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Related Experiment Video

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The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
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Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework

Julie M Fritz1, Tom Greene2, Gerard P Brennan3

  • 1Department of Physical Therapy & Athletic Training, University of Utah, 383 Colorow Drive, Room 391, Salt Lake City, UT, 84108, USA. julie.fritz@utah.edu.

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|February 24, 2023
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Summary

The OPTIMIZE trial adapted complex interventions for chronic low back pain using the FRAME. Modifications improved feasibility and addressed COVID-19 challenges, ensuring transparent reporting for future implementation.

Keywords:
Comparative effectiveness researchFidelityImplementationLow back painModificationPragmatic clinical trial

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Area of Science:

  • Comparative Effectiveness Research (CER)
  • Health Services Research

Background:

  • The OPTIMIZE trial is a multi-site CER study using a Sequential Multiple Assessment Randomized Trial (SMART) design.
  • It examines complex health interventions for chronic low back pain, including cognitive behavioral therapy, physical therapy, and mindfulness.
  • Modifications to complex interventions are anticipated in CER, with COVID-19 presenting further challenges.

Purpose of the Study:

  • To outline modifications made to the OPTIMIZE trial.
  • To use the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize these changes.
  • To detail adaptations in response to COVID-19 and other encountered challenges.

Main Methods:

  • The FRAME strategy was employed to identify and report modifications.
  • Modifications addressed lower-than-anticipated treatment initiation rates and COVID-19 restrictions.
  • Telehealth delivery replaced in-person treatments, and training was enhanced for personnel.

Main Results:

  • Modifications were developed collaboratively with patient and stakeholder advisory panels.
  • The primary goal was to enhance trial feasibility without compromising core intervention functions.
  • All modifications received approval from the study funder and trial steering committee.

Conclusions:

  • Transparent reporting of all trial modifications is crucial.
  • This detailed reporting aids in interpreting trial results.
  • It also supports future implementation efforts of evidence-based interventions.