EMR Tool Impact on HIT Documentation and Management

NCT05439265 | Completed

• 1 other identifier: 16092401-IRB01
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Heparin; Thrombocytopenia; Electronic Health Records

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Administration of heparin products with pending 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

• Documentation of 4T HIT score in patient medical record

  From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks

• Initiation or withholding of Direct Thrombin Inhibitor (DTI) appropriate based on probability of HIT as scored by the 4T HIT score

  From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks

• Number of Serotonin Release Assay labs drawn appropriately

  From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks

• Positive and negative predictive value of 4T score when performed by medical resident

  From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks

Study Arms (2)

Prior to 11/01/2014

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

After 11/30/2014

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

Other: Electronic medical record order panel and resident involvement

Interventions

Electronic medical record order panel and resident involvement 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.

After 11/30/2014

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 \[LAB0002639\]).

You may qualify if:

• HIT-Ab ordered
• Aged ≥ 18 years of age

You may not qualify if:

• Previously documented and confirmed HIT allergy prior to placement for new HIT-Ab
• Pregnancy

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (8)

• Kniuksta, Ruth, Amy Mozina, and Peggy Reed.

  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.

  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.

  PMID: 27377975 RESULT

• 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.

  PMID: 26386106 RESULT

• 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.

  PMID: 10939559 RESULT

• 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.

  PMID: 22261947 RESULT

• 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.

  PMID: 27229333 RESULT

• 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.

  PMID: 22935941 RESULT

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Gary D Peksa, PharmD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: June 30, 2022
• Study Start: January 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)