Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409136
Status:
COMPLETED
Last Update Posted:
2009-02-02
First Post:
2006-12-07
Brief Title:
Multi-Center Human Alert Trial to Prevent DVT and PE
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate physician response to human alerts that inform the clinician that hisher patient may be eligible for thromboprophylaxis Medical records are reviewed to evaluate prescribing decision and to evaluate rates of venous thromboembolism
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 North American and European prophylaxis guidelines have been widely disseminated However despite intensive educational efforts VTE prevention remains underutilized
At Brigham and Womens Hospital we undertook a comprehensive program 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 conducting a randomized controlled trial in which high risk patients without prophylaxis were randomized into an intervention or control group The intervention groups physicians received a single alert explaining that the patient was at high risk was not receiving prophylaxis and urged that prophylaxis be selected from a template of available pharmacological and mechanical options In contrast the control groups physicians received no alert
Each of 8 common risk factors was weighted according to a point scale At least 4 score points were required to be deemed at high risk for VTE
3 of the 8 risk factors were considered major and were assigned a score of 3 points each
1 Cancer
2 Prior VTE
3 Hypercoagulability
One of the 8 risk factors surgery was considered intermediate and was assigned a score of 2
4 of the 8 risk factors were considered minor and were assigned a score of 1 point each
1 Advanced age 70 years of age
2 Obesity Body Mass Index 29
3 Bed rest
4 Hormone replacement therapy or oral contraceptives
There were 2506 patients in the randomized controlled trial of a computer alert 1255 in the intervention group and 1251 in the control group The incidence of symptomatic VTE at 90 days was high 82 in the control group This high incidence validates the 8 risk factor and point score methodology
The intervention group had an overall 41 reduction in VTE without any increase in major bleeding There was a 60 reduction in the incidence of symptomatic pulmonary embolism
Identification of Patients at Risk for Venous Thromboembolism VTE
A VTE risk profile will be computed for each hospitalized patient using 8 common risk factors Each risk factor is weighted according to a point score To be included in this trial 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
Major High Risk Factors 3 POINTS each
Cancer active
Prior VTE
Hypercoagulability
Increased VTE risk is defined as a cumulative VTE risk score 4 so that patients with at least 1 major risk factor cancer prior VTE or hypercoagulability plus at least 1 additional intermediate risk factor major surgery or bed rest or minor risk factor advanced age obesity or hormone replacement therapyoral contraceptives become eligible In the absence of a major risk factor patients with 1 intermediate risk factor plus at least 2 minor risk factors become eligible
Screening for Venous Thromboembolism Prophylaxis
If the cumulative VTE risk score is ³4 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
Randomization
Randomization Envelopes containing the statement ALERT Intervention or NO ALERT Control will be provided by Harvard Clinical Research Institute HCRI to randomize patients who meet all inclusion criteria
The intervention is informing the responsible physician that 1 his or her patient is at high risk for VTE 2 is not receiving prophylaxis and 3 VTE prophylaxis is recommended For control patients VTE prevention guidelines are available but no specific prompt is provided to use them
Follow Up
Ninety-day follow-up is performed in all study patients by medical record review and through contact with the subjects Primary Care Physician
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 30 and 90 days respectively We define major bleeding as intracranial intraocular retroperitoneal pericardial or bleeding that requires surgical intervention or that resulted in a hemoglobin loss greater than 3 gl
DVT is diagnosed if there is loss of vein compressibility by ultrasound or a filling defect by CT scan or by conventional contrast venography PE is diagnosed by a positive contrast chest CT scan a high-probability ventilation perfusion scan or conventional pulmonary angiogram
Venous thromboembolism VTE is often avoidable in hospitalized patients because proven prevention strategies have been established for patients at risk North American and European prophylaxis guidelines have been widely disseminated However despite intensive educational efforts VTE prevention remains underutilized
At Brigham and Womens Hospital we undertook a comprehensive program 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 conducting a randomized controlled trial in which high risk patients without prophylaxis were randomized into an intervention or control group The intervention groups physicians received a single alert explaining that the patient was at high risk was not receiving prophylaxis and urged that prophylaxis be selected from a template of available pharmacological and mechanical options In contrast the control groups physicians received no alert
Each of 8 common risk factors was weighted according to a point scale At least 4 score points were required to be deemed at high risk for VTE
3 of the 8 risk factors were considered major and were assigned a score of 3 points each
1 Cancer
2 Prior VTE
3 Hypercoagulability
One of the 8 risk factors surgery was considered intermediate and was assigned a score of 2
4 of the 8 risk factors were considered minor and were assigned a score of 1 point each
1 Advanced age 70 years of age
2 Obesity Body Mass Index 29
3 Bed rest
4 Hormone replacement therapy or oral contraceptives
There were 2506 patients in the randomized controlled trial of a computer alert 1255 in the intervention group and 1251 in the control group The incidence of symptomatic VTE at 90 days was high 82 in the control group This high incidence validates the 8 risk factor and point score methodology
The intervention group had an overall 41 reduction in VTE without any increase in major bleeding There was a 60 reduction in the incidence of symptomatic pulmonary embolism
Identification of Patients at Risk for Venous Thromboembolism VTE
A VTE risk profile will be computed for each hospitalized patient using 8 common risk factors Each risk factor is weighted according to a point score To be included in this trial 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
Major High Risk Factors 3 POINTS each
Cancer active
Prior VTE
Hypercoagulability
Increased VTE risk is defined as a cumulative VTE risk score 4 so that patients with at least 1 major risk factor cancer prior VTE or hypercoagulability plus at least 1 additional intermediate risk factor major surgery or bed rest or minor risk factor advanced age obesity or hormone replacement therapyoral contraceptives become eligible In the absence of a major risk factor patients with 1 intermediate risk factor plus at least 2 minor risk factors become eligible
Screening for Venous Thromboembolism Prophylaxis
If the cumulative VTE risk score is ³4 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
Randomization
Randomization Envelopes containing the statement ALERT Intervention or NO ALERT Control will be provided by Harvard Clinical Research Institute HCRI to randomize patients who meet all inclusion criteria
The intervention is informing the responsible physician that 1 his or her patient is at high risk for VTE 2 is not receiving prophylaxis and 3 VTE prophylaxis is recommended For control patients VTE prevention guidelines are available but no specific prompt is provided to use them
Follow Up
Ninety-day follow-up is performed in all study patients by medical record review and through contact with the subjects Primary Care Physician
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 30 and 90 days respectively We define major bleeding as intracranial intraocular retroperitoneal pericardial or bleeding that requires surgical intervention or that resulted in a hemoglobin loss greater than 3 gl
DVT is diagnosed if there is loss of vein compressibility by ultrasound or a filling defect by CT scan or by conventional contrast venography PE is diagnosed by a positive contrast chest CT scan a high-probability ventilation perfusion scan or conventional pulmonary angiogram
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None