Venous ThromboembolismNCT03243708
Title: Randomized Trial of an EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients
A study testing Risk calculator in people with Venous Thromboembolism, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality. Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it increases the risk of bleeding and it is uncomfortable to receive. 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?
- Risk calculator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90,537 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 14 Apr 2019
- 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 adult patients (age ≥18 years) admitted to a medical service, including intensive care units, between September 1, 2017 and August 31, 2018 will be eligible.
Who cannot join
- patients not eligible to receive VTE prophylaxis because they are already receiving anticoagulation for another purpose (e.g. warfarin for atrial fibrillation or LMWH for DVT or PE present on admission),
- patients admitted with a terminal condition who are receiving comfort care only
- Surgical patients who are admitted to the medical service temporarily (e.g. hip fracture)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Health System
Cleveland, Ohio, 44195
About this study
Official title: Title: EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients
Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality. Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of bleeding. However, identifying patients at low risk for VTE can be difficult, because most patients have at least one risk factor for VTE and there are no validated risk prediction tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all approach with near-universal prophylaxis, putting many patients at unnecessary risk of bleeding. However, to provide care that is truly patient-centered, US physicians face several challenges. First, there is no accepted risk calculator that they can use to estimate an individual patient's risk. Second, risk calculators are not readily available at the point of care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an individual patient's risk of VTE. The tool is incorporated into the electronic health record in the form of a smart order set. In this randomized trial, we will assess the effects of the order set on physician behavior and patient outcomes . Examining the effectiveness of an electronic decision aid embedded in an EHR in routine clinical practice will test whether a smart order set can improve patient care by incorporating patient-specific factors into a complex decision process.
Read the detailed description
Specific Aim:
Assess the effects of a VTE risk calculator embedded in the admission order set vs. usual care on physician behavior and patient outcomes in a randomized trial
Research Strategy:
Utilizing a Step-Wedge design, this randomized controlled trial (RCT) will be conducted at 10 Cleveland Clinic hospitals in efforts to assess the effects of a VTE (venous thromboembolism) risk calculator embedded in the admission order set vs. usual care on physician behavior and patient outcomes. Hospitals will be randomized to display the risk calculator to physicians admitting patients or to the usual order set that contains only a description of VTE risk factors. The risk calculator will produce a predicted risk of VTE together with a recommendation regarding the use of prophylaxis for an individual patient. Physicians will be free to ignore the calculator or override its results if they so choose.
- Conditions
- Venous Thromboembolism
- Being tested
- Risk calculator
- Keywords
- Venous Thromboembolism Risk Calculator
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk calculatorBehavioural
Venous thromboembolism (VTE) risk calculator embedded in the admission order set with personalized recommendation for prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Control: Standard order set without risk calculator (usual care) |
| Risk calculator | Active comparator | Intervention: VTE risk calculator embedded in the smart order set incorporated into the EHR and activated for all medical patients Receives: Behavioral: Risk calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate VTE prophylaxis
Proportion of patients at high risk of VTE who receive prophylaxis and the proportion of patients at low risk who do not receive prophylaxis
Measured: within 48 hours of index hospitalization admission
Secondary outcomes (7)
Total patients receiving prophylaxis
All patients who received any chemoprophylaxis during hospitalization, regardless of risk status.
Measured: 14 days
Rate of VTE among high risk patients
Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.
Measured: 14 days
Rate of VTE among high risk patients
Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.
Measured: 45 days
Rate of major bleeding among high risk patients
Major bleeding events among patients with risk factors for bleeding.
Measured: 14 days
Average cost of prophylaxis
Total cost of prophylaxis received during hospitalization
Measured: 14 days
Average cost of hospitalization
Cost of hospitalization as determined by the hospital cost accounting system
Measured: Up to 30 days
Average length of stay
Total days in hospital
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start4 Dec 2017
- Primary completion14 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 The Cleveland ClinicThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- Step-Wedge Randomized controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 90,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rothberg, The Cleveland Clinic
- Investigators
- Michael Rothberg, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243708
- Sponsor's protocol ID
- 17-396
- Status last verified
- May 2019
- First submitted
- 10 Jul 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lederle FA, Zylla D, MacDonald R, Wilt TJ. Venous thromboembolism prophylaxis in hospitalized medical patients and those with stroke: a background review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2011 Nov 1;155(9):602-15. doi: 10.7326/0003-4819-155-9-201111010-00008.
PubMed 22041949Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.
PubMed 22204723Rothberg MB, Lahti M, Pekow PS, Lindenauer PK. Venous thromboembolism prophylaxis among medical patients at US hospitals. J Gen Intern Med. 2010 Jun;25(6):489-94. doi: 10.1007/s11606-010-1296-y. Epub 2010 Mar 30.
PubMed 20352366Cohen AT, Tapson VF, Bergmann JF, Goldhaber SZ, Kakkar AK, Deslandes B, Huang W, Zayaruzny M, Emery L, Anderson FA Jr; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008 Feb 2;371(9610):387-94. doi: 10.1016/S0140-6736(08)60202-0.
PubMed 18242412Khanna R, Vittinghoff E, Maselli J, Auerbach A. Unintended consequences of a standard admission order set on venous thromboembolism prophylaxis and patient outcomes. J Gen Intern Med. 2012 Mar;27(3):318-24. doi: 10.1007/s11606-011-1871-x. Epub 2011 Sep 24.
PubMed 21948203Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011 Nov 1;155(9):625-32. doi: 10.7326/0003-4819-155-9-201111010-00011.
PubMed 22041951Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.
PubMed 20738765Kucher 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 15758007Dunn AS, Brenner A, Halm EA. The magnitude of an iatrogenic disorder: a systematic review of the incidence of venous thromboembolism for general medical inpatients. Thromb Haemost. 2006 May;95(5):758-62.
PubMed 16676063Bhalla R, Berger MA, Reissman SH, Yongue BG, Adelman JS, Jacobs LG, Billett H, Sinnett MJ, Kalkut G. Improving hospital venous thromboembolism prophylaxis with electronic decision support. J Hosp Med. 2013 Mar;8(3):115-20. doi: 10.1002/jhm.1993. Epub 2012 Nov 26.
PubMed 23184857Zeidan AM, Streiff MB, Lau BD, Ahmed SR, Kraus PS, Hobson DB, Carolan H, Lambrianidi C, Horn PB, Shermock KM, Tinoco G, Siddiqui S, Haut ER. Impact of a venous thromboembolism prophylaxis "smart order set": Improved compliance, fewer events. Am J Hematol. 2013 Jul;88(7):545-9. doi: 10.1002/ajh.23450. Epub 2013 Jun 12.
PubMed 23553743Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015 Aug 17;16:354. doi: 10.1186/s13063-015-0840-9.
PubMed 26282553Shekelle PG, Wachter RM, Pronovost PJ, Schoelles K, McDonald KM, Dy SM, Shojania K, Reston J, Berger Z, Johnsen B, Larkin JW, Lucas S, Martinez K, Motala A, Newberry SJ, Noble M, Pfoh E, Ranji SR, Rennke S, Schmidt E, Shanman R, Sullivan N, Sun F, Tipton K, Treadwell JR, Tsou A, Vaiana ME, Weaver SJ, Wilson R, Winters BD. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Evid Rep Technol Assess (Full Rep). 2013 Mar;(211):1-945.
PubMed 24423049Rothberg MB, Hamilton AC, Hu B, Sheehan M, Fox J, Milinovich A, Lisheba O, Goto T, Speaker SL, Pappas MA. Impact of Embedding a Venous Thromboembolism Risk Assessment Model in the Electronic Health Record Versus Usual Care: A Cluster-Randomized Trial. Circ Cardiovasc Qual Outcomes. 2025 Aug;18(8):e010359. doi: 10.1161/CIRCOUTCOMES.123.010359. Epub 2024 Feb 6.
PubMed 38318703
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients
- ClinicalTrials.gov ID
- NCT03243708
- Acronym / sponsor ID
- 17-396
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism Risk Calculator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90,537 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 9 Aug 2017 (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.
Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality. Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of bleeding. However, identifying patients at low risk for VTE can be difficult, because most patients have at least one risk factor for VTE and there are no validated risk prediction tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all approach with near-universal prophylaxis, putting many patients at unnecessary risk of bleeding. However, to provide care that is truly patient-centered, US physicians face several challenges. First, there is no accepted risk calculator that they can use to estimate an individual patient's risk. Second, risk calculators are not readily available at the point of care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an individual patient's risk of VTE. The tool is incorporated into the electronic health record in the form of a smart order set. In this randomized trial, we will assess the effects of the order set on physician behavior and patient outcomes . Examining the effectiveness of an electronic decision aid embedded in an EHR in routine clinical practice will test whether a smart order set can improve patient care by incorporating patient-specific factors into a complex decision process.
Detailed description
Specific Aim:
Assess the effects of a VTE risk calculator embedded in the admission order set vs. usual care on physician behavior and patient outcomes in a randomized trial
Research Strategy:
Utilizing a Step-Wedge design, this randomized controlled trial (RCT) will be conducted at 10 Cleveland Clinic hospitals in efforts to assess the effects of a VTE (venous thromboembolism) risk calculator embedded in the admission order set vs. usual care on physician behavior and patient outcomes. Hospitals will be randomized to display the risk calculator to physicians admitting patients or to the usual order set that contains only a description of VTE risk factors. The risk calculator will produce a predicted risk of VTE together with a recommendation regarding the use of prophylaxis for an individual patient. Physicians will be free to ignore the calculator or override its results if they so choose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step-Wedge Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Control: Standard order set without risk calculator (usual care) |
| Risk calculator | Active comparator | Behavioral: Risk calculatorIntervention: VTE risk calculator embedded in the smart order set incorporated into the EHR and activated for all medical patients |
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 adult patients (age ≥18 years) admitted to a medical service, including intensive care units, between September 1, 2017 and August 31, 2018 will be eligible.
Key exclusion criteria (3 listed)
- patients not eligible to receive VTE prophylaxis because they are already receiving anticoagulation for another purpose (e.g. warfarin for atrial fibrillation or LMWH for DVT or PE present on admission),
- patients admitted with a terminal condition who are receiving comfort care only
- Surgical patients who are admitted to the medical service temporarily (e.g. hip fracture)
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 |
|---|---|---|
| Risk calculatorVenous thromboembolism (VTE) risk calculator embedded in the admission order set with personalized recommendation for prophylaxis | Behavioural | Risk calculator |
Primary outcome
Appropriate VTE prophylaxis
Time frame: within 48 hours of index hospitalization admission
Proportion of patients at high risk of VTE who receive prophylaxis and the proportion of patients at low risk who do not receive prophylaxis
7 secondary outcomes
Total patients receiving prophylaxis
Time frame: 14 days
Rate of VTE among high risk patients
Time frame: 14 days
Rate of VTE among high risk patients
Time frame: 45 days
Rate of major bleeding among high risk patients
Time frame: 14 days
Average cost of prophylaxis
Time frame: 14 days
Average cost of hospitalization
Time frame: Up to 30 days
Average length of stay
Time frame: Up to 30 days
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 24 May 2019.
- Background: PubMed 22041949Lederle FA, Zylla D, MacDonald R, Wilt TJ. Venous thromboembolism prophylaxis in hospitalized medical patients and those with stroke: a background review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2011 Nov 1;155(9):602-15. doi: 10.7326/0003-4819-155-9-201111010-00008.
- Background: PubMed 22204723Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.
- Background: PubMed 20352366Rothberg MB, Lahti M, Pekow PS, Lindenauer PK. Venous thromboembolism prophylaxis among medical patients at US hospitals. J Gen Intern Med. 2010 Jun;25(6):489-94. doi: 10.1007/s11606-010-1296-y. Epub 2010 Mar 30.
- Background: PubMed 18242412Cohen AT, Tapson VF, Bergmann JF, Goldhaber SZ, Kakkar AK, Deslandes B, Huang W, Zayaruzny M, Emery L, Anderson FA Jr; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008 Feb 2;371(9610):387-94. doi: 10.1016/S0140-6736(08)60202-0.
- Background: PubMed 21948203Khanna R, Vittinghoff E, Maselli J, Auerbach A. Unintended consequences of a standard admission order set on venous thromboembolism prophylaxis and patient outcomes. J Gen Intern Med. 2012 Mar;27(3):318-24. doi: 10.1007/s11606-011-1871-x. Epub 2011 Sep 24.
- Background: PubMed 22041951Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011 Nov 1;155(9):625-32. doi: 10.7326/0003-4819-155-9-201111010-00011.
- Background: PubMed 20738765Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.
- 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 16676063Dunn AS, Brenner A, Halm EA. The magnitude of an iatrogenic disorder: a systematic review of the incidence of venous thromboembolism for general medical inpatients. Thromb Haemost. 2006 May;95(5):758-62.
- Background: PubMed 23184857Bhalla R, Berger MA, Reissman SH, Yongue BG, Adelman JS, Jacobs LG, Billett H, Sinnett MJ, Kalkut G. Improving hospital venous thromboembolism prophylaxis with electronic decision support. J Hosp Med. 2013 Mar;8(3):115-20. doi: 10.1002/jhm.1993. Epub 2012 Nov 26.
- Background: PubMed 23553743Zeidan AM, Streiff MB, Lau BD, Ahmed SR, Kraus PS, Hobson DB, Carolan H, Lambrianidi C, Horn PB, Shermock KM, Tinoco G, Siddiqui S, Haut ER. Impact of a venous thromboembolism prophylaxis "smart order set": Improved compliance, fewer events. Am J Hematol. 2013 Jul;88(7):545-9. doi: 10.1002/ajh.23450. Epub 2013 Jun 12.
- Background: PubMed 26282553Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015 Aug 17;16:354. doi: 10.1186/s13063-015-0840-9.
- 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.
Michael Rothberg principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk calculator in people with Venous Thromboembolism, run by The Cleveland Clinic 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 1 inclusion and 3 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 24 May 2019. 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?
Appropriate VTE prophylaxis (time frame: within 48 hours of index hospitalization admission). 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 NCT03243708, which also lists 14 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 24 May 2019.