Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity.
Clinical workflow
Complex interventions
Implementation
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
03 2023
03 2023
Historique:
received:
08
10
2022
revised:
03
01
2023
accepted:
23
01
2023
pmc-release:
01
03
2024
pubmed:
29
1
2023
medline:
11
3
2023
entrez:
28
1
2023
Statut:
ppublish
Résumé
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. 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/). 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 36708968
pii: S1551-7144(23)00028-9
doi: 10.1016/j.cct.2023.107105
pmc: PMC10126825
mid: NIHMS1870907
pii:
doi:
Types de publication
Review
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
107105Subventions
Organisme : NCCIH NIH HHS
ID : U24 AT009676
Pays : United States
Organisme : NCCIH NIH HHS
ID : U24 AT010961
Pays : United States
Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
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