Multifaceted Implementation Research Articles

Applying the Cognitive Walkthrough for Implementation Strategies methodology to inform the redesign of a selection-quality implementation toolkit for use in schools.

Implementation strategies are key to enhancing thetranslation of new innovations but there is a need to systematically design and tailor strategies to match the targeted implementation context and address determinants. There are increasing methods to inform the development and tailoring of implementation strategies to maximize their usability, feasibility, and appropriateness in new settings such as the Cognitive Walkthrough for Implementation Strategies (CWIS) approach. The aim of the current project is to apply the CWIS approach to inform the redesign of a multifaceted selection-quality implementation toolkit entitled Adoption of Curricular supports Toolkit: Systematic Measurement of Appropriateness and Readiness for Translation in Schools (ACT SMARTS) for use in middle and high schools. We systematically applied CWIS as the second part of a community-partnered iterative redesign of ACT SMARTS for schools to evaluate the usability and inform further toolkit redesign areas. We conducted three CWIS user testing sessions with key end users of school district administrators (n = 3), school principals (n = 6), and educators (n = 6). Our CWIS application revealed that end users found ACT SMARTS acceptable and relevant but anticipate usability issues engaging in the ACT SMARTS process. Results informed the identification of eleven usability issues and corresponding redesign solutions to enhance the usability of ACT SMARTS for use in middle and high schools. Results indicated the utility of CWIS in assessing implementation strategy usability in service of informing strategy modification as part of our broader redesign to improve alignment with end user, end recipient, and setting needs. Recommendations regarding the use of this participatory approach are discussed.

Multifaceted implementation strategy to improve the evaluation of penicillin allergies in perioperative patients: a pre-post feasibility implementation study.

The U.S. Centers for Disease Control and Prevention encourages nurses to evaluate penicillin allergies as part of hospital-based antibiotic stewardship programs. We evaluated the feasibility of an implementation strategy to improve nurses' comprehensive documentation of penicillin allergies. We defined feasibility as the uptake and acceptability of documentation procedures. Six-month pre-post feasibility implementation study. Outpatient surgical areas of an academic medical center located in the U.S. The implementation strategy was guided by the Capability, Opportunity, Motivation Model for Behavior Change and included, building an interdisciplinary coalition to iteratively evaluate the implementation effort, educational meetings with surgical prescribers and perioperative nurses, the development and distribution of educational pocket cards, and structured communication messages in the electronic medical record. A total of 426 patients with 487 penicillin allergy records (216 records pre-implementation period, 271 records post-implementation period) were analyzed. Penicillin allergy documentation contained the following information in the pre- versus post-implementation period: symptoms of the reaction (87% vs 87%), timing/years since reaction (8% vs 26%), onset of reaction in relation to taking penicillin (0% vs 21%), how symptoms resolved (0% vs 21%), and penicillin re-exposure (3% vs 21%). Focus groups revealed nurses perceived documentation procedures as highly acceptable. Major drivers of acceptability included the perceived effectiveness of a detailed allergy history and self-efficacy in conducting a detailed allergy history. Nurses perceived the comprehensive documentation of penicillin allergy history intervention as acceptable, and uptake improved following a theory-informed implementation strategy. We offer implementation strategy components to facilitate nurses' engagement in penicillin allergy evaluation.

Improving the Use of Sensory Approaches in an Acute Inpatient Mental Health Unit Using a Co-Designed Multifaceted Implementation Strategy.

Despite the therapeutic benefits of sensory approaches being well documented, little research has focused on improving their implementation in acute mental health units. The use of implementation frameworks to improve the use of evidence-based practices has shown promising results in healthcare; however, there is little evidence for their use in acute mental health units. A pre-post comparison design was used to determine the effect of an 11-month co-designed theory-informed multifaceted implementation strategy on the use of sensory approaches and the use of seclusion/restraint in one acute mental health ward. This study was guided by Integrated Knowledge Translation (IKT) and informed by the Behaviour Change Wheel (BCW) approach. Implementation strategies were co-designed and included provision of sensory materials/resources; education/training; prompts/reminders; modelling; audit and feedback; workplace coalition; and facilitation. Data were collected through pre- and post-project questionnaires (pre- n = 37, post- n = 40) and routine clinical data. Data were analysed using SPSS and thematic analysis. Data for matched pairs (n = 19) revealed significant improvements between pre- and post-perceived levels of knowledge and confidence in using sensory approaches. Significant increases were found in the use of sensory kits, weighted modalities and sensory assessment/plans. Post participants' recommendations to sustain the use of sensory approaches in their unit included ongoing training; funding; maintenance and supply of sensory equipment; increased staffing; and support from colleagues. This is the first study to use the IKT and BCW to design, facilitate and evaluate a co-designed, theory-informed implementation strategy to improve the use of sensory approaches in an acute mental health unit.

Use of implementation mapping to develop a multifaceted implementation strategy for an electronic prospective surveillance model for cancer rehabilitation

BackgroundElectronic Prospective Surveillance Models (ePSMs) remotely monitor the rehabilitation needs of people with cancer via patient-reported outcomes at pre-defined time points during cancer care and deliver support, including links to self-management education and community programs, and recommendations for further clinical screening and rehabilitation referrals. Previous guidance on implementing ePSMs lacks sufficient detail on approaches to select implementation strategies for these systems. The purpose of this article is to describe how we developed an implementation plan for REACH, an ePSM system designed for breast, colorectal, lymphoma, and head and neck cancers.MethodsImplementation Mapping guided the process of developing the implementation plan. We integrated findings from a scoping review and qualitative study our team conducted to identify determinants to implementation, implementation actors and actions, and relevant outcomes. Determinants were categorized using the Consolidated Framework for Implementation Research (CFIR), and the implementation outcomes taxonomy guided the identification of outcomes. Next, determinants were mapped to the Expert Recommendations for Implementing Change (ERIC) taxonomy of strategies using the CFIR-ERIC Matching Tool. The list of strategies produced was refined through discussion amongst our team and feedback from knowledge users considering each strategy’s feasibility and importance rating via the Go-Zone plot, feasibility and applicability to the clinical contexts, and use among other ePSMs reported in our scoping review.ResultsOf the 39 CFIR constructs, 22 were identified as relevant determinants. Clinic managers, information technology teams, and healthcare providers with key roles in patient education were identified as important actors. The CFIR-ERIC Matching Tool resulted in 50 strategies with Level 1 endorsement and 13 strategies with Level 2 endorsement. The final list of strategies included 1) purposefully re-examine the implementation, 2) tailor strategies, 3) change record systems, 4) conduct educational meetings, 5) distribute educational materials, 6) intervene with patients to enhance uptake and adherence, 7) centralize technical assistance, and 8) use advisory boards and workgroups.ConclusionWe present a generalizable method that incorporates steps from Implementation Mapping, engages various knowledge users, and leverages implementation science frameworks to facilitate the development of an implementation strategy. An evaluation of implementation success using the implementation outcomes framework is underway.

Implementation of an electronic prospective surveillance model for cancer rehabilitation: a mixed methods study protocol

IntroductionAn electronic prospective surveillance model (ePSM) uses patient-reported outcomes to monitor impairments along the cancer pathway for timely management. Randomised controlled trials show that ePSMs can effectively manage cancer-related impairments....

Strengthening China’s National Essential Public Health Services Package for hypertension and diabetes care: protocol for an interrupted time series study with mixed-methods process evaluation and health economic evaluation

BackgroundDespite major primary health care (PHC) reforms in China with the 2009 launch of the National Essential Public Health Service Package, the country experiences many challenges in improving the management of non-communicable diseases in PHC facilities. “EMERALD” is a multifaceted implementation strategy to strengthen the management of hypertension and type-2 diabetes mellitus (T2DM) in PHC facilities. The study aims to: (1) examine the effectiveness of EMERALD in improving hypertension and T2DM management; (2) evaluate the implementation of the interventions; and (3) use the study findings to model the long-term health economic impact of the interventions.MethodsThe EMERALD intervention components include: (1) empowerment for PHC providers through training and capacity building; (2) empowerment for patient communities through multi-media health education; and (3) empowerment for local health administrators through health data monitoring and strengthening governance of local PHC programs. An interrupted time series design will be used to determine the effectiveness of the interventions based on routinely collected health data extracted from local health information systems. The primary effectiveness outcome is the guideline-recommended treatment rates for people with hypertension and T2DM. Secondary effectiveness outcomes include hypertension and T2DM diagnosis and control rates, and enrolment and adherence rates to the recommended care processes in the National Essential Public Health Service Package. A mixed-methods process evaluation will be conducted to evaluate the implementation of the interventions, including the reach of the target population, adequacy of adoption, level of implementation fidelity, and maintenance. Qualitative interviews with policy makers, health administrators, PHC providers, and patients with hypertension and/or T2DM will be conducted to further identify factors influencing the implementation. In addition, health economic modelling will be performed to explore the long-term incremental costs and benefits of the interventions.DiscussionThis study is expected to generate important evidence on the effectiveness, implementation, and health economic impact of complex PHC interventions to strengthen the primary care sector’s contribution to addressing the growing burden of non-communicable diseases in China.Trial registrationThe study has been registered on Chinese Clinical Trial Registry at https://www.chictr.org.cn/ (Registration number ChiCTR2400082036, on March 19th 2024).

Data-Driven Implementation Strategy to Optimise Clinician Behaviour Change at Scale in Complex Clinical Environments: A Multicentre Emergency Care Study.

To develop an evidence-driven, behaviour change focused strategy to maximise implementation and uptake of HIRAID (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, communication and reassessment) in 30 Australian rural, regional and metropolitan emergency departments. An embedded, mixed-methods study. This study is the first phase of a step-wedge cluster randomised control trial of HIRAID involving over 1300 emergency nurses. Concurrent quantitative and qualitative data were collected via an electronic survey sent to all nurses to identify preliminary barriers and enablers to HIRAID implementation. The survey was informed by the Theoretical Domains Framework, which is a synthesis of behavioural change theories that applies the science of intervention implementation in health care to effect change. Quantitative data were analysed using descriptive statistics and qualitative data with inductive content analysis. Data were then integrated to generate barriers and enablers to HIRAID implementation which were mapped to the Theoretical Domains Framework. Corresponding intervention functions and Behaviour Change techniques were selected and an overarching implementation strategy was developed through stakeholder consultation and application of the APEASE criteria (Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Side-effects/safety and Equity). Six barriers to HIRAID implementation were identified by 670 respondents (response rate ~58%) representing all 30 sites: (i) lack of knowledge about HIRAID; (ii) high workload, (iii) lack of belief anything would change; (iv) not suitable for workplace; (v), uncertainty about what to do and (vi) lack of support or time for education. The three enablers were as follows: (i) willingness to learn and adopt something new; (ii) recognition of the need for something new and (iii) wanting to do what is best for patient care. The 10 corresponding domains were mapped to seven intervention functions, 21 behaviour change techniques and 45 mechanisms. The major components of the implementation strategy were a scaffolded education programme, clinical support and environmental modifications. A systematic process guided by the behaviour change wheel resulted in the generation of a multifaceted implementation strategy to implement HIRAID across rural, regional and metropolitan emergency departments. Implementation fidelity, reach and impact now require evaluation. HIRAID emergency nursing assessment framework reduced clinical deterioration relating to emergency care and improved self-confidence and documentation in emergency departments in pilot studies. Successful implementation of any intervention in the emergency department is notoriously difficult due to workload unpredictability, the undifferentiated nature of patients and high staff turnover. Key barriers and enablers were identified, and a successful implementation strategy was developed. This study uses theoretical frameworks to identify barriers and enablers to develop a data-driven, behavioural-focused implementation strategy to optimise the uptake of HIRAID in geographically diverse emergency departments which can be used to inform future implementation efforts involving emergency nurses. The CROSS reporting method (Supporting Information S3) was used to adhere to EQUATOR guidelines. No Patient or Public Contribution. Australian New Zealand; Clinical Trials Registry (ANZCTR) number: ACTRN12621001456842, registered 25/10/2021.

Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned.

In 2019, Indiana University launched the Precision Health Initiative to enhance the institutional adoption of precision medicine, including pharmacogenetics (PGx) implementation, at university-affiliated practice sites across Indiana. The overarching goal of this PGx implementation program was to facilitate the sustainable adoption of genotype-guided prescribing into routine clinical care. To accomplish this goal, we pursued the following specific objectives: (i) to integrate PGx testing into existing healthcare system processes; (ii) to implement drug-gene pairs with high-level evidence and educate providers and pharmacists on established clinical management recommendations; (iii) to engage key stakeholders, including patients to optimize the return of results for PGx testing; (iv) to reduce health disparities through the targeted inclusion of underrepresented populations; (v) and to track third-party reimbursement. This tutorial details our multifaceted PGx implementation program, including descriptions of our interventions, the critical challenges faced, and the major program successes. By describing our experience, we aim to assist other clinical teams in achieving sustainable PGx implementation in their health systems.

Promoting the implementation of a computer-tailored physical activity intervention: development and feasibility testing of an implementation intervention

BackgroundAlthough there are many proven effective physical activity (PA) interventions for older adults, implementation in a real world setting is often limited. This study describes the systematic development of a multifaceted implementation intervention targeting the implementation of an evidence-based computer-tailored PA intervention and evaluates its use and feasibility.MethodsThe implementation intervention was developed following the Intervention Mapping (IM) protocol, supplemented with insights from implementation science literature. The implementation intervention targets the municipal healthcare policy advisors, as an important implementation stakeholder in Dutch healthcare system. The feasibility of the implementation intervention was studied among these stakeholders using a pretest–posttest design within 8 municipal healthcare settings. Quantitative questionnaires were used to assess task performance (i.e. achievement of performance objectives), and utilization of implementation strategies (as part of the intervention). Furthermore, changes in implementation determinants were studied by gathering quantitative data before, during and after applying the implementation intervention within a one-year period. Additionally, semi-structured interviews with stakeholders assessed their considerations regarding the feasibility of the implementation intervention.ResultsA multi-faceted implementation intervention was developed in which implementation strategies (e.g. funding, educational materials, meetings, building a coalition) were selected to target the most relevant identified implementation determinants. Most implementation strategies were used as intended. Execution of performance objectives for adoption and implementation was relatively high (75–100%). Maintenance objectives were executed to a lesser degree (13–63%). No positive changes in implementation determinants were found. None of the stakeholders decided to continue implementation of the PA intervention further, mainly due to the unforeseen amount of labour and the disappointing reach of end-users.ConclusionThe current study highlights the importance of a thorough feasibility study in addition to the use of IM. Although feasibility results may have demonstrated that stakeholders broadly accepted the implementation intervention, implementation determinants did not change favorably, and stakeholders had no plans to continue the PA intervention. Yet, choices made during the development of the implementation intervention (i.e. the operationalization of Implementation Mapping) might not have been optimal. The current study describes important lessons learned when developing an implementation intervention, and provides recommendations for developers of future implementation interventions.

Applying the Cognitive Walkthrough for Implementation Strategies Methodology to Inform the Redesign of a Selection-Quality Implementation Toolkit for Use in Schools.

Implementation strategies are key to enhancing translation of new innovations but there is a need to systematically design and tailor strategies to match the targeted implementation context and address determinants. There are increasing methods to inform the redesign and tailoring of implementation strategies to maximize their usability, feasibility, and appropriateness in new settings such as the Cognitive Walkthrough for Implementation Strategies (CWIS) approach. The aim of the current project is to apply the CWIS approach to inform the redesign of a multifaceted selection-quality implementation toolkit entitled ACT SMARTS for use in middle and high schools. We systematically applied CWIS as the second part of a community-partnered iterative redesign of ACT SMARTS for schools to evaluate the usability and inform further toolkit redesign areas. We conducted three CWIS user testing sessions with key end users of school district administrators, school principals, and educators. Our CWIS application revealed that end users found ACT SMARTS acceptable and relevant but anticipate usability issues engaging in the ACT SMARTS process. Results informed the identification of eleven usability issues and corresponding redesign solutions to enhance the usability of ACT SMARTS for use in middle and high schools. Results indicated the utility of CWIS in assessing implementation strategy usability in service of informing strategy tailoring and redesign to improve alignment with user and setting needs. Recommendations regarding the use of this participatory approach are discussed.

Effectiveness of a Multifaceted Implementation Strategy to Increase Equitable Hospital at Home Utilization: An Interrupted Time Series Analysis.

The number of Hospital-at-Home (HaH) programs rapidly increased during the COVID-19 pandemic and after issuance of Centers for Medicare and Medicaid Services' (CMS) Acute Hospital Care at Home (AHCaH) waiver. However, there remains little evidence on effective strategies to equitably expand HaH utilization. Evaluate the effects of a multifaceted implementation strategy on HaH utilization over time. Before and after implementation evaluation using electronic health record (EHR) data and interrupted time series analysis, complemented by qualitative interviews with key stakeholders. Between December 2021 and December 2022, we identified adults hospitalized at six hospitals in North Carolina approved by CMS to participate in the AHCaH waiver program. Eligible adults met criteria for HaH transfer (HaH-eligible clinical condition, qualifying home environment). We conducted semi-structured interviews with 12 HaH patients and 10 referring clinicians. Two strategies were studied. The discrete implementation strategy (weeks 1-12) included clinician-directed educational outreach. The multifaceted implementation strategy (weeks 13-54) included ongoing clinician-directed educational outreach, local HaH assistance via nurse navigators, involvement of clinical service line executives, and individualized audit and feedback. We assessed weekly averaged HaH capacity utilization, weekly counts of unique referring providers, and patient characteristics. We analyzed themes from qualitative data to determine barriers and facilitators to HaH use. Our evaluation showed week-to-week increases in HaH capacity utilization during the multifaceted implementation strategy period, compared to discrete-period trends (slope-change odds ratio-1.02, 1.01-1.04). Counts of referring providers also increased week to week, compared to discrete-period trends (slope-change means ratio-1.05, 1.03-1.07). The increase in HaH utilization was largest among rural residents (11 to 34%). Barriers included HaH-related information gaps and referral challenges; facilitators included patient-centeredness of HaH care. A multifaceted implementation strategy was associated with increased HaH capacity utilization, provider adoption, and patient diversity. Health systems may consider similar, contextually relevant multicomponent approaches to equitably expand HaH.

Multifaceted Implementation Strategy to Improve the Comprehensive Assessment of Penicillin Allergies in Perioperative Patient

Background: The CDC recommends that nurses improve the evaluation of penicillin allergies as part of antimicrobial stewardship programs. We evaluated the feasibility of a multifaceted implementation strategy to improve nurses’ documentation of penicillin allergy histories and to encourage nurses to notify prescribers of patients with low-risk symptoms of reported penicillin allergy. The implementation strategy was guided by the COM-B model of behavior change and addressed nurses’ capability, opportunity, and motivation to implement practices (Figure 1). The implementation strategy included education on the STORY mnemonic that details the questions of a penicillin allergy history, education on low-risk symptoms of penicillin allergy, dot phrases in EPIC to facilitate nurses’ documentation of STORY and communication of patients with low-risk penicillin allergy symptoms, and educational pocket cards and flyers. We define feasibility as the implementation and acceptability of practices. Methods: This was a six-month feasibility study conducted in an outpatient perioperative area. We compared penicillin allergy documentation pre- and post- implementation strategy and report on nurses’ notification of prescribers regarding patients with low-risk penicillin allergies in the post-implementation period. We engaged nurses in a focus group to assess factors that facilitated or hindered practice adoption. Results: A total of 426 unique patients with 482 penicillin allergy records were included in our study (n= 207 records pre-implementation, n = 275 records post-implementation). We found little to no change in the percentage of records that included symptom information post vs. pre-implementation (88.36% vs 88.41%). A greater percentage of allergy records in the post vs. pre-implementation periods included information on: timing/years since reaction (25.6% vs. 8.2%), onset of reaction (20.7% vs. 0%), resolution of symptoms (20.4% vs. 0%), and penicillin re-exposure (21.1% vs. 2.4%). There were 24 documented instances of nurses’ notifying prescribers of patients with a low-risk penicillin allergy. Focus group data revealed nurses perceived their comprehensive documentation of penicillin allergies highly acceptable and likely to improve patient care and outcomes. Whereas nurses’ notification of prescribers concerning patients meeting low-risk penicillin allergy criteria had little appeal. Nurses described the STORY mnemonic, pocket cards describing the penicillin allergy assessment mnemonic, and the associated dot phrase in EPIC as particularly helpful. Conclusions: A multifaceted implementation strategy showed promise in improving the comprehensive documentation of penicillin allergy histories. Future studies are needed to determine the efficacy of the multifaceted implementation strategy on penicillin allergy documentation, the selection of antibiotic prophylactic treatment, and clinical outcomes among surgical patients.

Economic Disparities in Utilization and Outcomes of Structural Heart Disease Interventions in the United States

BackgroundDisparities in access to care cause negative health consequences for underserved populations. Economic disparities in structural heart disease (SHD) interventions are not well characterized. ObjectivesThe objective of this study was to evaluate economic disparities in the utilization and outcomes of SHD interventions in the United States. MethodsWe queried the National Inpatient Sample (2016-2020) to examine economic disparities in the utilization, in-hospital outcomes, length of stay, and cost of SHD interventions among patients ≥65 years of age. Outcomes were determined using logistic regression models. ResultsA total of 401,005 weighted hospitalizations for transcatheter aortic valve replacement, left atrial appendage occlusion, transcatheter mitral valve repair, and transcatheter mitral valve replacement were included. Utilization rates (number of procedures performed per 100,000 hospitalizations) were higher in patients with high income compared with medium and low income for transcatheter aortic valve replacement (559 vs 456 vs 338), left atrial appendage occlusion (148 vs 136 vs 99), transcatheter mitral valve repair (65 vs 54 vs 41), and transcatheter mitral valve replacement (7.7 vs 6.7 vs 1.2) (all P < 0.01). Low- and medium-income patients had distinctive demographic and clinical risk profiles compared with high-income patients. There were no significant differences in the adjusted in-hospital mortality, key complications, or length of stay between high-, medium-, and low-income patients following any of the 4 SHD interventions. High-income patients incurred a modestly higher cost with any of the 4 SHD interventions compared with medium- and low-income patients. ConclusionsEconomic disparities exist in the utilization of SHD interventions in the United States. Nonetheless, adjusted in-hospital outcomes were comparable among high-, medium-, and low-income patients. Multifaceted implementation strategies are needed to attenuate these utilization disparities.

Optimization of implementation strategies using the Multiphase Optimization STratgey (MOST) framework: Practical guidance using the factorial design.

The Multiphase Optimization STrategy (MOST) is a framework that uses three phases-preparation, optimization, and evaluation-to develop multicomponent interventions that achieve intervention EASE by strategically balancing Effectiveness, Affordability, Scalability, and Efficiency. In implementation science, optimization of the intervention requires focus on the implementation strategies-things that we do to deliver the intervention-and implementation outcomes. MOST has been primarily used to optimize the components of the intervention related to behavioral or health outcomes. However, innovative opportunities to optimize discrete (i.e. single strategy) and multifaceted (i.e. multiple strategies) implementation strategies exist and can be done independently, or in conjunction with, intervention optimization. This article details four scenarios where the MOST framework and the factorial design can be used in the optimization of implementation strategies: (i) the development of new multifaceted implementation strategies; (ii) evaluating interactions between program components and a discrete or multifaceted implementation strategies; (iii) evaluating the independent effects of several discrete strategies that have been previously evaluated as a multifaceted implementation strategy; and (iv) modification of a discrete or multifaceted implementation strategy for the local context. We supply hypothetical school-based physical activity examples to illustrate these four scenarios, and we provide hypothetical data that can help readers make informed decisions derived from their trial data. This manuscript offers a blueprint for implementation scientists such that not only is the field using MOST to optimize the effectiveness of an intervention on a behavioral or health outcome, but also that the implementation of that intervention is optimized.

Evaluation of a multifaceted implementation strategy for semi-automated surveillance of surgical site infections after total hip or knee arthroplasty: a multicentre pilot study in the Netherlands

IntroductionTo promote the nation-wide implementation of semi-automated surveillance (AS) of surgical site infection after hip and knee arthroplasty, the Dutch National Institute for Public Health and the Environment (RIVM) deployed a decentralised multifaceted implementation strategy. This strategy consisted of a protocol specifying minimum requirements for an AS system, supported by a user manual, education module, individual guidance for hospitals and user-group meetings. This study describes an effect evaluation and process evaluation of the implementation strategy for AS in five frontrunner hospitals.MethodsTo evaluate the effect of the implementation strategy, the achieved phase of implementation was determined in each frontrunner hospital at the end of the study period. The process evaluation consisted of (1) an evaluation of the feasibility of strategy elements, (2) an evaluation of barriers and facilitators for implementation and (3) an evaluation of the workload for implementation. Interviews were performed as a basis for a subsequent survey quantifying the results regarding the feasibility as well as barriers and facilitators. Workload was self-monitored per profession. Qualitative data were analysed using a framework analysis, whereas quantitative data were analysed descriptively.ResultsOne hospital finished the complete implementation process in 240 person-hours. Overall, the elements of the implementation strategy were often used, positively received and overall, the strategy was rated effective and feasible. During the implementation process, participants perceived the relative advantage of AS and had sufficient knowledge about AS. However, barriers regarding complexity of AS data extraction, data-infrastructure, and validation, lack of capacity and motivation at the IT department, and difficulties with assigning roles and responsibilities were experienced.ConclusionA decentralised multifaceted implementation strategy is suitable for the implementation of AS in hospitals. Effective local project management, including clear project leadership and ownership, obtaining commitment of higher management levels, active involvement of stakeholders, and appropriate allocation of roles and responsibilities is important for successful implementation and should be facilitated by the implementation strategy. Sufficient knowledge about AS, its requirements and the implementation process should be available among stakeholders by e.g. an education module. Furthermore, exchange of knowledge and experiences between hospitals should be encouraged in user-group meetings.

Randomized trial of the leadership and organizational change for implementation (LOCI) strategy in substance use treatment clinics

IntroductionEvidence-based practice (EBP) implementation represents a strategic change that requires alignment of leadership and support throughout organizations. Leadership and Organizational Change for Implementation (LOCI) is a multifaceted implementation strategy that aims to improve implementation leadership and climate within organizations through iterative cycles of leadership and climate assessment and feedback, leadership training and coaching, and strategic planning with upper-level leaders. This study tested the effects of LOCI on transformational and implementation leadership, implementation climate, implementation citizenship behavior, and EBP reach. MethodsA multiple cohort, cluster randomized trial tests the effect of LOCI in 60 clinics across nine behavioral health organizations in California and Arizona, USA. The study randomized clinics within organizations to either LOCI or a leadership training webinar control condition in three consecutive cohorts. Repeated web-based surveys of direct service providers (nLOCI = 201, nControl = 179) assessed leadership, implementation climate, and implementation citizenship over time. Multilevel autoregressive modeling was the primary statistical analysis such that providers (level-1) were nested within clinics (level-2). The study predicted between-condition differences at 4-, 8-, and 12-month follow-up assessments. Provider engagement in a fidelity monitoring process assessed reach of motivational interviewing (i.e., number of sessions recorded/submitted for fidelity coding). An independent sample t-test explored between condition differences in motivational interviewing reach. ResultsResults indicated between condition differences at 4 months for implementation leadership, implementation climate, and implementation citizenship behavior such that greater improvements were evidenced in the LOCI condition compared to the control condition. Reach of MI was significantly greater in the LOCI vs control condition such that LOCI providers were significantly more likely to engage in the fidelity monitoring process (chi-square (1, n = 370) = 5.59, p = .018). ConclusionsLOCI was developed based on organizational theories of strategic leadership and climate to affect organizational change processes that communicate that innovation implementation is expected, supported, and recognized as a value of the organization. The LOCI implementation strategy resulted in more positive hypothesized outcomes compared to the control condition. Organizational change strategies have utility for implementing health innovations in complex, multilevel contexts and for greater sustainment of facilitative leader behaviors, strategic implementation climate, and improved implementation outcomes. Trial registrationThis study is registered with Clinicaltrials.gov gov (NCT03042832, 2 February 2017; retrospectively registered).

Evaluating a multifaceted implementation strategy and package of evidence-based interventions based on WHO PEN for people living with HIV and cardiometabolic conditions in Lusaka, Zambia: protocol for the TASKPEN hybrid effectiveness-implementation stepped wedge cluster randomized trial

BackgroundDespite increasing morbidity and mortality from non-communicable diseases (NCD) globally, health systems in low- and middle-income countries (LMICs) have limited capacity to address these chronic conditions, particularly in sub-Saharan Africa (SSA). There is an urgent need, therefore, to respond to NCDs in SSA, beginning by applying lessons learned from the first global response to any chronic disease—HIV—to tackle the leading cardiometabolic killers of people living with HIV (PLHIV). We have developed a feasible and acceptable package of evidence-based interventions and a multi-faceted implementation strategy, known as “TASKPEN,” that has been adapted to the Zambian setting to address hypertension, diabetes, and dyslipidemia. The TASKPEN multifaceted implementation strategy focuses on reorganizing service delivery for integrated HIV-NCD care and features task-shifting, practice facilitation, and leveraging HIV platforms for NCD care. We propose a hybrid type II effectiveness-implementation stepped-wedge cluster randomized trial to evaluate the effects of TASKPEN on clinical and implementation outcomes, including dual control of HIV and cardiometabolic NCDs, as well as quality of life, intervention reach, and cost-effectiveness.MethodsThe trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor’s Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM.DiscussionFindings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).

Application of the FRAME-IS to a multifaceted implementation strategy

BackgroundResearch demonstrates the importance of documenting adaptations to implementation strategies that support integration of evidence-based interventions into practice. While studies have utilized the FRAME-IS [Framework for Reporting Adaptations and Modifications for Implementation Strategies] to collect structured adaptation data, they are limited by a focus on discrete implementation strategies (e.g., training), which do not reflect the complexity of multifaceted strategies like practice facilitation. In this paper, we apply the FRAME-IS to our trial evaluating the effectiveness of PF on implementation fidelity of an evidence-based technology-facilitated team care model for improved hypertension control within a federally qualified health center (FQHC).MethodsThree data sources are used to document adaptations: (1) implementation committee meeting minutes, (2) narrative reports completed by practice facilitators, and (3) structured notes captured on root cause analysis and Plan-Do-Study-Act worksheets. Text was extracted from the data sources according to the FRAME-IS modules and inputted into a master matrix for content analysis by two authors; a third author conducted member checking and code validation.ResultsWe modified the FRAME-IS to include part 2 of module 2 (what is modified) to add greater detail of the modified strategy, and a numbering system to track adaptations across the modules. This resulted in identification of 27 adaptations, of which 88.9% focused on supporting practices in identifying eligible patients and referring them to the intervention. About half (52.9%) of the adaptations were made to modify the context of the PF strategy to include a group-based format, add community health workers to the strategy, and to shift the implementation target to nurses. The adaptations were often widespread (83.9%), affecting all practices within the FQHC. While most adaptations were reactive (84.6%), they resulted from a systematic process of reviewing data captured by multiple sources. All adaptations included the FQHC in the decision-making process.ConclusionWith modifications, we demonstrate the ability to document our adaptation data across the FRAME-IS modules, attesting to its applicability and value for a range of implementation strategies. Based on our experiences, we recommend refinement of tracking systems to support more nimble and practical documentation of iterative, ongoing, and multifaceted adaptations.Trial registrationClinicaltrials.gov NCT03713515, Registration date: October 19, 2018.

Overcoming Barriers to Collaborative Team Practice: A System Approach.

All healthcare systems are challenged to provide sufficient access to appropriate care for the individuals and communities they serve. Among the commonly discussed interventions in an era of clinical shortages is the establishment of team-based care, where team members can practice at the top of their license. This solution ensures that talent and ability are amplified. However, this vision has been thwarted by several barriers. Recognizing that complex causes prevent team-based care, CommonSpirit Health leadership has embarked on a multifaceted implementation of tactics to mitigate the barriers. The strategy addresses issues ranging from regulations, laws, and payment practices to a lack of knowledge and understanding between professions. A combination of solutions, rather than discrete tactics, holds the key to the system's strategy. The complement of actions put in place at CommonSpirit Health has included new executive roles, dyad leadership models, shared multidisciplinary education, targeted advocacy, best practice playbooks, and the flexibility to individualize local models as part of the journey to a more effective and efficient model of care.

Developing ACTIVE SCHOOL—The Design Process for Two School-Based Physical Activity Interventions

ABSTRACT Introduction Physical activity (PA) interventions in schools can improve children’s overall PA levels and positively affect academic performance. However, implementing PA during the school day can be challenging in the complex school setting. Many school-based PA studies do not present their interventions’ design processes, although this knowledge is important to replicate the intervention. Purpose This article aims to provide insights into the collaborative design process of the two PA interventions for third-grade pupils of the ACTIVE SCHOOL project. The evidence-based interventions focus on PA integrated into academic content (Move &amp; Learn intervention) as embodied learning or PA as moderate to vigorous activity performed during the school day (Run, Jump &amp; Fun intervention). The study’s objective was to engage teachers and pedagogues early in the design process to ensure the design was tailored to practice. Methods A team consisting of researchers, school staff, and experts were involved in the design process. The process lasted one school year and comprised three phases: exploration and analysis, construction and design, and reflection and evaluation. Multiple methods were used, including focus group interviews, a design workshop, and observations of iterative in-school testing. Results The result of the analysis and exploration phase was a set of learning points based on information about school culture, school staff competences, and needs. The design and construction phase produced a set of intervention skeletons, which were the actual elements of the interventions. The evaluation and reflection phase created the main results, which are specific principles and multifaceted implementation strategies for Move &amp; Learn and Run, Jump &amp; Fun, respectively. Finally, dose and timing of the interventions were specified. Conclusion Collaboration with schools and an iterative approach were determinants for designing interventions appropriate to the Danish school context and school staff practice.