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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое The multifaceted interventions
  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 rec
• Другое Routine VTE prophylaxis
  Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices

Первичные конечные точки

• Proportion of appropriate prophylaxis rate during hospitalization [Срок оценки: 90 days after hospital admission]
• The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE) [Срок оценки: 90 days after hospital admission]

Вторичные конечные точки (2)

• All-cause mortality [Срок оценки: 90 days after hospital admission]
• Proportion of complications related to the intervention [Срок оценки: 90 days after hospital admission]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Публикации

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• 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
• 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 PMID 27115264
• 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
• 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
• 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 PMID 32474204

Идентификаторы

NCT: NCT04211181 · CHIPs-VTE in inpatient

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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