Implementation of a goal-directed Care Bundle for intracerebral hemorrhage: Results of embedded process evaluation in the INTERACT3 trial

Journal
PLOS Global Public Health
ISSN
2767-3375
Date Issued
2024-12-19
Author(s)
Menglu Ouyang
Anila Anjum
Francisca Gonzalez Mc Cawley
Mohammad Wasay
Lu Ma
Xin Hu
Xiaoying Chen
Alejandra Malavera
Xi Li
H. Asita de Silva
Nguyen Huy Thang
Kolawole W. Wahab
Jeyaraj D. Pandian
Octavio M. Pontes-Neto
Carlos Abanto
Venessa Cano-Nigenda
Antonio Arauz
Chao You
Stephen Jan
Lili Song
Craig S. Anderson
Hueiming Liu
Type
journal-article
DOI
URL
Abstract
<jats:p>The third, stepped-wedge, cluster-randomized, Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3), has shown that a goal-directed multi-faceted Care Bundle incorporating protocols for the management of physiological variables was safe and effective for improving functional recovery in a broad range of patients with acute intracerebral hemorrhage (ICH). The INTERACT3 Care Bundle included time- and target-based protocols for the management of early intensive lowering of systolic blood pressure (SBP, target <140mmHg), glucose control (target 6.1–7.8 mmol/L in those without diabetes and 7.8–10.0 mmol/L in those with diabetes), anti-pyrexia treatment (target body temperature ≤37.5°C), and the rapid reversal of warfarin-related anticoagulation (target international normalized ratio <1.5). An embedded process evaluation was conducted to allow a better understanding of how the Care Bundle was implemented in different countries to enhance the transferability of this evidence in the international context. This study used a mixed-methods approach involving interviews, focus group discussions, and surveys to evaluate the implementation outcomes included fidelity, dose, reach, acceptability, appropriateness, adoption, and sustainability. Interviews (n = 27), focus group discussions (n = 3), and quantitative surveys (n = 48) were conducted in 7 low- and middle-income countries (LMICs) and 1 high-income country during 2019–2022. The Care Bundle was generally delivered as planned and well accepted by stakeholders, although some difficulties were reported in reaching the SBP and glycemic targets. Contextual factors including staff shortage, limited availability of antihypertensive drugs, and delayed systems of care processes, were common barriers to implementing the Care Bundle. Facilitating factors included good communication and collaboration with staff in emergency departments, the development of pathways within available resources, and regular training and monitoring. Our process evaluation provides useful insights into the contextual barriers which need to be addressed for effective scale up of the Care Bundle implementation in a global context.</jats:p>
<jats:p><jats:bold>Trial registration</jats:bold>: INTERACT3 is registered at Clinicaltrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT03209258" xlink:type="simple">NCT03209258</jats:ext-link>) and the Chinese Clinical Trial Registry (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.chictr.org.cn/showprojEN.html?proj=19647" xlink:type="simple">ChiCTR-IOC-17011787</jats:ext-link>).</jats:p>