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

Menglu Ouyang^{1

2}, Anila Anjum³, Francisca Gonzalez Mc Cawley⁴, Mohammad Wasay³, Lu Ma⁵, Xin Hu⁵, Xiaoying Chen¹, Alejandra Malavera¹, Xi Li⁵, Paula Muñoz Venturelli^{1

4}, H Asita de Silva⁶, Nguyen Huy Thang⁷, Kolawole W Wahab⁸, Jeyaraj D Pandian⁹, Octavio M Pontes-Neto¹⁰, Carlos Abanto¹¹, Venessa Cano-Nigenda¹², Antonio Arauz¹², Chao You⁵, Stephen Jan¹, Lili Song¹³, Craig S Anderson^{1

13

14

15}, Hueiming Liu^{1

16

17}; INTERACT3 Investigators

Affiliations

¹ The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
² The George Institute China Office, Beijing, China.
³ Clinical Trials Unit, The Aga Khan University, Karachi, Pakistan.
⁴ Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Chile.
⁵ Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
⁶ Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.
⁷ Stroke Unit, 115 Hospital, Ho Chi Minh City, Vietnam.
⁸ Department of Medicine, University of Ilorin & University of Ilorin Teaching Hospital, Ilorin, Nigeria.
⁹ Department of Neurology, Christian Medical College and Hospital, Ludhiana, India.
¹⁰ Department of Neurology, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto, Brazil.
¹¹ Cerebrovascular Disease Research Center, National Institute of Neurological Sciences, Lima, Peru.
¹² Stroke Clinic, Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suarez, Mexico City, Mexico.
¹³ Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University, Shanghai, China.
¹⁴ Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia.
¹⁵ Heart Health Research Center, Beijing, China.
¹⁶ Menzies Centre for Health Policy and Economics, University of Sydney, Sydney, Australia.
¹⁷ Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, Australia.

PMID: 39700102
PMCID: PMC11658503
DOI: 10.1371/journal.pgph.0003711

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

Menglu Ouyang et al. PLOS Glob Public Health. 2024.

. 2024 Dec 19;4(12):e0003711.

doi: 10.1371/journal.pgph.0003711. eCollection 2024.

Authors

Affiliations

¹ The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
² The George Institute China Office, Beijing, China.
³ Clinical Trials Unit, The Aga Khan University, Karachi, Pakistan.
⁴ Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Chile.
⁵ Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
⁶ Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.
⁷ Stroke Unit, 115 Hospital, Ho Chi Minh City, Vietnam.
⁸ Department of Medicine, University of Ilorin & University of Ilorin Teaching Hospital, Ilorin, Nigeria.
⁹ Department of Neurology, Christian Medical College and Hospital, Ludhiana, India.
¹⁰ Department of Neurology, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto, Brazil.
¹¹ Cerebrovascular Disease Research Center, National Institute of Neurological Sciences, Lima, Peru.
¹² Stroke Clinic, Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suarez, Mexico City, Mexico.
¹³ Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University, Shanghai, China.
¹⁴ Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia.
¹⁵ Heart Health Research Center, Beijing, China.
¹⁶ Menzies Centre for Health Policy and Economics, University of Sydney, Sydney, Australia.
¹⁷ Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, Australia.

PMID: 39700102
PMCID: PMC11658503
DOI: 10.1371/journal.pgph.0003711

Abstract

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. Trial registration: INTERACT3 is registered at Clinicaltrials.gov (NCT03209258) and the Chinese Clinical Trial Registry (ChiCTR-IOC-17011787).

Copyright: © 2024 Ouyang et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: LS reports funding from the Medical Research Council of the UK, Sichuan Credit Pharmaceutic, and Takeda China; and speaker fees from Takeda China. CSA has received grants from the National Health and Medical Research Council and Medical Research Futures Fund of Australia, the Medical Research Council of the UK, Penumbra, and Takeda China. CY has received funding from West China Hospital. The other authors have declared that no competing interests exist.

Figures

**Fig 1. Synthesis findings by implementation research logic model.**
BGL blood glucose level, BP denotes blood pressure, CI confidence interval, ED Emergency Department, ICH intracerebral haemorrhage, OR odds ratio.

See this image and copyright information in PMC

References

1. Feigin VL, Stark BA, Johnson CO, Roth GA, Bisignano C, Abady GG, et al.. Global, regional, and national burden of stroke and its risk factors, 1990–2019: a systematic analysis for the global burden of disease study 2019. Lancet Neurol. 2021;20:795–820. doi: 10.1016/S1474-4422(21)00252-0 - DOI - PMC - PubMed
1. Cordonnier C, Demchuk A, Ziai W, Anderson CS. Intracerebral hemorrhage: current approaches to acute management. Lancet. 2018;392:1257–1268. - PubMed
1. Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, et al.. Hematoma growth is a determinant of mortality and poor outcome after intracerebral haemorrhage. Neurology. 2006;66(8):1175–1181. - PubMed
1. Haupenthal D, Schwab S, Kuramatsu JB. Hematoma expansion in intracerebral haemorrhage—the right target? Neurol Res Pract. 2023. Jul 27;5(1):36. - PMC - PubMed
1. Li Q, Yakhkind A, Alexandrov AW, Anderson CS, Dowlatshahi D, Frontera JA, et al.. Code ICH: A Call to Action. Stroke. 2024. Feb;55(2):494–505. doi: 10.1161/STROKEAHA.123.043033 - DOI - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical