Rationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE–Acute Ischemic Stroke

doi:10.1016/j.ahj.2015.03.008

American Heart Journal

Volume 169, Issue 6, June 2015, Pages 767-774.e2

https://doi.org/10.1016/j.ahj.2015.03.008 Get rights and content

Background

Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke (AIS) in China.

Aims

This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention.

Design

This is a multicenter, 2-arm, open-label, cluster-randomized trial involving 40 clusters (hospitals) from China National Network of Stroke Research. Hospitals are randomized to receive a targeted multifaceted quality improvement intervention (experimental group) or routine standard of care (control group). The multifaceted intervention includes an evidence-based clinical pathway, written care protocols, a quality coordinator, and a monitoring and feedback system of performance measures. The number of enrolled patients in the trial will be 4,800. Primary outcome is the measure of the adherence to AIS evidence-based performance measures including the composite measure (defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients) and the all-or-none measure (defined as the proportion of eligible patients who receive all of the performance measure interventions for which they are eligible). Secondary patient outcomes include inhospital death; a new vascular event; disability; and all-cause death at 3, 6, and 12 months after initial symptom onset. All analyses will be performed according to the intention-to-treatment principle and accounted for clustering using generalized estimating equations.

Conclusions

If proven effective, this targeted multifaceted intervention model will be extended nationwide as a model to bridge the evidence-based gap in the AIS management in China.

Section snippets

Study aim

The aim is to evaluate whether a multifaceted quality improvement intervention will improve the adherence to individual, composite, and all-or-none measures for patients with AIS presenting within the first 7 days from stroke symptom onset and reduce the incidence of inhospital death; a new vascular event; disability; and all-cause death at 3, 6, and 12 months after the initial symptom onset.

Design

Golden Bridge–AIS is a multicenter, 2-arm, open-label, parallel, cluster-randomized, controlled trial

Discussion

Stroke registries aim to track delivery of care to hospitalized stroke patients as well as guide and monitor improvements in the quality of stroke care. This strategy has been proven effective and sustainable.30, 31 The Get With The Guidelines (GWTG)–Stroke program was developed as a national stroke quality improvement initiative to substantially address the treatment gap of AIS in United States.³² Although there have been substantial improvements in stroke care over time, as it was not a

Disclosures

Competing interest: All authors report no potential conflict of interest relevant to this article except as follows:

Dr Schwamm is the chair of the GWTG-Stroke Clinical Workgroup (unpaid) and serves as a stroke system of care consultant to the Joint Commission, Center for Disease Control, and Massachusetts Department of Public Health. He is the primary investigator of a National Institute of Neurological Disorders and Stroke–funded clinical trial of extended window thrombolysis for which

Acknowledgements

We thank all participating hospitals, their physicians and nurses, and the GOLDEN BRIDGE–AIS Steering Committee members.

References (34)

G. Yang et al.
Rapid health transition in China, 1990-2010: findings from the Global Burden of Disease Study 2010
Lancet
(2013)
M. Liu et al.
Stroke in China: epidemiology, prevention, and management strategies
Lancet Neurol
(2007)
Y. Wang et al.
Clopidogrel with aspirin in acute minor stroke or transient ischemic attack
N Engl J Med
(2013)
D.G. Sherman et al.
The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison
Lancet
(2007)
K.R. Lees et al.
Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials
Lancet
(2010)
Z.C.
The third national survey on the cause of death. Ministry of Health
(2008)
Stroke prevention: the need for a global response
Lancet Neurol
(2011)
S.M. Davis et al.
Clinical practice. Secondary prevention after ischemic stroke or transient ischemic attack
N Engl J Med
(2012)
The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. International Stroke Trial Collaborative Group
Lancet
(1997)
CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group
Lancet
(1997)

M. Dennis et al.

Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial

Lancet

(2009)

C. Mazzone et al.

Physical methods for preventing deep vein thrombosis in stroke

Cochrane Database Syst Rev

(2004)

M.K. Gould et al.

Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis. A meta-analysis of randomized, controlled trials

Ann Intern Med

(1999)

D.J. Ramsey et al.

Early assessments of dysphagia and aspiration risk in acute stroke patients

Stroke

(2003)

L. Perry et al.

Screening for dysphagia and aspiration in acute stroke: a systematic review

Dysphagia

(2001)

P. Amarenco et al.

High-dose atorvastatin after stroke or transient ischemic attack

N Engl J Med

(2006)

W.J. Wang et al.

Clinical characteristics, management, and functional outcomes in Chinese patients within the first year after intracerebral hemorrhage: analysis from China National Stroke Registry

CNS Neurosci Ther

(2012)

Cited by (19)

Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study
2020, Journal of the Neurological Sciences
Citation Excerpt :
Underlying barriers for thrombolysis in Asia include delayed presentation from the onset of symptoms, concerns over harm, inexperience, and high cost of thrombolysis treatment when there is no health insurance coverage [31,34,35]. Although ASU care is defined as multidisciplinary and a Level I guideline recommendation, early rehabilitation is less common in China and India/Sri Lanka, and many other resource settings in LMICs, in part due to limited availability of allied healthcare professionals and ethnic/cultural differences in the understanding of ‘passive’ and ‘active’ rehabilitation [11,33,36,37]. Additionally, compared to AU/UK, the recommendation for assessment by a speech pathologist and assisted feeding is explicit stroke management guidelines in China and India [38,39], which also influences their implementation into practice [40].
Access to acute stroke unit (ASU) care is known to vary worldwide. We aimed to quantify regional variations in the various components of ASU care.
Secondary analysis of the Head Positioning in acute Stroke Trial (HeadPoST), an international, multicentre, cluster crossover trial of head-up versus head-down positioning in 11,093 acute stroke patients at 114 hospitals in 9 countries. Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America [Brazil/Chile/Colombia]). Variations in process of ASU care estimates were obtained in hierarchical mixed models, with adjustment for study design and potential patient- and hospital-level confounders.
Of 11,086 patients included in analyses, 59.7% (n = 6620) had an ASU admission. In China, India/Sri Lanka and South America, ASU patients were older, had greater neurological severity and more premorbid conditions than non-ASU patients. ASU patients were more likely to receive reperfusion therapy and multidisciplinary care within regions, but the components of care varied across regions. With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12–0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
There is significant variation in the components of stroke care across economically-defined regions of the world. Ongoing efforts are required to reduce disparities and optimise health outcomes, especially in resource poor areas.
HeadPoST is registered at ClinicalTrials.gov (NCT02162017).
Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China: CHIPS-VTE Study for Thromboprophylaxis
2020, American Heart Journal
Citation Excerpt :
In this multicenter cluster randomization trial, intervention is applied at hospital level. Written consent will be obtained from directors at hospital level with agreement for participation and randomization, avoiding selection bias potentially induced by differences in consent refusal between hospitals.27-29 QI intervention is supposed to be beneficial in HA-VTE prevention among hospitalized patients through effective implementation of recommended prophylaxis.
Venous thromboembolism (VTE) is a life-threatening disease that can affect each hospitalized patient. But the current in-hospital thromboprophylaxis remains suboptimal and there exists a large gap between clinical practice and guideline-recommended care in China.
To facilitate implementation of guideline recommendations, we conduct a multicenter, adjudicator-blinded, cluster-randomized clinical trial, aiming to assess the effectiveness of a system-wide multifaceted quality improvement (QI) strategy on VTE prophylaxis improvement and thromboembolism reduction in clinical setting. Hospitals are randomized into intervention or control group. In intervention group, hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education. In control, hospitals receive the concept of recommended prophylaxis alone without QI. Thromboprophylaxis will be at the discretion of hospitals and conducted as usual. With a final sample size of 5760 hospitalized patients in 32 hospitals on mainland China, this trial will examine the effect of QI on improvement in thromboprophylaxis and patient-centered outcomes. This is an open-label trial that patients and healthcare professionals will know group allocation after enrollment, but endpoint adjudicators and statisticians will be blinded. RCT# NCT04211181
The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.
An international cluster-randomized quality improvement trial to increase the adherence to evidence-based therapies for acute ischemic stroke and transient ischemic attack patients: Rationale and design of the BRIDGE STROKE Trial
2019, American Heart Journal
Citation Excerpt :
Additionally, the multilevel and multifaceted educational intervention proposed by the IMPACT trial, conducted in 48 centers from Argentina, Brazil, China, India, and Romania, resulted in a 9.1% difference in the use of oral anticoagulants for atrial fibrillation patients between intervention and control groups after 12 months.36 Recently, the Golden Bridge Study, aiming to improve the quality of care for AIS patients in China, also showed a 3.54% absolute increase in the use of evidence-based therapies.29,35 To the best of our knowledge, BRIDGE Stroke represents the first international cluster-randomized trial developed in Latin American countries and evaluating the effect of a quality improvement intervention on the composite adherence score (comprising the multidisciplinary nature of stroke care), “all or none” measures, and clinical outcomes in patients with AIS or TIA.
Translating evidence into clinical practice in the management of acute ischemic stroke (AIS) and transient ischemic attack (TIA) is challenging especially in low- and middle-income countries.
The aim of this study is to assess the effect of a multifaceted quality improvement intervention on adherence to evidence-based therapies for AIS and TIA patients care.
We designed a pragmatic, 2-arm cluster-randomized trial involving 36 clusters and 1624 patients from Brazil, Argentina, and Peru. Hospitals are randomized to receive a multifaceted quality improvement intervention (intervention group) or to routine care (control group). The BRIDGE Stroke multifaceted quality improvement intervention includes case management, reminders, health care providers’ educational materials (including treatment algorithms), interactive workshops, and audit and feedback reports. Primary outcome is a composite adherence score to AIS and TIA performance measures. Secondary outcomes include an “all or none” composite end point to performance measures, the individual components of the composite end points, and clinical outcomes at 90 days following admission (stroke recurrence, death, and disability measured by the modified Rankin scale).
The BRIDGE Stroke Trial is an international pragmatic evaluation of a multifaceted quality improvement intervention. If effective, this intervention could be potentially extended widely to improve the quality of care and outcomes of patients with AIS or TIA.
Achieving best outcomes for patients with cardiovascular disease in China by enhancing the quality of medical care and establishing a learning ealth-care system
2015, The Lancet
Citation Excerpt :
The CPACS group identified barriers to implementation of the clinical pathway,64 including absence of leadership support, variation in the capacity for care, and health-care funding constraints, and provided instructions for relevant efforts in the future. Several other studies are in progress and will provide further insights into quality improvement strategies for cardiovascular care.65,66 In addition to the need to better apply existing knowledge, China urgently needs to expand the evidence for what treatment strategy works best for which subgroup of patients.
China has an immediate need to address the rapidly growing population with cardiovascular disease events and the increasing number of people living with this illness. Despite progress in increasing access to services, China faces the dual challenge of addressing gaps in quality of care and producing more evidence to support clinical practice. In this Review, we address opportunities to strengthen performance measurement, programmes to improve quality of care, and national capacity to produce high-impact knowledge for clinical practice. Moreover, we propose recommendations, with implications for other diseases, for how China can immediately make use of its Hospital Quality-Monitoring System and other existing national platforms to assess and improve performance of medical care, and to generate new knowledge to inform clinical decisions and national policies.
Interventions for the uptake of evidence-based recommendations in acute stroke settings
2023, Cochrane Database of Systematic Reviews
Effect of the Shanghai Stroke Service System (4S) on the quality of stroke care and outcomes: A prospective quality improvement project
2023, International Journal of Stroke

View all citing articles on Scopus

: Randomized controlled trial number NCT02212912.

: C Michael Gibson, MS, MD served as guest editor for this article.

: Author contributions: Yongjun Wang, Eric D Peterson, Sidney C Smith, Lee H Schwamm, Gregg C Fonarow, David Wang, Janet Prvu Bettger, Ying Xian, Yilong Wang, and Xingquan Zhao: original idea, the trial design, and manuscript reviews. Chunxue Wang, Liping Liu, Zixiao Li, and Chunjuan Wang: the trial design, literature review, manuscript drafting, and updating. Hao Li, Haipeng Shen, and Yuesong Pan: statistical method drafting.

: This study is supported by the grants from the Ministry of Science and Technology of the People's Republic of China (2011BAI08B02, 2012ZX09303, and 2013BAI09B03), Beijing Institute for Brain Disorders (BIBD-PXM2013_014226_07_000084). This trial was registered at clinicaltrials.gov (NCT02212912).

ⁿ: These 2 authors contributed equally to the manuscript.

View full text

Trial DesignRationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE–Acute Ischemic Stroke

Background

Aims

Design

Conclusions

Section snippets

Study aim

Design

Discussion

Disclosures

Acknowledgements

Lancet

Lancet Neurol

N Engl J Med

Lancet

Lancet

The third national survey on the cause of death. Ministry of Health

Stroke prevention: the need for a global response

Lancet Neurol

Clinical practice. Secondary prevention after ischemic stroke or transient ischemic attack

N Engl J Med

The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. International Stroke Trial Collaborative Group

Lancet

CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group

Lancet

Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial

Lancet

Physical methods for preventing deep vein thrombosis in stroke

Cochrane Database Syst Rev

Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis. A meta-analysis of randomized, controlled trials

Ann Intern Med

Early assessments of dysphagia and aspiration risk in acute stroke patients

Stroke

Screening for dysphagia and aspiration in acute stroke: a systematic review

Dysphagia

High-dose atorvastatin after stroke or transient ischemic attack

N Engl J Med

Clinical characteristics, management, and functional outcomes in Chinese patients within the first year after intracerebral hemorrhage: analysis from China National Stroke Registry

CNS Neurosci Ther

Trial Design
Rationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE–Acute Ischemic Stroke