Deep Vein ThrombosisNCT03812848
Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program
A study testing Anticoagulation Stewardship Program in people with Deep Vein Thrombosis and Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in Egyptian tertiary hospital to promote a culture of safety around anticoagulants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Atrial Fibrillation, Mitral Valve Disease
- What is being tested?
- Anticoagulation Stewardship Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 5 Jun 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period.
Who cannot join
- Patients whose age is less than 18 years old.
- Patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin.
- Patients already admitted for bleeding or thrombosis.
- Malignancy patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program in An Egyptian Tertiary Care Hospital
This study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in Egyptian tertiary hospital to promote a culture of safety around anticoagulants.
Read the detailed description
One of the high-alert medication categories that may cause significant patient harm if not used correctly is anticoagulants. It is not clear if medication errors are more common with this category in specific compared to other medication categories, but the ramifications of a medication error with the use of anticoagulation agents is without a doubt detrimental to the patient's health and more serious than most of other drug categories.
This prospective study evaluates the impact of implementing an anticoagulation stewardship program, led by clinical pharmacists, on anticoagulation therapy outcomes during patient hospitalization by the percent of medication errors reduction, percent of adverse drug events reduction, and percent of evidence-based guidelines compliance improvement.
- Being tested
- Anticoagulation Stewardship Program
- Keywords
- anticoagulation, stewardship program, anticoagulants, clinical pharmacist, heparin, warfarin
- Medical subject headings
- Venous Thrombosis, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation Stewardship ProgramOther
A clinical-pharmacist led anticoagulation stewardship program that includes:
- Warfarin monitoring and dosing protocol. 1a.Warfarin initial dosing algorithm. 1b.Recommended International normalized ration (INR) target and duration of Warfarin therapy by indication.
1c.Warfarin dosage adjustment algorithms.
1d.Management of high INR values. 2-Heparin weight-based protocol. 3-Perioperative anticoagulation use protocol. 4-Policies that address baseline and ongoing laboratory monitoring for anticoagulants.
5-Protocol for Heparin Induced Thrombocytopenia(HIT) management. 6-Anticoagulation reversal protocol. 7-Booklet for anticoagulant drugs and all of previously prepared protocols. 8-Education programs regarding anticoagulation's therapy for health care team dealing with anticoagulation and patients.
| Study group | Role | What they receive |
|---|---|---|
| Pre program implementation | No intervention | All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program. |
| Post program implementation | Experimental | All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program. Receives: Other: Anticoagulation Stewardship Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of medication errors change
Detect the medication error according to (National Coordinating Council for Medication Errors Reporting and Prevention NCC MERP) Index for Categorizing Medication Errors using NCC MERP Index for Categorizing Medication Errors Algorithm.
Measured: one year and half
percent of adverse drug events change
Detect bleeding and thrombotic-related adverse drug events
Measured: one year and half
Percent of evidence-based guidelines compliance improvement
Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy.
Measured: one year and half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jan 2018
- Primary completion5 Jun 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Quasi experimental study (separate sample pre-test post-test design)
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed El-Bosily, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812848
- Sponsor's protocol ID
- 165
- Status last verified
- Sep 2022
- First submitted
- 18 Jan 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not clear according to the clinical research guidelines at Faculty of Pharmacy, Ain Shams University.
Publications
Broussard M, Bass PF 3rd, Arnold CL, McLarty JW, Bocchini JA Jr. Preprinted order sets as a safety intervention in pediatric sedation. J Pediatr. 2009 Jun;154(6):865-8. doi: 10.1016/j.jpeds.2008.12.022. Epub 2009 Feb 1.
PubMed 19181332Burnett AE, Trujillo TC. The future of inpatient anticoagulation management. J Thromb Thrombolysis. 2013 Apr;35(3):375-86. doi: 10.1007/s11239-013-0892-1.
PubMed 23417781Dreijer AR, Kruip MJ, Diepstraten J, Polinder S, Brouwer R, Leebeek FW, Vulto AG, van den Bemt PM. Antithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy outcomes during and after hospitalisation: a study protocol. BMJ Open. 2016 Dec 20;6(12):e011537. doi: 10.1136/bmjopen-2016-011537.
PubMed 27998897Fanikos J, Stapinski C, Koo S, Kucher N, Tsilimingras K, Goldhaber SZ. Medication errors associated with anticoagulant therapy in the hospital. Am J Cardiol. 2004 Aug 15;94(4):532-5. doi: 10.1016/j.amjcard.2004.04.075.
PubMed 15325949Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e24S-e43S. doi: 10.1378/chest.11-2291.
PubMed 22315264Goldspiel B, Hoffman JM, Griffith NL, Goodin S, DeChristoforo R, Montello CM, Chase JL, Bartel S, Patel JT. ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. Am J Health Syst Pharm. 2015 Apr 15;72(8):e6-e35. doi: 10.2146/sp150001. No abstract available.
PubMed 25825193Levinson, D. R., & General, I. (2010). Adverse events in hospitals: national incidence among Medicare beneficiaries. Department of Health and Human Services Office of the Inspector General. Retrieved from https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf
Levy JH, Spyropoulos AC, Samama CM, Douketis J. Direct oral anticoagulants: new drugs and new concepts. JACC Cardiovasc Interv. 2014 Dec;7(12):1333-51. doi: 10.1016/j.jcin.2014.06.014.
PubMed 25523529Lucado, J., Paez, K., & Elixhauser, A. (2010). Statistical brief# 109. Journal of General Internal Medicine, 25(1), 31-38.
Lysogorski MC, Hassan AK, Lampkin SJ, Geisler R. The impact of pharmacy monitoring and intervention in patients receiving intravenous heparin. Int J Clin Pharm. 2017 Aug;39(4):844-850. doi: 10.1007/s11096-017-0482-y. Epub 2017 May 15.
PubMed 28508323Padron M, Miyares MA. Development of an anticoagulation stewardship program at a large tertiary care academic institution. J Pharm Pract. 2015 Feb;28(1):93-8. doi: 10.1177/0897190013514091. Epub 2013 Dec 10.
PubMed 24326411Reardon DP, Atay JK, Ashley SW, Churchill WW, Berliner N, Connors JM. Implementation of a Hemostatic and Antithrombotic Stewardship program. J Thromb Thrombolysis. 2015 Oct;40(3):379-82. doi: 10.1007/s11239-015-1189-3.
PubMed 25669625Rose, A. (Ed.). (2015). Anticoagulation Management. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-22602-6
Sharma M, Krishnamurthy M, Snyder R, Mauro J. Reducing Error in Anticoagulant Dosing via Multidisciplinary Team Rounding at Point of Care. Clin Pract. 2017 Apr 20;7(2):953. doi: 10.4081/cp.2017.953. eCollection 2017 Apr 6.
PubMed 28484587U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). Anticoagulants. In National Action Plan for Adverse Drug Event Prevention.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program in An Egyptian Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT03812848
- Acronym / sponsor ID
- 165
- Keywords
- anticoagulation, stewardship program, anticoagulants, clinical pharmacist, heparin, warfarin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 23 Jan 2019 (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.
This study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in Egyptian tertiary hospital to promote a culture of safety around anticoagulants.
Detailed description
One of the high-alert medication categories that may cause significant patient harm if not used correctly is anticoagulants. It is not clear if medication errors are more common with this category in specific compared to other medication categories, but the ramifications of a medication error with the use of anticoagulation agents is without a doubt detrimental to the patient's health and more serious than most of other drug categories.
This prospective study evaluates the impact of implementing an anticoagulation stewardship program, led by clinical pharmacists, on anticoagulation therapy outcomes during patient hospitalization by the percent of medication errors reduction, percent of adverse drug events reduction, and percent of evidence-based guidelines compliance improvement.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi experimental study (separate sample pre-test post-test design)
| Arm | Type | Receives |
|---|---|---|
| Pre program implementation | No intervention | –All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program. |
| Post program implementation | Experimental | Other: Anticoagulation Stewardship ProgramAll hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period.
Key exclusion criteria (4 listed)
- Patients whose age is less than 18 years old.
- Patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin.
- Patients already admitted for bleeding or thrombosis.
- Malignancy patients.
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 |
|---|---|---|
| Anticoagulation Stewardship ProgramA clinical-pharmacist led anticoagulation stewardship program that includes: 1. Warfarin monitoring and dosing protocol. 1a.Warfarin initial dosing algorithm. 1b.Recommended International normalized ration (INR) target and duration of Warfarin therapy by indication. 1c.Warfarin dosage adjustment algorithms. 1d.Management of high INR values. 2-Heparin weight-based protocol. 3-Perioperative anticoagulation use protocol. 4-Policies that address baseline and ongoing laboratory monitoring for anticoagulants. 5-Protocol for Heparin Induced Thrombocytopenia(HIT) management. 6-Anticoagulation reversal protocol. 7-Booklet for anticoagulant drugs and all of previously prepared protocols. 8-Education programs regarding anticoagulation's therapy for health care team dealing with anticoagulation and patients. | Other | Post program implementation |
Primary outcome
Percent of medication errors change
Time frame: one year and half
Detect the medication error according to (National Coordinating Council for Medication Errors Reporting and Prevention NCC MERP) Index for Categorizing Medication Errors using NCC MERP Index for Categorizing Medication Errors Algorithm.
percent of adverse drug events change
Time frame: one year and half
Detect bleeding and thrombotic-related adverse drug events
Percent of evidence-based guidelines compliance improvement
Time frame: one year and half
Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy.
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 21 Sep 2022.
- Background: PubMed 19181332Broussard M, Bass PF 3rd, Arnold CL, McLarty JW, Bocchini JA Jr. Preprinted order sets as a safety intervention in pediatric sedation. J Pediatr. 2009 Jun;154(6):865-8. doi: 10.1016/j.jpeds.2008.12.022. Epub 2009 Feb 1.
- Background: PubMed 23417781Burnett AE, Trujillo TC. The future of inpatient anticoagulation management. J Thromb Thrombolysis. 2013 Apr;35(3):375-86. doi: 10.1007/s11239-013-0892-1.
- Background: PubMed 27998897Dreijer AR, Kruip MJ, Diepstraten J, Polinder S, Brouwer R, Leebeek FW, Vulto AG, van den Bemt PM. Antithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy outcomes during and after hospitalisation: a study protocol. BMJ Open. 2016 Dec 20;6(12):e011537. doi: 10.1136/bmjopen-2016-011537.
- Background: PubMed 15325949Fanikos J, Stapinski C, Koo S, Kucher N, Tsilimingras K, Goldhaber SZ. Medication errors associated with anticoagulant therapy in the hospital. Am J Cardiol. 2004 Aug 15;94(4):532-5. doi: 10.1016/j.amjcard.2004.04.075.
- Background: PubMed 22315264Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e24S-e43S. doi: 10.1378/chest.11-2291.
- Background: PubMed 25825193Goldspiel B, Hoffman JM, Griffith NL, Goodin S, DeChristoforo R, Montello CM, Chase JL, Bartel S, Patel JT. ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. Am J Health Syst Pharm. 2015 Apr 15;72(8):e6-e35. doi: 10.2146/sp150001. No abstract available.
- BackgroundLevinson, D. R., & General, I. (2010). Adverse events in hospitals: national incidence among Medicare beneficiaries. Department of Health and Human Services Office of the Inspector General. Retrieved from https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf
- Background: PubMed 25523529Levy JH, Spyropoulos AC, Samama CM, Douketis J. Direct oral anticoagulants: new drugs and new concepts. JACC Cardiovasc Interv. 2014 Dec;7(12):1333-51. doi: 10.1016/j.jcin.2014.06.014.
- BackgroundLucado, J., Paez, K., & Elixhauser, A. (2010). Statistical brief# 109. Journal of General Internal Medicine, 25(1), 31-38.
- Background: PubMed 28508323Lysogorski MC, Hassan AK, Lampkin SJ, Geisler R. The impact of pharmacy monitoring and intervention in patients receiving intravenous heparin. Int J Clin Pharm. 2017 Aug;39(4):844-850. doi: 10.1007/s11096-017-0482-y. Epub 2017 May 15.
- Background: PubMed 24326411Padron M, Miyares MA. Development of an anticoagulation stewardship program at a large tertiary care academic institution. J Pharm Pract. 2015 Feb;28(1):93-8. doi: 10.1177/0897190013514091. Epub 2013 Dec 10.
- Background: PubMed 25669625Reardon DP, Atay JK, Ashley SW, Churchill WW, Berliner N, Connors JM. Implementation of a Hemostatic and Antithrombotic Stewardship program. J Thromb Thrombolysis. 2015 Oct;40(3):379-82. doi: 10.1007/s11239-015-1189-3.
- Institute for Safe Medication Practices. (2010). ISMP's Guidelines for Standard Order Sets.Link provided by the sponsor.
- Institute for Safe Medication Practices. (2014). ISMP list of High-Alert MedicationsLink provided by the sponsor.
- Institute for Safe Medication Practices (ISMP) Monitoring FDA MedWatch Reports. (2015, September). Quarter Watch (Q 3-4) 2014. Institute for Safe Medication Practices (ISMP).Link provided by the sponsor.
- Institute for Safe Medication Practices (ISMP) ,Quarter Watch (Q4): monitoring FDA MedWatch Reports. (2017, July). Quarter Watch Q4 2016. Retrieved July 13, 2017, from http://www.ismp.org/QuarterWatch/Link provided by the sponsor.
- NCCMERP. (2014, July 18). Types of Medication Errors \[Text\].Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not clear according to the clinical research guidelines at Faculty of Pharmacy, Ain Shams University.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation Stewardship Program in people with Deep Vein Thrombosis and Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 4 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 21 Sep 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 Egypt. 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?
Percent of medication errors change (time frame: one year and half). The study lists 3 primary outcomes in all. 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 NCT03812848, which also lists 17 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 21 Sep 2022.