Background: Implementation support practitioners (ISPs) are professionals that support others to implement evidence-informed practices, programs, and policies in various service delivery settings to achieve population outcomes. Measuring the use of competencies by ISPs provides a unique opportunity to assess an understudied facet of implementation science-how knowledge, attitudes, and skills used by ISPs affects sustainable change in complicated and complex service systems. This study describes the development and validation of a measure-the Implementation Support Competencies Assessment (ISCA)-that assesses implementation support competencies, with versatile applications across service contexts.
Methods: Recently developed practice guide materials included operationalizations of core competencies for ISPs across three domains: co-creation and engagement, ongoing improvement, and sustaining change. These operationalizations, in combination with recent empirical and conceptual work, provided an initial item pool and foundation on which to advance measurement development, largely from a confirmatory perspective (as opposed to exploratory). The measure was further refined through modified cognitive interviewing with three highly experienced ISPs and pilot-testing with 39 individuals enrolled in a university-based certificate program in implementation practice. To recruit a sample for validation analyses, we leveraged a listserv of nearly 4,000 individuals who have registered for or expressed interest in various events and trainings focused on implementation practice offered by an implementation science collaborative housed within a research-intensive university in the Southeast region of the United States. Our final analytic sample included 357 participants who self-identified as ISPs.
Results: Assessments of internal consistency reliability for each competency-specific item set yielded evidence of strong reliability. Results from confirmatory factor analyses provided evidence for the factorial and construct validity of all three domains and associated competencies in the ISCA.
Conclusions: The findings suggest that one's possession of high levels of competence across each of the three competency domains is strongly associated with theorized outcomes that can promote successful and sustainable implementation efforts among those who receive implementation support from an ISP. The ISCA serves as a foundational tool for workforce development to formally measure and assess improvement in the skills that are required to tailor a package of implementation strategies situated in context.
Background: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation.
Methods: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system.
Discussion: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics.
Trial registration: Clinicaltrials.gov - NCT05628207. Prospectively registered 11/28/2022, https://classic.
Clinicaltrials: gov/ct2/show/NCT05628207 .
Background: Reducing low-value care (LVC) is crucial to improve the quality of patient care while increasing the efficient use of scarce healthcare resources. Recently, strategies to de-implement LVC have been mapped against the Expert Recommendation for Implementing Change (ERIC) compilation of strategies. However, such strategies' effectiveness across different healthcare practices has not been addressed. This overview of systematic reviews aimed to investigate the effectiveness of de-implementation initiatives and specific ERIC strategy clusters.
Methods: We searched MEDLINE (Ovid), Epistemonikos.org and Scopus (Elsevier) from 1 January 2010 to 17 April 2023 and used additional search strategies to identify relevant systematic reviews (SRs). Two reviewers independently screened abstracts and full texts against a priori-defined criteria, assessed the SR quality and extracted pre-specified data. We created harvest plots to display the results.
Results: Of 46 included SRs, 27 focused on drug treatments, such as antibiotics or opioids, twelve on laboratory tests or diagnostic imaging and seven on other healthcare practices. In categorising de-implementation strategies, SR authors applied different techniques: creating self-developed strategies (n = 12), focussing on specific de-implementation strategies (n = 14) and using published taxonomies (n = 12). Overall, 15 SRs provided evidence for the effectiveness of de-implementation interventions to reduce antibiotic and opioid utilisation. Reduced utilisation, albeit inconsistently significant, was documented in the use of antipsychotics and benzodiazepines, as well as in laboratory tests and diagnostic imaging. Strategies within the adapt and tailor to context, develop stakeholder interrelationships, and change infrastructure and workflow ERIC clusters led to a consistent reduction in LVC practices.
Conclusion: De-implementation initiatives were effective in reducing medication usage, and inconsistent significant reductions were observed for LVC laboratory tests and imaging. Notably, de-implementation clusters such as change infrastructure and workflow and develop stakeholder interrelationships emerged as the most encouraging avenues. Additionally, we provided suggestions to enhance SR quality, emphasising adherence to guidelines for synthesising complex interventions, prioritising appropriateness of care outcomes, documenting the development process of de-implementation initiatives and ensuring consistent reporting of applied de-implementation strategies.
Registration: OSF Open Science Framework 5ruzw.
Background: Implementing evidence that changes practice in emergency departments (EDs) is notoriously difficult due to well-established barriers including high levels of uncertainty arising from undifferentiated nature of ED patients, resource shortages, workload unpredictability, high staff turnover, and a constantly changing environment. We developed and implemented a behaviour-change informed strategy to mitigate these barriers for a clinical trial to implement the evidence-based emergency nursing framework HIRAID® (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, communication, and reassessment) to reduce clinical variation, and increase safety and quality of emergency nursing care.
Aim: To evaluate the behaviour-change-informed HIRAID® implementation strategy on reach, effectiveness, adoption, quality (dose, fidelity) and maintenance (sustainability).
Methods: An effectiveness-implementation hybrid design including a step-wedge cluster randomised control trial (SW-cRCT) was used to implement HIRAID® with 1300 + emergency nurses across 29 Australian rural, regional, and metropolitan EDs. Evaluation of our behaviour-change informed strategy was informed by the RE-AIM Scoring Instrument and measured using data from (i) a post HIRAID® implementation emergency nurse survey, (ii) HIRAID® Instructor surveys, and (iii) twelve-week and 6-month documentation audits. Quantitative data were analysed using descriptive statistics to determine the level of each component of RE-AIM achieved. Qualitative data were analysed using content analysis and used to understand the 'how' and 'why' of quantitative results.
Results: HIRAID® was implemented in all 29 EDs, with 145 nurses undertaking instructor training and 1123 (82%) completing all four components of provider training at 12 weeks post-implementation. Modifications to the behaviour-change informed strategy were minimal. The strategy was largely used as intended with 100% dose and very high fidelity. We achieved extremely high individual sustainability (95% use of HIRAID® documentation templates) at 6 months and 100% setting sustainability at 3 years.
Conclusion: The behaviour-change informed strategy for the emergency nursing framework HIRAID® in rural, regional, and metropolitan Australia was highly successful with extremely high reach and adoption, dose, fidelity, individual and setting sustainability across substantially variable clinical contexts.
Trial registration: ANZCTR, ACTRN12621001456842 . Registered 25 October 2021.
Background: This study is a cost-effectiveness study of two implementation strategies designed to train therapists in college and university counseling centers to deliver interpersonal psychotherapy. Costs of implementing a train-the-trainer (TTT) strategy versus an expert consultation strategy were estimated, and their relative effects upon therapist outcomes were calculated and compared.
Methods: Twenty four counseling centers were recruited across the United States. These centers were randomized to either a TTT (experimental) condition, in which an in-house therapist trained other center therapists, or an expert consultation condition, in which center therapists participated in a workshop and received 12 months of ongoing supervision. The main outcome was therapist fidelity (adherence and competence) to interpersonal psychotherapy, assessed via audio recordings of therapy sessions, and analyzed using linear mixed models. Costs of each condition were quantified using time-driven activity-based costing methods, and involved a costing survey administered to center directors, follow up interviews and validation checks, and comparison of time tracking logs of trainers in the expert condition. Mean costs to produce one therapist were obtained for each condition. The costs to produce equivalent improvements in therapist-level outcomes were then compared between the two conditions.
Results: Mean cost incurred by counseling centers to train one therapist using the TTT strategy was $3,407 (median = $3,077); mean cost to produce one trained therapist in the control condition was $2,055 (median = $1,932). Therapists in the TTT condition, on average, demonstrated a 0.043 higher adherence score compared to therapists in the control condition; however, this difference was not statistically significant. For the competence outcome, effect size for therapists in the TTT condition was in the large range (1.16; 95% CI: 0.85-1.46; p < .001), and therapists in this condition, on average, demonstrated a 0.073 higher competence score compared to those in the expert consultation condition (95% CI, 0.008-0.14; p = .03). Counseling centers that used the TTT model incurred $353 less in training costs to produce equivalent improvements in therapist competence.
Conclusions: Despite its higher short run costs, the TTT implementation strategy produces greater increases in therapist competence when compared to expert consultation. Expanding resources to support this platform for service delivery can be an effective way to enhance the mental health care of young people seeking care in college and university counseling centers.
Trial registration: ClinicalTrials.gov Identifier: NCT02079142.
Background: Complex health interventions (CHIs) are increasingly used in public health, clinical research and education to reduce the burden of disease worldwide. Numerous theories, models and frameworks (TMFs) have been developed to support implementation of CHIs. This systematic review aims to identify and critique theoretical frameworks concerned with three features of implementation; adaptability, scalability and sustainability (ASaS). By dismantling the constituent theories, analysing their component concepts and then exploring factors that influence each theory the review team hopes to offer an enhanced understanding of considerations when implementing CHIs.
Methods: This review searched PubMed MEDLINE, CINAHL, Web of Science, and Google Scholar for research investigating the TMFs of complex health interventions. Narrative synthesis was employed to examine factors that may influence the adaptability, scalability and sustainability of complex health interventions.
Results: A total of 9763 studies were retrieved from the five databases (PubMed, MEDLINE, CINAHL, Web of Science, and Google Scholar). Following removal of duplicates and application of the eligibility criteria, 35 papers were eligible for inclusion. Influencing factors can be grouped within outer context (socio-political context; leadership funding, inter-organisational networks), inner context; (client advocacy; organisational characteristics), intervention characteristics (supervision, monitoring and evaluation), and bridging factors (individual adopter or provider characteristics).
Conclusion: This review confirms that identified TMFS do not typically include the three components of adaptability, scalability, and sustainability. Current approaches focus on high income countries or generic "whole world" approaches with few frameworks specific to low- and middle-income countries. The review offers a starting point for further exploration of adaptability, scalability and sustainability, within a low- and middle-income context.
Trial registration: Not registered.
Background: Antibiotics are globally overprescribed for the treatment of upper respiratory tract infections (URTI), especially in persons living with HIV. However, most URTIs are caused by viruses, and antibiotics are not indicated. De-implementation is perceived as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excessive or inappropriate antibiotic use for URTI, through the employment of evidence-based interventions to reduce these practices. Research into strategies that lead to successful de-implementation of unnecessary antibiotic prescriptions within the primary health care setting is limited in Mozambique. In this study, we propose a protocol designed to evaluate the use of a clinical decision support algorithm (CDSA) for promoting the de-implementation of unnecessary antibiotic prescriptions for URTI among ambulatory HIV-infected adult patients in primary healthcare settings.
Methods: This study is a multicenter, two-arm, cluster randomized controlled trial, involving six primary health care facilities in Maputo and Matola municipalities in Mozambique, guided by an innovative implementation science framework, the Dynamic Adaption Process. In total, 380 HIV-infected patients with URTI symptoms will be enrolled, with 190 patients assigned to both the intervention and control arms. For intervention sites, the CDSAs will be posted on either the exam room wall or on the clinician´s exam room desk for ease of reference during clinical visits. Our sample size is powered to detect a reduction in antibiotic use by 15%. We will evaluate the effectiveness and implementation outcomes and examine the effect of multi-level (sites and patients) factors in promoting the de-implementation of unnecessary antibiotic prescriptions. The effectiveness and implementation of our antibiotic de-implementation strategy are the primary outcomes, whereas the clinical endpoints are the secondary outcomes.
Discussion: This research will provide evidence on the effectiveness of the use of the CDSA in promoting the de-implementation of unnecessary antibiotic prescribing in treating acute URTI, among ambulatory HIV-infected patients. Findings will bring evidence for the need to scale up strategies for the de-implementation of unnecessary antibiotic prescription practices in additional healthcare sites within the country.
Trial registration: ISRCTN, ISRCTN88272350. Registered 16 May 2024, https://www.isrctn.com/ISRCTN88272350.
Background: There are no criteria specifically for evaluating the quality of implementation research and recommending implementation strategies likely to have impact to practitioners. We describe the development and application of the Best Practices Tool, a set of criteria to evaluate the evidence supporting HIV-specific implementation strategies.
Methods: We developed the Best Practices Tool from 2022-2023 in three phases. (1) We developed a draft tool and criteria based on a literature review and key informant interviews. We purposively selected and recruited by email interview participants representing a mix of expertise in HIV service delivery, quality improvement, and implementation science. (2) The tool was then informed and revised through two e-Delphi rounds using a survey delivered online through Qualtrics. The first and second round Delphi surveys consisted of 71 and 52 open and close-ended questions, respectively, asking participants to evaluate, confirm, and make suggestions on different aspects of the rubric. After each survey round, data were analyzed and synthesized as appropriate; and the tool and criteria were revised. (3) We then applied the tool to a set of research studies assessing implementation strategies designed to promote the adoption and uptake of evidence-based HIV interventions to assess reliable application of the tool and criteria.
Results: Our initial literature review yielded existing tools for evaluating intervention-level evidence. For a strategy-level tool, additions emerged from interviews, for example, a need to consider the context and specification of strategies. Revisions were made after both Delphi rounds resulting in the confirmation of five evaluation domains - research design, implementation outcomes, limitations and rigor, strategy specification, and equity - and four evidence levels - best, promising, more evidence needed, and harmful. For most domains, criteria were specified at each evidence level. After an initial pilot round to develop an application process and provide training, we achieved 98% reliability when applying the criteria to 18 implementation strategies.
Conclusions: We developed a tool to evaluate the evidence supporting implementation strategies for HIV services. Although specific to HIV in the US, this tool is adaptable for evaluating strategies in other health areas.