Intervention delivery complexity and adaptations for implementation of non-pharmacologic pain interventions.

BACKGROUND

Delivering evidence-based interventions remains challenging, particularly for complex conditions like chronic musculoskeletal pain. Non-pharmacologic treatments are recommended for many pain conditions, but implementing these can be difficult due to their complexity and resource demands. Pragmatic trials, especially embedded designs, provide a method to see how interventions are being implemented and adapted in real-world settings throughout the trial process. This study explored how intervention delivery complexity and adaptations differ between non-pharmacologic pain trials and non-pain trials to provide guidance on future treatment delivery and implementation.

METHODS

From July to October 2023, an online survey was distributed to members of three NIH Trial Collaboratories to assess intervention delivery complexity and adaptations during their pragmatic trials. Participants rated their trial's intervention delivery complexity using a 7-item tool and reported any adaptations to intervention delivery throughout the trial process. Data analysis compared complexity and adaptations between the two trial types to explore differences and relationships between intervention delivery complexity and adaptations.

RESULTS

We analyzed 12 pain and 12 non-pain trials and found that intervention delivery complexity was not discernibly different between the two trial types, however, pain trials did have a slightly higher average intervention delivery complexity, overall. Pain trials also had more adaptations in the workflow domain compared to non-pain trials, while adaptations across other domains were similar between the two types. Workflow emerged as the most challenging domain for adaptation among all trials.

CONCLUSION

Intervention delivery complexity may be higher for pragmatic trials that are investigating non-pharmacologic pain interventions versus non-pain trials, but only in very specific areas.