EMR Tool Impact on HIT Documentation and Management

NCT ID: NCT05439265

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-04-30

Brief 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.

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.

Conditions

Heparin; Thrombocytopenia; Electronic Health Records

Keywords

HIT; Heparin Induced Thrombocytopenia; Electronic Medical Record; Electronic Health Records

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Prior to 11/01/2014

Group prior to the implementation of an electronic medical record order panel and pharmacy resident involvement

No interventions assigned to this group

After 11/30/2014

Group after implementation of an electronic medical record order panel and pharmacy resident involvement

Electronic medical record order panel and resident involvement

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary D Peksa, PharmD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

Kniuksta, Ruth, Amy Mozina, and Peggy Reed.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 27377975 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26386106 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10939559 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22261947 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27229333 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22935941 (View on PubMed)

Other Identifiers

16092401-IRB01

Identifier Type: -

Identifier Source: org_study_id