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Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

ABSTRACT: The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable.We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions.Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework.Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology.Clinical trials.gov: NCT02160249.

SUBMITTER: De Silva MJ

PROVIDER: S-EPMC4227087 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

De Silva Mary J MJ Breuer Erica E Lee Lucy L Asher Laura L Chowdhary Neerja N Lund Crick C Patel Vikram V

Trials 20140705

<h4>Background</h4>The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are ...[more]

PMID: 24996765

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Project description:BackgroundThere is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research.MethodsThe intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood?ResultsA complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change.ConclusionsWe have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

Project description:BACKGROUND:The idea of using serious games to effectuate better outcomes in health care has gained significant traction among a growing community of researchers, developers, and health care professionals. Many now recognize the importance of creating evidence-based games that are purposefully designed to address physical and mental health challenges faced by end users. To date, no regulatory resources have been established to guide the development of serious games for health (SGH). Developers must therefore look elsewhere for guidance. Although a more robust level of evidence exists in the research literature, it is neither structured nor is there any clear consensus. Developers currently use a variety of approaches and methodologies. The establishment of a well-defined framework that represents the consensus views of the SGH research community would help developers improve the efficiency of internal development processes, as well as chances of success. A consensus framework would also enhance the credibility of SGH and help provide quality evidence of their effectiveness. OBJECTIVE:This research aimed to (1) identify and evaluate the requirements, recommendations, and guidelines proposed by the SGH community in the research literature, and; (2) develop a consensus framework to guide developers, designers, researchers, and health care professionals in the development of evidence-based SGH. METHODS:A critical review of the literature was performed in October to November 2018. A 3-step search strategy and a predefined set of inclusion criteria were used to identify relevant articles in PubMed, ScienceDirect, Institute of Electrical and Electronics Engineers Xplore, CiteSeerX, and Google Scholar. A supplemental search of publications from regulatory authorities was conducted to capture their specific requirements. Three researchers independently evaluated the identified articles. The evidence was coded and categorized for analysis. RESULTS:This review identified 5 categories of high-level requirements and 20 low-level requirements suggested by the SGH community. These advocate a methodological approach that is multidisciplinary, iterative, and participatory. On the basis of the requirements identified, we propose a framework for developing theory-driven, evidence-based SGH. It comprises 5 stages that are informed by various stakeholders. It focuses on building strong scientific and design foundations that guide the creative and technical development. It includes quantitative trials to evaluate whether the SGH achieve the intended outcomes, as well as efforts to disseminate trial findings and follow-up monitoring after the SGH are rolled out for use. CONCLUSIONS:This review resulted in the formulation of a framework for developing theory-driven, evidence-based SGH that represents many of the requirements set out by SGH stakeholders in the literature. It covers all aspects of the development process (scientific, technological, and design) and is transparently described in sufficient detail to allow SGH stakeholders to implement it in a wide variety of projects, irrespective of discipline, health care segments, or focus.

Project description:PurposeTo design and develop a complex, evidence‑based, theory‑driven, and culturally appropriate character strengths-based intervention (CSI) for breast cancer patients, following the Medical Research Council (MRC) framework.MethodsFrom 2018 September to 2020 November, a complex intervention perspective was adopted. The rationale, methods, and processes employed in carrying out the study were reported. The acceptability and feasibility of intervention program were evaluated as a part of subsequent pilot study. Based on piloting, a refined and optimized definitive intervention was obtained. The development of the intervention is an iterative process involving input from three key stakeholders: experts, medical staff, and patient representatives.ResultsThe systematic review revealed CSIs were effective and the selected theory served as a guide and indicated theory-inspired modifications. A representative team of breast cancer patients and oncology nurses collaboratively developed and tailored the intervention content and format with attention to the acceptability and feasibility. Five main strategies, including peripheral, evidential, linguistic, constituent-involving, and sociocultural strategies, were used to achieve and strengthen the cultural appropriateness. After the pilot phase, several refinements were made on the CSI program, such as editorial changes in the booklet or alternative suggestions for difficult strengths-based activities (e.g., outdoor activities). All participants not only expressed satisfaction with the program in process evaluation, but also reported perceived benefits such as enjoyable and sociable experience, better well-being, and increased confidence.ConclusionConsideration of the MRC framework, theory guidance, and suggestions from stakeholders during intervention development can optimize uptake and sustainability in the clinical setting. It is recommended that randomized controlled trial be used in future studies to assess the intervention, the process and the mechanisms of the intervention. Our approach may offer implications for the design and implementation of similar initiatives to support cancer patients.Trial registrationClinicalTrials.gov Register Identifier: NCT04219267, 07/01/2020, retrospectively registered.

Project description:BackgroundThe continuing gap between available evidence and current practice in health care reinforces the need for more effective solutions, in particular related to organizational context. Considerable advances have been made within the U.S. Veterans Health Administration (VA) in systematically implementing evidence into practice. These advances have been achieved through a system-level program focused on collaboration and partnerships among policy makers, clinicians, and researchers. The Quality Enhancement Research Initiative (QUERI) was created to generate research-driven initiatives that directly enhance health care quality within the VA and, simultaneously, contribute to the field of implementation science. This paradigm-shifting effort provided a natural laboratory for exploring organizational change processes. This article describes the underlying change framework and implementation strategy used to operationalize QUERI.Strategic approach to organizational changeQUERI used an evidence-based organizational framework focused on three contextual elements: 1) cultural norms and values, in this case related to the role of health services researchers in evidence-based quality improvement; 2) capacity, in this case among researchers and key partners to engage in implementation research; 3) and supportive infrastructures to reinforce expectations for change and to sustain new behaviors as part of the norm. As part of a QUERI Series in Implementation Science, this article describes the framework's application in an innovative integration of health services research, policy, and clinical care delivery.ConclusionQUERI's experience and success provide a case study in organizational change. It demonstrates that progress requires a strategic, systems-based effort. QUERI's evidence-based initiative involved a deliberate cultural shift, requiring ongoing commitment in multiple forms and at multiple levels. VA's commitment to QUERI came in the form of visionary leadership, targeted allocation of resources, infrastructure refinements, innovative peer review and study methods, and direct involvement of key stakeholders. Stakeholders included both those providing and managing clinical care, as well as those producing relevant evidence within the health care system. The organizational framework and related implementation interventions used to achieve contextual change resulted in engaged investigators and enhanced uptake of research knowledge. QUERI's approach and progress provide working hypotheses for others pursuing similar system-wide efforts to routinely achieve evidence-based care.

Project description:BackgroundNovel technical solutions are called for to promote home-based exercise among community-dwelling stroke survivors supported by their caregivers. Lack of resources and knowledge about how to accomplish it, has been demonstrated. The objective of this study is to describe in detail the development of ActivABLES, a technical intervention to promote home-based exercise and physical activity engagement of community-dwelling stroke survivors with support from their caregivers.MethodsThe technical development process of ActivABLES was guided by the Medical Research Council (MRC) framework for development and evaluation of complex interventions as well as by principles of human-centred design and co-design. The main steps included: (1) Synthesis of evidence supporting the inclusion of balance exercises, mobility and walking exercises and exercises for the upper arm; (2) Implementation of initial user studies with qualitative data collection from individual interviews with stroke survivors, and focus group interviews with caregivers and health professionals; (3) Preliminary testing of eight prototypes with seven stroke survivors and their caregivers.ResultsAfter the preliminary testing of eight prototypes, four prototypes were not further developed whereas four prototypes were modified further. In addition, two new prototypes were developed, leaving six prototypes for further modification: 1) ActivFOAM for balance exercises, 2) WalkingSTARR to facilitate walking, 3) ActivBALL for hand exercises, 4) ActivSTICKS for upper arm exercises, and 5) ActivLAMP and 6) ActivTREE which both give visual feedback on progress of daily exercise and physical activities. ActivFOAM, ActivBALL and ActivSTICKS are all connected to a tablet where exercise instructions are given. All the exercise prototypes can be connected to ActivLAMP and ActivTREE to give feedback on how much exercise the user has done. Settings can be individualised and recommended daily time and/or repetition can easily be changed as the user progresses to higher activity levels.ConclusionsThe development process of ActivABLES was guided by the principles of human-centred design, with iterative testing of future users, and by the MRC framework of complex intervention, with a repeated process of development and testing. This process resulted in six prototypes which are available for feasibility testing among a small group of community-dwelling stroke survivors.

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Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

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Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

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