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

NCT04211181 | Recruiting DMC

• 1 other identifier: CHIPs-VTE in inpatient
• Study Type: interventional
• Target: 5,800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Quality improvement; Venous Thromboembolism; Hospital Associated-VTE

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• All-cause mortality

  90 days after hospital admission

• Proportion of complications related to the intervention

  90 days after hospital admission

Study Arms (2)

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.

Other: The multifaceted interventions

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.

Other: Routine VTE prophylaxis

Interventions

The multifaceted interventions OTHER

1. An evidence-based clinical guideline and pathway in hospital. 2. A series Written care protocols for the implementation of performance measures. 3. A newly developed mobile application (mini-program) will be employed to facilitate venous thromboembolism (VTE) risk assessment and prophylaxis. Patients will scan a QR code to enroll in the program and be linked with their physician. Through the application, patients will complete standardized self-assessments of VTE risk, and physicians will receive periodic reminders indicating whether the assessment and prophylaxis orders have been completed.The application also provides educational modules and targeted messages for both patients and physicians, and enables interactive communication. 4. A quality-control team will receive weekly feedback reports to verify whether all enrolled patients underwent appropriate prophylaxis.

The multifaceted QI interventions

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

Routine VTE prophylaxis in local clinical practice

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥14 years
• Have an expected hospital stay ≥72 hours for medical and/or surgical treatment
• Written informed consent

You may not qualify if:

• Inability to be followed-up at until 3 months after randomization
• Have participated in similar trials or are undergoing other clinical trials
• Refuse or are unable to give informed consent
• VTE identified on CTPA or lower extremity vein ultrasound at or any time before enrollment
• Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 19364975 BACKGROUND

• 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.

  PMID: 23279972 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.

  PMID: 15758007 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.

  PMID: 27115264 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.

  PMID: 19584716 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.

  PMID: 16961674 BACKGROUND

• 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.

  PMID: 32474204 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Thrombosis

Study Officials

• Zhenguo Zhai, Doctor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenguo Zhai, Doctor

CONTACT

86-10-84206265; zhaizhenguo2011@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 26, 2019
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)