Dataset Information

The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects.

ABSTRACT:

Background

Numerous models, frameworks, and theories exist for specific aspects of implementation research, including for determinants, strategies, and outcomes. However, implementation research projects often fail to provide a coherent rationale or justification for how these aspects are selected and tested in relation to one another. Despite this need to better specify the conceptual linkages between the core elements involved in projects, few tools or methods have been developed to aid in this task. The Implementation Research Logic Model (IRLM) was created for this purpose and to enhance the rigor and transparency of describing the often-complex processes of improving the adoption of evidence-based interventions in healthcare delivery systems.

Methods

The IRLM structure and guiding principles were developed through a series of preliminary activities with multiple investigators representing diverse implementation research projects in terms of contexts, research designs, and implementation strategies being evaluated. The utility of the IRLM was evaluated in the course of a 2-day training to over 130 implementation researchers and healthcare delivery system partners.

Results

Preliminary work with the IRLM produced a core structure and multiple variations for common implementation research designs and situations, as well as guiding principles and suggestions for use. Results of the survey indicated a high utility of the IRLM for multiple purposes, such as improving rigor and reproducibility of projects; serving as a "roadmap" for how the project is to be carried out; clearly reporting and specifying how the project is to be conducted; and understanding the connections between determinants, strategies, mechanisms, and outcomes for their project.

Conclusions

The IRLM is a semi-structured, principle-guided tool designed to improve the specification, rigor, reproducibility, and testable causal pathways involved in implementation research projects. The IRLM can also aid implementation researchers and implementation partners in the planning and execution of practice change initiatives. Adaptation and refinement of the IRLM are ongoing, as is the development of resources for use and applications to diverse projects, to address the challenges of this complex scientific field.

SUBMITTER: Smith JD

PROVIDER: S-EPMC7523057 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

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.

Project description:Inadequate planning, selective reporting, and incomplete reporting of outcomes in randomized controlled trials (RCTs) contribute to the problem of waste of research. We aimed to describe such a waste and to examine to what extent this waste could be avoided.This research-on-research study was based on RCTs included in Cochrane reviews with a summary of findings (SoF) table. We considered the outcomes reported in the SoF tables as surrogates for important outcomes for patients and other decision makers. We used a three-step approach. (1) First, in each review, we identified, for each important outcome, RCTs that were excluded from the corresponding meta-analysis. (2) Then, for these RCTs, we systematically searched for registrations and protocols to distinguish between inadequate planning (an important outcome was not reported in registries or protocols), selective reporting (an important outcome was reported in registries or protocols but not in publications), and incomplete reporting (an important outcome was incompletely reported in publications). (3) Finally, we assessed, with the consensus of five experts, the feasibility and cost of measuring the important outcomes that were not planned. We considered inadequately planned or selectively or incompletely reported important outcomes as avoidable waste if the outcome could have been easily measured at no additional cost based on expert evaluation.Of the 2711 RCTs included in the main comparison of 290 reviews, 2115 (78%) were excluded from at least one meta-analysis of important outcomes. Every trial contributed to 55%, on average, of the meta-analyses of important outcomes. Of the 310 RCTs published in 2010 or later, 156 were registered. Inadequate planning affected 79% of these RCTs, whereas incomplete and selective reporting affected 41% and 15%, respectively. For 63% of RCTs, we found at least one missing important outcome for which the waste was avoidable and for 30%, the waste was avoidable for all important outcomes.Most of the RCTs included in our sample did not contribute to all the important outcomes in meta-analyses, mostly because of inadequate planning or incomplete reporting. A large part of this waste of research seemed to be avoidable.

Project description:BackgroundRealist synthesis is an increasingly popular approach to the review and synthesis of evidence, which focuses on understanding the mechanisms by which an intervention works (or not). There are few published examples of realist synthesis. This paper therefore fills a gap by describing, in detail, the process used for a realist review and synthesis to answer the question 'what interventions and strategies are effective in enabling evidence-informed healthcare?' The strengths and challenges of conducting realist review are also considered.MethodsThe realist approach involves identifying underlying causal mechanisms and exploring how they work under what conditions. The stages of this review included: defining the scope of the review (concept mining and framework formulation); searching for and scrutinising the evidence; extracting and synthesising the evidence; and developing the narrative, including hypotheses.ResultsBased on key terms and concepts related to various interventions to promote evidence-informed healthcare, we developed an outcome-focused theoretical framework. Questions were tailored for each of four theory/intervention areas within the theoretical framework and were used to guide development of a review and data extraction process. The search for literature within our first theory area, change agency, was executed and the screening procedure resulted in inclusion of 52 papers. Using the questions relevant to this theory area, data were extracted by one reviewer and validated by a second reviewer. Synthesis involved organisation of extracted data into evidence tables, theming and formulation of chains of inference, linking between the chains of inference, and hypothesis formulation. The narrative was developed around the hypotheses generated within the change agency theory area.ConclusionsRealist synthesis lends itself to the review of complex interventions because it accounts for context as well as outcomes in the process of systematically and transparently synthesising relevant literature. While realist synthesis demands flexible thinking and the ability to deal with complexity, the rewards include the potential for more pragmatic conclusions than alternative approaches to systematic reviewing. A separate publication will report the findings of the review.

Project description:BackgroundUnder- and uninsured cancer survivors have significant medical, social, and economic complexity. For these survivors, effective care coordination between oncology and primary care teams is critical for high-quality, comprehensive care. While evidence-based interventions exist to improve coordination between healthcare teams, testing implementation of these interventions for cancer survivors seen in real-world safety-net settings has been limited. This study aimed to (1) identify factors influencing implementation of a multicomponent care coordination intervention (nurse coordinator plus patient registry) focused on cancer survivors with multiple comorbidities in an integrated safety-net system and (2) identify mechanisms through which the factors impacted implementation outcomes.MethodsWe conducted semi-structured interviews (patients, providers, and system leaders), structured observations of primary care and oncology operations, and document analysis during intervention implementation between 2016 and 2020. The practice change model (PCM) guided data collection to identify barriers and facilitators of implementation; the PCM, Consolidated Framework for Implementation Research, and Implementation Research Logic Model guided four immersion/crystallization data analysis and synthesis cycles to identify mechanisms and assess outcomes. Implementation outcomes included appropriateness, acceptability, adoption, and penetration.ResultsThe intervention was appropriate and acceptable to primary care and oncology teams based on reported patient needs and resources and the strength of the evidence supporting intervention components. Active and sustained partnership with system leaders facilitated these outcomes. There was limited adoption and penetration early in implementation because the study was narrowly focused on just breast and colorectal cancer patients. This created barriers to real-world practice where patients with all cancer types receive care. Over time, flexibility intentionally designed into intervention implementation facilitated adoption and penetration. Regular feedback from system partners and rapid cycles of implementation and evaluation led to real-time adaptations increasing adoption and penetration.DiscussionEvidence-based interventions to coordinate care for underserved cancer survivors across oncology and primary care teams can be implemented successfully when system leaders are actively engaged and with flexibility in implementation embedded intentionally to continuously facilitate adoption and penetration across the health system.

Project description:A research team from Boston Children's Hospital and Harvard Medical School conducted a community-based feeding study in collaboration with Framingham State University (FSU) and Sodexo, the food service contractor at FSU. The study was a randomized controlled trial, implemented on the FSU campus. For the final year of the study, a satellite feeding site was established at Assabet Valley Regional Technical High School. The purpose of the study was to assess the biological effects of different macronutrient diets. An academia-industry partnership was developed to overcome common challenges associated with hospital-based feeding studies. Benefits included the following: a study site outside of Boston (reducing inconvenience for participants), access to a large commercial kitchen and study-specific kiosk (promoting efficiency), collaboration with Sodexo chefs (ensuring palatability of meals), and opportunity to procure food from contracted vendors. The research (academia) and food service (industry) teams worked together to design, plan, and execute intervention protocols using an integrated approach. During execution, the research team was primarily responsible for overseeing treatment fidelity, whereas the food service team provided culinary expertise, with a strong focus on hospitality and food quality. The study was conducted in 3 cohorts between August 2014 and May 2017. Participants received all of their food for ?30 wk, totaling >160,000 meals. For all 3 cohorts combined, 234 participants provided informed consent, 229 started a standard run-in weight-loss diet, 164 lost a mean ± SD 12% ± 2% of baseline body weight and were randomly assigned to different macronutrient diets for weight-loss maintenance, and 148 completed the study. During the final and largest cohort, as many as 114 participants received daily meals concurrently. The daily cost per participant for preparation and service of weighed meals and snacks was ?$65. This academia-industry partnership provides a model for controlled feeding protocols in nutrition research, potentially with enhanced cost-effectiveness, practicality, and generalizability. This trial was registered at http://www.clinicaltrials.gov as NCT02068885.

Project description:BackgroundFrench community pharmacists are facing an increasing demand to provide a wider range of services to meet the needs of the population. These new missions must be evaluated by primary care research studies. This study aims to explore the factors that influence French community pharmacists' willingness to participate in research projects.MethodsA mixed-method design was adopted for this study, comprising an initial quantitative online survey followed by semi-directed interviews. The investigation was conducted at two French faculties of pharmacy, Angers and Nantes, involving students in their 6th and final year of pharmacy education, and their community pharmacist tutors. The survey items were based on a study by Saini et al. and participants responded using five-point Likert scales. The semi-directed interviews were conducted after the quantitative analysis, only with volunteer and already graduated community pharmacists.ResultsA total of 131 people participated in the quantitative analysis, comprising 75 students and 56 pharmacists. Pharmacists and students agreed on the significance of two key aspects: the research must possess a clear and meaningful purpose, and researchers must keep the pharmacists informed about the study's results. Among the 27 proposed items, only three showed significantly different results between students and pharmacists. Moreover, 11 semi-structured interviews were conducted. Research in the community pharmacy domain is relatively new for many pharmacists. Despite limited training, their willingness to participate is contingent on being actively involved from the outset, receiving appropriate support and training. However, the research should be seamlessly integrated into their daily practice, without being too time-consuming and administratively burdensome. Time constraints emerged as the main obstacle, along with concerns about the availability of human resources. Pharmacists expressed strong motivation driven by the research topic's relevance, and its potential impact on patients or the profession. While financial compensation is desirable, it did not appear to be the main criterion for participation in a study.ConclusionsFrench pharmacists are willing to participate in research projects to improve patient care and develop the profession. Research teams must guide and involve from the project's inception.