Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: Prespecified Analysis of the NUDGE-FLU Trial.

BACKGROUND: Influenza vaccines have been demonstrated to effectively reduce the incidence of influenza infection and potentially associated risks of cardiovascular events in patients with cardiovascular disease (CVD). Despite strong guideline and public health endorsements, global influenza vaccination rates in patients with CVD are highly variable. This prespecified analysis of NUDGE-FLU (Nationwide Utilization of Danish Government Electronic Letter System for Increasing Influenza Vaccine Uptake) examined the effect of digital behavioral nudges on influenza vaccine uptake based on the presence of CVD. METHODS: NUDGE-FLU was a randomized, pragmatic, nationwide, register-based trial that included Danish citizens 65 years of age or older during the 2022 to 2023 influenza season. Households were randomized in a 9:1:1:1:1:1:1:1:1:1 ratio to usual care or 9 electronic letters with designs based on behavioral concepts. Danish nationwide registers were used to collect baseline and outcome data. The primary end point was receipt of an influenza vaccine on or before January 1, 2023. The effects of the intervention letters were examined according to the presence of CVD and across cardiovascular subgroups that included heart failure, ischemic heart disease, and atrial fibrillation. RESULTS: Of 964 870 NUDGE-FLU participants from 691 820 households, 264 392 (27.4%) had CVD. During follow-up, 83.1% of participants with CVD versus 79.2% of participants without CVD received an influenza vaccination (P<0.001). Compared with usual care, a letter emphasizing the potential cardiovascular benefits of influenza vaccination increased vaccination rates; this effect was consistent in participants with CVD (absolute difference, +0.60 percentage points [99.55% CI, -0.48 to 1.68]) and without CVD (+0.98 percentage points [99.55% CI, 0.27-1.70; P for interaction=0.41). A repeated letter strategy with a reminder follow-up letter 14 days later was also effective in increasing influenza vaccination, irrespective of CVD (CVD: absolute difference, +0.80 percentage points [99.55% CI, -0.27 to 1.86]; no CVD: +0.67 percentage points [99.55% CI, -0.06 to 1.40]; P for interaction=0.77). Effectiveness of both nudging strategies was consistent across all major CVD subgroups. None of the other 7 nudging strategies were effective, regardless of CVD status. CONCLUSIONS: Electronic letter interventions emphasizing the potential cardiovascular benefits of influenza vaccination and using a reminder letter strategy were similarly beneficial in increasing influenza vaccination rates among older adults with and without CVD and across cardiovascular subgroups. Electronic nudges may improve influenza vaccine uptake in individuals with CVD. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT05542004.

National implementation trial of BeUpstanding™: an online initiative for workers to sit less and move more.

BACKGROUND: The online BeUpstanding™ program is an eight-week workplace-delivered intervention for desk-based workers to raise awareness of the benefits of sitting less and moving more and build a supportive culture for change. A workplace representative (the "champion") delivers the program, which includes a workshop where teams collectively choose their sit less/move more strategies. A toolkit provides the champion with a step-by-step guide and associated resources to support program uptake, delivery, and evaluation. Here we report on the main findings from the Australian national implementation trial of BeUpstanding. METHODS: Recruitment (12/06/2019 to 30/09/2021) was supported by five policy and practice partners, with desk-based work teams from across Australia targeted. Effectiveness was measured via a single arm, repeated-measures trial. Data were collected via online surveys, toolkit analytics, and telephone calls with champions. The RE-AIM framework guided evaluation, with adoption/reach (number and characteristics); effectiveness (primary: self-reported workplace sitting time); implementation (completion of core components; costs); and, maintenance intentions reported here. Linear mixed models, correcting for cluster, were used for effectiveness, with reach, adoption, implementation, and maintenance outcomes described. RESULTS: Of the 1640 website users who signed-up to BeUpstanding during the recruitment period, 233 were eligible, 198 (85%) provided preliminary consent, and 118 (50.6%) champions consented and started the trial, with 94% (n = 111 champions) completing. Trial participation was from across Australia and across industries, and reached 2,761 staff, with 2,248 participating in the staff survey(s): 65% female; 64% university educated; 17% from a non-English speaking background. The program effectively changed workplace sitting (-38.5 [95%CI -46.0 to -28.7] minutes/8-hour workday) and all outcomes targeted by BeUpstanding (behaviours and culture), with small-to-moderate statistically-significant effects observed. All participating teams (n = 94) completed at least 5/7 core steps; 72.4% completed all seven. Most champions spent $0 (72%) or >$0-$5 (10%) per team member; most (67/70 96%) intended to continue or repeat the program. CONCLUSIONS: BeUpstanding can be adopted and successfully implemented by a range of workplaces, reach a diversity of staff, and be effective at creating a supportive culture for teams of desk-based workers to sit less and move more. Learnings will inform optimisation of the program for longer-term sustainability. TRIAL REGISTRATION: ACTRN12617000682347.

Tracking modifications to implementation strategies: a case study from SNaP - a hybrid type III randomized controlled trial to scale up integrated systems navigation and psychosocial counseling for PWID with HIV in Vietnam.

INTRODUCTION: Evaluation of implementation strategies is core to implementation trials, but implementation strategies often deviate from the original plan to adjust to the real-world conditions. The optimal approach to track modifications to implementation strategies is unclear, especially in low-resource settings. Using data from an implementation trial for people who inject drugs (PWID) with HIV in Vietnam, we describe the tracking of implementation strategy modifications and present findings of this process. METHODS: SNaP (Systems Navigation and Psychosocial Counseling) is a hybrid type-III effectiveness-implementation randomized controlled trial aiming to scale up the evidence-based intervention, integrated systems navigation and psychosocial counseling, for PWID with HIV in Vietnam. Forty-two HIV testing sites were randomized 1:1 to a standard or tailored arm. While the standard arm (SA) received a uniform package of strategies, implementation strategies for the tailored arm (TA) were tailored to address specific needs of each site. The central research team also met monthly with the TA to document how their tailored strategies were implemented over time. Five components were involved in the tracking process: describing the planned strategies; tracking strategy use; monitoring barriers and solutions; describing modifications; and identifying and describing any additional strategies. RESULTS: Our approach allowed us to closely track the modifications to implementation strategies in the tailored arms every month. TA sites originally identified 27 implementation strategies prior to implementation. During implementation, five strategies were dropped by four sites and two new strategies were added to twelve sites. Modifications of five strategies occurred at four sites to accommodate their changing needs and resources. Difficulties related to the COVID-19 pandemic, low number of participants recruited, high workload at the clinic, lack of resources for HIV testing and high staff turnover were among barriers of implementing the strategies. A few challenges to tracking modifications were noted, including the considerable amount of time and efforts needed as well as the lack of motivation from site staff to track and keep written documentations of modifications. CONCLUSIONS: We demonstrated the feasibility of a systematic approach to tracking implementation strategies for a large-scale implementation trial in a low-resource setting. This process could be further enhanced and replicated in similar settings to balance the rigor and feasibility of implementation strategy tracking. Our findings can serve as additional guidelines for future researchers planning to report and track modifications to implementation strategies in large, complex trials. TRIAL REGISTRATION: clinicaltrials.gov ID: NCT03952520 (first posted 2019-05-16).

Optimising diagnosis and management of kidney disease: an implementation trial of a clinical decision support system future health today.

BACKGROUND: Chronic kidney disease affects more than 10% of the world's population and is a non-communicable disease of global concern and priority. There is a significant implementation gap between best practice guideline recommendations and current kidney disease management. Previous research has shown the need to partner with primary care to improve education, collaboration, and kidney disease awareness. This implementation trial will explore use of an innovative clinical decision support software, Future Health Today, to improve screening, diagnosis, and management of kidney disease in primary care. The program will be supported by tertiary care outreach services. The primary aim is to test the hypothesis that the Future Health Today implementation program will improve screening, diagnosis, and management of kidney disease. Secondary aims are to evaluate primary care satisfaction and broader health service impacts. METHODS: This pre-post implementation trial using an interrupted time series design will evaluate the clinical and service outcomes of Future Health Today, using a mixed methods study in twenty general practices with an estimated population size of 150,000. Deidentified patient data will be extracted from participating practices to examine the primary aims of the study. Surveys and semi-structured interviews with general practice will inform secondary hypotheses. Data linkage between primary care and tertiary care data will examine the broader health service impacts. DISCUSSION: This investigator driven trial will assess the impact of Future Health Today software coupled with education and clinical outreach support. Investigators hypothesise that there will be improvement in appropriate screening, diagnosis, and management of kidney disease. This program has the potential to be scaled more broadly. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry: ACTRN12623001096640.

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 .

Study protocol of an economic evaluation embedded in the Midwives and Obstetricians Helping Mothers to Quit Smoking (MOHMQuit) trial.

BACKGROUND: Tobacco smoking during pregnancy is the most important preventable risk factor for pregnancy complications and adverse birth outcomes and can have lifelong consequences for infants. Smoking during pregnancy is associated with higher healthcare costs related to birth complications and during childhood. Psychosocial interventions to support pregnant women to quit are effective, yet provision of smoking cessation support has been inconsistent. The Midwives and Obstetricians Helping Mothers to Quit Smoking (MOHMQuit) intervention provides systems change, and leadership and clinician elements, to support clinicians to help women stop smoking in pregnancy. There have been few long-term analyses conducted of the cost-effectiveness of smoking cessation interventions for pregnant women that target healthcare providers. This protocol describes the economic evaluation of the MOHMQuit trial, a pragmatic stepped-wedge cluster-randomised controlled implementation trial in nine public maternity services in New South Wales (NSW), Australia, to ascertain whether MOHMQuit is cost-effective in supporting clinicians to help women quit smoking in pregnancy compared to usual care. METHODS: Two primary analyses will be carried out comparing MOHMQuit with usual care from an Australian health care system perspective: i) a within-trial cost-effectiveness analysis with results presented as the incremental cost per additional quitter; and ii) a lifetime cost-utility analysis using a published probabilistic decision analytic Markov model with results presented as incremental cost per quality-adjusted life-year (QALY) gained for mother and child. Patient-level data on resource use and outcomes will be used in the within-trial analysis and extrapolated and supplemented with national population statistics and published data from the literature for the lifetime analysis. DISCUSSION: There is increasing demand for information on the cost-effectiveness of implementing healthcare interventions to provide policy makers with critical information for the best value for money within finite budgets. Economic evaluation of the MOHMQuit trial will provide essential, policy-relevant information for decision makers on the value of evidence-based implementation of support for healthcare providers delivering services for pregnant women. TRIAL REGISTRATIONS: ACTRN12622000167763, registered 2 February 2022.

The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for older adults with diabetes and multiple chronic conditions: study protocol for a randomized controlled trial.

BACKGROUND: Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers. METHODS: We will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential. DISCUSSION: An interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP. TRIAL REGISTRATION: Clinical Trials.gov Identifier NCT03664583 . Registration date: September 10, 2018.

A randomised controlled trial of an implementation strategy delivered at scale to increase outdoor free play opportunities in early childhood education and care (ECEC) services: a study protocol for the get outside get active (GOGA) trial.

BACKGROUND: Increased outdoor play time in young children is associated with many health and developmental benefits. This study aims to evaluate the impact of a multi-strategy implementation strategy delivered at scale, to increase opportunities for outdoor free play in Early Childhood Education and Care (ECEC) services. METHODS: The study will employ a parallel-group randomised controlled trial design. One hundred ECEC services in the Hunter New England region of New South Wales, Australia, will be recruited and randomised to receive either a 6-month implementation strategy or usual care. The trial will seek to increase the implementation of an indoor-outdoor routine (whereby children are allowed to move freely between indoor and outdoor spaces during periods of free play), to increase their opportunity to engage in outdoor free play. Development of the strategy was informed by the Behaviour Change Wheel to address determinants identified in the Theoretical Domains Framework. ECEC services allocated to the control group will receive 'usual' implementation support delivered as part of state-wide obesity prevention programs. The primary trial outcome is the mean minutes/day (calculated across 5 consecutive days) of outdoor free play opportunities provided in ECEC services measured at baseline, 6-months (primary end point) and 18-months post baseline. Analyses will be performed using an intention-to-treat approach with ECEC services as the unit of analysis, using a linear mixed effects regression model to assess between-group differences. A sensitivity analysis will be undertaken, adjusting for service characteristics that appear imbalanced between groups at baseline, and a subgroup analysis examining potential intervention effect among services with the lowest baseline outdoor free play opportunities. DISCUSSION: Identifying effective strategies to support the implementation of indoor-outdoor routines in the ECEC setting at scale is essential to improve child population health. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12621000987864 ). Prospectively registered 27th July 2021, ANZCTR - Registration.

Baseline representativeness of patients in clinics enrolled in the PRimary care Opioid Use Disorders treatment (PROUD) trial: comparison of trial and non-trial clinics in the same health systems.

BACKGROUND: Pragmatic primary care trials aim to test interventions in "real world" health care settings, but clinics willing and able to participate in trials may not be representative of typical clinics. This analysis compared patients in participating and non-participating clinics from the same health systems at baseline in the PRimary care Opioid Use Disorders treatment (PROUD) trial. METHODS: This observational analysis relied on secondary electronic health record and administrative claims data in 5 of 6 health systems in the PROUD trial. The sample included patients 16-90 years at an eligible primary care visit in the 3 years before randomization. Each system contributed 2 randomized PROUD trial clinics and 4 similarly sized non-trial clinics. We summarized patient characteristics in trial and non-trial clinics in the 2 years before randomization ("baseline"). Using mixed-effect regression models, we compared trial and non-trial clinics on a baseline measure of the primary trial outcome (clinic-level patient-years of opioid use disorder (OUD) treatment, scaled per 10,000 primary care patients seen) and a baseline measure of the secondary trial outcome (patient-level days of acute care utilization among patients with OUD). RESULTS: Patients were generally similar between the 10 trial clinics (n = 248,436) and 20 non-trial clinics (n = 341,130), although trial clinics' patients were slightly younger, more likely to be Hispanic/Latinx, less likely to be white, more likely to have Medicaid/subsidized insurance, and lived in less wealthy neighborhoods. Baseline outcomes did not differ between trial and non-trial clinics: trial clinics had 1.0 more patient-year of OUD treatment per 10,000 patients (95% CI: - 2.9, 5.0) and a 4% higher rate of days of acute care utilization than non-trial clinics (rate ratio: 1.04; 95% CI: 0.76, 1.42). CONCLUSIONS: trial clinics and non-trial clinics were similar regarding most measured patient characteristics, and no differences were observed in baseline measures of trial primary and secondary outcomes. These findings suggest trial clinics were representative of comparably sized clinics within the same health systems. Although results do not reflect generalizability more broadly, this study illustrates an approach to assess representativeness of clinics in future pragmatic primary care trials.

Wireless versus routine physiologic monitoring after cesarean delivery to reduce maternal morbidity and mortality in a resource-limited setting: protocol of type 2 hybrid effectiveness-implementation study.

BACKGROUND: Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth globally. Despite increases in facility-based childbirth, gaps in quality of care at facilities have limited reductions in maternal deaths. Infrequent physiologic monitoring of women around childbirth is a major gap in care that leads to delays in life-saving interventions for women experiencing complications. METHODS: We will conduct a type-2 hybrid effectiveness-implementation study over 12 months to evaluate using a wireless physiologic monitoring system to detect and alert clinicians of abnormal vital signs in women for 24 h after undergoing emergency cesarean delivery at a tertiary care facility in Uganda. We will provide physiologic data (heart rate, respiratory rate, temperature and blood pressure) to clinicians via a smartphone-based application with alert notifications if monitored women develop predefined abnormalities in monitored physiologic signs. We will alternate two-week intervention and control time periods where women and clinicians use the wireless monitoring system during intervention periods and current standard of care (i.e., manual vital sign measurement when clinically indicated) during control periods. Our primary outcome for effectiveness is a composite of severe maternal outcomes per World Health Organization criteria (e.g. death, cardiac arrest, jaundice, shock, prolonged unconsciousness, paralysis, hysterectomy). Secondary outcomes include maternal mortality rate, and case fatality rates for postpartum hemorrhage, hypertensive disorders, and sepsis. We will use the RE-AIM implementation framework to measure implementation metrics of the wireless physiologic system including Reach (proportion of eligible women monitored, length of time women monitored), Efficacy (proportion of women with monitoring according to Uganda Ministry of Health guidelines, number of appropriate alerts sent), Adoption (proportion of clinicians utilizing physiologic data per shift, clinical actions in response to alerts), Implementation (fidelity to monitoring protocol), Maintenance (sustainability of implementation over time). We will also perform in-depth qualitative interviews with up to 30 women and 30 clinicians participating in the study. DISCUSSION: This is the first hybrid-effectiveness study of wireless physiologic monitoring in an obstetric population. This study offers insights into use of wireless monitoring systems in low resource-settings, as well as normal and abnormal physiologic parameters among women delivering by cesarean. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04060667 . Registered on 08/01/2019.

Considering treatment-as-prevention scale-up for Australian prisons: a qualitative sub-study of expert stakeholders from the Australian 'surveillance and treatment of prisoners with hepatitis C' project (SToP-C).

BACKGROUND: With direct-acting antivirals dramatically reshaping the public health response to the hepatitis C virus (HCV), prisons are set to play a critical role in elimination efforts. Despite the theoretical demonstration of HCV treatment-as-prevention in prison in mathematical modeling, limited empirical data exist. The Australian 'Surveillance and Treatment of Prisoners with Hepatitis C' project (SToP-C) is the world's first trial of HCV treatment-as-prevention in prison. Drawing on interviews with HCV expert stakeholders, this paper explores the factors respondents identified as crucial to the success of future scale-up. Accounting for such perspectives matters because of the influence expert discourse has in shaping implementation. METHODS: Semi-structured interviews were conducted with nineteen HCV experts working across key policy, advocacy, research and clinical dimensions of the Australian HCV response. Data were coded using qualitative data management software (NVivo 11). Analysis proceeded via a hybrid deductive and inductive approach. RESULTS: Notwithstanding concerns regarding the lack of primary prevention in Australian prisons, stakeholders reported broad levels of support for the intervention and for the future scale-up of HCV treatment. A number of considerations, both external and internal to the prison system, were identified as key. The principal external factor was an enabling political-cum-policy environment; internal factors included: obtaining support from prisons' executive and custodial staff; promoting health within a security-first institutional culture; allocating time for treatment within prisoners' tightly regulated schedules; ensuring institutional stability during treatment given the routine movement of prisoners between prisons; prioritizing the availability of retreatment given the paucity of primary prevention; and securing sufficient clinical space for treatment. CONCLUSION: The challenges to implementation are considerable, ranging from macrolevel concerns to in-prison logistical matters. Nonetheless, we argue that prisons remain an obvious setting for treatment scale-up, not only for prevention and potential elimination benefit, but for the treatment opportunities they afford a socially disadvantaged and underserved population. While noting widespread concerns among respondents regarding the paucity of primary prevention in Australian prisons, results indicate broad levels of support among expert stakeholders for HCV treatment scale-up in prison.

Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial.

BACKGROUND: Older adults (> 65 years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home. Care transitions for this population are often poorly coordinated and fragmented, resulting in increased readmission rates, adverse medical events, decreased patient satisfaction and safety, and increased caregiver burden. There is a dearth of evidence on best practices in the provision of transitional care for older adults with MCC and depressive symptoms transitioning from hospital-to-home. This paper presents a protocol for a two-armed, multi-site pragmatic effectiveness-implementation trial of Community Assets Supporting Transitions (CAST), an evidence-informed nurse-led six-month intervention that supports older adults with MCC and depressive symptoms transitioning from hospital-to-home. The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities. METHODS: Participants will be considered eligible if they are > 65 years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms. A total of 216 eligible and consenting participants will be randomly assigned to the control (usual care) or intervention (CAST) arm. The intervention consists of tailored care delivery comprising in-home visits, telephone follow-up and system navigation support. The primary measure of effectiveness is mental health functioning of the older adult participant. Secondary outcomes include changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months. Caregivers will be assessed for caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs. Descriptive and qualitative data from older adult and caregiver participants, and the nurse interventionists will be used to examine implementation of the intervention, how the intervention is adapted within each study region, and its potential for sustainability and scalability to other jurisdictions. DISCUSSION: A nurse-led transitional care strategy may provide a feasible and effective means for improving health outcomes and patient/caregiver experience and reduce service use and costs in this vulnerable population. TRIAL REGISTRATION: # NCT03157999 . Registration Date: April 4, 2017.

Trial implementation of CIRCuiTS cognitive remediation therapy for people with schizophrenia in Orange, New South Wales.

OBJECTIVE: Many people with schizophrenia experience cognitive impairments and current practice guidelines recommend cognitive remediation therapy. This implementation trial examined aspects of feasibility, acceptability and outcomes of the computerised interactive remediation of cognition-interactive training for schizophrenia cognitive remediation therapy program in our local context. DESIGN: A longitudinal design was utilised with participants providing outcome data at commencement of the computerised interactive remediation of cognition-interactive training for schizophrenia program, completion and at follow-up 3 months later. SETTING: Our trial was conducted in the inpatient and community mental health contexts within the New South Wales regional city of Orange, between January 2017 and December 2018. PARTICIPANTS: Fifty-three adult volunteers commenced the computerised interactive remediation of cognition-interactive training for schizophrenia program and participated in this trial. Forty-five participants were currently admitted to psychiatric rehabilitation inpatient units at Bloomfield hospital, and eight were referred by Orange Community Mental Health Service. MAIN OUTCOME MEASURE(S): Participants completed measures of cognitive functioning (repeatable battery for the assessment of neuropsychological status), functional independence (Adaptive Behaviour Assessment Scales 3) and Goal attainment scaling. RESULTS: Most participants reported they liked computerised interactive remediation of cognition-interactive training for schizophrenia therapy and made excellent progress towards their goals. Those who completed the program made significant gains in the domains of attention, memory and independence in key aspects of daily living. Gains in functional independence were sustained for a small sample following program completion. CONCLUSION: This implementation trial showed the computerised interactive remediation of cognition-interactive training for schizophrenia cognitive remediation therapy program was feasible, acceptable and contributed to strong outcomes in both the inpatient and community contexts. Efforts are in progress to translate the computerised interactive remediation of cognition-interactive training for schizophrenia program, and future research will focus on longer term outcomes, cost-benefit analyses and the experiences of participants and therapists.

An Overview of Research and Evaluation Designs for Dissemination and Implementation.

The wide variety of dissemination and implementation designs now being used to evaluate and improve health systems and outcomes warrants review of the scope, features, and limitations of these designs. This article is one product of a design workgroup that was formed in 2013 by the National Institutes of Health to address dissemination and implementation research, and whose members represented diverse methodologic backgrounds, content focus areas, and health sectors. These experts integrated their collective knowledge on dissemination and implementation designs with searches of published evaluations strategies. This article emphasizes randomized and nonrandomized designs for the traditional translational research continuum or pipeline, which builds on existing efficacy and effectiveness trials to examine how one or more evidence-based clinical/prevention interventions are adopted, scaled up, and sustained in community or service delivery systems. We also mention other designs, including hybrid designs that combine effectiveness and implementation research, quality improvement designs for local knowledge, and designs that use simulation modeling.

Protocol for the home hazards removal program (HARP) study: a pragmatic, randomized clinical trial and implementation study.

BACKGROUND: Falls remain the leading cause of injury, long-term disability, premature institutionalization, and injury-related mortality in the older adult population. Home modifications, when delivered by occupational therapists, can reduce falls among high-risk community-dwelling older adults by 39%. However, home-modification implementation is not standard practice in the United States. The goal of the Home Hazard Removal Program (HARP) study is to implement an evidence-based home modification intervention for older adults designed to reduce the incidence of falls through an aging services network. METHODS: We will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who are randomized and followed for 12 months. Participants who are randomized to treatment will receive the home modification intervention provided by an occupational therapist in addition to usual care, defined as continued services from the area agency on aging. We will compare the effectiveness of the program and usual care using survival analysis with the time to the first fall over 12 months as the primary outcome of interest. Secondary outcomes include daily activity performance, fall self-efficacy, and health-related quality of life. Fidelity, dose, adherence, safety, cost, and health care utilization will also be examined in the implementation component of this study. DISCUSSION: This intervention targets an underserved, difficult to reach population of older adults. The tailored approach of the study intervention is a strength in improving adherence, as each recommendation is individualized to be acceptable to the participant. The effectiveness/implementation design of the study allows for rapid dissemination of results and implementation of the intervention in a United States social services agency. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02392013 . Retrospectively registered on March 5, 2015.

Does an outreaching stepped care program reduce depressive symptoms in community-dwelling older adults? A randomized implementation trial.

OBJECTIVES: To examine the effects of an outreaching stepped care intervention program (Lust for Life) compared with usual care on depressive symptoms in older adults living in the community. DESIGN: Randomized clinical implementation trial. SETTING: 18 general practices and a home care organization in the Netherlands. PARTICIPANTS: 263 community-dwelling 65+-year-olds with depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9). INTERVENTION: After three months of watchful waiting, participants could sequentially choose between the following evidence-based interventions: 1) guided self-help or an exercise program, 2) problem solving treatment or life review, and 3) a referral to their general practitioner. MEASUREMENTS: The outcome measure was depression severity (PHQ-9), measured every three months over 2 years. RESULTS: After the provision of the stepped care program, a significant short-term positive effect on depressive symptoms was found in the first three months after implementation, in which average PHQ-9 scores dropped from 9.34 (SE: 0.61, 95% CI: 8.14-10.5) to 7.83 (SE: 0.51, 95% CI: 6.84-8.81). CONCLUSIONS: The Lust for Life program has a promising potential to relieve depressive symptoms of older adults in primary care in the short term. Providing one single clinical intervention in accordance with participants' choices instead of stepped care could be sufficient.

Effect and Process Evaluation of an Intervention to Improve Hand Hygiene Compliance in Long-Term Care Facilities.

OBJECTIVES: This study evaluated the effect of a tailored, multifaceted improvement strategy on hand hygiene compliance in long-term care facilities (LTCFs). We also performed a process evaluation to explore the mechanisms through which our strategy brought about change. DESIGN: We conducted a stepped-wedge cluster-randomized controlled trial with a sequential rollout of the improvement strategy to all participating LTCFs. The strategy consisted of education, training, reminders, observation sessions (including feedback), and team meetings (including feedback). SETTING AND PARTICIPANTS: The study included nursing professionals from 14 LTCFs (23 wards) in the Netherlands. METHODS: Hand hygiene compliance was observed during 5 measurement periods using WHO's "Five Moments for Hand Hygiene." Multilevel analyses and corresponding tests were completed on an intention-to-treat basis. RESULTS: The absolute intervention effect of overall hand hygiene compliance (primary outcome measure) was 13% (95% CI 9.3-16.7, P < .001), adjusted for time and clustering. The adjusted absolute effect was 23% (95% CI 7-39, P < .002) before a clean and aseptic procedure, 18% (95% CI 10-26, P < .001) after touching a resident, 14% (95% CI 7-22, P < .003) before touching a resident, 10% (95% CI 5-15, P < .001) after contact with body fluid, and 1% (95% CI -11 to 13, P = .8) after touching a resident's surroundings. With the exception of leadership, participants at LTCFs with more exposure to the intervention components showed statistically significantly more improvement than those at facilities with lower exposure scores. CONCLUSIONS AND IMPLICATIONS: Our strategy was successful in improving hand hygiene compliance. LTCFs with more team members exposed to the different intervention components, demonstrated a greater effect from the intervention. To strengthen the impact of our intervention, we recommend that future improvement strategies provide more support to managers to ensure they are better equipped to take on their leadership roles and enable their teams to improve and maintain hand hygiene compliance.

Opportunities to Advance Equity Through Implementation Strategy Design.

Background: Implementation strategies are potential tools for advancing equity goals in healthcare. Implementation scientists have increased attention to the integration of equity considerations into implementation research, but limited concrete guidance is available for developing implementation strategies to improve equity. Main: In parallel to an active hybrid effectiveness-implementation trial in two large health systems, our research team explored potential inequities in implementation across four non-study clinics, developed equity focused audit and feedback procedures, examined the feasibility of our approach, and identified design insights that could be tested in future work to inform equitable program scale-up. Based on our experiences deploying these strategies in pilot format, our research team identified key complexities meriting further examination in future work. These considerations are vital given the dearth of guidance on delivering feedback to clinicians in efforts to improve equity. Key takeaways include the importance of understanding local data culture, engaging constituents in co-design for the full feedback cycle, leveraging feedback for shared discourse, and centering multi-level strategies as part of robust implementation approaches. Conclusion: Prioritizing health equity in implementation science requires that research teams probe, interrogate, and innovate - and in doing so, grapple with central conceptual and pragmatic considerations that arise in the design of implementation strategies. Our work emphasizes the value of bidirectional and continuous learning.

Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): Study Protocol for a National Implementation Trial.

Background: Globally, women 15-24 years are at heightened risk of sexual violence victimization, a risk factor for adverse mental, physical, and behavioral health outcomes. Sexual violence is common at universities and most often perpetrated by men, yet few evidence-based prevention strategies targeting men have been tested in low- and middle-income countries. GlobalConsent is a six-module, web-based educational program adapted from an efficacious U.S.-based program. Nine months post-treatment in a randomized trial in Vietnam, GlobalConsent reduced men's sexually violent behavior (Odds Ratio [OR] = 0.71, 95%CI 0.50-1.00) and increased prosocial intervening behavior (OR = 1.51, 1.00-2.28) relative to an attention-control. Evidence regarding optimal implementation strategies for scale up is needed. Methods: We will randomize six medical universities in North, Central, and South Vietnam to deliver GlobalConsent using two different packages of implementation strategies that vary in intensity. Higher-intensity strategies will include greater 1) pre- and post-implementation engagement with university leaders and faculty, and 2) greater pre-implementation outreach, follow-up, and incentives for students to promote engagement and completion of GlobalConsent. Higher intensity universities will receive additional training and support for their added activities. We will compare implementation drivers and outcomes, intervention effectiveness, and cost-effectiveness across the two implementation bundles. Our mixed-methods comparative interrupted time-series design includes 1) qualitative interviews and quantitative surveys with university leaders and implementation teams to assess implementation barriers and facilitators; 2) repeated surveys with leaders and faculty, implementation teams, and male students to assess multilevel implementation drivers and outcomes, 3) repeated surveys with male students to assess behavioral outcomes (sexual violence and intervening behavior) and mediating variables (knowledge, attitudes, affect, and capacities), and 4) time diaries and cost tracking to assess cost effectiveness of the two implementation-strategies bundles. Discussion: This project is the first to assess packages of implementation strategies to deliver an efficacious web-based sexual-violence-prevention program for undergraduate men across all regions of Vietnam and synergizes with a violence-prevention training initiative (D43TW012188). This approach will produce rigorous evidence about how to disseminate GlobalConsent nationally, which holds promise to reduce gender-based health inequities linked to sexual violence as GlobalConsent is brought to scale. Trial registration: NCT06443541. Retrospectively registered with clinicaltrials.gov.

Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial.

BACKGROUND: Patients with opioid use disorder (OUD) have increased emergency and hospital utilization. The PROUD trial showed that implementation of office-based addiction treatment (OBAT) increased OUD medication treatment compared to usual care, but did not decrease acute care utilization in patients with OUD documented pre-randomization (clinicaltrials.gov/study/NCT03407638). This paper reports secondary emergency and hospital utilization outcomes in patients with documented OUD in the PROUD trial. METHODS: This cluster-randomized implementation trial was conducted in 12 clinics from 6 diverse health systems (March 2015-February 2020). Patients who visited trial clinics and had an OUD diagnosis within 3 years pre-randomization were included in primary analyses; secondary analyses added patients with OUD who were new to the clinic or with newly-documented OUD post-randomization. Outcomes included days of emergency care and hospital utilization over 2 years post-randomization. Explanatory outcomes included measures of OUD treatment. Patient-level analyses used mixed-effect regression with clinic-specific random intercepts. RESULTS: Among 1988 patients with documented OUD seen pre-randomization (mean age 49, 53 % female), days of emergency care or hospitalization did not differ between intervention and usual care; OUD treatment also did not differ. In secondary analyses among 1347 patients with OUD post-randomization, there remained no difference in emergency or hospital utilization despite intervention patients receiving 32.2 (95 % CI 4.7, 59.7) more days of OUD treatment relative to usual care. CONCLUSIONS: Implementation of OBAT did not reduce emergency or hospital utilization among patients with OUD, even in the sample with OUD first documented post-randomization in whom the intervention increased treatment.