The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare.
Ontology highlight
ABSTRACT: Background
Implementation strategies are necessary to ensure that evidence-based practices are successfully incorporated into routine clinical practice. Such strategies, however, are frequently modified to fit local populations, settings, and contexts. While such modifications can be crucial to implementation success, the literature on documenting and evaluating them is virtually nonexistent. In this paper, we therefore describe the development of a new framework for documenting modifications to implementation strategies.Discussion
We employed a multifaceted approach to developing the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS), incorporating multiple stakeholder perspectives. Development steps included presentations of initial versions of the FRAME-IS to solicit structured feedback from individual implementation scientists ("think-aloud" exercises) and larger, international groups of researchers. The FRAME-IS includes core and supplementary modules to document modifications to implementation strategies: what is modified, the nature of the modification (including the relationship to core elements or functions), the primary goal and rationale for the modification, timing of the modification, participants in the modification decision-making process, and how widespread the modification is. We provide an example of application of the FRAME-IS to an implementation project and provide guidance on how it may be used in future work.Conclusion
Increasing attention is being given to modifications to evidence-based practices, but little work has investigated modifications to the implementation strategies used to implement such practices. To fill this gap, the FRAME-IS is meant to be a flexible, practical tool for documenting modifications to implementation strategies. Its use may help illuminate the pivotal processes and mechanisms by which implementation strategies exert their effects.
SUBMITTER: Miller CJ
PROVIDER: S-EPMC8024675 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundDeveloping effective implementation strategies requires adequate tracking and reporting on their application. Guidelines exist for defining and reporting on implementation strategy characteristics, but not for describing how strategies are adapted and modified in practice. We built on existing implementation science methods to provide novel methods for tracking strategy modifications.MethodsThese methods were developed within a stepped-wedge trial of an implementation strategy package designed to help community clinics adopt social determinants of health-related activities: in brief, an 'Implementation Support Team' supports clinics through a multi-step process. These methods involve five components: 1) describe planned strategy; 2) track its use; 3) monitor barriers; 4) describe modifications; and 5) identify / describe new strategies. We used the Expert Recommendations for Implementing Change taxonomy to categorize strategies, Proctor et al.'s reporting framework to describe them, the Consolidated Framework for Implementation Research to code barriers / contextual factors necessitating modifications, and elements of the Framework for Reporting Adaptations and Modifications-Enhanced to describe strategy modifications.ResultsWe present three examples of the use of these methods: 1) modifications made to a facilitation-focused strategy (clinics reported that certain meetings were too frequent, so their frequency was reduced in subsequent wedges); 2) a clinic-level strategy addition which involved connecting one study clinic seeking help with community health worker-related workflows to another that already had such a workflow in place; 3) a study-level strategy addition which involved providing assistance in overcoming previously encountered (rather than de novo) challenges.ConclusionsThese methods for tracking modifications made to implementation strategies build on existing methods, frameworks, and guidelines; however, as none of these were a perfect fit, we made additions to several frameworks as indicated, and used certain frameworks' components selectively. While these methods are time-intensive, and more work is needed to streamline them, they are among the first such methods presented to implementation science. As such, they may be used in research on assessing effective strategy modifications and for replication and scale-up of effective strategies. We present these methods to guide others seeking to document implementation strategies and modifications to their studies.Trial registrationclinicaltrials.gov ID: NCT03607617 (first posted 31/07/2018).
| S-EPMC8235850 | biostudies-literature
Project description:BackgroundThe OPTIMIZE trial is a multi-site, comparative effectiveness research (CER) study that uses a Sequential Multiple Assessment Randomized Trial (SMART) designed to examine the effectiveness of complex health interventions (cognitive behavioral therapy, physical therapy, and mindfulness) for adults with chronic low back pain. Modifications are anticipated when implementing complex interventions in CER. Disruptions due to COVID have created unanticipated challenges also requiring modifications. Recent methodologic standards for CER studies emphasize that fully characterizing modifications made is necessary to interpret and implement trial results. The purpose of this paper is to outline the modifications made to the OPTIMIZE trial using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize modifications to the OPTIMIZE trial in response to the COVID pandemic and other challenges encountered.MethodsThe FRAME outlines a strategy to identify and report modifications to evidence-based interventions or implementation strategies, whether planned or unplanned. We use the FRAME to characterize the process used to modify the aspects of the OPTIMIZE trial. Modifications were made to improve lower-than-anticipated rates of treatment initiation and COVID-related restrictions. Contextual modifications were made to permit telehealth delivery of treatments originally designed for in-person delivery. Training modifications were made with study personnel to provide more detailed information to potential participants, use motivational interviewing communication techniques to clarify potential participants' motivation and possible barriers to initiating treatment, and provide greater assistance with scheduling of assigned treatments.ResultsModifications were developed with input from the trial's patient and stakeholder advisory panels. The goals of the modifications were to improve trial feasibility without compromising the interventions' core functions. Modifications were approved by the study funder and the trial steering committee.ConclusionsFull and transparent reporting of modifications to clinical trials, whether planned or unplanned, is critical for interpreting the trial's eventual results and considering future implementation efforts.Trial registrationClinicalTrials.gov NCT03859713. Registered on March 1, 2019.
| S-EPMC9947905 | biostudies-literature
Project description:BackgroundThere is growing evidence that context mediates the effects of implementation interventions intended to increase healthcare professionals' use of research evidence in clinical practice. However, conceptual clarity about what comprises context is elusive. The purpose of this study was to advance conceptual clarity on context by developing the Implementation in Context Framework, a meta-framework of the context domains, attributes and features that can facilitate or hinder healthcare professionals' use of research evidence and the effectiveness of implementation interventions in clinical practice.MethodsWe conducted a meta-synthesis of data from three interrelated studies: (1) a concept analysis of published literature on context (n = 70 studies), (2) a secondary analysis of healthcare professional interviews (n = 145) examining context across 11 unique studies and (3) a descriptive qualitative study comprised of interviews with heath system stakeholders (n = 39) in four countries to elicit their tacit knowledge on the attributes and features of context. A rigorous protocol was followed for the meta-synthesis, resulting in development of the Implementation in Context Framework. Following this meta-synthesis, the framework was further refined through feedback from experts in context and implementation science.ResultsIn the Implementation in Context Framework, context is conceptualized in three levels: micro (individual), meso (organizational), and macro (external). The three levels are composed of six contextual domains: (1) actors (micro), (2) organizational climate and structures (meso), (3) organizational social behaviour (meso), (4) organizational response to change (meso), (5) organizational processes (meso) and (6) external influences (macro). These six domains contain 22 core attributes of context and 108 features that illustrate these attributes.ConclusionsThe Implementation in Context Framework is the only meta-framework of context available to guide implementation efforts of healthcare professionals. It provides a comprehensive and critically needed understanding of the context domains, attributes and features relevant to healthcare professionals' use of research evidence in clinical practice. The Implementation in Context Framework can inform implementation intervention design and delivery to better interpret the effects of implementation interventions, and pragmatically guide implementation efforts that enhance evidence uptake and sustainability by healthcare professionals.
| S-EPMC10408185 | biostudies-literature
Project description:Improving access to culturally appropriate mental healthcare has been recognised as a key strategy to address the often greater burden of mental health issues experienced by Indigenous populations. We present data from the evaluation of a national attempt at improving access to culturally appropriate mental healthcare for Indigenous Australians through a mainstream primary mental healthcare program, the Access to Allied Psychological Services program, whilst specifically focusing on the implementation strategies and perspectives of service providers.We conducted semi-structured interviews with 31 service providers (primary care agency staff, referrers, and mental health professionals) that were analysed thematically and descriptively.Agency-level implementation strategies to enhance service access and cultural appropriateness included: the conduct of local service needs assessments; Indigenous stakeholder consultation and partnership development; establishment of clinical governance frameworks; workforce recruitment, clinical/cultural training and supervision; stakeholder and referrer education; and service co-location at Indigenous health organisations. Dedicated provider-level strategies to ensure the cultural appropriateness of services were primarily aimed at the context and process of delivery (involving, flexible referral pathways, suitable locations, adaptation of client engagement and service feedback processes) and, to a lesser extent, the nature and content of interventions (provision of culturally adapted therapy).This study offers insights into key factors underpinning the successful national service implementation approach. Study findings highlight that concerted national attempts to enhance mainstream primary mental healthcare for Indigenous people are critically dependent on effective local agency- and provider-level strategies to optimise the integration, adaptation and broader utility of these services within local Indigenous community and healthcare service contexts. Despite the explicit provider focus, this study was limited by a lack of Indigenous stakeholder perspectives. Key study findings are of direct relevance to inform the future implementation and delivery of culturally appropriate primary mental healthcare programs for Indigenous populations in Australia and internationally.
| S-EPMC5985563 | biostudies-other
Project description:BackgroundHealthcare-related adverse events occur because of complex healthcare systems. The patient safety reporting system is a core component of patient safety initiatives in hospitals. However, hospital management often encounters a cultural barrier with its implementation and struggles to overcome the same. Implementation science would be useful for analysing implementation strategies. This study determines the effects of the implemented strategy on an increase in the number of patient safety reports and the determinants of successful implementation, using the implementation framework.MethodsMixed method analysis was performed in Fujita Health University Hospital (FHUH), a large volume hospital in Japan. We identified strategies to implement the patient safety reporting system by scrutinising internal documents using the Consolidated Framework for Implementation Research (CFIR). The electronic reporting systems developed in 2004 in the FHUH and the number of reports were analysed using the staff data and hospital volumes.ResultsReports (n = 110,058) issued between April 2004 and March 2020 were analysed. The number of reports increased from 2004 to 2008 and from 2013 to 2019, reaching 14,037 reports per year. Between 2009 and 2012, the FHUH experienced a stagnation period where the number of reports were not increasing. From the qualitative materials, we identified 74 strategies which contributed to the implementation of the patient safety reporting system. Among these, the domain of 'intervention characteristics' in the CFIR contained 12 strategies, 'outer settings' contained 20, 'inner settings' contained 21, 'characteristics of individuals' contained 8, and 'process' contained 13. There were two concentrated periods of the implemented strategies, the number was 17 in 2007 and 10 in 2016. These concentrated periods preceded a remarkable increase in the number of patient safety reports.ConclusionsA safety culture had been fostered in FHUH in the study period. A relationship between number of strategies and development of a reporting culture was observed. The intensity of adequate strategies was needed for implementation of patient safety reporting system. Therefore, the implementation framework is useful for analysing patient safety initiatives for safety culture.
| S-EPMC8962011 | biostudies-literature
Project description:BackgroundThere have been calls for greater consideration of applicability and transferability in systematic reviews, to improve their usefulness in informing policy and practice. Understanding how evidence is, or is not applicable and transferable to varying local situations and contexts, is a key challenge for systematic review synthesis in healthcare. Assessing applicability and transferability in systematic reviews is reported to be difficult, particularly in reviews of complex interventions. There is a need for exploration of factors perceived to be important by policy-makers, and for further guidance on which items should be reported. In this paper we focus on the process of development of a framework that can be used by systematic reviewers to identify and report data across studies relating to applicability and transferability.MethodsThe framework was developed by scrutinising existing literature on applicability and transferability, examining data during a systematic review of highly complex changes to health service delivery, and was informed by stakeholder engagement. The items of the framework were thus grounded in both data identified during a real review, and stakeholder input. The paper describes examples of data identified using the framework during a review of integrated care interventions, and outlines how it informed analysis and reporting of the review findings.ResultsThe Framework for Implementation Transferability Applicability Reporting (FITAR) comprises 44 items which can be used to structure analysis and reporting across studies during systematic reviews of complex interventions. The framework prompts detailed consideration of contextual data during extraction and reporting, within areas of: patient type and populations; type of organisations and systems; financial and commissioning processes; systems leadership elements; features of services; features of the workforce; and finally elements of the interventions/initiatives.ConclusionsUse of the framework during our review of complex healthcare interventions helped the review team to surface contextual data, which may not be commonly extracted, analysed and reported. Further exploration and evaluation of systems for identifying and reporting these factors during reviews is required.
| S-EPMC6472061 | biostudies-literature
Project description:BackgroundPilot data suggest that a multifaceted approach may increase HIV testing rates, but the scalability of this approach and the level of support needed for successful implementation remain unknown.ObjectiveTo evaluate the effectiveness of a scaled-up multi-component intervention in increasing the rate of risk-based and routine HIV diagnostic testing in primary care clinics and the impact of differing levels of program support.DesignThree arm, quasi-experimental implementation research study.SettingVeterans Health Administration (VHA) facilities.PatientsPersons receiving primary care between June 2009 and September 2011 INTERVENTION: A multimodal program, including a real-time electronic clinical reminder to facilitate HIV testing, provider feedback reports and provider education, was implemented in Central and Local Arm Sites; sites in the Central Arm also received ongoing programmatic support. Control Arm sites had no interventionMain measuresFrequency of performing HIV testing during the 6 months before and after implementation of a risk-based clinical reminder (phase I) or routine clinical reminder (phase II).Key resultsThe adjusted rate of risk-based testing increased by 0.4 %, 5.6 % and 10.1 % in the Control, Local and Central Arms, respectively (all comparisons, p?<?0.01). During phase II, the adjusted rate of routine testing increased by 1.1 %, 6.3 % and 9.2 % in the Control, Local and Central Arms, respectively (all comparisons, p?<?0.01). At study end, 70-80 % of patients had been offered an HIV test.ConclusionsUse of clinical reminders, provider feedback, education and social marketing significantly increased the frequency at which HIV testing is offered and performed in VHA facilities. These findings support a multimodal approach toward achieving the goal of having every American know their HIV status as a matter of routine clinical practice.
| S-EPMC3785651 | biostudies-literature
Project description:Implementation of artificial intelligence systems for healthcare is challenging. Understanding the barriers and implementation strategies can impact their adoption and allows for better anticipation and planning. This study's objective was to create a detailed inventory of barriers to and strategies for AI implementation in healthcare to support advancements in methods and implementation processes in healthcare. A sequential explanatory mixed method design was used. Firstly, scoping reviews and systematic literature reviews were identified using PubMed. Selected studies included empirical cases of AI implementation and use in clinical practice. As the reviews were deemed insufficient to fulfil the aim of the study, data collection shifted to the primary studies included in those reviews. The primary studies were screened by title and abstract, and thereafter read in full text. Then, data on barriers to and strategies for AI implementation were extracted from the included articles, thematically coded by inductive analysis, and summarized. Subsequently, a direct qualitative content analysis of 69 interviews with healthcare leaders and healthcare professionals confirmed and added results from the literature review. Thirty-eight empirical cases from the six identified scoping and literature reviews met the inclusion and exclusion criteria. Barriers to and strategies for AI implementation were grouped under three phases of implementation (planning, implementing, and sustaining the use) and were categorized into eleven concepts; Leadership, Buy-in, Change management, Engagement, Workflow, Finance and human resources, Legal, Training, Data, Evaluation and monitoring, Maintenance. Ethics emerged as a twelfth concept through qualitative analysis of the interviews. This study illustrates the inherent challenges and useful strategies in implementing AI in healthcare practice. Future research should explore various aspects of leadership, collaboration and contracts among key stakeholders, legal strategies surrounding clinicians' liability, solutions to ethical dilemmas, infrastructure for efficient integration of AI in workflows, and define decision points in the implementation process.
| S-EPMC11315296 | biostudies-literature
Project description:BackgroundEvidence based practice in health care has become increasingly popular over the last decades. Many guidelines have been developed to improve evidence informed decision making in health care organisations, however it is often overlooked that the actual implementation strategies for these guidelines are as important as the guidelines themselves. The effectiveness of these strategies is rarely ever tested specifically for the allied health therapy group.MethodsCochrane, Medline, Embase and Scopus databases were searched from 2000 to October 2019. Level I and II studies were included if an evidence informed implementation strategy was tested in allied health personnel. The SIGN method was used to evaluate risk of bias. The evidence was synthesised using a narrative synthesis. The National Health and Medical Research Council (NHMRC) model was applied to evaluate the grade for recommendation.ResultsA total of 490 unique articles were identified, with 6 primary studies meeting the inclusion criteria. Three different implementation strategies and three multi-faceted components strategies were described. We found moderate evidence for educational meetings, local opinion leaders and patient mediated interventions. We found stronger evidence for multi-faceted components strategies.ConclusionFew studies describe the effectiveness of implementation strategies for allied healthcare, but evidence was found for multi-faceted components for implementing research in an allied health therapy group population. When considering implementation of evidence informed interventions in allied health a multi-pronged approach appears to be more successful.
| S-EPMC7977260 | biostudies-literature
Project description:BACKGROUND:Amid the current burden of non-communicable (NCD) diseases in Malaysia, there is a growing demand for more efficient service delivery of primary healthcare. A complex intervention is proposed to improve NCD management in Malaysia. This exploratory study aimed to assess primary healthcare providers' receptiveness towards change prior to implementation of the proposed complex intervention. METHOD:This study was conducted using an exploratory qualitative approach on purposely selected healthcare providers at primary healthcare clinics. Twenty focus group discussions and three in-depth interviews were conducted using a semi-structured interview guide. Consent was obtained prior to interviews and for audio-recordings. Interviews were transcribed verbatim and thematically analysed, guided by the Consolidated Framework for Implementation Research (CFIR), a framework comprised of five major domains promoting implementation theory development and verification across multiple contexts. RESULTS:The study revealed via CFIR that most primary healthcare providers were receptive towards any proposed changes or intervention for the betterment of NCD care management. However, many challenges were outlined across four CFIR domains-intervention characteristics, outer setting, inner setting, and individual characteristics-that included perceived barriers to implementation. Perception of issues that triggered proposed changes reflected the current situation, including existing facilitating aspects that can support the implementation of any future intervention. The importance of strengthening the primary healthcare delivery system was also expressed. CONCLUSION:Understanding existing situations faced at the primary healthcare setting is imperative prior to implementation of any intervention. Healthcare providers' receptiveness to change was explored, and using CFIR framework, challenges or perceived barriers among healthcare providers were identified. CFIR was able to outline the clinics' setting, individual behaviour and external agency factors that have direct impact to the organisation. These are important indicators in ensuring feasibility, effectiveness and sustainability of any intervention, as well as future scalability considerations.
| S-EPMC6636000 | biostudies-literature