Background
Few studies have described the extent, type and reasons for making changes to a program prior to and during its delivery using a consistent taxonomy. Physical Activity 4 Everyone (PA4E1) is a secondary school physical activity program that was scaled-up for delivery to a greater number of schools. We aimed to describe the extent, type and reasons for changes to the PA4E1 program (the evidence-based physical activity practices, implementation support strategies and evaluation methods) made before its delivery at scale (adaptations) and during its delivery in a scale-up trial (modifications).
Methods
The Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) was used to describe adaptations (planned and made prior to the scale-up trial) and modifications (made during the conduct of the trial). A list of adaptations was generated from a comparison of the efficacy and scale-up trials via published PA4E1 protocols, trial registrations and information provided by trial investigators. Monthly trial team meetings tracked and coded modifications in ‘real-time’ during the conduct of the scale-up trial. The extent, type and reasons for both adaptations and modifications were summarized descriptively.
Results
In total, 20 adaptations and 20 modifications were identified, these were to physical activity practices (n = 8; n = 3), implementation support strategies (n = 6; n = 16) and evaluation methods (n = 6, n = 1), respectively. Few adaptations were ‘fidelity inconsistent’ (n = 2), made ‘unsystematically’ (n = 1) and proposed to have a ‘negative’ impact on the effectiveness of the program (n = 1). Reasons for the adaptations varied. Of the 20 modifications, all were ‘fidelity consistent’ and the majority were made ‘proactively’ (n = 12), though most were ‘unsystematic’ (n = 18). Fifteen of the modifications were thought to have a ‘positive’ impact on program effectiveness. The most common decision-maker in the modification process was the ‘program manager’ (n = 17). The main reason for modification was the ‘available resources’ (n = 14) of the PA4E1 Implementation Team. For both adaptations and modifications respectively, the most common goal was to ‘improve fit with recipients’ (n = 8; n = 7).
Conclusions
A considerable number of adaptations and modifications were made for scale-up that could have important impacts on intervention effects and are important to the interpretation of trial findings.
Trial Registration
Australia New Zealand Clinical Trial Registry: ACTRN12617000681358