Venous ThromboembolismE-SENTRYNCT01401725
Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients
A study testing Electronic Order Entry System + CDSS and Electronic Order Entry System Only in people with Venous Thromboembolism, run by McMaster University at 3 sites in Canada.
Trial summary
Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. They can block normal blood flow, damage organs, and even cause death. The risk of VTE is increased in people who are sick or immobile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Electronic Order Entry System + CDSS and Electronic Order Entry System Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2011to Jun 2012
- 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
- Adult patients at least 18 years of age
- Hospitalization on a general internal medicine ward
Who cannot join
- Receiving therapeutic anticoagulation at time of hospitalization
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
About this study
Official title: Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients
Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. They can block normal blood flow, damage organs, and even cause death. The risk of VTE is increased in people who are sick or immobile. VTE is the most common preventable cause of death in hospitalized patients, and its VTE prevention should be a top patient safety priority. Though there is good evidence that injectable blood thinners and/or compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton, Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the process of introducing "electronic order sets" - computer programs that help doctors order medications and other healthcare interventions for their patients. The investigators would like to study if these electronic order sets can help improve the rate of appropriate VTE prevention in hospitalized medical patients. The investigators will examine the rate before and after the introduction of electronic order sets at the Juravinski Hospital and the Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an additional computer program, called a computerized decision support system (CDSS), that helps them decide on the best strategy to prevent VTE in individual patients. The rates of VTE prevention at each hospital will be compared to each other, and to the rates at St. Joseph's Healthcare Hamilton, which will receive neither the order sets nor the CDSS.
- Conditions
- Venous Thromboembolism
- Being tested
- Electronic Order Entry System + CDSS, Electronic Order Entry System Only, Usual Care
- Keywords
- venous thromboembolism, thromboprophylaxis, anticoagulants, hospitalized medical patients, electronic order sets, decision support, knowledge translation, patient safety
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Order Entry System + CDSSBehavioural
Physicians at this hospital will use an Electronic Order Entry System plus a computerized decision support system (CDSS) to support VTE prophylaxis decisions.
Electronic Order Entry System OnlyBehavioural
Physicians at this hospital will use an Electronic Order Entry System
Usual CareOther
Physicians at this hospital will practice usual care (no Electronic Order Entry System and no CDSS for VTE prophylaxis decisions)
| Study group | Role | What they receive |
|---|---|---|
| Hamilton General Hospital | Experimental | Not described Receives: Behavioral: Electronic Order Entry System + CDSS |
| Juravinski Hospital | Active comparator | Not described Receives: Behavioral: Electronic Order Entry System Only |
| St. Joseph's Hospital | Other | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of hospitalized medical patients who are appropriately managed for VTE prophylaxis
'Appropriate management' is defined as: (i) appropriate non-receipt of any form of prophylaxis when the patient has no VTE risk factors; (ii) appropriate receipt of pharmacologic prophylaxis when VTE risk factors are present and the patient has no contraindications for pharmacologic prophylaxis; or (iii) appropriate receipt of mechanical prophylaxis, when VTE risk factors are present and the patient has contraindications for pharmacologic prophylaxis.
Measured: Participants will be followed for the duration of their hospital stay on a medical ward, an expected average of 5 days
Secondary outcomes (2)
Hospital-acquired venous thromboembolism
VTE is defined as the presence of DVT or PE objectively confirmed by at least one of compression ultrasonography, venography, ventilation-perfusion lung scanning, CT pulmonary angiography, or a conventional pulmonary arteriogram.
'Hospital-acquired' VTE is that which is not clinically evident or suspected at the time of admission, but is diagnosed during or up to 30 days after hospital admission.
Measured: Participants will be followed for 30 days, from the date of hospital admission
Major bleeding
Major bleeding is defined using the International Society of Haemostasis and Thrombosis criteria.
Measured: Participants will be followed for 30 days, from the date of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Menaka Pai, McMaster University
- Investigators
- Menaka Pai, MD, FRCPC, Principal investigator, McMaster University, Hamilton Health Sciences, Corporation - Hamilton General HospitalJames D Douketis, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401725
- Sponsor's protocol ID
- HHS150411
- Acronym
- E-SENTRY
- Status last verified
- Oct 2015
- First submitted
- 19 Jul 2011
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
PubMed 18574271Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007 Feb 20;146(4):278-88. doi: 10.7326/0003-4819-146-4-200702200-00007.
PubMed 17310052Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.
PubMed 15758007Durieux P, Nizard R, Ravaud P, Mounier N, Lepage E. A clinical decision support system for prevention of venous thromboembolism: effect on physician behavior. JAMA. 2000 Jun 7;283(21):2816-21. doi: 10.1001/jama.283.21.2816.
PubMed 10838650Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
PubMed 15755945
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients
- ClinicalTrials.gov ID
- NCT01401725
- Acronym / sponsor ID
- E-SENTRY / HHS150411
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboembolism, thromboprophylaxis, anticoagulants, hospitalized medical patients, electronic order sets, decision support, knowledge translation, patient safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jul 2011 (estimated)
- 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.
Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. They can block normal blood flow, damage organs, and even cause death. The risk of VTE is increased in people who are sick or immobile. VTE is the most common preventable cause of death in hospitalized patients, and its VTE prevention should be a top patient safety priority. Though there is good evidence that injectable blood thinners and/or compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton, Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the process of introducing "electronic order sets" - computer programs that help doctors order medications and other healthcare interventions for their patients. The investigators would like to study if these electronic order sets can help improve the rate of appropriate VTE prevention in hospitalized medical patients. The investigators will examine the rate before and after the introduction of electronic order sets at the Juravinski Hospital and the Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an additional computer program, called a computerized decision support system (CDSS), that helps them decide on the best strategy to prevent VTE in individual patients. The rates of VTE prevention at each hospital will be compared to each other, and to the rates at St. Joseph's Healthcare Hamilton, which will receive neither the order sets nor the CDSS.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hamilton General Hospital | Experimental | Behavioral: Electronic Order Entry System + CDSS |
| Juravinski Hospital | Active comparator | Behavioral: Electronic Order Entry System Only |
| St. Joseph's Hospital | Other | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients at least 18 years of age
- Hospitalization on a general internal medicine ward
Key exclusion criteria (1 listed)
- Receiving therapeutic anticoagulation at time of hospitalization
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 Order Entry System + CDSSPhysicians at this hospital will use an Electronic Order Entry System plus a computerized decision support system (CDSS) to support VTE prophylaxis decisions. | Behavioural | Hamilton General Hospital |
| Electronic Order Entry System OnlyPhysicians at this hospital will use an Electronic Order Entry System | Behavioural | Juravinski Hospital |
| Usual CarePhysicians at this hospital will practice usual care (no Electronic Order Entry System and no CDSS for VTE prophylaxis decisions) | Other | St. Joseph's Hospital |
Primary outcome
Proportion of hospitalized medical patients who are appropriately managed for VTE prophylaxis
Time frame: Participants will be followed for the duration of their hospital stay on a medical ward, an expected average of 5 days
'Appropriate management' is defined as: (i) appropriate non-receipt of any form of prophylaxis when the patient has no VTE risk factors; (ii) appropriate receipt of pharmacologic prophylaxis when VTE risk factors are present and the patient has no contraindications for pharmacologic prophylaxis; or (iii) appropriate receipt of mechanical prophylaxis, when VTE risk factors are present and the patient has contraindications for pharmacologic prophylaxis.
2 secondary outcomes
Hospital-acquired venous thromboembolism
Time frame: Participants will be followed for 30 days, from the date of hospital admission
Major bleeding
Time frame: Participants will be followed for 30 days, from the date of hospital admission
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 16 Oct 2015.
- Background: PubMed 18574271Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
- Background: PubMed 17310052Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007 Feb 20;146(4):278-88. doi: 10.7326/0003-4819-146-4-200702200-00007.
- Background: PubMed 15758007Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.
- Background: PubMed 10838650Durieux P, Nizard R, Ravaud P, Mounier N, Lepage E. A clinical decision support system for prevention of venous thromboembolism: effect on physician behavior. JAMA. 2000 Jun 7;283(21):2816-21. doi: 10.1001/jama.283.21.2816.
- Background: PubMed 15755945Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
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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.
Menaka Pai, MD, FRCPC principal investigator
McMaster University, Hamilton Health Sciences, Corporation - Hamilton General Hospital
James D Douketis, MD, FRCPC principal investigator
McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Order Entry System + CDSS and Electronic Order Entry System Only in people with Venous Thromboembolism, run by McMaster University at 3 sites in Canada.
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 1 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 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Proportion of hospitalized medical patients who are appropriately managed for VTE prophylaxis (time frame: Participants will be followed for the duration of their hospital stay on a medical ward, an expected average of 5 days). 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 NCT01401725, which also lists 5 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 16 Oct 2015.