Background: Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention during the trial, and/or ability to detect meaningful differences in outcomes.
Methods: We conducted a literature review, developed a tool, and conducted two rounds of phone calls with NIH Pragmatic Trials Collaboratory Demonstration Project principal investigators to develop the Intervention Delivery Complexity Tool. After refining the tool, we piloted it with Collaboratory demonstration projects and developed an online version of the tool using the R Shiny application (https://duke-som.shinyapps.io/ICT-ePCT/).
Results: The 6-item tool consists of internal and external factors. Internal factors pertain to the intervention itself and include workflow, training, and the number of intervention components. External factors are related to intervention delivery at the system level including differences in healthcare systems, the dependency on setting for implementation, and the number of steps between the intervention and the outcome.
Conclusion: The Intervention Delivery Complexity Tool was developed as a standard way to overcome communication challenges of intervention delivery within an embedded pragmatic trial. This version of the tool is most likely to be useful to the trial team and its health system partners during trial planning and conduct. We expect further evolution of the tool as more pragmatic trials are conducted and feedback is received on its performance outside of the NIH Pragmatic Trials Collaboratory.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10126825 | PMC |
http://dx.doi.org/10.1016/j.cct.2023.107105 | DOI Listing |
JMIR Hum Factors
January 2025
Hackensack Meridian School of Medicine, 123 Metro Blvd, Nutley, NJ, 07110, United States, 1 7248419463.
Background: Transgender and nonbinary (TGNB) individuals are increasingly intentionally becoming pregnant to raise children, and hospital websites should reflect these trends. For prospective TGNB parents, a hospital website is the only way they can assess their safety from discrimination while receiving perinatal care. Cisnormativity enforced by communication gaps between medical institutions and TGNB patients can and has caused delays in receiving urgent care during their pregnancy.
View Article and Find Full Text PDFJ Integr Complement Med
January 2025
Integrative Medecine, Rafael Institute, Levallois-Perret, France.
Complementary and integrative medicine (CIM) encompasses over 400 modalities, according to the World Health Organization (WHO). In 2011, 70% of the European Union's population reported having used CIM at least once, with 25% using it annually. This study examines the engagement, motivations, and satisfaction of users in the French health care system through data from Medoucine, France's largest online platform for complementary therapies.
View Article and Find Full Text PDFCommunity Dent Oral Epidemiol
January 2025
School of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Aim: To explore the views of patients, caregivers, and dental professionals on the factors that influence implementation, processes, and effectiveness of a guided self-help cognitive behavioural therapy (CBT) intervention, 'Your teeth, you are in control' (YTYAIC), in the CALM trial.
Methods: Semi-structured interviews were conducted as part of this qualitative component of the process evaluation, and data were analysed using a framework approach based on the Consolidated Framework for Implementation Research (CFIR) and the Five Areas Model of CBT.
Results: Thirty-seven participants were recruited.
Unlabelled: Policy Points A redirection of measurement in health care from a narrow focus on diseases and care processes towards assessing whole person health, as perceived by the person themself, may provide a galvanizing view of how health care can best meet the needs of people and help patients feel heard, seen, and understood by their care team. This review identifies key tensions to navigate as well as four overarching categories of whole person health for consideration in developing an instrument optimized for clinical practice. The categories (body and mind, relationships, living environment and finances, and engagement in daily life) include nine constituent domains.
View Article and Find Full Text PDFCurr Drug Targets
January 2025
Pharmaceutics Research Projects Laboratory, Department of Pharmaceutical Sciences, Dr. Harisingh Gour Vishwavidyalaya, Sagar (M.P.) 470003, India.
Breast cancer remains the second most prevalent cancer among women in the United States. Despite advancements in surgical, radiological, and chemotherapeutic techniques, multidrug resistance continues to pose significant challenges in effective treatment. Combination chemotherapy has emerged as a promising approach to address these limitations, allowing multiple drugs to target malignancies via distinct mechanisms of action.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!