What is the clinical evidence from this study?

Study design: RCT. Population: Hospitalized medical patients at risk for venous thromboembolism (n=2611). Intervention: Multicomponent knowledge-translation intervention (education, risk assessment algorithm, printed orders, audit and feedback) vs. Usual care (no active strategies for thromboprophylaxis). Primary outcome: Proportion of eligible medical patients appropriately managed for thromboprophylaxis within 24 hours of admission (OR 0.80, 95% CI 0.50, 1.28, p=0.36).

January 2, 2013Implementation Science381 citationsOpen Access

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial

MPMenaka Pai NLN Lloyd JCJi Cheng

Key Result

A multicomponent knowledge-translation intervention did not significantly improve the rate of appropriate venous thromboprophylaxis in hospitalized medical patients compared to usual care (OR 0.80).

Study Design

Type

RCT (n=2,611)

Blinding

Open-label

Randomization

Cluster randomized

Multicenter

Yes

Structured PICO

Does a multicomponent knowledge-translation intervention improve appropriate VTE prophylaxis rates in hospitalized medical patients?

Population

2,611 medical inpatients aged 18 and older admitted to general internal medicine across six hospitals, evaluated for appropriate venous thromboprophylaxis within 24 hours of admission.

Intervention

Multicomponent knowledge-translation intervention comprising clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions.

Comparator

Usual care (no active strategies for thromboprophylaxis in place).

Outcome

Proportion of medical patients appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, and feasibility of conducting the study on a larger scale.

A multicomponent knowledge-translation intervention did not significantly improve the rates of appropriate VTE prophylaxis in hospitalized medical patients, highlighting significant implementation barriers.

Main Result

Odds Ratio: 0.8 (95% CI 0.5–1.28)

Absolute Event Rate: 64.5% vs 66.6%

p-value: p=0.36

Limitations

Intervention forms were not available in the emergency department where patients are initially assessed
Ambiguously defined and inconsistently documented variables (e.g., immobility) in patient charts
Lack of documentation regarding physicians' clinical judgment when inappropriately prescribing or omitting prophylaxis
Potential contamination from house staff providing coverage across both intervention and control academic centers
Lack of data on intervention fidelity (e.g., form uptake rates, education session attendance)
Study was not designed to measure safety and efficacy outcomes of thromboprophylaxis
Lack of baseline data on appropriate thromboprophylaxis rates at each hospital prior to implementation
Baseline differences in VTE risk between intervention and control groups
Sample size was not adjusted for clustering
Poor attendance by clinical staff at education and feedback sessions
Difficulty locating preprinted orders
Lack of involvement by clinical and administrative leaders

Abstract

BACKGROUND: Venous thromboembolism (VTE) is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. METHODS: We conducted a 16-week pilot cluster randomized controlled trial (RCT) to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters) in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place). Blinding was not used. RESULTS: A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group) were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022), and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE prophylaxis strategy, including local champions, support from clinical and administrative leaders, mandatory use, and a simple, clinically relevant risk assessment tool. CONCLUSIONS: Hospitals allocated to our multicomponent intervention did not have a higher rate of medical inpatients appropriately managed for thromboprophylaxis than did hospitals that were not allocated to this strategy.

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