Randomized Implementation Trial Research Articles

Nurse Care Management of Opioid Use Disorder Treatment After 3 Years

The Primary Care Opioid Use Disorders (PROUD) treatment trial was a 2-year implementation trial that demonstrated the Massachusetts office-based addiction treatment (OBAT) model of nurse care management for opioid use disorder (OUD) increased OUD treatment in the 2 years after implementation began (8.2 more patient-years of OUD treatment per 10 000 primary care patients). The intervention was continued for a third year, permitting evaluation of 3-year outcomes. To compare OUD medication treatment in intervention and usual care clinics over 3 years of implementation. This is a preplanned secondary analysis of a cluster randomized implementation trial, conducted in 6 health systems in 5 states (2 primary care clinics per health system) with clinic randomization stratified by system (assignment notification February 28, 2018 [August 31, 2018, in 1 system]). Data were obtained from electronic health records and insurance claims. Eligible patients were those aged 16 to 90 years visiting intervention or usual care clinics from 3 years before to 2 years after randomization. Patients new to clinics during the third year after randomization could not be included because COVID-19-era transitions to virtual care precluded assignment of patients to clinics. Data analysis occurred from November 2023 to September 2024. Clinics were randomized to intervention or care as usual. Intervention included 3 implementation components: salary for 1 full-time OBAT nurse per intervention clinic; training and ongoing technical assistance for nurses; and 3 or more primary care buprenorphine prescribers. Patient-years of OUD treatment (buprenorphine or extended-release naltrexone) per 10 000 primary care patients in the 3 years postrandomization. Mixed-effect models adjusted for baseline values of the outcome and included a health system-specific random intercept to account for correlation of clinic pairs within a system. Prerandomization, a total of 290 071 primary care patients were seen, including 130 618 in intervention clinics (mean [SD] age, 48.6 [17.7] years; mean [SD] female, 59.3% [4.0%]) and 159 453 in usual care clinics (mean [SD] age, 47.2 [17.5] years; mean [SD] female, 64.0% [5.3%]). Over 3 years postrandomization, intervention clinics provided 19.7 (95% CI, 11.1-28.4) more patient-years of OUD treatment per 10 000 primary care patients compared with usual care clinics. In this secondary analysis of the PROUD cluster randomized trial, after an added year of the intervention, OUD treatment continued to increase in intervention clinics compared with usual care. The treatment increase over 3 years exceeded that of the first 2 years, suggesting that implementation of the Massachusetts OBAT model leads to ongoing increases in OUD treatment among primary care patients in the third year of implementation. ClinicalTrials.gov Identifier: NCT03407638.

Electronic Nudges to Increase Influenza Vaccination in Patients With Chronic Diseases

Despite strong worldwide guideline recommendations, influenza vaccination rates remain suboptimal among young and middle-aged patients with chronic diseases. Effective scalable strategies to increase vaccination are needed. To investigate whether electronically delivered letter-based nudges informed by behavioral science could increase influenza vaccination uptake among patients aged 18 to 64 years with chronic diseases. Nationwide pragmatic registry-based randomized clinical implementation trial conducted between September 24, 2023, and May 31, 2024, enrolling all Danish citizens aged 18 to 64 years who met criteria for free-of-charge influenza vaccination in light of preexisting chronic disease. All trial data were sourced from nationwide administrative health registries. Randomized in 2.45:1:1:1:1:1:1 ratio to no letter (usual care) or 6 different behaviorally informed electronic letters. The primary end point was receipt of influenza vaccination on or before January 1, 2024, assessed in 7 prespecified coprimary comparisons (all intervention groups pooled vs usual care and each individual intervention group vs usual care). Absolute risk difference in proportions and a crude relative risk were calculated for each comparison. A total of 299 881 participants (53.2% [159 454] female, median age, 52.0 [IQR, 39.8-59.0] years) were randomized. Compared with usual care, influenza vaccination rates were higher among those receiving any intervention letter (any intervention letter, 39.6% vs usual care, 27.9%; difference, 11.7 percentage points; 99.29% CI, 11.2-12.2 percentage points; P < .001). Each individual letter type significantly increased influenza vaccination with the largest effect sizes observed with a repeated letter sent 10 days after the initial letter (repeated letter, 41.8% vs usual care, 27.9%; difference, 13.9 percentage points; 99.29% CI, 13.1-14.7 percentage points; P < .001) and a letter emphasizing potential cardiovascular benefits of vaccination (cardiovascular gain, 39.8% vs usual care, 27.9%; difference, 11.9 percentage points; 99.29% CI, 11.1-12.7 percentage points; P < .001). Vaccination rates were improved across major subgroups. In a nationwide randomized clinical implementation trial, electronically delivered letter-based nudges markedly increased influenza vaccination compared with usual care among young and middle-aged patients with chronic diseases. The results of this study suggest that simple, scalable, and cost-efficient electronic letter strategies may have substantial public health implications. ClinicalTrials.gov Identifier: NCT06030739.

Effectiveness of Integrating Suicide Care in Primary Care : Secondary Analysis of a Stepped-Wedge, Cluster Randomized Implementation Trial.

Primary care encounters are common among patients at risk for suicide. To evaluate the effectiveness of implementing population-based suicide care (SC) in primary care for suicide attempt prevention. Secondary analysis of a stepped-wedge, cluster randomized implementation trial. (ClinicalTrials.gov: NCT02675777). 19 primary care practices within a large health care system in Washington State, randomly assigned launch dates. Adult patients (aged ≥18 years) with primary care visits from January 2015 to July 2018. Practice facilitators, electronic medical record (EMR) clinical decision support, and performance monitoring supported implementation of depression screening, suicide risk assessment, and safety planning. Clinical practice and patient measures relied on EMR and insurance claims data to compare usual care (UC) and SC periods. Primary outcomes included documented safety planning after population-based screening and suicide risk assessment and suicide attempts or deaths (with self-harm intent) within 90 days of a visit. Mixed-effects logistic models regressed binary outcome indicators on UC versus SC, adjusted for randomization stratification and calendar time, accounting for repeated outcomes from the same site. Monthly outcome rates (percentage per 10 000 patients) were estimated by applying marginal standardization. During UC, 255 789 patients made 953 402 primary care visits and 228 255 patients made 615 511 visits during the SC period. The rate of safety planning was higher in the SC group than in the UC group (38.3 vs. 32.8 per 10 000 patients; rate difference, 5.5 [95% CI, 2.3 to 8.7]). Suicide attempts within 90 days were lower in the SC group than in the UC group (4.5 vs. 6.0 per 10 000 patients; rate difference, -1.5 [CI, -2.6 to -0.4]). Suicide care was implemented in combination with care for depression and substance use. Implementation of population-based SC concurrent with a substance use program resulted in a 25% reduction in the suicide attempt rate in the 90 days after primary care visits. National Institute of Mental Health.

Electronic nudges for sustained influenza vaccination uptake in older adults: the nationwide randomized NUDGE-FLU-2 trial.

Digital letter interventions have proven effective in increasing influenza vaccination rates. In this trial, we sought to further refine these strategies and investigated whether the effectiveness of the strategies could be sustained across consecutive influenza seasons. We enrolled all eligible Danish citizens 65 years of age or older in a nationwide registry-based randomized implementation trial during the 2023-2024 influenza season. Households of participants were randomly assigned in a 2.45:1:1:1:1:1:1 ratio to usual care or six different behaviorally informed electronic letter-based nudges delivered before the influenza vaccination period. The primary endpoint was receipt of influenza vaccination. Statistical analyses accounted for household-level clustering. A total of 881,373 participants (mean age 74.1 ± 6.5 years, 52.1% female) were randomized across 649,487 households. The primary endpoint was met; influenza vaccination rates were higher in the pooled intervention letter group compared to usual care (76.32% versus 76.02%; difference, 0.31 percentage points; 99.29% confidence interval, 0.00-0.61; P = 0.007). Although no individual letter significantly increased influenza vaccination rates, the directionality of effect was consistent across all letters. Effectiveness was particularly pronounced in participants who had not received influenza vaccination during the preceding season (Pinteraction = 0.010). Effectiveness was consistent regardless of whether participants had received a similar electronic letter-based nudge in the preceding season (Pinteraction = 0.26). In summary, electronic letter-based nudges successfully increased influenza vaccination among older adults, and our results suggest that these highly scalable strategies can be implemented effectively and safely across consecutive vaccination seasons.ClinicalTrials.gov registration: NCT06030726 .

Interactive assistance via eHealth for small- and medium-sized enterprises’ employer and health care manager teams on tobacco control (eSMART-TC): A cluster randomized hybrid type II trial (N-EQUITY2101/J-SUPPORT2102).

10606 Background: Organizational commitment and consistent leadership are crucial to facilitate implementation of workplace wellness programs. We aimed to investigate whether interactive assistance for SME managers to implement tobacco control programs (compared with usual practice) would increase 6-month abstinence rates in tobacco-smoking employees. Methods: This hybrid type II cluster randomized effectiveness implementation trial was done in Japan. SMEs in the intervention group received interactive assistance to employers and health managers for 6 months by supporting employees through campaigns, tailored ongoing facilitation, and ensuring executive engagement and support, aiming to promote utilization of reimbursed smoking cessation treatments and implement smoke-free workplaces. SMEs in the control group received feedback on the results of the baseline survey and information on smoking cessation measures. Stratified randomization was used to allocate SMEs to either group. The primary outcome was salivary cotinine-validated 7-day point-prevalence abstinence rate at 6 months, and the key secondary outcome was the adoption score of the two recommended measures (promote smoking cessation standard treatment visits, and smoke-free policy) at each SME at 6 months (range: 0–2). Other secondary outcomes included implementation and process outcomes (e.g., proportion of smoking cessation treatment use). Results: Between July 1, 2021, and May 16, 2022, 38 SMEs enrolled. Twenty SMEs were randomly assigned to the intervention group and 18 SMEs to the control group. Among 2,929 employees enrolled, 2,556 responded the baseline survey (response rate: 87.3%; men 65.0%; mean age 44.8 years) and 713 of them (27.9%) indicated being a current smoker in the baseline. Then 176 (6.9%) were omitted because of missing primary outcome data (mainly owing to not responding, turnover, resignation, or retirement); therefore, 537 participants (21.0%) were included in the intention-to-treat based analyses of the primary outcome. At 6 months, the validated 7-day point-prevalence abstinence rate in the intervention group was significantly higher than that in the control group (11.2% vs 4.6%; difference = 6.6%, 95% confidence interval: 2.2%–11.1%, p=0.004). Regarding the analysis for key secondary outcomes, all randomized SMEs were included. At 6 months, adoption score of the two recommended measures was also significantly higher than that in the control group (1.5 vs 1.1; difference = 0.4, 95% confidence interval: 0.01–0.86, p=0.047). Conclusions: Interactive support for SME managers to implement tobacco control measures (compared with usual practice) can accelerate the implementation of evidence-based smoking cessation measures and significantly increase 6-month abstinence rates. Clinical trial information: UMIN000044526.

Clinical Outcomes With Electronic Nudges to Increase Influenza Vaccination : A Prespecified Analysis of a Nationwide, Pragmatic, Registry-Based, Randomized Implementation Trial.

In the NUDGE-FLU (Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake) trial, electronic letters incorporating cardiovascular (CV) gain-framing and repeated messaging increased influenza vaccination by approximately 1 percentage point. To evaluate the effects of the successful nudging interventions on downstream clinical outcomes. Prespecified exploratory analysis of a nationwide randomized implementation trial. (ClinicalTrials.gov: NCT05542004). The 2022 to 2023 influenza season. 964 870 Danish citizens aged 65 years or older. Usual care or 9 different electronically delivered behavioral nudging letters. Cardiovascular, respiratory, and other clinical end points during follow-up from intervention delivery (16 September 2022) through 31 May 2023. The analysis set included 691 820 participants. Hospitalization for pneumonia or influenza occurred in 3354 of 346 327 (1.0%) participants in the usual care group, 396 of 38 586 (1.0%) in the CV gain-framing group (hazard ratio [HR], 1.06 [95% CI, 0.95 to 1.18]; versus usual care), and 403 of 38 231 (1.1%) in the repeated letter group (HR, 1.09 [CI, 0.98 to 1.21]; versus usual care). In the usual care group, 44 682 (12.9%) participants were hospitalized for any cause, compared with 5002 (13.0%) in the CV gain-framing group (HR, 1.00 [CI, 0.97 to 1.03]; versus usual care) and 4965 (13.0%) in the repeated letter group (HR, 1.01 [CI, 0.98 to 1.04]; versus usual care). A total of 6341 (1.8%) participants died in the usual care group, compared with 721 (1.9%) in the CV gain-framing group (HR, 1.02 [CI, 0.94 to 1.10]; versus usual care) and 646 (1.7%) in the repeated letter group (HR, 0.92 [CI, 0.85 to 1.00]; versus usual care). Prespecified but exploratory analysis, potential misclassification of events in routinely collected registry data, and results may not be generalizable to other health systems or countries with other racial compositions and/or cultural or societal norms. In a prespecified exploratory analysis, modest increases in influenza vaccination rates seen with electronic nudges did not translate into observable improvements in clinical outcomes. Seasonal influenza vaccination should remain strongly recommended. Sanofi.

Increasing the uptake of Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) through seasonal malaria chemoprevention channel delivery: protocol of a multicenter cluster randomized implementation trial in Mali and Burkina Faso

BackgroundThe uptake of Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) remains unacceptably low, with more than two-thirds of pregnant women in sub-Saharan Africa still not accessing the three or more doses recommended by the World Health Organisation (WHO). In contrast, the coverage of Seasonal Malaria Chemoprevention (SMC), a more recent strategy recommended by the WHO for malaria prevention in children under five years living in Sahelian countries with seasonal transmission, including Mali and Burkina-Faso, is high (up to 90%). We hypothesized that IPTp-SP delivery to pregnant women through SMC alongside antenatal care (ANC) will increase IPTp-SP coverage, boost ANC attendance, and increase public health impact. This protocol describes the approach to assess acceptability, feasibility, effectiveness, and cost-effectiveness of the integrated strategy.Methods and analysisThis is a multicentre, cluster-randomized, implementation trial of IPTp-SP delivery through ANC + SMC vs ANC alone in 40 health facilities and their catchment populations (20 clusters per arm). The intervention will consist of monthly administration of IPTp-SP through four monthly rounds of SMC during the malaria transmission season (July to October), for two consecutive years. Effectiveness of the strategy to increase coverage of three or more doses of IPTp-SP (IPTp3 +) will be assessed using household surveys and ANC exit interviews. Statistical analysis of IPT3 + and four or more ANC uptake will use a generalized linear mixed model. Feasibility and acceptability will be assessed through in-depth interviews and focus group discussions with health workers, pregnant women, and women with a child < 12 months.DiscussionThis multicentre cluster randomized implementation trial powered to detect a 45% and 22% increase in IPTp-SP3 + uptake in Mali and Burkina-Faso, respectively, will generate evidence on the feasibility, acceptability, effectiveness, and cost-effectiveness of IPTp-SP delivered through the ANC + SMC channel. The intervention is designed to facilitate scalability and translation into policy by leveraging existing resources, while strengthening local capacities in research, health, and community institutions. Findings will inform the local national malaria control policies.Trial registrationRetrospectively registered on August 11th, 2022; registration # PACTR202208844472053.Protocol v4.0 dated September 04, 2023.Trail sponsor: University of Sciences Techniques and Technologies of Bamako (USTTB), Mali.

481 Integrating cystic fibrosis-cognitive behavioral therapy into teambased care for adults with cystic fibrosis: initiation of a randomized implementation trial in U.S. and Canadian cystic fibrosis centers

481 Integrating cystic fibrosis-cognitive behavioral therapy into teambased care for adults with cystic fibrosis: initiation of a randomized implementation trial in U.S. and Canadian cystic fibrosis centers

Implementation Outcomes of Strategies to Promote Short-Course Radiation for Nonspine Bone Metastases in an Academic-Community Partnership: Survey Results from the ALIGNMENT Trial

Local treatment of nonspine bone metastases has become increasingly complex, resulting in physician practice variability nationwide. The purpose of this study was to assess physician perceptions of 3 implementation strategies to promote adoption of short course radiotherapy (RT) for nonspine bone metastases. ALIGNMENT ("Alliance Group for Bone Metastasis") was a multi-institutional stepped wedge cluster randomized implementation trial testing strategies to increase use of ≤5 fractions for nonspine bone metastases conducted across 3 clinical sites in an academic-community partnership. Strategies included a) multidisciplinary consensus guidelines, b) e-Consults, an email-based consultation platform, and c) personalized audit and feedback (A&F) reports with peer comparison. Using the Proctor et al. framework and validated questions from Weiner et al., physician surveys were used to assess each strategy's usefulness, acceptability (i.e., "I welcome [strategy]"), appropriateness (i.e., "[strategy] seems like a good match"), and feasibility (i.e., "[strategy] seems implementable" or "easy to use"). Survey responses were anonymized, so Fisher's Exact test was used to compare proportions with significance set at p<0.05. Overall, 29 of 38 and 30 of 38 physicians participated in the pre- and post-implementation surveys, respectively, with 80% completing both. Pre-implementation, guidelines was most often ranked 1st in terms of usefulness (61%), followed by eConsults (38%) and A&F (3%). Post-implementation, guidelines and eConsults had the most and least favorable acceptability, appropriateness, and feasibility scores, respectively (Table), with 77% of physicians being likely to recommend the guidelines to other oncologists. In contrast, while 43% of physicians reported having at least 1 difficult clinical question regarding bone metastases during the study, only 33% of physicians preferred eConsults, while 50% preferred reaching out to a friend/colleague. Lastly, although A&F had the lowest perceived usefulness pre-implementation, A&F had the greatest increase in acceptability (72%→90%; p = 0.10), appropriateness (66%→90%; p = 0.03) feasibility ("implementable": 59%→93%, p = 0.002; "easy to use": 45%→93%, p<0.001). In this multicenter trial, all strategies were acceptable, appropriate, and feasible, with guidelines and A&F showing the most favorable outcomes post-implementation. While guidelines were assessed as the most useful, A&F had significant increases in appropriateness and feasibility.

New Antenatal Model in Africa and India (NAMAI) study: implementation research to improve antenatal care using WHO recommendations

BackgroundIn 2020, an estimated 287 000 women died globally from pregnancy‐related causes and 2 million babies were stillborn. Many of these outcomes can be prevented by quality healthcare during pregnancy and childbirth. Within the continuum of maternal health, antenatal care (ANC) is a key moment in terms of contact with the health system, yet it remains an underutilized platform. This paper describes the protocol for a study conducted in collaboration with Ministries of Health and country research partners that aims to employ implementation science to systematically introduce and test the applicability of the adapted WHO ANC package in selected sites across four countries.MethodsStudy design is a mixed methods stepped-wedge cluster randomized implementation trial with a nested cohort component (in India and Burkina Faso). The intervention is composed of two layers: (i) the country- (or state)-specific ANC package, including evidence-based interventions to improve maternal and newborn health outcomes, and (ii) the co-interventions (or implementation strategies) to help delivery and uptake of the adapted ANC package. Using COM-B model, co-interventions support behaviour change among health workers and pregnant women by (1) training health workers on the adapted ANC package and ultrasound (except in India), (2) providing supplies, (3) conducting mentoring and supervision and (4) implementing community mobilization strategies. In Rwanda and Zambia, a fifth strategy includes a digital health intervention. Qualitative data will be gathered from health workers, women and their families, to gauge acceptability of the adapted ANC package and its components, as well as experience of care. The implementation of the adapted ANC package of interventions, and their related costs, will be documented to understand to what extent the co-interventions were performed as intended, allowing for iteration.DiscussionResults from this study aim to build the global evidence base on how to implement quality ANC across different settings and inform pathways to scale, which will ultimately lead to stronger health systems with better maternal and perinatal outcomes. On the basis of the study results, governments will be able to adopt and plan for national scale-up, aiming to improve ANC nationally. This evidence will inform global guidance.Trial registration number: ISRCTN, ISRCTN16610902. Registered 27 May 2022. https://www.isrctn.com/ISRCTN16610902

Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial

BackgroundShared decision-making (SDM) is highly relevant in oncology but rarely implemented in routine care. In a stepped-wedge cluster randomized implementation trial, the outcome evaluation of a theoretically and empirically based multi-component SDM implementation program did not show a statistically significant effect on patient-reported SDM uptake. Within this SDM implementation trial, a thorough a priori planned process evaluation was conducted. Thus, the aim of this study was to investigate factors influencing SDM implementation in the context of a multi-component SDM implementation program.MethodsWe conducted qualitative process evaluation of a stepped-wedge SDM implementation trial. Qualitative data included interviews with nurses and physicians of participating departments, field notes by the study team, and meeting minutes. Data were analyzed via deductive and inductive qualitative content analysis on basis of the Consolidated Framework for Implementation Research (CFIR).ResultsTranscripts of 107 interviews with 126 nurses and physicians, 304 pages of field note documentation, and 125 pages of meeting minutes were analyzed. Major factors influencing SDM implementation were found for all domains of the CFIR: a) four regarding characteristics of the individuals involved (e.g., perceived personal relevance, individual motivation to change), b) eleven regarding the inner setting (e.g., leadership engagement, networks and communication, available resources, compatibility with clinical practice), c) two regarding the outer setting (e.g., culture of health care delivery), d) eight regarding characteristics of the intervention (e.g., relative advantage, adaptability), and e) three regarding the implementation process (e.g., integration into existing structures). Furthermore, we found strong interrelations between several of the influencing factors within and between domains.ConclusionsThis comprehensive process evaluation complements the outcome evaluation of the SDM implementation trial and adds to its interpretation. The identified influencing factors can be used for planning, conducting, and evaluating SDM implementation in the future.Trial registrationclinicaltrials.gov, NCT03393351, registered 8 January 2018, https://clinicaltrials.gov/ct2/show/NCT03393351

Interactive assistance via eHealth for small- and medium-sized enterprises’ employer and health care manager teams on tobacco control (eSMART-TC): protocol for a cluster randomized hybrid type II trial (N-EQUITY2101/J-SUPPORT2102)

BackgroundTobacco control should be a higher public health priority in Japan. Some workplaces provide smoking cessation support and connect employees to effective smoking cessation treatments such as outpatient clinics. However, tobacco control measures have not been sufficiently implemented in Japan, especially in small- and medium-sized enterprises (SMEs), where resources are limited. Organizational commitment and consistent leadership are crucial to facilitate implementation, but research on whether supporting organizational leaders leads to health behavior changes among employees is limited.MethodsThis hybrid type II cluster randomized effectiveness implementation trial (eSMART-TC) aims to examine the effects of interactive assistance for SME management on health and implementation outcomes. We will provide interactive assistance to employers and health managers for 6 months, aiming to promote the utilization of reimbursed smoking cessation treatments by public health insurance and to implement smoke-free workplaces. The intervention will consist of three strategies: supporting employees through campaigns, tailored ongoing facilitation, and ensuring executive engagement and support. The primary health and implementation outcomes will be salivary cotinine-validated 7-day point-prevalence abstinence rate, and the adoption of two recommended measures (promoting utilization of smoking cessation treatment and implementing smoke-free workplaces) 6 months after the initial session, respectively. Other outcomes for implementation (e.g., penetration of smoking cessation clinic visits), health (e.g., salivary cotinine-validated 7-day point-prevalence abstinence rate at 12 months), and process (e.g., adherence and potential moderating factors) will be collected via questionnaires, interviews, logbooks, and interventionists’ notes at 6 and 12 months. An economic analysis will be undertaken to assess the cost-effectiveness of the implementation interventions at 12 months.DiscussionThis will be the first cluster randomized controlled trial to evaluate the effectiveness of an implementation intervention with interactive assistance for employers and health managers in SMEs on smoking cessation and implementation of evidence-based tobacco control measures in SMEs. The findings of this trial targeting management in SMEs have the potential to accelerate the implementation of evidence-based smoking cessation methods as well as abstinence rates among employees in SMEs across Japan.Trial registrationThe study protocol has been registered in the UMIN Clinical Trials Registry (UMIN-CTR; ID: UMIN000044526). Registered on 06/14/2021.

A multistep mediation model examining how consultation in prolonged exposure therapy affects PTSD treatment outcomes.

Prolonged exposure therapy (PE) is an evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD) that is underutilized in the military health system. Previous research suggests that postworkshop consultation is important for successful implementation. However, little is known about how consultation may relate to EBP adoption or patient outcomes. The present study addressed these gaps by examining associations between consultation, provider self-efficacy, use of PE, and patient outcomes using a multistep mediation model. This study used data from Foa et al. (2020), a two-armed randomized implementation trial comparing two PE training models: standard training (workshop only) and extended training (workshop + 6-8 months of postworkshop expert consultation) at three U.S. Army sites. Participants were patients with PTSD (N = 242) receiving care from the participating providers (N = 103). Providers who received extended training reported greater PE self-efficacy compared to standard training providers, but self-efficacy was unrelated to their use of PE components or to patient outcomes. Extended training providers used more PE components and had superior patient outcomes than standard training providers, and patient outcomes were mediated by the use of PE components. To our knowledge, this is the first study to demonstrate that EBP consultation leads to improved clinical outcomes for patients through increased use of the EBP. PE adoption (i.e., use of PE components in therapy) was not explained by increases in self-efficacy among providers who received extended training. Therefore, future research should assess how other factors may influence provider behavior in implementing EBPs. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Predicting adherence to postdischarge malaria chemoprevention in Malawian pre-school children: A prognostic multivariable analysis

Chemoprevention with antimalarials is a key strategy for malaria control in sub-Saharan Africa. Three months of postdischarge malaria chemoprevention (PDMC) reduces malaria-related mortality and morbidity in pre-school children recently discharged from hospital following recovery from severe anemia. Research on adherence to preventive antimalarials in children is scarce. We aimed to investigate the predictors for caregivers' adherence to three courses of monthly PDMC in Malawi. We used data from a cluster randomized implementation trial of PDMC in Malawi (n = 357). Modified Poisson regression for clustered data was used to obtain relative risks of predictors for full adherence to PDMC. We did not find a conclusive set of predictors for PDMC adherence. The distribution of households across a socio-economic index and caregivers' education showed mixed associations with poor adherence. Caregivers of children with four or more malaria infections in the past year were associated with reduced adherence. With these results, we cannot confirm the associations established in the literature for caregiver adherence to artemisinin-based combination therapies (ACTs). PDMC combines multiple factors that complicate adherence. Our results may indicate that prevention interventions introduce a distinct complexity to ACT adherence behavior. Until we better understand this relationship, PDMC programs should ensure high program fidelity to sustain adherence by caregivers during implementation.

Integrating Alcohol-Related Prevention and Treatment Into Primary Care

Unhealthy alcohol use is common and affects morbidity and mortality but is often neglected in medical settings, despite guidelines for both prevention and treatment. To test an implementation intervention to increase (1) population-based alcohol-related prevention with brief interventions and (2) treatment of alcohol use disorder (AUD) in primary care implemented with a broader program of behavioral health integration. The Sustained Patient-Centered Alcohol-Related Care (SPARC) trial was a stepped-wedge cluster randomized implementation trial, including 22 primary care practices in an integrated health system in Washington state. Participants consisted of all adult patients (aged ≥18 years) with primary care visits from January 2015 to July 2018. Data were analyzed from August 2018 to March 2021. The implementation intervention included 3 strategies: practice facilitation; electronic health record decision support; and performance feedback. Practices were randomly assigned launch dates, which placed them in 1 of 7 waves and defined the start of the practice's intervention period. Coprimary outcomes for prevention and AUD treatment were (1) the proportion of patients who had unhealthy alcohol use and brief intervention documented in the electronic health record (brief intervention) for prevention and (2) the proportion of patients who had newly diagnosed AUD and engaged in AUD treatment (AUD treatment engagement). Analyses compared monthly rates of primary and intermediate outcomes (eg, screening, diagnosis, treatment initiation) among all patients who visited primary care during usual care and intervention periods using mixed-effects regression. A total of 333 596 patients visited primary care (mean [SD] age, 48 [18] years; 193 583 [58%] female; 234 764 [70%] White individuals). The proportion with brief intervention was higher during SPARC intervention than usual care periods (57 vs 11 per 10 000 patients per month; P < .001). The proportion with AUD treatment engagement did not differ during intervention and usual care (1.4 vs 1.8 per 10 000 patients; P = .30). The intervention increased intermediate outcomes: screening (83.2% vs 20.8%; P < .001), new AUD diagnosis (33.8 vs 28.8 per 10 000; P = .003), and treatment initiation (7.8 vs 6.2 per 10 000; P = .04). In this stepped-wedge cluster randomized implementation trial, the SPARC intervention resulted in modest increases in prevention (brief intervention) but not AUD treatment engagement in primary care, despite important increases in screening, new diagnoses, and treatment initiation. ClinicalTrials.gov Identifier: NCT02675777.

Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake (NUDGE-FLU): Study protocol for a nationwide randomized implementation trial

BackgroundAnnual influenza vaccination is widely recommended in older adults and other high-risk groups including patients with cardiovascular disease. The real-world effectiveness of influenza vaccination is limited by suboptimal uptake and effective strategies for increasing vaccination rates are therefore needed. The purpose of this trial is to investigate whether behavioral nudges digitally delivered via the Danish nationwide mandatory governmental electronic letter system can increase influenza vaccination uptake among older adults. MethodsThe NUDGE-FLU trial is a randomized implementation trial randomizing all Danish citizens aged 65 years and above without an exemption from the Danish mandatory governmental electronic letter system to receive no digitally delivered behavioral nudge (usual care arm) or to receive one of 9 electronic letters (intervention arms) each leveraging different behavioral science strategies. The trial has randomized 964,870 participants with randomization clustered at the household level (n = 691,820 households). Intervention letters were delivered on September 16, 2022, and follow-up is currently ongoing. All trial data are captured using the nationwide Danish administrative health registries. The primary end point is the receipt of an influenza vaccine on or before January 1, 2023. The secondary end point is time to vaccination. Exploratory end points include clinical events such as hospitalization for influenza or pneumonia, cardiovascular events, all-cause hospitalization, and all-cause mortality. DiscussionThe nationwide randomized NUDGE-FLU trial is one of the largest implementation trials ever conducted and will provide important insights into effective communication strategies to maximize vaccination uptake among high-risk groups. Trial RegistrationClinicaltrials.gov: NCT05542004, registered September 15, 2022, https://clinicaltrials.gov/ct2/show/NCT05542004.

A randomized implementation trial to increase adoption of evidence-informed consent practices.

Several evidence-informed consent practices (ECPs) have been shown to improve informed consent in clinical trials but are not routinely used. These include optimizing consent formatting, using plain language, using validated instruments to assess understanding, and involving legally authorized representatives when appropriate. We hypothesized that participants receiving an implementation science toolkit and a social media push would have increased adoption of ECPs and other outcomes. We conducted a 1-year trial with clinical research professionals in the USA (n = 1284) who have trials open to older adults or focus on Alzheimer's disease. We randomized participants to receive information on ECPs via receiving a toolkit with a social media push (intervention) or receiving an online learning module (active control). Participants completed a baseline survey and a follow-up survey after 1 year. A subset of participants was interviewed (n = 43). Participants who engaged more with the toolkit were more likely to have tried to implement an ECP during the trial than participants less engaged with the toolkit or the active control group. However, there were no significant differences in the adoption of ECPs, intention to adopt, or positive attitudes. Participants reported the toolkit and social media push were satisfactory, and participating increased their awareness of ECPs. However, they reported lacking the time needed to engage with the toolkit more fully. Using an implementation science approach to increase the use of ECPs was only modestly successful. Data suggest that having institutional review boards recommend or require ECPs may be an effective way to increase their use.

A Waitlist Randomized Implementation Trial of Classroom Pivotal Response Teaching for Students With Autism.

Classroom Pivotal Response Teaching (CPRT) is a community-partnered adaptation of a naturalistic developmental behavioral intervention identified as an evidence-based practice for autistic children. The current study evaluated student outcomes in a randomized, wait-list controlled implementation trial across classrooms. Participants included teachers (n = 126) and students with autism (n = 308). Teachers participated in 12 hours of didactic, interactive training and additional in-classroom coaching. Generalized Estimating Equations accounted for clustering. Adjusted models evaluated the relative effects of training group, CPRT fidelity, and classroom quality on student outcomes. Results indicate higher CPRT fidelity was associated with greater increases in student learning. Having received CPRT training predicted increased student engagement and greater decreases in reported approach/withdrawal problems. These differences may be linked to the theoretical foundations of CPRT of increasing student motivation and engagement and collaborative adaptation to increase feasibility in schools. Overall, results suggest CPRT may be a beneficial approach for supporting autistic students.

The design of the Dashboard Activated Services and Telehealth for Heart Failure (DASH-HF) study: A pragmatic quality improvement randomized implementation trial for patients with heart failure with reduced ejection fraction

BackgroundGaps in the receipt and dosing of guideline-directed medical therapy (GDMT) persist for patients with heart failure with reduced ejection fraction (HFrEF) [1]. In 2020, the Veterans Affairs (VA) developed a heart failure (HF) specific population dashboard to monitor care quality and performance on standard HFrEF performance measures [2]. MethodsThe Dashboard Activated Services and Telehealth for HF (DASH-HF) study is a pragmatic randomized quality improvement study designed to evaluate the utility of proactive population management clinics using the VA's HF dashboard to optimize GDMT for patients with HFrEF. Panel management telemedicine clinics incorporated multidisciplinary clinicians to perform chart review and impromptu telephone encounters to evaluate current HFrEF management and opportunities to optimize GDMT. The study will evaluate the efficacy of proactive panel management to usual care at 6 months as quantified by the GDMT optimization potential score. Secondary outcomes include hospitalizations, mortality, and clinician time per intervention. The study completed enrollment and randomization of 300 participants. The intervention was performed from September to December 2021. ConclusionDASH-HF will contribute to the literature by evaluating use of the existing VA dashboard to identify HF patients with the lowest adherence to GDMT and proactively target this group for the intervention.Registration:https://clinicaltrials.gov/. Unique identifier: NCT05001165.

Implementing a text-messaging intervention for unhealthy alcohol use in emergency departments: protocol for implementation strategy development and a pilot cluster randomized implementation trial

BackgroundUnhealthy alcohol use (UAU) is a leading cause of premature mortality among adults in the USA. Emergency departments (EDs) are key intervention settings for UAU but often have limited time and resources. One low-burden, scalable approach to address UAU is text-messaging interventions. Despite strong research support and promise for scalability, there is little research on how to implement such interventions in healthcare settings. The process of providers making them available to patients in an efficient way within already busy and overburdened ED workflows and patients adopting them remains a new area of research. The purpose of this three-phase study is to develop and test an implementation strategy for UAU text-messaging interventions in EDs.MethodOur first aim is to examine barriers and facilitators to staff offering and patients accepting a text-messaging intervention in the ED using an explanatory, sequential mixed methods approach. We will examine alcohol screening data in the electronic health records of 17 EDs within a large integrated health system in the Northeast and conduct surveys among chairpersons in each. This data will be used to purposively sample 4 EDs for semi-structured interviews among 20 clinical staff, 20 patients, and 4 chairpersons. Our second aim is to conduct a stakeholder-engaged intervention mapping process to develop a multi-component implementation strategy for EDs. Our third aim is to conduct a mixed method 2-arm cluster randomized pilot study in 4 EDs that serve ~11,000 UAU patients per year to assess the feasibility, acceptability, and preliminary effectiveness of the implementation strategy. The Integrated Promoting Action on Research Implementation in Health Services framework will guide study activities.DiscussionLow-burden technology, like text messaging, along with targeted implementation support and strategies driven by identified barriers and facilitators could sustain large-scale ED-based alcohol screening programs and provide much needed support to patients who screen positive while reducing burden on EDs. The proposed study would be the first to develop and test this targeted implementation strategy and will prepare for a larger, fully powered hybrid effectiveness-implementation trial. Findings may also be broadly applicable to implementation of patient-facing mobile health technologies.Trial registrationThis study was registered at ClinicalTrials.gov (NCT05350878) on 4/28/2022.