Implementation science communications最新文献

Background: Appropriately and comprehensive applying implementation frameworks is one of the key challenges in implementation science resulting in increased use of multiple implementation frameworks within projects. This is particularly true for frameworks such as PARIHS/i-PARIHS. Therefore, this systematic review aimed to examine if and why the PARIHS/i-PARIHS framework has been applied in research with other implementation frameworks.

Methods: We searched six databases from 2016 (the year following i-PARIHS' publication) to April 2024 and supplemented this with a citation search of the seminal i-PARIHS paper. We included studies that 1) were peer-reviewed with a protocol or empirical study design, 2) have applied the PARIHS or i-PARIHS framework for implementation planning, delivery, analysis, or evaluation and 3) also used at least one other implementation framework. Descriptive statistics were conducted to report on study characteristics and frequency for each implementation framework used with PARIHS/i-PARIHS. A qualitative, content analysis was used to analyse the answers to open-ended extraction questions.

Results: Thirty-six articles met criteria for inclusion and included 16 protocols and 20 empirical articles (twelve intervention and eight cross-sectional studies). Thirty-four of the studies used one additional implementation framework and two studies used two additional implementation frameworks. In total, nine implementation frameworks were applied with PARIHS/i-PARIHS, including: 1) RE-AIM, 2) CFIR, 3) NPT, 4) REP, 5) TDF, 6), DSF, 7) KTA, 8) Stetler's Model, and 9) SIF. Thirty-four reported a rationale for using PARIHS/i-PARIHS and 34 reported a rationale for using the other implementation framework. Only eleven reported a rationale for using more than one implementation framework. Only three reported strengths of combining implementation frameworks.

Conclusions: Overall, this review identified that implementation researchers are using PARIHS/i-PARIHS in combination with other implementation frameworks and providing little to no rationale for why. Use of multiple implementation frameworks without detailed rationales compromises our ability to evaluate mechanisms of effectiveness. Implementation researchers and practitioners need to be more explicit about their framework selection, detailing the complementary strengths of the frameworks that are being used in combination, including why using one is not sufficient.

Trial registration: This systematic review was registered with PROSPERO: ID: 392147.

Background: Qualitative methodologies offer a nuanced approach to understanding stakeholder perspectives, preferences, and context in implementation research. However, traditional qualitative data analysis can be time consuming and create barriers to responsive implementation of interventions. Rapid qualitative methods that yield timely, actionable results have emerged to expedite the evidence-to-practice gap, but often require all analysts to have implementation science expertise and resources for interview transcription. This study describes a novel rapid qualitative method to identify participant-driven social care recommendations in real time.

Methods: Caregivers of pediatric patients were enrolled onsite at two primary care clinics and one emergency department affiliated with a large urban pediatric healthcare system. A semi-structured interview guide was developed using the Health Equity Implementation Framework and Integrated Behavioral Model in partnership with multidisciplinary implementation stakeholders. Telephone interviews explored 60 caregivers' experiences with and perceptions of receiving social resources from healthcare. For traditional analysis, NVivo12 was used to code the first 10 verbatim transcripts to generate themes in an integrated inductive/deductive approach. In the rapid approach, a summary notes template designed to capture implementation-related data was completed immediately following the same 10 interviews. A secondary analyst used the templates to create participant-level summaries and identify implementation-related themes. Themes found in each method were quantified and mapped onto each other using an analytic matrix to compare the number and consistency of themes.

Results: Themes generated in both methods mapped consistently onto each other; 92.8% of themes found in traditional analysis were accounted for within our rapid method. The quantity of themes was similar between the two methods: the traditional approach generated 69 themes and 22 subthemes, while our rapid approach generated 72 themes and 21 subthemes.

Conclusions: Our interview notes-based rapid qualitative method was successful in producing themes consistent with the traditional approach in both content and quantity. This approach is also pragmatic, as it does not require analysts to have deep implementation science expertise and saves transcription costs. By balancing rigor with time to actionable results, this rapid method provides a tool for implementation researchers to generate qualitative findings on an accelerated timeline to inform policy and practice.

Clinical trial registration: This study was registered at ClinicalTrials.gov, #NCT05251311, https://www.

Clinicaltrials: gov/study/NCT05251311 , on September 30, 2021.

Background: A framework to evaluate implementation of Major System Change (MSC) in healthcare has been developed and applied to implementation of longer-term system changes. This was the first study to apply the five domains of the MSC framework to rapid healthcare system change. We aimed to: i) evaluate implementation of rapid MSC, using England COVID-19 remote home monitoring services as a case study and ii) consider whether and how the MSC framework can be applied to rapid MSC.

Methods: A mixed-methods rapid evaluation in England, across 28 primary and secondary healthcare sites (October 2020-November 2021; data collection: 4 months). We conducted 126 interviews (5 national leads, 59 staff, 62 patients/carers) and surveyed staff (n = 292) and patients/carers (n = 1069). Service providers completed cost surveys. Aggregated and patient-level national datasets were used to explore enrolment, service use and clinical outcomes. The MSC framework was applied retrospectively. Qualitative data were analysed thematically to explore key themes within each MSC framework domain. Descriptive statistics and multivariate analyses were used to analyse experience, costs, service use and clinical outcomes.

Results: Decision to change/Decision on model: Service development happened concurrently: i) early local development motivated by urgent clinical need, ii) national rollout using standard operating procedures, and iii) local implementation and adaptation. Implementation approach: Services were tailored to local needs to consider patient, staff, organisational and resource factors. Implementation outcomes: Patient enrolment was low (59% services <10%). Service models and implementation approaches varied substantially. Intervention outcomes: No associations found between services and clinical outcomes. Patient and staff experiences were generally positive. However, barriers to delivery and engagement were found; with some groups finding it harder to engage.

Conclusions: Low enrolment rates and substantial variation due to tailoring services to local contexts meant it was not possible to conclusively determine service effectiveness. Process outcomes indicated areas of improvement. The MSC framework can be used to analyse rapid MSC. Implementation and factors influencing implementation may differ to non-rapid contexts (e.g. less uniformity, more tailoring). Our mixed-methods approach could inform future evaluations of large-scale rapid and non-rapid MSC in a range of conditions and services internationally.

Background: Methods of integrating qualitative data across diverse studies and within multi-site research consortia are less developed than those for integrating quantitative data. The development ofsuchmethods is essential to support the data exchange needed for cross-study qualitative inquiry and given the increasing emphasis on data sharing and open science. We describe methods for qualitative data integration within the National Cancer Institute's Improving the Management of symPtoms During And following Cancer Treatment (IMPACT) Consortium funded by the Cancer Moonshot^SM. Data collection and analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Our case study highlights potential solutions for unique challenges faced when integrating qualitative data across multiple settings in a research consortium.

Methods: The IMPACT consortium is comprised of three research centers (RCs) each conducting pragmatic trials examining the effectiveness of routine symptom management on patient-centered outcomes. After reaching consensus on use of CFIR as the common implementation determinant framework, RCs developed a semi-structured interview guide and tailored it to features of their healthcare setting and symptom management interventions. RCs conducted interviews/focus groups with healthcare system partners to examine contextual factors impacting implementation. RCs exchanged 1-2 transcripts (n = 5 total) for purposes of pilot testing the methodology.

Results: Given the heterogeneity of study settings and contexts, it was challenging to simultaneously assign codes at both domain and construct levels and the process was resource intensive. Recommendations include employing a common framework for data collection and analyses from the outset, coding at domain level first and then incorporating construct codes, and centralizing processes via a coordinating center (or similar entity) and combining coded transcripts using qualitative software. We also generated an iteratively refined codebook that employed the CFIR schema and incorporated CFIR 2.0 to provide detailed guidance for coders conducting cross-study qualitative inquiry.

Conclusions: Limited guidance exists on how to support qualitative data integration, data exchange, and sharing across multiple studies. This paper describes a systematic method for employing an implementation determinant framework-guided approach to foster data integration. This methodology can be adopted by other research consortia to support qualitative data integration, cross-site qualitative inquiry, and generate improved understanding of evidence-based intervention implementation.

Background: While facilitation is a widely used implementation strategy with proven effectiveness, the development of the facilitator-recipient relationship, i.e., working alliance, has received limited attention. However, we hypothesize that working alliance may be part of the mechanism by which facilitation activates change. This study aimed to examine the associations between working alliance, facilitation, and change in clinical care in a hybrid type 3 trial of a manualized intervention, Getting to Implementation (GTI).

Methods: This concurrent triangulation mixed-methods study was conducted at 12 sites in a stepped-wedge trial. We collected surveys using the Working Alliance Inventory-Short instrument (WAI), which includes three subscales of goal alignment, task alignment, and affective bond, from three respondent types (clinical facilitator, evaluation facilitator, and site team members) after a year of intervention. Facilitation activity type and dose were tracked. Summative qualitative interviews with site champions and facilitators) elicited perceptions on working alliance, facilitation, and experiences with the intervention, and results were triangulated with statistical bivariate analyses. The associations between WAI and facilitation time, fidelity, and change in liver cancer screening rate (the primary trial outcome) were assessed.

Results: Across 12 sites, facilitators and site team members completed 21 interviews and 40 WAI surveys, with site aggregate average working alliance scores of 5.9 ± 0.4 on a seven-point scale. Bond scores were highest (6.1 ± 0.5), followed by Goal (6.0 ± 0.4) and Task (5.8 ± 0.5) scores. Overall and subscale scores differed by respondent type, with site respondents consistently rating items higher than facilitators, particularly in Task items. Fidelity to the GTI process (e.g., timely completion of steps and tools) was significantly positively associated with WAI scores overall (r = 0.41, p = 0.007) and subscale scores, including Goal (r = 0.39, p = 0.011), Task (r = 0.42, p = 0.006), and Bond (r = 0.33, p = 0.039). WAI scores were not correlated with facilitation time (dose). WAI scores overall and the Bond and Goal scores were significantly positively associated with sustained improvement in cancer screening rates (r = 0.57, p = 0.015).

Conclusions: In this implementation trial, working alliance between site teams and facilitators was positively associated with both fidelity and cancer screening outcomes and was notably independent of time spent providing facilitation. Findings highlight the importance of working alliance in implementation studies.

Trial registration: This project was registered at ClinicalTrials.Gov ( NCT04178096 ) on 4/29/20.

Background: Local public health departments in the United States are responsible for implementing cancer-related programs and policies in their communities; however, many staff have not been trained to use evidence-based processes, and the organizational climate may be unsupportive of evidence-based processes. A promising approach to address these gaps is through academic-public health department (AHD) partnerships, in which practitioners and academics collaborate to improve public health practice and education through joint research projects and educational opportunities. Prior research has demonstrated the benefits of AHD partnerships to public health practice and education. However, knowledge about how AHD partnerships should be structured to support implementation of programs and policies is sparse.

Methods: This is a mixed methods, two-phase study, guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) Framework, in which AHD partnerships are a relational type of bridging factor. A positive deviance approach will be used to understand how AHD partnerships are best structured and supported. In the formative phase, we will survey academics and local health department staff (n = 500) to characterize AHD partnerships and understand contextual influences. We will conduct in-depth interviews with eight AHD partnerships (four high and four low engagement), to identify differences between high and low engagement partnerships. The second, experimental phase will be a paired group randomized trial with 28 AHD partnerships (n = 14 randomized to implementation arm and n = 14 to the control arm). A menu of strategies will be refined through survey and interview findings, literature, and our team's previous work. The trial will assess whether these strategies can be used to strengthen partnerships and improve adoption of cancer prevention and control programs and policies. We will evaluate changes in AHD partnership engagement and implementation of evidence-based programs and policies.

Discussion: This first-of-its-kind study will focus on collaborations that leverage complementary expertise of health department staff and academics to improve public health practice. Our results can impact the field by identifying new, sustainable models for how public health practitioners and academics can work together to meet common goals, increase the use of evidence-based programs and policies, and expand our understanding of bridging factors within the EPIS framework.

Trial registration: Prospective registered on 9/17/2024 at clinicaltrials.gov no. NCT06605196 ( https://clinicaltrials.gov/study/NCT06605196 ).

Background: Hospital-focused maternal health safety and quality guidelines have been found to reduce pregnancy-related and -associated morbidity and mortality (PRAMM). Unfortunately, quality of obstetric care can improve without affecting disparities. This project is the first controlled implementation trial to test approaches to implementing safety guidelines that: (1) target PRAMM disparities; and (2) focus on community care (care provided outside hospitals in outpatient and other community settings, and coordination among care settings), where most deaths occur. It is also one of the first to test scale-up or sustainment implementation approaches to addressing maternal morbidity and mortality disparities.

Methods: This project, one of three in the federally funded Multilevel Interventions for Raci.a.l Equity (MIRACLE) Maternal Health Research Center of Excellence, will develop and evaluate an implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide. The scale-up approach will be co-developed with partners, and then tested using a cluster randomized stepped-wedge trial of 12 Michigan counties with a total population of nearly 6 million. Randomization occurs at the county level; birthing people and providers are clustered within counties. PRAMM outcomes (individual level; primary) will be extracted from a pre-existing statewide linked dataset that includes Medicaid claims and vital records data. The sample will include all Medicaid insured individuals in the 12 counties observed during pregnancy, at birth, and up to 1 year postpartum during the project period (~ 151,920 births, including ~ 49,110 births to Black and/or Hispanic mothers). Implementation outcomes (provider level) will be collected using annual provider (n = 600) surveys and will include scale-up (penetration, reach, control for delivery, and intervention effectiveness at scale) and sustainment (maintenance of fidelity to core elements, health benefits, and capacity to deliver core elements over time) of bundles and cost-effectiveness of implementation approaches.

Discussion: This implementation trial will be the first to evaluate an implementation approach to scaling community health equity-focused maternal safety guidelines, addressing an understudied aspect of implementation science (i.e., scale-up). The study will also provide information about implementation cost-effectiveness needed to drive policy decisions.

Trial registration: The study was prospectively registered on Clinicaltrials.gov (NCT06541951) on August 6, 2024. The first participant has not yet been recruited. The url for the trial registration is: https://clinicaltrials.gov/study/NCT06541951?locStr=Flint,%20MI&country=United%20States&state=Michigan&city=Flint&rank=1 .

Background: Understanding factors affecting adoption of an innovation is critical to its long-term success. Maternity waiting homes (MWHs) increase access to facility-based delivery in low-resourced settings; yet, quality issues deter utilization of this innovative approach. We sought to understand how attributes that are thought to promote diffusion of innovations (e.g., relative advantage, compatibility, observability, complexity, etc.) affected MWH use after implementation of an improved quality MWH model in rural Zambia compared to standard of care.

Methods: We conducted 158 in-depth interviews (IDIs) with randomly selected rural-living women who had delivered a baby in the prior 12 months. Half lived in catchment areas where new quality MWHs were constructed, half in catchment areas with standard of care (ranging from low quality community structures to no MWH). We applied content analysis to identify themes.

Results: Utilization of MWHs was higher among intervention (65.4%) than control women (42.5%). Respondents in both study arms perceived relative advantages to pregnant women staying at MWHs compared to going directly to health facilities when labor begins. MWH stays allowed for clinical staff to routinely check on and educate women, and address complications immediately. Compatibility of the homes with cultural values and needs depended on implementation. While some women from intervention sites complained about overcrowding, women in control sites more often perceived the lack of cleanliness, amenities, and safety as deterrents to utilization. Women at intervention sites received sensitization about MWHs from a wider range of sources, including traditional leaders. Required preparations needed to stay at MWHs (e.g. delivery supplies, food, and childcare) made adoption complex and may have deterred utilization.

Conclusions: The improved MWH model addressed most community concerns around quality. Having opinion leaders who communicate the relative advantage of MWHs to pregnant women and their social networks may facilitate MWH utilization. The complexity of decisions and resources needed to stay at MWHs remains a critical barrier to use. To facilitate equitable adoption of MWHs among the most vulnerable women, planners should explore how to support women during their delivery preparations and MWH stays, particularly regarding food security and lack of social support for childcare.

Trial registration: clinicaltrials.gov, NCT02620436, Registered 02 December 2015, https://clinicaltrials.gov/study/NCT02620436?term=NCT02620436&rank=1.

Background: Variation in perioperative care persists globally. Consensus discussions may facilitate standardisation, yet the processes used to reach agreement are poorly understood. This study aimed to develop a model for conducting local consensus discussions when implementing standardised perioperative pathways. Specifically, we 1) describe how local consensus discussions are operationalised; 2) identify what guides decision making and consensus between clinicians; and 3) formulate explanatory mechanisms and identify determinants that facilitate consensus discussions.

Methods: A qualitative, modified grounded theory study was conducted in one private hospital in metropolitan Sydney, Australia. Thirty-one participants from clinical disciplines and hospital management/leadership were included. Data were collected from nine semi-structured interviews and 16 h of participant observations during consensus development or implementation meetings. Data collection and analysis occurred concurrently until theoretical saturation was achieved. Interviews and field notes were recorded and transcribed verbatim. Data were analysed using coding, constant comparison, detailed memo writing and data interpretation.

Results: Seven individual and contextual factors crucial for building consensus, and eight mechanisms for reaching agreement were identified and integrated into a conceptual model. Seeking evidence to support decision-making emerged as the primary driver of consensus. Strong research evidence in support of a pathway component facilitated swift agreement. Where there was ambiguous evidence for a pathway component, clinicians based their decisions on a desire for professional autonomy, consideration of how their peers practice, patient preferences, practices from external organisations, or the feasibility of implementing the pathway component.

Conclusions: The Consensus Model for Standardising Healthcare provides a map for healthcare organisations seeking to conduct local consensus discussions to reduce variation in care. Our findings advance our understanding of how local consensus discussions are conducted and factors that impact success when standardising care amongst clinicians.

Background: Initial Canadian federal regulations for the abortion pill, mifepristone, had the potential to impede safe and equitable access to this medication. To catalyze evidence-based regulatory change, we engaged health policy, health system, and health services decision makers, and health professional organizations in integrated knowledge translation (iKT), a research approach that engages the users of research as equal partners.

Methods: We conducted a realist evaluation of what iKT strategies worked, for whom, and in what context to impact federal mifepristone regulations. We constructed initial program theories (if-then statements about how iKT worked). We tested the initial program theories using interviews with researchers and knowledge partners and triangulated with analysis of research programme documents. We configured the evidence in relation to the initial program theories, and refined program theories into causal explanatory configurations.

Results: We analyzed 38 interviews with researchers, health professional leaders, advocacy group leaders, and administrative government policy makers, as well as 49 program documents. Our results indicated that researcher partnerships with stakeholders had a meaningful impact on the removal of restrictions. We found key components of the causal explanatory configurations included: researcher motivation to move evidence into action, trusted reputations as credible sources of evidence, strategic partnerships, understanding of health policy processes, and researcher roles as a trusted convenor between key groups and decision makers.

Conclusions: Our study identifies several practical and transferable approaches to impactful iKT. The findings may be of relevance to researchers focused on public health topics subject to stigma.