ArticleFrontiers in medicine2022
Process Evaluation of an Implementation Trial: Design, Rationale, and Early Lessons Learnt From an International Cluster Clinical Trial in Intracerebral Hemorrhage.
Article in Frontiers in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03209258 (An Investigator Initiated and Conducted, International, Multicenter, Stepped Wedge Cluster Randomized Study of a Care Bundle of Physiological Control Strategies in Acute Intracerebral Hemorrhage), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Investigator Initiated and Conducted, International, Multicenter, Stepped Wedge Cluster Randomized Study of a Care Bundle of Physiological Control Strategies in Acute Intracerebral Hemorrhage
Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Implementation of a goal-directed Care Bundle for intracerebral hemorrhage: Results of embedded process evaluation in the INTERACT3 trial.PLOS global public health · 2024Article
- Factors influencing implementation of a care coordination intervention for cancer survivors with multiple comorbidities in a safety-net system: an application of the Implementation Research Logic Model.Implementation science : IS · 2023Article
Corrections and comments
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Authors and funding
12 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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 are used to evaluate the implementation outcomes of fidelity, reach, dose, acceptability, appropriateness, adoption, sustainability, and relevant contextual factors and mechanisms affecting delivery of the care bundle. Semi-structured interviews and non-participant observations are conducted with the primary implementers (physicians and nurses) and patients/carers to explore how the care bundle was integrated into routine care. Focus group discussions are conducted with investigators and project operational staff to understand challenges and possible solutions in the organization of the trial. Data from observational records, surveys, routine monitoring data, field notes and case report forms, inform contextual factors, and adoption of the intervention. Purposive sampling of sites according to pre-specified criteria is used to achieve sample representativeness. Discussion: Implementation outcomes, and relevant barriers and facilitators to integrating the care bundle into routine practice, will be reported after completion of the process evaluation. The embedded process evaluation will aid understanding of the causal mechanisms between care bundle elements and clinical outcomes within complex health systems across diverse LMIC settings. Trial Registration: The INTERACT3 study is registered at ClinicalTrials.gov (NCT03209258).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.