Table 4 Treatment fidelity execution and assessment plan
Treatment fidelity strategies grouped by category | Plan for execution and assessment |
|---|---|
Treatment design (defined as the extent to which the design of the trial ensures that the active ingredients of the intervention are operationalized, the measures capture theoretical constructs, and potentially threats to validity are identified) | |
Treatment dose in the intervention condition • Length of contact • Number of contacts • Duration of contact over time • Content of treatment | 4 contacts over a 9-month period: • 2 h of game play within 2 weeks of enrollment • 20 min of game play at 90 days, 180 days, and 270 days Night Shift 2024 covers 10 trauma triage principles derived from the American College of Surgeons guidelines and a review of the literature (see Table 1 for additional details) |
Treatment dose in the comparison condition • Length of contact • Number of contacts • Duration of contact over time • Content of treatment | Not applicable |
Specification of provider credentials that are needed | Not applicable |
Clear articulation of theoretical model on which the intervention is based | The dual process model of cognition (see eFigure 1 and Table 1) |
Plan to identify potential confounders of trial results | Semi-structured interviews with a subset of trial participants (n = 20) and key decision makers (n = 80) conducted at month 1 and month 6 to understand contextual factors that modify adoption, implementation, and maintenance |
Plan to address possible setbacks in delivery of the intervention (i.e., back systems or providers) | Loading of application to iOS Apple Store so that participants can access it independently |
If more than one intervention is described, all are described equally well | Not applicable |
Training providers (defined as strategies to standardize training between providers and monitoring provider skills over time) | |
Not applicable | |
Delivery of treatment (defined as treatment differentiation, treatment competency, and treatment adherence) | |
Method of ensuring that the content and dose of intervention is delivered as specified | Intervention—game transmits details of game usage (cases completed, time spent) to a secure database whenever iPad linked to WiFi |
Method to assess participants’ contact with the information | Intervention—information captured automatically from the application |
Assessment of nonspecific treatment effects (i.e., competency or quality of delivery of intervention) | Not applicable |
Use of treatment manual | Not applicable |
Plan for the assessment of whether the active ingredients were delivered | We will categorize the number of trauma triage principles reviewed by trial participants (n = 10) |
Plan for assessment of whether proscribed components were delivered (e.g., components that were unnecessary or unhelpful) | Not applicable |
Plan to minimize contamination between conditions | Accessing the game requires a login id (i.e., an email address), which will allow us to determine if participants in the control group have played it |
A priori specification of acceptable treatment fidelity (e.g., providers adhere to delivering > 80% of components) | We will define acceptable treatment fidelity as a minimum of 2 h of game play (intervention) |
Receipt of treatment (defined as extent to which participants understand and have the ability to use the knowledge, skills, or recommendations communicated in the intervention) | |
Assessment of the degree to which participants understood the intervention | Self-report after first round of game play (intervention) |
Specification of strategies to improve participant comprehension of the intervention | Not applicable |
Participant ability to perform the intervention skills is assessed during the intervention period | Use of SONAR (a tool designed to measure phySician behaviOr iN trAuma tRiage) to quantify determinants of physician decision making after first round of game play (intervention) or completion of CME (control) |
Multicultural factors considered in the development and delivery of the intervention (e.g., provided in native language; protocol is consistent with the values of the target group) | Playtesting of game with end users to refine content and game mechanics; stakeholder panel to provide advice about study protocol |
Enactment of treatment skills (defined as the ability of participants to use behavioral skills and cognitive strategies in real-world settings) | |
Participant performance of the intervention skills will be assessed in settings in which the intervention might be applied | Claims data to capture performance in real life during the study |
A strategy will be used to assess performance of the intervention skills in settings in which the intervention might be applied | Indirect observation |