Tobacco, Alcohol, and Drug Use Among Young Adults with Serious Mental Illness.

To inform early intervention, this study describes correlates of substance use among young people with serious mental illness (SMI) enrolled in integrated care in community mental health settings. 227 adults ages 18-35 were assessed for clinical characteristics and substance use. Logistic regressions were used to describe relationships between substance use and participant characteristics. Over a third (38.9%) reported daily cannabis, 15.9% past month other illicit drug, 13.5% frequent/heavy alcohol and 47.4% any of these; 50.2% reported daily tobacco smoking and 23.3% current vaping. Daily cannabis and tobacco were the most common combination. Alcohol, drug, and cannabis with tobacco were associated with higher mental health symptoms but not with emergency room or hospital utilization. Cannabis and other substance use was common and associated with higher symptoms but not with greater hospital utilization, suggesting that early intervention could prevent long-term negative consequences.

Leveraging an implementation science partnership network to understand how Federally Qualified Health Centers operationalize and address health equity.

Health equity-focused implementation research requires using definitions and approaches that are relevant and meaningful to implementation partners. We examined how health equity was operationalized and addressed at Federally Qualified Health Centers (FQHCs). We conducted semi-structured interviews with leadership (n = 19) and staff (n = 12) at 10 FQHCs in an implementation science partnership network for cancer control equity to understand how they operationalized and addressed health equity. We performed rapid qualitative analysis and shared findings with a larger group of 13 community health centers (including the 10 FQHCs) at an Implementation Learning Community (ILC) to identify action areas for research and practice, followed by a second phase of synthesizing qualitative codes into themes and mapping themes onto a framework for advancing health equity in healthcare organizations. Participants defined health equity as central to the mission of FQHCs, and identified barriers (e.g. financing models) and facilitators (e.g. interpreter services) to advancing health equity at FQHCs. These findings resonated with ILC participants who emphasized the challenge of addressing root cause social determinants of inequities using limited available resources in FQHCs and the importance of developing meaningful collaboration with communities for data collection, data interpretation, data use, and data ownership. Themes captured recommendations to advance health equity in daily work at FQHCs, including investments in staffing, training, and resources. Mapping qualitative themes from health equity-centered interviews with FQHC partners onto a framework for advancing health equity in healthcare organizations can provide clear, context-specific direction for actions aimed at improving health and healthcare equity.

Health equity-focused implementation research requires using definitions and approaches that are relevant and meaningful to implementation partners. Toward this goal, our research team asked leadership and staff at Federally Qualified Health Centers (FQHCs) to share how they defined and addressed health equity at their practice settings. FQHC participants defined health equity as the essential mission of FQHCs as safety net organizations delivering care to medically underserved populations. In addition, key informants identified barriers (e.g. financing models) and facilitators (e.g. interpreter services) to advancing health equity at FQHCs. We presented these findings to a larger group of FQHC stakeholders who recommended that future implementation research and practice consider how FQHCs are challenged to address the root causes of healthcare inequities with limited resources. They also highlighted the importance of meaningful collaboration among researchers, FQHCs, and communities for data collection, data interpretation, data use, and data ownership to advance health equity. Conducting research to understand the perspectives and experiences of FQHC partners can provide clear, context-specific direction for actions to improve health equity and can inform future approaches to health equity-focused implementation research that ismeaningful to FQHC partners and the communities they serve.

Factors influencing engagement in in-person and remotely delivered lifestyle interventions for young adults with serious mental illness: A qualitative study.

AIM: Young adults (ages 18-35) are underrepresented in lifestyle interventions for people with serious mental illness (SMI), such as schizophrenia, bipolar disorder, and severe depression, and little is known about factors influencing their engagement in these programmes. This qualitative study examined factors affecting engagement amongst young adults with SMI who were enrolled in a lifestyle intervention trial at community mental health centres. METHODS: Seventeen young adults with SMI participated in this qualitative study. Participants were drawn from a 12-month randomized controlled trial (n = 150) comparing an in-person group lifestyle intervention augmented with mobile health technology (PeerFIT) to one-on-one personalized remote health coaching (BEAT) using purposive sampling. The 17 participants completed semi-structured qualitative interviews at post-intervention to explore their perceived benefits of the intervention and factors impacting engagement. We used a team-based descriptive qualitative approach to code transcripts and identify themes in the data. RESULTS: Participants across both interventions reported experiencing improved ability to engage in health behaviour change. Participants described managing psychosocial stressors and family and other responsibilities that limited their ability to attend in-person PeerFIT sessions. The remote and flexible BEAT remote health coaching intervention appeared to facilitate engagement even in the context of challenging life circumstances. CONCLUSIONS: Remotely delivered lifestyle interventions can facilitate engagement amongst young adults with SMI navigating social stressors.

Factors Shaping the Implementation of Strategies to Prevent Acute Kidney Injury: A Qualitative Study.

Reducing the prevalence of acute kidney injury (AKI) is an important patient safety objective set forth by the National Quality Forum. Despite international guidelines to prevent AKI, there continues to be an inconsistent uptake of these interventions by cardiac teams across practice settings. The IMPROVE-AKI study was designed to test the effectiveness and implementation of AKI preventive strategies delivered through team-based coaching activities. Qualitative methods were used to identify factors that shaped sites' implementation of AKI prevention strategies. Semi-structured interviews were conducted with staff in a range of roles within the cardiac catheterization laboratories, including nurses, laboratory managers, and interventional cardiologists (N = 50) at multiple time points over the course of the study. Interview transcripts were qualitatively coded, and aggregated code reports were reviewed to construct main themes through memoing. In this paper, we report insights from semi-structured interviews regarding workflow, organizational culture, and leadership factors that impacted implementation of AKI prevention strategies.

Integrating a focus on health equity in implementation science: Case examples from the national cancer institute's implementation science in cancer control centers (ISC3) network.

Background: A Health Equity Task Force (HETF) of members from seven Centers funded by the National Cancer Institute's (NCI) Implementation Science in Cancer Control Centers (ISC3) network sought to identify case examples of how Centers were applying a focus on health equity in implementation science to inform future research and capacity-building efforts. Methods: HETF members at each ISC3 collected information on how health equity was conceptualized, operationalized, and addressed in initial research and capacity-building efforts across the seven ISC3 Centers funded in 2019-2020. Each Center completed a questionnaire assessing five health equity domains central to implementation science (e.g., community engagement; implementation science theories, models, and frameworks (TMFs); and engaging underrepresented scholars). Data generated illustrative examples from these five domains. Results: Centers reported a range of approaches focusing on health equity in implementation research and capacity-building efforts, including (1) engaging diverse community partners/settings in making decisions about research priorities and projects; (2) applying health equity within a single TMF applied across projects or various TMFs used in specific projects; (3) evaluating health equity in operationalizing and measuring health and implementation outcomes; (4) building capacity for health equity-focused implementation science among trainees, early career scholars, and partnering organizations; and (5) leveraging varying levels of institutional resources and efforts to engage, include, and support underrepresented scholars. Conclusions: Examples of approaches to integrating health equity across the ISC3 network can inform other investigators and centers' efforts to build capacity and infrastructure to support growth and expansion of health equity-focused implementation science.

Adapting Connect for Health pediatric weight management program for telehealth in response to the COVID-19 pandemic.

BACKGROUND: To address the evolving needs and context changes due to the COVID-19 pandemic, we adapted Connect for Health, an evidence-based, primary care, pediatric weight management intervention. The objective of this study is to describe the planned adaptation process to ensure continued and equitable program uptake during the pandemic. METHODS: Guided by adaptation frameworks, we identified the core functions and forms of Connect for Health and then adapted the intervention in response to a changing healthcare context. We engaged stakeholders and surveyed parents of children with a BMI ≥ 85th percentile and pediatric clinicians and examined their experiences using telehealth for pediatric weight management and needs and preferences. Using multivariable logistic regression, we examined the preferences of parents with limited English proficiency regarding key aspects of pediatric weight management. RESULTS: We surveyed 200 parents and 43% had a primary language of Spanish. Parents wanted care to be a combination of in-person and virtual visits (80%). We found that parents with limited English proficiency had a higher odds ratio of affirming in-person visits are better than virtual visits for ensuring their child's health concern can be taken care of (OR: 2.91; 95% CI: 1.36, 6.21), feeling comfortable when discussing personal information (OR: 3.91; 95% CI: 1.82, 8.43), talking about healthy behaviors and setting goals (OR: 3.09; 95% CI: 1.39, 6.90), and talking about mental health and overall well-being (OR: 4.02; 95% CI: 1.83, 8.87) than parents without limited English proficiency. We surveyed 75 clinicians and 60% felt telehealth was a useful tool to provide care for pediatric weight management. Clinicians felt virtual visits did not pose barriers to all aspects of care. Informed by the surveys and stakeholder input, we made clinician- and family-level adaptations while retaining the program's function. CONCLUSIONS: By engaging stakeholders and adapting the program for telehealth, we optimized the reach and fit of Connect for Health to ensure its continued uptake. We have provided a real-world example of how clinical innovations can evolve and how to systematically plan adaptations in response to changing healthcare contexts. TRIAL REGISTRATION: Clinicaltrials.gov (NCT04042493), Registered on August 2, 2019.

Challenges and recommendations for measuring time devoted to implementation and intervention activities in health equity-focused, resource-constrained settings: a qualitative analysis.

BACKGROUND: There is little guidance for conducting health equity-focused economic evaluations of evidence-based practices in resource-constrained settings, particularly with respect to staff time use. Investigators must balance the need for low-touch, non-disruptive cost data collection with the need for data on providing services to priority subpopulations. METHODS: This investigation took place within a pilot study examining the implementation of a bundled screening intervention combining screening for social determinants of health and colorectal cancer at four federally qualified health centers (FQHCs) in the Boston metropolitan area. Methods for collecting data on personnel costs for implementation and intervention activities, including passive (automatic) and active (non-automatic, requiring staff time and effort) data collection, as well as three alternate wordings for self-reporting time-use, were evaluated qualitatively using data collected through interviews with FQHC staff (including clinicians, population health staff, and community health workers) and assessments of data completeness. RESULTS: Passive data collection methods were simple to execute and resulted in no missing data, but missed implementation and intervention activities that took place outside planned meetings. Active cost data collection using spreadsheets was simple for users when applied to care processes already tracked in this fashion and yielded accurate time use data. However, for tasks where this was not typical, and when tasks were broken up over multiple sessions, spreadsheets were more challenging to use. Questions asking about time use for a typical rather than specific time period, and for typical patients, yielded the most reliable and actionable data. Still, even the best-performing question had substantial variability in time use estimates. Participants noted that patient characteristics of interest for equity-focused research, including language spoken, adverse social determinants of health, and issues related to poverty or mental health, all contributed significantly to this variability. CONCLUSIONS: Passively collected time use data are the least burdensome and should be pursued in research efforts when possible, but should be accompanied by qualitative assessments to ensure the data are an accurate reflection of effort. When workflows are already tracked by active data collection, these are also strong data collection methods. Self-reported time use will be most accurate when questions inquire about "typical" tasks and specific types of patients.

Embedding community-engaged research principles in implementation science: The implementation science center for cancer control equity.

Gaps in the implementation of effective interventions impact nearly all cancer prevention and control strategies in the US including Massachusetts. To close these implementation gaps, evidence-based interventions must be rapidly and equitably implemented in settings serving racially, ethnically, socioeconomically, and geographically diverse populations. This paper provides a brief overview of The Implementation Science Center for Cancer Control Equity (ISCCCE) and describes how we have operationalized our commitment to a robust community-engaged center that aims to close these gaps. We describe how ISCCCE is organized and how the principles of community-engaged research are embedded across the center. Principles of community engagement have been operationalized across all components of ISCCCE. We have intentionally integrated these principles throughout all structures and processes and have developed evaluation strategies to assess whether the quality of our partnerships reflects the principles. ISCCCE is a comprehensive community-engaged infrastructure for studying efficient, pragmatic, and equity-focused implementation and adaptation strategies for cancer prevention in historically and currently disadvantaged communities with built-in methods to evaluate the quality of community engagement. This engaged research center is designed to maximize the impact and relevance of implementation research on cancer control in community health centers.

The New Hampshire Hospital Screening and Referral Algorithm (NHHSRA) for Substance Use in People With Serious Mental Illness.

Objective: Substance use is a common co-occurrence among psychiatrically hospitalized adults, yet it is especially difficult to identify in those with serious mental illness. Existing screening instruments are not feasible for individuals with serious mental illness, as they rely heavily on subjective self-report. This study aimed to develop and validate an objective substance use screening instrument for use in seriously mentally ill patient populations.Methods: Objective elements were extracted from existing substance use screening instruments and used to develop a new, data-driven referral tool, the New Hampshire Hospital screening and referral algorithm (NHHSRA). Descriptive statistics were employed to compare NHHSRA summed score and individual patient data elements in a convenience sample of patients who were referred to the Addiction Services by expert addiction psychiatrist evaluation to those who were not referred. Pearson correlation coefficients and logistic regression models assessed the association between patient referral and the overall NHHSRA score and individual items. The NHHSRA was then piloted in a smaller convenience sample of patients against the standard clinical-based identification for substance use treatment needs.Results: The instrument consists of 5 objective items. These were tested in a sample of 302 sequentially admitted adults with serious mental illness. Three of the items were significantly associated with likelihood of benefitting from referral for substance use interventions (maximum likelihood estimate and standard deviation [SD] for positive non-tetrahydrocannabinol [non-THC] toxicology screen or > 0% blood alcohol level = 3.61 [0.6]; diagnosis of a substance use disorder = 4.89 [0.73]; and medication-assisted treatment or relapse prevention = 2.78 [0.67]), and these were prioritized in building a decision tree algorithm. The area under the receiver operating characteristic (ROC) curve for the NHHSRA was 0.96, indicating that the NHHSRA has high overall sensitivity and the algorithm was capable of distinguishing between patients needing substance use intervention versus those who do not with 96% accuracy. In the pilot implementation study of another 20 patient admissions, the NHHSRA accurately identified 100% (n = 6) of patients deemed to benefit from substance use interventions by expert addiction psychiatric evaluation. The standard clinical-based referral process identified only 33% (n = 2) and erroneously identified another 4 for referral to substance use intervention that would not have been warranted.Conclusions: The NHHSRA holds promise in its ability to improve objective and timely identification of substance use in a seriously mentally ill inpatient population, helping to facilitate treatment.

Team-Based Coaching Intervention to Improve Contrast-Associated Acute Kidney Injury: A Cluster-Randomized Trial.

BACKGROUND: Up to 14% of patients in the United States undergoing cardiac catheterization each year experience AKI. Consistent use of risk minimization preventive strategies may improve outcomes. We hypothesized that team-based coaching in a Virtual Learning Collaborative (Collaborative) would reduce postprocedural AKI compared with Technical Assistance (Assistance), both with and without Automated Surveillance Reporting (Surveillance). METHODS: The IMPROVE AKI trial was a 2×2 factorial cluster-randomized trial across 20 Veterans Affairs medical centers (VAMCs). Participating VAMCs received Assistance, Assistance with Surveillance, Collaborative, or Collaborative with Surveillance for 18 months to implement AKI prevention strategies. The Assistance and Collaborative approaches promoted hydration and limited NPO and contrast dye dosing. We fit logistic regression models for AKI with site-level random effects accounting for the clustering of patients within medical centers with a prespecified interest in exploring differences across the four intervention arms. RESULTS: Among VAMCs' 4517 patients, 510 experienced AKI (235 AKI events among 1314 patients with preexisting CKD). AKI events in each intervention cluster were 110 (13%) in Assistance, 122 (11%) in Assistance with Surveillance, 190 (13%) in Collaborative, and 88 (8%) in Collaborative with Surveillance. Compared with sites receiving Assistance alone, case-mix-adjusted differences in AKI event proportions were -3% (95% confidence interval [CI], -4 to -3) for Assistance with Surveillance, -3% (95% CI, -3 to -2) for Collaborative, and -5% (95% CI, -6 to -5) for Collaborative with Surveillance. The Collaborative with Surveillance intervention cluster had a substantial 46% reduction in AKI compared with Assistance alone (adjusted odds ratio=0.54; 0.40-0.74). CONCLUSIONS: This implementation trial estimates that the combination of Collaborative with Surveillance reduced the odds of AKI by 46% at VAMCs and is suggestive of a reduction among patients with CKD. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: IMPROVE AKI Cluster-Randomized Trial (IMPROVE-AKI), NCT03556293.

Factors associated with weight gain prevention in young adults with serious mental illness.

AIM: The purpose of this study was to examine factors associated with weight gain prevention among young adults with serious mental illness who participated in the Fit Forward randomized controlled trial evaluating lifestyle interventions adapted for this high-risk group. The aims were to: (1) examine baseline differences between participants that gained weight and those that lost or maintained weight at six and 12 months, and (2) evaluate whether changes in weight control strategies were associated with weight gain prevention at 6 and 12 months. METHODS: This study was a secondary analysis of the Fit Forward Study. Participants were young adults (age 18-35) with a serious mental illness and a body mass index in the overweight or obese range. Participants completed assessments at baseline and 6 and 12 months. t-Tests and chi-squared tests were used to examine baseline differences between those that gained weight and those that lost/maintained weight. Logistic regression was used to evaluate whether changes in weight control strategies were associated with weight gain prevention in the sample overall. RESULTS: Lower baseline BMI was significantly associated with weight gain prevention at six and 12 months. Greater increases in weight control strategies total score and psychological coping subscale were significantly associated with weight gain prevention at six and 12 months. CONCLUSIONS: Weight control strategies, particularly psychological coping tools that support positive thinking and reduce negative self-talk should be considered as core strategies in healthy lifestyle interventions aimed at preventing weight gain in young adults with serious mental illness.

Health status of young adults with serious mental illness enrolled in integrated care.

AIMS: People with serious mental illness (SMI) are more likely to develop chronic health conditions and die prematurely. Timely identification of modifiable health risk factors may enable early intervention. We aimed to describe the physical health characteristics and service utilization of young people with SMI. METHODS: Young people with SMI enrolled in an integrated community mental health clinic (CMHC) and primary care program were assessed for physical and mental health history and past year service utilization. RESULTS: A total of 122 participants, ages 16-35 (m = 27.0 ± 5.0 years), half male, 78.3% White were assessed. Half smoked cigarettes, half had obesity, almost half (47.5%, n = 56) had hypertension, and about a third had laboratory metabolic abnormalities. The group averaged 10.7 ± 5.1 h of sedentary behavior per day. Obesity was associated with high blood pressure, prediabetes, poor self-rated health abilities, sedentary behavior and low health satisfaction. Over half had been to the emergency department (ED) for a medical reason (55.0%, n = 66) and 24.6% had been hospitalized for a health condition in the past year. Over half had a lifetime cardiovascular risk score indicating a 50-67% chance of having a cardiovascular event; simply quitting smoking would reduce the number with this risk by almost half. Most physical health diagnoses were not recorded in the CMHC record. CONCLUSION: Young people with SMI newly enrolled in integrated care had high rates of smoking, obesity, hypertension, and other cardio-metabolic abnormalities contributing to high risk for future disease. Research is needed to examine appealing, scalable interventions to improve health, reduce unnecessary medical care, and prevent disparate chronic disease in this group.

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.

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.

Applying mixed methods to pilot feasibility studies to inform intervention trials.

BACKGROUND: Pilot feasibility studies serve a uniquely important role in preparing for larger scale intervention trials by examining the feasibility and acceptability of interventions and the methods used to test them. Mixed methods (collecting, analyzing, and integrating quantitative and qualitative data and results) can optimize what can be learned from pilot feasibility studies to prepare rigorous intervention trials. Despite increasing use of mixed method designs in intervention trials, there is limited guidance on how to apply these approaches to address pilot feasibility study goals. The purpose of this article is to offer methodological guidance for how investigators can plan to integrate quantitative and qualitative methods within pilot feasibility studies to comprehensively address key research questions. METHODS: We used an informal consensus-based process informed by key methodological resources and our team's complementary expertise as intervention researchers and mixed methodologists to develop guidance for applying mixed methods to optimize what can be learned from pilot feasibility studies. We developed this methodological guidance as faculty in the Mixed Methods Research Training Program (MMRTP) for the Health Sciences (R25MH104660) funded by the National Institutes of Health through the Office of Behavioral and Social Science Research. RESULTS: We provide the following guidance for applying mixed methods to optimize pilot feasibility studies: (1) identify feasibility domain(s) that will be examined using mixed methods, (2) align quantitative and qualitative data sources for the domain(s) selected for mixing methods, (3) determine the timing of the quantitative and qualitative data collection within the flow of the pilot study, (4) plan integrative analyses using joint displays to understand feasibility, and (5) prepare to draw meta-inferences about feasibility and implications for the future trial from the integrated data. CONCLUSIONS: By effectively integrating quantitative and qualitative data within pilot feasibility studies, investigators can harness the potential of mixed methods for developing comprehensive and nuanced understandings about feasibility. Our guidance can help researchers to consider the range of key decisions needed during intervention pilot feasibility testing to achieve a rigorous mixed methods approach generating enhanced insights to inform future intervention trials.

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.

Sleep quality and its relationship to mental health, physical health and health behaviours among young adults with serious mental illness enrolled in a lifestyle intervention trial.

AIM: To characterize subjective sleep quality and examine its associations with mental health, physical health and health behaviours in a transdiagnostic sample of young adults with serious mental illness (SMI) enrolled in a lifestyle intervention trial. METHODS: Baseline data from a lifestyle intervention trial with young adults (ages 18-35 years) with SMI included the Pittsburgh Sleep Quality Index (PSQI), mental health, physical health and health behaviour outcomes. Descriptive statistics and multiple linear regression were used in analyses. RESULTS: Of 150 participants, 76% were categorized with poor sleep quality. Depressive symptoms were significantly associated with sleep quality (ß = .438, p < .001); however, no association was found with physical health and health behaviours. CONCLUSIONS: Young adults with SMI enrolled in lifestyle interventions may benefit from treatment that addresses sleep as part of a comprehensive approach to health promotion with attention to the role of depressive symptoms in sleep quality.

Group Lifestyle Intervention With Mobile Health for Young Adults With Serious Mental Illness: A Randomized Controlled Trial.

OBJECTIVE: Evidence-based lifestyle interventions tailored to young adults with serious mental illness are needed to reduce their cardiometabolic risk. This study evaluated the effectiveness of a group lifestyle intervention ("PeerFIT") enhanced with mobile health (mHealth) compared with one-on-one mHealth coaching (basic education supported by activity tracking [BEAT]) for young adults with serious mental illness who were overweight or obese. METHODS: Participants were young adults ages 18-35 years with serious mental illness and a body mass index ≥25 kg/m2, who were randomly assigned to PeerFIT or BEAT. Research staff collected data at baseline and at 6 and 12 months. Main outcomes were clinically significant changes from baseline in weight (≥5% weight loss), cardiorespiratory fitness (CRF; increase of >50 m on the 6-minute walk test), and cardiovascular disease (CVD) risk reduction (clinically significant weight loss or CRF improvement). RESULTS: Participants were 150 young adults with a mean ± SD body mass index of 37.1±7.4. Intent-to-treat analyses revealed no significant between-group difference for weight-loss, CRF, or CVD outcomes at 6 and 12 months. Participants in both conditions achieved clinically significant CVD risk reduction, weight loss, and CRF from baseline to 6 and 12 months, and all these improvements were statistically significant (p<0.01). CONCLUSION: The PeerFIT group lifestyle intervention was not superior to one-on-one mHealth coaching in achieving clinically significant changes in weight, CRF, and CVD risk reduction. Although both interventions improved outcomes, low-intensity mHealth coaching may be a more scalable approach for addressing modifiable cardiometabolic risk factors among young adults with serious mental illness.

A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease.

OBJECTIVE: Poor sleep is common in inflammatory bowel disease (IBD), associated with worse overall disease course and predominantly attributable to insomnia. While cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment for chronic insomnia, it is untested in IBD. It is unclear if CBT-I will be as effective in this group given the extent of night-time symptoms people with IBD experience. Thus, we evaluated the feasibility and preliminary efficacy of CBT-I in IBD. DESIGN: We comprehensively assessed sleep in people with mild-to-moderately active IBD using questionnaires, daily diaries and actigraphy. People with significant insomnia symptoms were allocated to a single-arm, uncontrolled pilot feasibility study of gold-standard CBT-I treatment. They were then reassessed post-treatment. RESULTS: 20 participants with IBD completed a baseline assessment. 10 were experiencing insomnia and were allocated to CBT-I. All participants who were offered CBT-I elected to complete it, and all completed 5/5 sessions. Participants rated treatment acceptability highly and daily diary and actigraphy completion rates were >95%. At baseline, participants with insomnia evidenced significantly worse sleep than participants without insomnia. Following CBT-I, participants reported significant improvements in diary and actigraphy measures of sleep continuity, dysfunctional sleep-related beliefs and IBD disease activity. CONCLUSION: CBT-I was feasible and acceptable and demonstrated a signal for efficacy in the treatment of insomnia in IBD. Importantly, the improvements in sleep continuity were consistent with the extant literature. Future fully powered randomised controlled studies should evaluate whether treatment of insomnia can improve other aspects of IBD, including pain and inflammation. TRIAL REGISTRATION NUMBER: NCT04132024.

Applying an Equity Lens to Characterizing the Process and Reasons for an Adaptation to an Evidenced-based Practice.

BACKGROUND: Adaptations to evidence-based practices (EBPs) are common but can impact implementation and patient outcomes. In our prior research, providers in routine care made a fidelity-inconsistent adaptation to an EBP that improved health outcomes in people with serious mental illness (SMI). The purpose of this study was to characterize the process and reasons for the adaptation using a framework for reporting adaptations and modifications to EBPs, with a focus on equity. METHODS: This study used qualitative data collected during a national implementation of the InSHAPE EBP addressing obesity in persons with SMI. We reviewed transcripts from five behavioral health organizations that made a successful fidelity-inconsistent adaptation to a core component of InSHAPE that was associated with cardiovascular risk reduction. We coded the data using the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) with an emphasis on exploring whether the adaptation addressed inequities in using the EBP related to social determinants of health. RESULTS: Across the five agencies, the fidelity-inconsistent adaptation was characterized as unplanned and reactive in response to challenges InSHAPE teams experienced delivering the intervention in community fitness facilities as intended. In all cases, the goal of the adaptation was to improve intervention access, feasibility and fit. Social and economic disadvantage were noted obstacles to accessing fitness facilities or gyms among participants with SMI, which led agencies to adapt the program by offering sessions at the mental health center. CONCLUSIONS: Findings from this study show the advantages of applying a health equity lens to evaluate how obstacles such as poverty and discrimination influence EBP adaptations. Recommendations can also assist researchers and community partners in making proactive decisions about allowable adaptations to EBPs.