Process Evaluation of an Implementation Trial: Design, Rationale, and Early Lessons Learnt From an International Cluster Clinical Trial in Intracerebral Hemorrhage.

ABSTRACT:

Background

The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3) is an ongoing, international, multicenter, stepped-wedge cluster, prospective, randomized, open, blinded endpoint assessed trial evaluating the effectiveness of a quality improvement "care bundle" for the management of patients with acute spontaneous intracerebral hemorrhage (ICH) in low- and middle-income countries (LMICs). An embedded process evaluation aims to explore the uptake and implementation of the intervention, and understand the context and stakeholder perspectives, for interpreting the trial outcomes.

Methodology

The design was informed by Normalization Process Theory and the UK Medical Research Council process evaluation guidance. Mixed methods

SUBMITTER: Ouyang M 

PROVIDER: S-EPMC9240283 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature