Implementation Science最新文献

Background: For nearly two decades, it has been widely recognized that individuals in jail settings have a high prevalence of opioid use disorders (OUD) and are highly susceptible to fatal overdose upon their release. This setting provides a public health opportunity to address OUD with Medication for Opioid Use Disorders (MOUDs). Yet, 56% of jails do not provide MOUD, creating a pressing need for better implementation approaches in jail and the hand-off to the community. Two successful implementation strategies, NIATx external coaching and the Extension for Community Healthcare Outcomes (ECHO) case management telementoring model, were compared to address this persistent treatment gap.

Methods: This 2 × 2 design compared high (n = 12) and low (n = 4) dose coaching with and without ECHO in a 12-month intervention and 12 M sustainability period. The national trial included 25 jails and 13 community-based partners. MOUD trends for buprenorphine, methadone, injectable naltrexone, and combined MOUD between the study arms were assessed.

Results: Jail sizes ranged from 24% with < 100 and 24% with > 500 daily population, and community-based treatment providers ranged from 63% with < 50 and 7% with > 500 average monthly OUD intakes. New patient counts were found to significantly increase across the intervention phase for buprenorphine (p < .01) and combined MOUD (p < .01). Injectable naltrexone and methadone showed no consistent, significant gains. For sites with low coaching without ECHO, new patient counts for combined MOUD were predicted to increase by 47.44% during the intervention phase and 7.30% during the sustainability phase. ECHO demonstrated that MOUD use did not significantly increase compared to coaching across MOUDs in the intervention phase (p = .517). High- and low-dose coaching showed no significant differences in MOUD use during the intervention phase (p = .124).

Conclusions: Coaching emerged as a more effective implementation strategy than ECHO for increasing buprenorphine use in jail settings. In practice, ECHO sessions offered considerable overlap with coaching strategies. While high-dose coaching had greater gains for MOUDs overall than low-dose coaching, those gains were statistically insignificant, suggesting low-dose coaching to be more economical. To increase MOUD use in jail settings, jurisdictions should focus on new MOUDs so all three MOUDs are available and enhance the post-incarceration continuum of care.

Trial registration: Name of registry: ClinicalTrials.gov.

Trial registration number: NCT04363320. Date of registration: 2020-07-30. URL of trial registry record: https://clinicaltrials.gov/study/NCT04363320?term=molfenter&rank=7 .

Background: While key to interpreting findings and assessing generalizability, implementation fidelity is underreported in mobile health (mHealth) literature. We evaluated implementation fidelity of an opt-in, hybrid, two-way texting (2wT) intervention previously demonstrated to improve 12-month retention on antiretroviral therapy (ART) among people living with HIV (PLHIV) in a quasi-experimental study in Lilongwe, Malawi.

Methods: Short message service (SMS) data and ART refill visit records were used to evaluate adherence to 2wT content, frequency and duration through the lens of the Conceptual Framework for Implementation Fidelity. Message delivery and 2wT participant interactions were considered across four core 2wT components: 1) weekly motivational SMS messages; 2) proactive SMS appointment reminders; 3) SMS reminders after missed appointments; and 4) interactive messaging with 2wT staff about transfers and appointment rescheduling. Using mixed-effects logistic regression models adjusted for participant demographics, we examined the effect of core 2wT component fidelity on a) on-time appointment attendance and b) timely return to care after a missed appointment, presenting adjusted odds ratios (aORs) and 95% confidence intervals (CIs).

Results: The 468 2wT participants had a median of 52 study weeks (interquartile range [IQR] 34 - 52) with 6 ART appointments (IQR 4-7) of which 2 (IQR 1 - 3) were missed. On average, participants received a motivation message for 75% (IQR 56%-83%) of enrolled weeks, a reminder before 83% (IQR 67%-100%) of appointments, and after 67% (IQR 0%-100%) of missed appointments. Participants reported 9 transfers and rescheduled 46 appointments through 2wT prompts; 196 appointments were changed via unprompted interaction. Participants with 10% higher expected motivation message delivery were more likely to attend clinic appointments on time (aOR: 1.08; 95%CI: 1.01 - 1.16, p = 0.03). Receiving and responding to an appointment reminder in any way were also associated with increased on-time appointment attendance (aOR: 1.35; 95%CI: 1.03 - 1.79, p = 0.03 and aOR: 1.47, 95%CI: 1.16 - 1.87, p = 0.001, respectively). No associations were found for 2wT messages and timely return to care following a missed appointment.

Conclusion: Greater 2wT implementation fidelity was associated with improved care outcomes. Although implementation fidelity monitoring of mHealth interventions is complex, it should be integrated into study design.

Background: Public health nutrition interventions, including school-based programs, are a recommended approach to improve child dietary behaviours. However, the adoption of effective school-based nutrition programs face numerous challenges, including the limited evidence on effective strategies to maximise implementation and adoption of such programs. This study aimed to address this evidence gap by employing a novel collaborative network trial design to evaluate a series of implementation strategies employed by three NSW Local Health Districts, to improve school adoption of an effective school-based nutrition program ('SWAP IT').

Methods: Three independent, two arm parallel group randomised controlled trials were conducted simultaneously to examine the potential effectiveness of implementation strategies on school adoption of SWAP IT. Schools were randomised to either a high intensity (various implementation strategies), or a business as usual (minimal support) group. Measures and data collection processes were harmonised across the three trials to provide individual school-level data for planned pooled analyses. The primary outcome was school adoption of SWAP IT, objectively measured via electronic registration records. Logistic regression analyses were used to assess school adoption of SWAP IT for each trial. Meta-analyses were also conducted to pool the effects of the three trials and allow the comparison of the potential relative effects of the different strategies.

Results: A total of 287 schools were included in the study: Trial 1 (n = 164), Trial 2 (n = 64) and Trial 3 (n = 59). Relative to control, we found increased odds of adoption in Trial 1 that employed a combination of the educational materials and local facilitation strategies (OR 8.78; 95%CI 2.90, 26.56; p < 0.001), but no significant differences in adoption in Trial 2 or 3 that employed solely the educational materials strategy. Pooled data suggests the combination of educational materials and local facilitation has a greater effect on adoption compared to educational materials alone (OR 4.18; 95%CI 1.60, 10.04; n = 3 studies; indirect effect).

Conclusion: Findings of this study indicate that local facilitation is an important strategy to increase school adoption of SWAP IT, and potentially other health promotion programs.

Trial registration: The trials were prospectively registered with Australia New Zealand Clinical Trials Register: ANZCTR, ACTRN12622000257763, Registered 11/2/2022, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383515&isReview=true ANZCTR, ACTRN12622000406707, Registered 9/3/2022 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383701&isReview=true ANZCTR, ACTRN12622000252718, Registered on 11/2/2022, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383513&isReview=true.

Background: Despite evidence supporting interventions that improve outcomes for patients with stroke, their implementation remains suboptimal. Facilitation can support implementation of research into clinical practice by helping people develop the strategies to implement change. However, variability in the amount (dose) and type of facilitation activities/facilitator roles that make up the facilitation strategies (content), may affect the effectiveness of facilitation. This review aimed to determine if, and how, facilitation dose is measured or reported and the type of facilitation strategies used to support adoption of stroke interventions in hospitals and subacute settings. We also assessed whether the included studies had reporting checklists or guidelines.

Methods: The scoping review was based on Arksey and O'Malley's framework. Cochrane, CINAHL and MEDLINE databases were searched to identify randomised trials and quasi-experimental studies of stroke interventions published between January 2017 and July 2023. Accompanying publications (quantitative, qualitative, mixed methods or process evaluation papers) from eligible studies were also included. Narrative data synthesis was undertaken.

Results: Ten studies (23 papers) from 649 full-text papers met the inclusion criteria. Only two studies reported the total facilitation dose, measured as the frequency and duration of facilitation encounters. Authors of the remaining eight studies reported only the frequency and/or duration of varying facilitation activities but not the total dose. The facilitation activities included remote external facilitator support via ongoing telecommunication (phone calls, emails, teleconferences), continuous engagement from on-site internal facilitators, face-to-face workshops and/or education sessions from external or internal facilitators. Facilitator roles were broad: site-specific briefing, action planning and/or goal setting; identifying enablers and barriers to change; coaching, training, education or feedback; and network support. Only two studies included reporting checklists/guidelines to support researchers to describe interventions and implementation studies in sufficient detail to enable replication.

Conclusions: There is a paucity of information on the measurement of facilitation dose and reporting on specific details of facilitation activities in stroke implementation studies. Detailed reporting of dose and content is needed to improve the scientific basis of facilitation as strategic support to enable improvements to stroke care. Development of a standardised measurement approach for facilitation dose would inform future research and translation of findings.

Background: Remaking Recess (RR) is a school-based evidence-based peer social engagement intervention for autistic students. RR involves direct training and coaching with educators; however, educators face several barriers to implementation at both the individual- and organizational-levels. This protocol paper describes a multi-site study that will test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize educators' use (fidelity and sustainment) of RR for autistic students and their peers who are socially-isolated, rejected, or peripheral and may need additional support during recess.

Methods: This study will employ a hybrid type-3 effectiveness-implementation trial. Fifty-five elementary schools will be recruited as well as 121 educators (e.g., classroom assistants, aides), 55 general and special educator teachers, and 83-138 other school personnel (e.g., administrators). Additionally, at least 118 autistic students and allistic or non-autistic classmates will be recruited as RR recipients. Participants will complete baseline assessments at the beginning of the year, and all schools will be provided RR training. Schools will be randomized to coaching with or without school-based teams. This study will measure RR fidelity (primary outcome), RR sustainment, as well as peer engagement, social network inclusion, and social skills (secondary outcomes). It is expected that coaching with school-based teams will improve both RR fidelity and social network inclusion, while coaching with and without school-based teams will result in improved peer engagement and social skills.

Discussion: Previous research has documented barriers to RR implementation at both the individual- (provider) and organization-level (school). Using multi-level implementation strategies such as coaching with school-based teams may address these barriers and support RR implementation in schools. Findings from this study may guide future efforts to scale up tailored implementation strategies for use in public school districts, with the ultimate goal of increasing intervention access and improving student outcomes.

Trial registration: Name of the Registry: clinicaltrials.gov.

Trial registration: Clinical Trials ID: NCT06559267 . Date of Registration: August 15, 2024. Prospectively registered.

Background: The COVID-19 pandemic has highlighted the need for more effective immunization programs, including in limited resource settings. This paper presents outcomes and lessons learnt from a COVID-19 vaccination campaign (VC), which used a tailored adaptive strategy to optimise vaccine uptake in the Boeny region of Madagascar.

Methods: Guided by the Dynamic Sustainability Framework (DSF), the VC implementation was regularly reviewed through multi-sectoral stakeholder feedback, key informant interviews, problem-solving meetings, and weekly monitoring of outcome indicators to identify and apply key adaptations. Qualitative data on processes were collected and analysed using a rapid assessment approach. Outcome indicators, including pre- and post-VC vaccine hesitancy and trends in vaccine doses administered, were analysed using generalized linear models. Additionally, vaccination coverage, geographic reach, and target population characteristics, and sustainability indicators, such as staff trained, facilities equipped, and degree of integration of operational and educational materials were also tracked.

Results: Key strategy adaptations included using a proactive campaign approach, community-led awareness and outreach, particularly in remote areas, and addressing cold chain, waste management, vaccine transport, and information technology (IT) equipment gaps. Over six months, 24,888 COVID-19 vaccines were administered. The adapted strategy led to an 8% increase in doses administered weekly (RR = 1.08, CI 95%: 1.01-1.15). However, vaccine hesitancy among the unvaccinated population remained unchanged (∆ = 0.02, CI 95%: -0.04-0.08). In terms of sustainability, 340 staff were trained, and 10 primary healthcare facilities were equipped and refurbished.

Conclusions: Implementing collaborative, multi-sectoral vaccination strategies that integrate healthcare services with proactive outreach and community-driven campaigns are effective in increasing vaccine coverage in resource-limited settings. It demonstrates how theory-based adaptive strategies can enhance vaccination rates, even if they do not significantly impact COVID-19 vaccine hesitancy within the community. More generally, this initiative has important implications for adult vaccination programmes other than those related to COVID-19.

Background: Designing for Dissemination and Sustainability (D4DS) principles and methods can support the development of research products (interventions, tools, findings) that match well with the needs and context of the intended audience and setting. D4DS principles and methods are not well-known or used during clinical and public health research; research teams would benefit from applying D4DS. This paper presents the development of a new digital platform for research teams to learn and apply a D4DS process to their work.

Methods: A user-centered design (UCD) approach engaged users (n = 14) and an expert panel (n = 6) in an iterative design process from discovery to prototyping and testing. We led five design sessions using Zoom and Figma software over a 5-month period. Users (71% academics; 29% practitioners) participated in at least 2 sessions. Following design sessions, feedback from users was summarized and discussed to generate design decisions. A prototype was then built and heuristically tested with 11 users who were asked to complete multiple tasks within the platform while verbalizing their decision-making using the 'think aloud' procedure. The System Usability Scale (SUS) was administered at the end of each testing session. After refinements to the platform were made, usability was reassessed with 7 of 11 same users to examine changes.

Results: The interactive digital platform (the D4DS Planner) has two main components: 1) the Education Hub (e.g., searchable platform with literature, videos, websites) and 2) the Action Planner. The Action Planner includes 7 interactive steps that walk users through a set of activities to generate a downloadable D4DS action plan for their project. Participants reported that the prototype tool was moderately usable (SUS = 66) but improved following refinements (SUS = 71).

Conclusions: This is a first of its kind tool that supports research teams in learning about and explicitly applying D4DS to their work. The use of this publicly available tool may increase the adoption, impact, and sustainment of a wide range of research products. The use of UCD yielded a tool that is easy to use. This tool's future use and impact will be evaluated with a broader sample of community partners and projects and the tool will continue to be refined and improved.

Background: A central goal of implementation science is to generate insights that allow evidence-based practices to be successfully applied across diverse settings. However, challenges often arise in preserving programs' effectiveness outside the context of their intervention development. We propose that qualitative data can inform generalizability via elucidating mechanisms of an intervention. Critical realist thematic analysis provides a framework for applying qualitative data to identify causal relationships. This approach can be used to develop mechanism maps, a tool rooted in policy that has been used in health systems interventions, to explain how and why interventions work. We illustrate use of these approaches through a case example of a community health worker (CHW)-delivered gestational diabetes (GDM) screening intervention in Pune, India. CHWs successfully improved uptake of oral glucose tolerance tests (OGTT) among pregnant women, however clinical management of GDM was suboptimal.

Methods: Qualitative interviews were conducted with 53 purposively sampled participants (pregnant women, CHWs, maternal health clinicians). Interview transcripts were reviewed using a critical realist thematic analysis approach to develop a coding scheme pertinent to our research questions: "What caused high uptake of GDM screening?" and "Why did most women with GDM referred to clinics did not receive evidence-based management?". Mechanism maps were retrospectively generated using short- and long-term outcomes as fenceposts to illustrate causal pathways of the CHW-delivered program and subsequent clinical GDM management.

Results: Critical realist thematic analysis generated mechanism maps showed that CHWs facilitated GDM screening uptake through affective, cognitive and logistic pathways of influence. Lack of evidence-based treatment of GDM at clinics was caused by 1) clinicians lacking time or initiative to provide GDM counseling and 2) low perceived pre-test probability of GDM in this population of women without traditional risk factors. Mechanism mapping identified areas for adaptation to improve the intervention for future iterations.

Conclusions: Mechanism maps created by repeated engagement following the critical realist thematic analysis method can provide a retrospective framework to understand causal relationships between factors driving intervention successes or failures. This process, in turn, can inform the generalizability of health programs by identifying constituent factors and their interrelationships that are central to implementation.

Background: Between 2012-2022 opioid-related overdose deaths in the United States, including Washington State, have risen dramatically. Opioid use disorder (OUD) is a complex, chronic, and criminalized illness with biological, environmental, and social causes. One-fifth of people with OUD have recent criminal-legal system involvement; > 50% pass through WA jails annually. Medications for Opioid Use Disorder (MOUD) can effectively treat OUD. WA has prioritized improving access to MOUD, including for those in jails. As patients in jail settings are systematically marginalized due to incarceration, it is critical to foster connections to MOUD services upon release, an acknowledged period of high overdose risk. Currently, there is insufficient focus on developing strategies to foster linkages between jail-based MOUD and referral services. The Systems Analysis and Improvement Approach (SAIA), an evidence-based implementation strategy, may optimize complex care cascades like MOUD provision and improve linkages between jail- and community-based providers. SAIA bundles systems engineering tools into an iterative process to guide care teams to visualize cascade drop-offs and prioritize steps for improvement; identify modifiable organization-level bottlenecks; and propose, implement, and evaluate modifications to overall cascade performance. The SAIA-MOUD study aims to strengthen the quality and continuity of MOUD care across jail and referral clinics in King County, WA, and ultimately reduce recidivism and mortality.

Methods: We will conduct a quasi-experimental evaluation of SAIA effectiveness on improving MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics; examine determinants of SAIA-MOUD adoption, implementation, and sustainment; and determine SAIA-MOUD's cost and cost-effectiveness. Clinic teams with study team support will deliver the SAIA-MOUD intervention at the jail-based MOUD program and three referral clinics over a two-year intensive phase, followed by a one-year sustainment phase where SAIA implementation will be led by King County Jail MOUD staff without study support to enable pragmatic evaluation of sustained implementation.

Discussion: SAIA packages user-friendly systems engineering tools to guide decision-making by front-line care providers to identify low-cost, contextually appropriate health care improvement strategies. By integrating SAIA into MOUD care provision in jail and linked services, this pragmatic trial is designed to test a model for national scale-up.

Trial registration: ClinicalTrials.gov NCT06593353 (registered 09/06/2024; https://register.

Clinicaltrials: gov/prs/beta/studies/S000EVJR00000029/recordSummary ).