Multi-centered Discharge Alert to Prevent DVT and PE at Hospital Discharge
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 2,515
- Locations
- 22
- Primary Endpoint
- Clinically diagnosed DVT and/or PE
Study Overview
Brief Summary
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.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Alert (Behavioral)
Outcomes
Primary Outcomes
Clinically diagnosed DVT and/or PE
Time Frame: 90 days after discharge
Secondary Outcomes
- Mortality(30 and 90 days)
- Hemorrhagic events(30 and 90 days)