Discharge ALERT: Quality Improvement Initiative

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00853463
First received: February 26, 2009
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

Brigham and Women's Hospital will coordinate a Quality Improvement Initiative at other hospitals that focuses on whether physician notification prior to discharge of high risk VTE patients will reduce the incidence of VTE after hospital discharge.


Condition Intervention
Pulmonary Embolism
Deep Vein Thrombosis
Prophylaxis
Venous Thromboembolism
Prevention
Behavioral: Alert

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multi-centered Discharge Alert to Prevent DVT and PE at Hospital Discharge

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Clinically diagnosed DVT and/or PE [ Time Frame: 90 days after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
  • Hemorrhagic events [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]

Enrollment: 2515
Study Start Date: April 2009
Study Completion Date: May 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Alert
The responsible physician of a patient randomized to the control arm will not be contacted regarding the increased VTE risk of the patient.
Alert
The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders
Behavioral: Alert
The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders
Other Name: "Alert"

  Hide Detailed Description

Detailed Description:

BACKGROUND INFORMATION AND RATIONALE FOR THE STUDY

Venous thromboembolism (VTE) is often avoidable in hospitalized patients because proven prevention strategies have been established for patients at risk (1). North American and European prophylaxis guidelines have been widely disseminated. However, despite focus on strategies for the prevention of VTE in hospitalized patients at the time of admission to the hospital, there has been little focus on prevention of VTE at the time of discharge from the hospital (2,3).

At Brigham and Women's Hospital, we undertook a previous Quality Improvement Initiative (BWH protocol # 2000P000328) aimed at increasing the frequency of VTE prophylaxis in high risk patients. This novel strategy required: 1) devising a risk score that reliably and quickly identified patients at high risk of VTE, and 2) randomizing high-risk patients without prophylaxis into an intervention group or control group. The intervention group's physicians received a single electronic, computerized alert explaining that the patient was at high risk, was not receiving prophylaxis, and suggesting that prophylaxis be ordered from a template of available pharmacological and mechanical options. In contrast, the control group's physicians received no alert (4).

Each of 8 common risk factors was weighted according to a point scale. To be labeled as "high-risk" for VTE, the point score must equal or exceed 4 points.

There were 2,506 patients in the Quality Improvement Initiative: 1,255 in the intervention group and 1,251 in the control group. The incidence of symptomatic VTE at 90 days was high: 8.2% in the control group and 4.9% in the intervention group (4).

Currently, an investigator initiated Quality Improvement Initiative (BWH protocol # 2005-P-002527) of human alerts rather than electronic, computerized alerts, has been undertaken in high risk patients not receiving prophylaxis. Enrollment of 2,500 patients at 25 centers located throughout the United States was completed in November 2007 with a follow-up rate that exceeded 99%. Analysis of the data is currently being conducted.

Limited research focus has been placed on high-risk VTE subjects in the community, outside of the hospital setting. Since most VTE prophylaxis has focused upon protection of high-risk patients at the time of hospital admission, there is a need to focus on VTE prophylaxis within 48 hours of hospital discharge. It is clear that as preparations are being made for hospital discharge, many patients remain at high risk for DVT and acute pulmonary embolism. After discharge, some patients will have an even higher risk than during hospitalization because of prolonged immobilization and bed rest at home (5).

The Discharge Alert Quality Improvement Initiative will determine whether alerting physicians about the importance of continued VTE prophylaxis just prior to the time of planned hospital discharge will lower the incidence of outpatient VTE. This new strategy is unproven and might not be effective, but this Quality Improvement Initiative should provide a definitive answer.

We will also implement as part of our Discharge Alert Trial an in-hospital Quality Improvement Initiative of intensive patient education at Brigham and Women's Hospital to improve patient adherence to physician-ordered pharmacological venous thromboembolism (VTE) prophylaxis. We hypothesize that after implementation of this education program, fewer patients will decline physician-ordered doses of enoxaparin or unfractionated heparin (UFH) compared with a recent cohort of patients at risk for VTE who did not receive specialized education about VTE.

METHODOLOGY

Identification of Patients at Risk for Venous Thromboembolism (VTE)

Hospitalized patients awaiting planned discharge within 48 hours will be evaluated with a previously validated (BWH protocol # 2000P000328) VTE risk profile. The VTE risk profile will be computed for each patient awaiting discharge using 8 common risk factors. Each risk factor is weighted according to a point score. To be labeled as "high risk" for VTE, the point score must equal or exceed 4 points.

Minor (Low) Risk Factors (1 POINT each):

  • Advanced Age (> 70 years of age)
  • Obesity (BMI > 29, or the presence of the word "obesity" in admission exam notes)
  • Bed rest / Immobility (not related to surgery)
  • Female Hormone Replacement Therapy or Oral Contraceptives

Intermediate Risk Factor (2 POINTS each):

  • Major Surgery (> 60 minutes, during this admission)

Major (High) Risk Factors (3 POINTS each):

  • Cancer (active)
  • Prior VTE
  • Hypercoagulability

Screening for Venous Thromboembolism Prophylaxis

If the cumulative VTE risk score is at least 4, orders are reviewed to detect ongoing mechanical or pharmacological prophylactic measures. Mechanical prophylactic measures include graduated compression stockings and intermittent pneumatic compression devices. Pharmacological prophylactic measures include unfractionated heparin, enoxaparin, dalteparin, fondaparinux, tinzaparin, and warfarin.

At Brigham and Women's Hospital, we will also identify all new orders for pharmacological VTE prophylaxis with enoxaparin and UFH using the BWH computerized order entry system as part of an additional component of the Quality Improvement Initiative. For this component of the Quality Improvement Initiative, eligibility is defined as having a DVT Risk Score of 3 or higher and having electronically entered physician's orders for appropriate pharmacologic VTE thromboprophylaxis.

Quality Improvement Intervention

The intervention will take place within 48 hours of planned hospital discharge. If randomized to the alert, the responsible physician will be notified that: 1) his or her patient is at high risk for VTE, and 2) VTE prophylaxis should be considered in the Discharge orders. If randomized to no alert (control patients), the responsible physician will not be contacted.

At Brigham and Women's Hospital, we will also provide 500 eligible patients in a prospective cohort with one-on-one education using a scripted dialog to describe the rationale and importance of pharmacological VTE prophylaxis.

Prophylaxis Guidelines at Discharge

"Consider Venous Thromboembolism prophylaxis at the time of hospital discharge in patients with congestive heart failure or respiratory disease or prolonged immobility."

"For those without contraindication, consider pharmacological prophylaxis with low-molecular weight heparin, unfractionated heparin, or fondaparinux."

"For those at high risk of bleeding, consider mechanical prophylaxis with intermittent pneumatic compression devices or graduated compression stockings."

Follow Up

A 90-day follow-up will be performed for all study patients. If patient outcomes cannot be determined by medical record review alone, then study representatives may contact the subject's Primary Care Physician (PCP) for necessary information. IRB approval must be obtained at each participating hospital prior to any contact with subjects' PCPs.

Data Collection and Study Endpoints

The primary endpoint is clinically diagnosed DVT or PE at 90 days. Safety endpoints include total mortality and hemorrhagic events at 90 and 30 days, respectively. These are the same endpoints utilized in our prior Quality Improvement Initiative (BWH protocol # 2000P000328).

Hemorrhagic events will be classified according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial criteria. Bleeding events will be classified as severe or life-threatening if they are intracerebral or if they result in substantial hemodynamic compromise requiring treatment. Moderate bleeding is defined by the need for transfusion. Minor events refer to bleeding not requiring transfusion or causing hemodynamic compromise. We will report rates of "major bleeding" which will be defined as GUSTO severe/life-threatening or moderate bleeding.

For the additional component of the Quality Improvement Initiative at Brigham and Women's Hospital, we will also assess improvement of medication adherence with enoxaparin and UFH following an intensive and individualized patient education program compared with our recently completed cohort study in which no uniform education program was targeted at VTE prophylaxis.

Statistical Analysis

The initial sample size (power 80%, two-sided alpha 5%) has been calculated at 2,500 patients based on an estimated 7% rate of the primary end point in the control group, and an odds ratio of 0.59 for the primary endpoint in intervention group patients. This yields a sample size requirement of 2,138 patients, plus an estimated 362 patients who will withdraw from the study.

We will use Wilcoxon rank-sum tests for comparisons in the distributions of continuous variables between groups, and chi-square tests or Fisher's exact test for comparisons of categorical variables. The primary analysis is the difference in the Kaplan-Meier estimator for freedom from VTE at day 90 between intervention and control patients. The log-rank test will estimate the cumulative probability of the primary endpoint in the intervention and control groups. We will use the proportional-hazards model for estimation of the relative hazard of clinical endpoints associated with the physician alert. All p-values reported are two-sided.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 years of age
  • Planned discharge within 48 hours
  • Cumulative VTE risk score at least 4
  • Patients from Medical Services

Exclusion Criteria:

  • VTE risk score <4
  • Patients <18 years of age
  • Full anticoagulation therapy planned upon discharge, i.e., atrial fibrillation, mechanical heart valve, venous thromboembolism treatment, etc.
  • Patient is admitted to a non-medical service, i.e., surgical service, orthopedics, obstetrics/gynecology, neurology, psychiatry, or other non-medical service
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853463

Locations
United States, California
Long Beach VA Healthcare System
Long Beach, California, United States, 90822
UC Irvine
Orange, California, United States, 92868
UC Davis
Sacramento, California, United States, 95817
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80262
United States, Connecticut
William Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Maryland
Medstar Research Frankin Square Hospital
Baltimore, Maryland, United States, 21237
Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
North Shore Medical Center
Salem, Massachusetts, United States, 01970
United States, Michigan
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Missouri
University of Missouri- Columbia
Columbia, Missouri, United States, 65212
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, New Mexico
Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Indiana Regional Medical Center
Indiana, Pennsylvania, United States, 15701
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
Washington Hospital
Washington, Pennsylvania, United States, 15301
United States, Texas
Presbyterian Hospital Texas Health
Dallas, Texas, United States, 75231
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84143
University of Utah Hospital Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Brigham and Women's Hospital
Sanofi
Investigators
Principal Investigator: Samuel Z Goldhaber, MD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Samuel Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00853463     History of Changes
Other Study ID Numbers: 2008-P-001083
Study First Received: February 26, 2009
Last Updated: May 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Pulmonary Embolism
Deep Vein Thrombosis
Prophylaxis
Venous thromboembolism
Prevention
Medical patients

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014