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Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been established in several countries or hospitals.However,no exit effective protocol has been demonstrated well enough or adequate to drive breakthrough levels of improvement. A reliable and practical QI that can support hospitals or physicians in China is warranted.To evaluate the multifaceted quality improvement intervention effect in clinical setting, we will conduct a cluster-randomized clinical trial among China PUlmonary Thromboembolism REgistry Study (CURES) group, aiming to test whether it's applicable to real-world practice in China.
A multicenter, two-arms, open-label clinical trial has been designed to determine whether the system-wide multifaceted intervention could increase the rate of at-risk participants who received prophylaxis (RP) and decrease the incidence of any hospital-associated VTE in 90 days during and after hospital admission. .Selected hospital will be regarded as a cluster and randomized into interventional or control group.In interventional group, eligible hospitalized patients will receive a variety of the multifaceted quality improvement(QI) interventions since admitted in hospital.In control group, patients will receive no more than common recommended care or an existing policy.The primary outcomes are the proportion of appropriate prophylaxis in hospitalized patients and the incidence of HA-VTE in 90 days after hospital admission.
Hospitals nationwide which have willingness to participate this study in CURES group will be selected. Each selected hospital will be regarded as a cluster and randomized into interventional or control group.
During the study period, eligible patients enrolled in hospitals assigned to interventional group will receive a variety of the multifaceted quality improvement(QI) interventions, including mandatory risk assessment, a computer alert(computer-based clinical decision support system and computerized reminders), strengthened education, and audit. Patients in hospitals assigned to control group will receive common recommended care only, or an existing policy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The multifaceted QI interventions | Experimental | Hospitals randomized into experimental group will implement follow interventions including：the distribution of the guideline and pathway, a computer alert(computer-based clinical decision support system and computerized reminders),audit and feedback. |
|
| Routine VTE prophylaxis in local clinical practice | Active Comparator | Patients in the routine VTE prophylaxis(control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The multifaceted interventions | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of appropriate prophylaxis rate during hospitalization | The proportion of appropriate prophylaxis is defined as the number of appropriate prophylaxis among the patients at risk of VTE and without corresponding contraindications. | 90 days after hospital admission |
| The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE) | The incidence of HA-VTE is defined as the proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE) | 90 days after hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Proportion of participants who was dead(all-cause mortality) | 90 days after hospital admission |
| Proportion of complications related to the intervention | complications(i.e. major bleeding,minor bleeding, thrombocytopenia) related to the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenguo Zhai, Doctor | Contact | 86-10-84206265 | zhaizhenguo2011@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenguo Zhai, Doctor | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19364975 | Background | Piazza G, Rosenbaum EJ, Pendergast W, Jacobson JO, Pendleton RC, McLaren GD, Elliott CG, Stevens SM, Patton WF, Dabbagh O, Paterno MD, Catapane E, Li Z, Goldhaber SZ. Physician alerts to prevent symptomatic venous thromboembolism in hospitalized patients. Circulation. 2009 Apr 28;119(16):2196-201. doi: 10.1161/CIRCULATIONAHA.108.841197. Epub 2009 Apr 13. | |
| 23279972 |
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|
| Routine VTE prophylaxis | Other | Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices |
|
| 90 days after hospital admission |
| Pai M, Lloyd NS, Cheng J, Thabane L, Spencer FA, Cook DJ, Haynes RB, Schunemann HJ, Douketis JD. Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial. Implement Sci. 2013 Jan 2;8:1. doi: 10.1186/1748-5908-8-1. |
| 15758007 | Background | Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533. |
| 27115264 | Background | Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet); Cavalcanti AB, Bozza FA, Machado FR, Salluh JI, Campagnucci VP, Vendramim P, Guimaraes HP, Normilio-Silva K, Damiani LP, Romano E, Carrara F, Lubarino Diniz de Souza J, Silva AR, Ramos GV, Teixeira C, Brandao da Silva N, Chang CC, Angus DC, Berwanger O. Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 12;315(14):1480-90. doi: 10.1001/jama.2016.3463. |
| 19584716 | Background | Garcia DA, Highfill J, Finnerty K, Varoz E, McConkey S, Hutchinson K, Libby E. A prospective, controlled trial of a pharmacy-driven alert system to increase thromboprophylaxis rates in medical inpatients. Blood Coagul Fibrinolysis. 2009 Oct;20(7):541-5. doi: 10.1097/MBC.0b013e32832d6cfc. |
| 16961674 | Background | Fontaine A, Mahe I, Bergmann JF, Fiessinger JN, Dhote R, Cohen P, Vinceneux P. Effectiveness of written guidelines on the appropriateness of thromboprophylaxis prescriptions for medical patients: a prospective randomized study. J Intern Med. 2006 Oct;260(4):369-76. doi: 10.1111/j.1365-2796.2006.01699.x. |
| 32474204 | Derived | Dong F, Zhen K, Zhang Z, Si C, Xia J, Zhang T, Xia L, Wang W, Jia C, Shan G, Zhai Z, Wang C; Chinese Prevention Strategy for Venous Thromboembolism (CHIPS-VTE) study group. 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. Am Heart J. 2020 Jul;225:44-54. doi: 10.1016/j.ahj.2020.04.020. Epub 2020 May 7. |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D013927 | Thrombosis |
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