HeparinNCT05439265
EMR Tool Impact on HIT Documentation and Management
An observational study of Heparin and Thrombocytopenia, run by Rush University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heparin, Thrombocytopenia, Electronic Health Records
- What is being tested?
- Electronic medical record order panel and resident involvement
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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]).
Who may be able to join
- HIT-Ab ordered
- Aged ≥ 18 years of age
Who cannot join
- Previously documented and confirmed HIT allergy prior to placement for new HIT-Ab
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Effect of an Electronic Medical Record Tool on the Documentation and Management of Newly Suspected Heparin Induced Thrombocytopenia
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.
Read the 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
- Being tested
- Electronic medical record order panel and resident involvement
- Keywords
- HIT, Heparin Induced Thrombocytopenia, Electronic Medical Record, Electronic Health Records
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic medical record order panel and resident involvementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Electronic medical record order panel and resident involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess appropriate allergy documentation
- Completion of appropriate allergy documentation will include all of the following:
- Heparin allergy documented i. Pending result ii. Positive result b. Heparin allergy removed i. Negative result
Measured: 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
- 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
Measured: 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
Defined as documentation in a patient medical note, i-vent, or lab result
Measured: 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
- Initiation appropriate for 4T HIT score of greater than 5
- Withholding appropriate for 4T HIT score of 3 or less (in absence of clot)
Measured: 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
- Appropriate defined as drawn secondary to a positive HIT-Ab
- Inappropriate defined as drawn prior to ordering a HIT-Ab
Measured: 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
- 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
Measured: 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 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
Measured: From the date of first ordering of a HIT-Ab until HIT allergy is determined as positive or negative, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study startJan 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HeparinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary D Peksa, PharmD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439265
- Sponsor's protocol ID
- 16092401-IRB01
- Status last verified
- Jun 2022
- First submitted
- 18 Oct 2016
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 27377975Bayat 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.
PubMed 26386106Andreescu 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.
PubMed 10939559Smythe 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.
PubMed 22261947Burnett 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.
PubMed 27229333Floresca 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.
PubMed 22935941
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Electronic Medical Record Tool on the Documentation and Management of Newly Suspected Heparin Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05439265
- Acronym / sponsor ID
- 16092401-IRB01
- Conditions
- Heparin, Thrombocytopenia, Electronic Health Records
- Keywords
- HIT, Heparin Induced Thrombocytopenia, Electronic Medical Record, Electronic Health Records
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Electronic medical record order panel and resident involvementGroup after implementation of an electronic medical record order panel and pharmacy resident involvement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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]).
Key inclusion criteria (2 listed)
- HIT-Ab ordered
- Aged ≥ 18 years of age
Key exclusion criteria (2 listed)
- Previously documented and confirmed HIT allergy prior to placement for new HIT-Ab
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic medical record order panel and resident involvementPrior 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. | Other | After 11/30/2014 |
Primary outcome
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- BackgroundKniuksta, Ruth, Amy Mozina, and Peggy Reed.
- BackgroundKonkle 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.
- Results publication: PubMed 27377975Hasan 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.
- Results publication: PubMed 26386106Bayat 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.
- Results publication: PubMed 10939559Andreescu 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.
- Results publication: PubMed 22261947Smythe 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.
- Results publication: PubMed 27229333Burnett 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.
- Results publication: PubMed 22935941Floresca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary D Peksa, PharmD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin and Thrombocytopenia, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05439265, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.