Title: Randomized Trial of an EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients

NCT03243708 | Completed DMC

• 1 other identifier: 17-396
• Study Type: interventional
• Target: 90,537
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Venous Thromboembolism

Keywords

Venous Thromboembolism Risk Calculator

Outcome Measures

Primary Outcomes (1)

• 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

  within 48 hours of index hospitalization admission

Secondary Outcomes (7)

• Total patients receiving prophylaxis

  14 days

• Rate of VTE among high risk patients

  14 days

• Rate of VTE among high risk patients

  45 days

• Rate of major bleeding among high risk patients

  14 days

• Average cost of prophylaxis

  14 days

Study Arms (2)

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

Behavioral: Risk calculator

Interventions

Risk calculator BEHAVIORAL

Venous thromboembolism (VTE) risk calculator embedded in the admission order set with personalized recommendation for prophylaxis

Risk calculator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Health System

Cleveland, Ohio, 44195, United States

Location

Related Publications (14)

• 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.

  PMID: 22041949 BACKGROUND

• Kakkar 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.

  PMID: 22204723 BACKGROUND

• Rothberg 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.

  PMID: 20352366 BACKGROUND

• Cohen 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.

  PMID: 18242412 BACKGROUND

• Khanna 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.

  PMID: 21948203 BACKGROUND

• Qaseem 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.

  PMID: 22041951 BACKGROUND

• Barbar 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.

  PMID: 20738765 BACKGROUND

• Kucher 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.

  PMID: 15758007 BACKGROUND

• Dunn 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.

  PMID: 16676063 BACKGROUND

• Bhalla 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.

  PMID: 23184857 BACKGROUND

• Zeidan 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.

  PMID: 23553743 BACKGROUND

• Baio 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.

  PMID: 26282553 BACKGROUND

• Shekelle 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.

  PMID: 24423049 BACKGROUND

• Rothberg 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.

  PMID: 38318703 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael Rothberg

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: Step-Wedge Randomized controlled trial (RCT)

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: August 9, 2017
• Study Start: December 4, 2017
• Primary Completion: April 14, 2019
• Study Completion: April 14, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)