EMR Tool Impact on HIT Documentation and Management

Thrombocytopenia Clinical Trial

Official title:

Effect of an Electronic Medical Record Tool on the Documentation and Management of Newly Suspected Heparin Induced Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439265
• Other study ID #: 16092401-IRB01
• Status: Completed
• Start date: January 2014
• Est. completion date: April 2017

Study information

• Verified date: June 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse drug reaction to heparin products which results in a prothrombotic state. Heparin-induced thrombocytopenia generally occurs several days after the start of unfractionated heparin or low molecular weight heparin and is diagnosed based on clinical presentation, and presence of thrombocytopenia. HIT has an incidence of 0.1% to 5% and if recognized early can help prevent major complications. As of November 2014, the responsibility for documenting heparin allergies in the electronic medical record (EMR) has shifted from the physician/medical resident to the pharmacy resident. The purpose of this study is to compare the number, rate, and appropriateness of heparin allergy documentation in order to help decrease adverse medical events related to heparin.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Electronic Health Records
• Heparin
• Thrombocytopenia

Intervention

Other:
• Electronic medical record order panel and resident involvement
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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. 201 — View Citation

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. — View Citation

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: — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess appropriate allergy documentation	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
Secondary	Administration of heparin products with pending HIT-Ab	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	From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
Secondary	Documentation of 4T HIT score in patient medical record	Defined as documentation in a patient medical note, i-vent, or lab 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
Secondary	Initiation or withholding of Direct Thrombin Inhibitor (DTI) appropriate based on probability of HIT as scored by the 4T HIT score	Initiation appropriate for 4T HIT score of greater than 5; Withholding appropriate for 4T HIT score of 3 or less (in absence of clot)	From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
Secondary	Number of Serotonin Release Assay labs drawn appropriately	Appropriate defined as drawn secondary to a positive HIT-Ab; Inappropriate defined as drawn prior to ordering a HIT-Ab	From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
Secondary	Positive and negative predictive value of 4T score when performed by medical resident	The percent of all positive tests that are true positives is the Positive Predictive Value.; The percent of all negative tests that are true negatives is the Negative Predictive Value	From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
Secondary	Positive and negative predictive value of 4T score when performed by pharmacy residents	The percent of all positive tests that are true positives is the Positive Predictive Value.; The percent of all negative tests that are true negatives is the Negative Predictive Value	From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks