Methods for exploring implementation variation and local context within a cluster randomised community intervention trial.

Abstract

Insignificant or modest findings in intervention trials may be attributable to poorly designed or theorised interventions, poorly implemented interventions, or inadequate evaluation methods. The pre-existing context may also account for the effects observed. A combination of qualitative and quantitative methods is outlined that will permit the determination of how context level factors might modify intervention effectiveness, within a cluster randomised community intervention trial to promote the health of mothers with new babies. The methods include written and oral narratives, key informant interviews, impact logs, and inter-organisational network analyses. Context level factors, which may affect intervention uptake, success, and sustainability are the density of inter-organisational ties within communities at the start of the intervention, the centrality of the primary care agencies expected to take a lead with the intervention, the extent of context-level adaptation of the intervention, and the amount of local resources contributed by the participating agencies. Investigation of how intervention effects are modified by context is a new methodological frontier in community intervention trial research.