots, analysis of variance, and t-tests. RESULTS: The IST engaged stakeholders to design and test TCM workflows and EHR prototypes. This resulted in rapid, iterative improvements and system-wide spread of new processes. In the month following implementation, TCM calls and visits quadrupled and increased during 18 subsequent months. Pragmatically, most discharged patients (95% in a subsample) did not receive both the TCM call and visit, serving as a comparison group. The Readmission rate for patients receiving complete TCM services was 5.0% (n = 101) versus 11.9% for comparators (n = 2103, P = .03). Billing codes increased initially, then returned to baseline. CONCLUSIONS: Our approach led to rapid, sustained scaling of TCM calls and visits in a rural primary care group. Patients who received TCM calls and visits had significantly fewer readmissions. Training of new staff, including PCPs, is required for sustainability. Future research is warranted to increase adoption and evaluate additional outcomes including mortality rates, patient satisfaction, and health care economics.

Assessing a digital peer support self-management intervention for adults with serious mental illness: feasibility, acceptability, and preliminary effectiveness.

OBJECTIVE: To assess the feasibility, acceptability, and preliminary effectiveness of digital peer support integrated medical and psychiatric self-management intervention ("PeerTECH") for adults with a serious mental illness. METHODS: Twenty-one adults with a chart diagnosis of a serious mental illness (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, or treatment-refractory major depressive disorder) and at least one medical comorbidity (i.e., cardiovascular disease, obesity, diabetes, chronic obstructive pulmonary disease, hypertension, and/or high cholesterol) aged 18 years and older received the PeerTECH intervention in the community. Nine peer support specialists were trained to deliver PeerTECH. Data were collected at baseline and 12-weeks. RESULTS: This pilot study demonstrated that a 12-week, digital peer support integrated medical and psychiatric self-management intervention for adults with serious mental illness was feasible and acceptable among peer support specialists and patients and was associated with statistically significant improvements in self-efficacy to manage chronic disease and personal empowerment. In addition, pre/post non-statistically significant improvements were observed in psychiatric self-management, medical self-management skills, and feelings of loneliness. CONCLUSIONS: This single-arm pre/post pilot study demonstrated preliminary evidence peer support specialists could offer a fidelity-adherent digital peer support self-management intervention to adults with serious mental illness. These findings build on the evidence that a digital peer support self-management intervention for adults with serious mental illness designed to improve medical and psychiatric self-management is feasible, acceptable, and shows promising evidence of improvements in clinical outcomes. The use of technology among peer support specialists may be a promising tool to facilitate the delivery of peer support and guided evidence-based self-management support.People with serious mental illness (SMI; defined as individuals diagnosed with schizophrenia spectrum disorder, bipolar disorder, or treatment-refractory major depressive disorder) are increasingly utilizing peer support services to support their health and recovery. Peer support is defined as shared knowledge, experience, emotional, social, and/or practical assistance to support others with similar lived experiences (Solomon, 2004). Most recently the definition also includes the provision of evidence-based peer-supported self-management services (Fortuna et al., 2020). Mental health peer support can augment the traditional mental health treatment system through providing support services to maintain recovery between clinical encounters (Solomon, 2004) and is classified by the World Health Organization as an essential element of recovery (World, Health, and Organization, About social determinants of health, 2017).