Prospective application of theoretical implementation frameworks to improve health care in hospitals - a systematic review.

BACKGROUND: Health Service implementation projects are often guided by theoretical implementation frameworks. Little is known about the effectiveness of these frameworks to facilitate change in processes of care and patient outcomes within the inpatient setting. The aim of this review was to assess the effectiveness of the application of theoretical implementation frameworks in inpatient healthcare settings to change processes of care and associated patient outcomes. METHOD: We conducted a search in CINAHL, MEDLINE, EMBASE, PsycINFO, EMCARE and Cochrane Library databases from 1st January 1995 to 15th June 2021. Two reviewers independently applied inclusion and exclusion criteria to potentially eligible studies. Eligible studies: implemented evidence-based care into an in-patient setting using a theoretical implementation framework applied prospectively; used a prospective study design; presented process of care or patient outcomes; and were published in English. We extracted theoretical implementation frameworks and study design against the Workgroup for Intervention Development and Evaluation Research (WIDER) Checklist and implementation strategies mapped to the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy. We summarised all interventions using the Template for Intervention Description and Replication (TIDieR) checklist. We appraised study quality using the Item bank on risk of bias and precision of observational studies and the revised Cochrane risk of bias tool for cluster randomised trials. We extracted process of care and patient outcomes and described descriptively. We conducted meta-analysis for process of care and patient outcomes with reference to framework category. RESULTS: Twenty-five studies met the inclusion criteria. Twenty-one used a pre-post (no comparison), two a pre-post with a comparison, and two a cluster randomised trial design. Eleven theoretical implementation frameworks were prospectively applied: six process models; five determinant frameworks; and one classic theory. Four studies used two theoretical implementation frameworks. No authors reported their justification for selecting a particular framework and implementation strategies were generally poorly described. No consensus was reached for a preferred framework or subset of frameworks based on meta-analysis results. CONCLUSIONS: Rather than the ongoing development of new implementation frameworks, a more consistent approach to framework selection and strengthening of existing approaches is recommended to further develop the implementation evidence base. TRIAL REGISTRATION: CRD42019119429.

Developing an implementation strategy for a digital health intervention: an example in routine healthcare.

BACKGROUND: Evidence on how to implement new interventions into complex healthcare environments is often poorly reported and indexed, reducing its potential to inform initiatives to improve healthcare services. Using the implementation of a digital intervention within routine National Health Service (NHS) practice, we provide an example of how to develop a theoretically based implementation plan and how to report it transparently. In doing so we also highlight some of the challenges to implementation in routine healthcare. METHODS: The implemented intervention was HeLP-Diabetes, a digital self-management programme for people with Type 2 Diabetes, which was effective in improving diabetes control. The target setting for the implementation was an inner city London Clinical Commissioning Group in the NHS comprised of 34 general practices. HeLP-Diabetes was designed to be offered to patients as part of routine diabetes care across England. Evidence synthesis, engagement of local stakeholders, a theory of implementation (Normalization Process Theory), feedback, qualitative interviews and usage data were used to develop an implementation plan. RESULTS: A new implementation plan was developed to implement HeLP-Diabetes within routine practice. Individual component strategies were selected and developed informed by Normalization Process Theory. These strategies included: engagement of local opinion leaders, provision of educational materials, educational visits, educational meetings, audit and feedback and reminders. Additional strategies were introduced iteratively to address barriers that arose during the implementation. Barriers largely related to difficulties in allocating resources to implement the intervention within routine care. CONCLUSION: This paper provides a worked example of implementing a digital health intervention. The learning from this work can inform others undertaking the work of planning and executing implementation activities in routine healthcare. Of particular importance is: the selection of appropriate theory to guide the implementation process and selection of strategies; ensuring that enough attention is paid to planning implementation; and a flexible approach that allows response to emerging barriers.

Evaluating the Application of the RE-AIM Planning and Evaluation Framework: An Updated Systematic Review and Exploration of Pragmatic Application.

BACKGROUND: RE-AIM is one of the most widely applied frameworks to plan and evaluate the implementation of public health and health behavior change interventions. The objective of this review is to provide an updated synthesis of use of the RE-AIM (Reach Effectiveness Adoption Implementation and Maintenance) planning and evaluation framework and explore pragmatic use (i.e., partial application of the framework) and how this is reported. METHODS: Systematic review. MEDLINE (R) and PsycINFO were searched, via the Ovid interface, between January 2011 and December 2017. Studies that applied RE-AIM as a planning and/or evaluation framework were included. RESULTS: One hundred fifty-seven articles met inclusion criteria. One hundred forty-nine reported using RE-AIM for evaluation, three for planning and five for planning and evaluation. Reach was the most frequently reported dimension (92.9%), followed by implementation (90.3%), adoption (89.7%), effectiveness (84.5%), and maintenance (77.4%). One hundred forty-seven/one hundred fifty-seven articles originated from high-income economy countries. Within a sub-set analysis (10% of included articles), 9/15 articles evaluated all dimensions. Of the 6/15 articles that did not evaluate all dimensions, five provided no justification for pragmatic application. CONCLUSIONS: RE-AIM has gained increased use in recent years and there is evidence that it is being applied pragmatically. However, the rationale for pragmatic use is often not reported. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42017054616).

Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review.

BACKGROUND: Over 60 implementation frameworks exist. Using multiple frameworks may help researchers to address multiple study purposes, levels, and degrees of theoretical heritage and operationalizability; however, using multiple frameworks may result in unnecessary complexity and redundancy if doing so does not address study needs. The Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) are both well-operationalized, multi-level implementation determinant frameworks derived from theory. As such, the rationale for using the frameworks in combination (i.e., CFIR + TDF) is unclear. The objective of this systematic review was to elucidate the rationale for using CFIR + TDF by (1) describing studies that have used CFIR + TDF, (2) how they used CFIR + TDF, and (2) their stated rationale for using CFIR + TDF. METHODS: We undertook a systematic review to identify studies that mentioned both the CFIR and the TDF, were written in English, were peer-reviewed, and reported either a protocol or results of an empirical study in MEDLINE/PubMed, PsycInfo, Web of Science, or Google Scholar. We then abstracted data into a matrix and analyzed it qualitatively, identifying salient themes. FINDINGS: We identified five protocols and seven completed studies that used CFIR + TDF. CFIR + TDF was applied to studies in several countries, to a range of healthcare interventions, and at multiple intervention phases; used many designs, methods, and units of analysis; and assessed a variety of outcomes. Three studies indicated that using CFIR + TDF addressed multiple study purposes. Six studies indicated that using CFIR + TDF addressed multiple conceptual levels. Four studies did not explicitly state their rationale for using CFIR + TDF. CONCLUSIONS: Differences in the purposes that authors of the CFIR (e.g., comprehensive set of implementation determinants) and the TDF (e.g., intervention development) propose help to justify the use of CFIR + TDF. Given that the CFIR and the TDF are both multi-level frameworks, the rationale that using CFIR + TDF is needed to address multiple conceptual levels may reflect potentially misleading conventional wisdom. On the other hand, using CFIR + TDF may more fully define the multi-level nature of implementation. To avoid concerns about unnecessary complexity and redundancy, scholars who use CFIR + TDF and combinations of other frameworks should specify how the frameworks contribute to their study. TRIAL REGISTRATION: PROSPERO CRD42015027615.