CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211181
• Other study ID #: CHIPs-VTE in inpatient
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2023
• Source: China-Japan Friendship Hospital
• Contact: Zhenguo Zhai, Doctor
• Phone: 86-10-84206265
• Email: zhaizhenguo2011[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5800
• Est. completion date: March 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

1. Aged =14 years

2. Have an expected hospital stay =72 hours for medical and/or surgical treatment

3. Written informed consent

Exclusion Criteria:

1. Inability to be followed-up at until 3 months after randomization

2. Have participated in similar trials or are undergoing other clinical trials

3. Refuse or are unable to give informed consent

4. VTE identified on CTPA or lower extremity vein ultrasound at or any time before enrollment

5. Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation).

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Quality Improvement
• Thromboembolism
• Thrombosis
• Venous Thromboembolic Disease
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Other:
• The multifaceted interventions
An evidence-based clinical guideline and pathway in hospital. A series Written care protocols for the implementation of performance measures. A computer-based clinical decision support system(CDSSs) and a computerized reminder, which was referred to as a key element to enhance VTE assessment and prophylaxis. A well-designed computer program will be integrated into the Electronic Medical Record(EMR) of intervention group and By processing, analyzing, summarizing and representing crucial information, physicians can be altered. A full-time quality coordinator A trained physician or nurse in each intervention cluster will be acted as a quality coordinator. The responsibility of the quality coordinator includes:
• Routine VTE prophylaxis
Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Circulation. 2010 Jul 6;122(1):e4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	All-cause mortality	Proportion of participants who was dead(all-cause mortality)	90 days after hospital admission
Secondary	Proportion of complications related to the intervention	complications(i.e. major bleeding,minor bleeding, thrombocytopenia) related to the intervention	90 days after hospital admission