Pulmonary embolism (PE) remains a high mortality and morbidity disease state. The investigators have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas. The use of artificial intelligence (AI) may help streamline and systematically ensure unbiased mechanism for activation of PERT for discussion of patients with siginficant clot burden and hemodynamic abnormalities. AI algorithms have been FDA approved for use of triage of the PE patient. The institutional PERT program will adapt the use of an AI algorithm for activation as routine care; the efficiency of activation will be compared to our retrospective historical comparison for efficiency and appropriateness of activation. The active phase of the study is designed to further differentiate between patients who are considered to be intermediate-high risk category but yet do not clearly qualify for invasive therapy (catheter-directed therapy, systemic thrombolysis, or invasive hemodynamic support). These patients will undergo walking test to further understand noninvasive hemodynamic compromise and undergo 2:1 randomization to early-invasive strategy versus mtranditional medical therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
PERT will be activated by AI algorithm. As a result of the discussion, patients will either be determined to be appropriate for immediate invasive strategy versus watchful waiting depending on whether high-risk PE criteria are met. For those in the intermediate-high risk category, there remains ambiguity on timing and appropriateness of invasive intervention. On day 1 of admission, patients will undergo a walking test evaluating for abnormalities in heart rate, heart rate recovery, and oxygen need. If criteria is met, patients will be randomized in a 2:1 fashion (treatment versus control) to evaluate use of early-invasive strategy.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Time-to-activation
Activation of PERT from time of CT scan to call; compared to historical control
Time frame: 3 days
Length of stay
Total length of hospital stay
Time frame: 30 days
6-minute walk test (6MWT)
The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.
Time frame: 6 minutes
Change in quality of life as measured by PEmb QoL
PEmb-QoL summary score (0-100, higher score indicate worse outcome)
Time frame: Baseline, 30 days, 90 days
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