- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05439265
EMR Tool Impact on HIT Documentation and Management
Effect of an Electronic Medical Record Tool on the Documentation and Management of Newly Suspected Heparin Induced Thrombocytopenia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Heparin-induced thrombocytopenia is a unique form of drug induced thrombocytopenia associated with increased clotting risk. The incidence of HIT ranges from 0.1% to 5%. Heparin-induced thrombocytopenia occurs when an antibody forms a complex with platelet factor 4 and heparin. This complex activates platelets which increases the risk of thrombus formation. Normally, HIT presents 5 to 14 days after exposure, but can occur with heparin exposure within the past 100 days. The presentation of HIT is often first suspected secondary to a decrease in platelet counts of 50% or more from baseline.
At Rush University Medical Center (RUMC), HIT is diagnosed through a combination of clinical factors and laboratory tests. When HIT is first suspected, a 4T HIT score, which is used to estimate the probability of true HIT, is calculated. The following score ranges correspond to the probability of true HIT; score of 0-3 indicates a low probability, score of 4-5 indicates an intermediate probability, and a score of 6-8 indicates a high probability of true HIT.
If the score indicates a likelihood of HIT, a HIT-Ab is sent off. This test has a sensitivity of more than 95% and a specificity of 74% to 86%. Accordingly, if this HIT-Ab test result is negative, HIT is ruled out. If the result is equivocal or positive, a confirmatory Serotonin Release Assay (SRA) test should be performed (sensitivity of 89% to 100% and a specificity of 88 % to 100%).
Prior to 2014, there was no formal process for evaluation of patients with HIT. In November of 2014, an EMR tool was created in an effort to improve heparin allergy documentation and HIT management. This EMR tool prompts the medical team to perform the 4T score, displays the appropriate HIT labs, alternative anticoagulation strategies, instructs the nurse to apply an allergy bracelet, and notifies the pharmacy resident through the order verification queue. The pharmacy resident then performs an independent 4T score, discontinues all heparin products, documents the heparin allergy in the medical record, and assesses the need for alternative anticoagulation.
Many studies have shown the value of the 4T HIT scoring system and the use of pharmacists in reducing the inappropriate use of alternative anticoagulation and unnecessary testing. Pharmacists have helped to improve patient outcomes and decrease costs associated with HIT. The purpose of this study is to evaluate the impact of an EMR tool and pharmacy residents on allergy documentation and the management of HIT.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study will be retrospective, and collected data will be a result of routine care. Adult patients 18 years of age or older with an order for a HIT-Ab while admitted to RUMC will be assessed for inclusion
Patients will be reviewed from 01/01/2014 to 09/30/2015. A list of patients will be generated by a laboratory order for HIT-Ab (Heparin Induced Thrombocytopenia AB [LAB0002639]).
Description
Inclusion Criteria:
- HIT-Ab ordered
- Aged ≥ 18 years of age
Exclusion Criteria:
- Previously documented and confirmed HIT allergy prior to placement for new HIT-Ab
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prior to 11/01/2014
Group prior to the implementation of an electronic medical record order panel and pharmacy resident involvement
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After 11/30/2014
Group after implementation of an electronic medical record order panel and pharmacy resident involvement
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Prior to 2014, there was no formal process for evaluation of patients with HIT.
In November of 2014, an EMR tool was created in an effort to improve heparin allergy documentation and HIT management.
This EMR tool prompts the medical team to perform the 4T score, displays the appropriate HIT labs, alternative anticoagulation strategies, instructs the nurse to apply an allergy bracelet, and notifies the pharmacy resident through the order verification queue.
The pharmacy resident then performs an independent 4T score, discontinues all heparin products, documents the heparin allergy in the medical record, and assesses the need for alternative anticoagulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess appropriate allergy documentation
Time Frame: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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1. Completion of appropriate allergy documentation will include all of the following: a. Heparin allergy documented i. Pending result ii. Positive result b. Heparin allergy removed i. Negative result |
From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Administration of heparin products with pending HIT-Ab
Time Frame: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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a. Defined as ordering of HIT-Ab or 4T score greater than 5 i.
Low Probability: 0-3 ii.
Intermediate Probability: 4-5 iii.
High Probability: 6-8
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From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Documentation of 4T HIT score in patient medical record
Time Frame: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Defined as documentation in a patient medical note, i-vent, or lab result
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From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Initiation or withholding of Direct Thrombin Inhibitor (DTI) appropriate based on probability of HIT as scored by the 4T HIT score
Time Frame: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Number of Serotonin Release Assay labs drawn appropriately
Time Frame: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Positive and negative predictive value of 4T score when performed by medical resident
Time Frame: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Positive and negative predictive value of 4T score when performed by pharmacy residents
Time Frame: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gary D Peksa, PharmD, Rush University Medical Center
Publications and helpful links
General Publications
- Kniuksta, Ruth, Amy Mozina, and Peggy Reed.
- Konkle B. Chapter 115. Disorders of Platelets and Vessel Wall. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 18e. New York, NY: McGraw-Hill; 2012. Accessed August 14, 2016.
- Hasan M, Malalur P, Agastya M, Malik AO, Dawod Y, Jaradat M, Yoo JW, Makar R. A high-value cost conscious approach to minimize heparin induced thrombocytopenia antibody (HITAb) testing using the 4T score. J Thromb Thrombolysis. 2016 Oct;42(3):441-6. doi: 10.1007/s11239-016-1396-6.
- Bayat M, Macedo FY, Ansari AS, Bracey AW, Akinyele S, Salazar M. Evaluation of clinical and laboratory data for early diagnosis of heparin-induced thrombocytopenia. Am J Health Syst Pharm. 2015 Oct 1;72(19):1649-55. doi: 10.2146/ajhp140778.
- Andreescu AC, Possidente C, Hsieh M, Cushman M. Evaluation of a pharmacy-based surveillance program for heparin-induced thrombocytopenia. Pharmacotherapy. 2000 Aug;20(8):974-80. doi: 10.1592/phco.20.11.974.35264.
- Smythe MA, Mehta TP, Koerber JM, Forsyth LL, Sykes E, Corbets LR, Melendy SM, Parikh R. Development and implementation of a comprehensive heparin-induced thrombocytopenia recognition and management protocol. Am J Health Syst Pharm. 2012 Feb 1;69(3):241-8. doi: 10.2146/ajhp110313.
- Burnett AE, Bowles H, Borrego ME, Montoya TN, Garcia DA, Mahan C. Heparin-induced thrombocytopenia: reducing misdiagnosis via collaboration between an inpatient anticoagulation pharmacy service and hospital reference laboratory. J Thromb Thrombolysis. 2016 Nov;42(4):471-8. doi: 10.1007/s11239-016-1381-0.
- Floresca D, Dupree L, Basile S, Tan P. Evaluation of appropriate serologic testing for suspected heparin-induced thrombocytopenia. Am J Health Syst Pharm. 2012 Sep 15;69(18):1581-7. doi: 10.2146/ajhp110513.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16092401-IRB01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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