BY MARY JO M. DALES
SAN DIEGO -- The rates of hospital-acquired cases of venous thromboembolism and pulmonary embolism declined by 50% each, and the rate of adequate VTE prophylaxis rose to 98%, in a prospective study of a risk assessment protocol developed at the University of California, San Diego Medical Center.
The protocol, which was incorporated into computerized provider entry orders, combined a risk factor assessment for VTE with appropriate options for prophylaxis at each level of risk. Although several risk assessment models have been developed, this protocol is among the first to be validated in a prospective study.
| THE STUDY WAS ABOUT DILIGENCE IN EVALUATING PATIENTS, AND NOT ABOUT THE SELECTION OF TREATMENTS OR AGENTS. |
The intervention also reduced the number of hospital-acquired cases of VTE that would have been "preventable" with proper prophylaxis. In the first year of the study, there were 43 cases, and in the second year 22 cases; in the year after the protocol was added to the order set, there were 6 cases. Similarly, hospital-acquired pulmonary embolisms were reduced from 27 cases and 31 cases in the first 2 years to 13 cases in the third year. Hospital-acquired deep vein thromboses were reduced from 137 cases and 158 cases in the first 2 years to 93 cases in the third.
In all cases, the differences in comparisons of the first 2 years of data and the third year of data were statistically significant (P less than .05). VTEs were documented with digital imaging. Analysis of administrative data and chart review showed no increase in heparin-induced thrombocytopenia or bleeding events.
There was no difference in the number of community-acquired VTE cases during the course of the study.
The study, which was also presented as a poster at the meeting, was led by Dr. Greg Maynard, chief of the division of hospital medicine at UCSD. The VTE protocol developed by Dr. Maynard and his team, which included Dr. Morris, won the Society of Hospital Medicine's first Team Approaches in Quality Improvement Award. Their VTE protocol has now been implemented at more than 25 sites, according to the society.
During the first 2 years of their study, the investigators built agreement and support for the VTE risk assessment protocol at their institution. Physicians were asked to evaluate their patients for a series of VTE risk factors that were used to classify patients as having a low, medium, or high risk for VTE. For each level of risk, optimal prophylaxis options were suggested. Physicians were then asked to document contraindications to prophylaxis and whether they prescribed prophylaxis.
The risk-management model was integrated into a protocol and computerized provider order entry model in the third year of the study. Each level of risk was linked to optimal options for prophylaxis. The order set was actively monitored, and physicians who did not adhere to the protocol were identified and asked to complete the evaluation.
The protocol was tested by five observers for interobserver agreement in 150 patients. The order set also was adjusted based on active monitoring. Throughout the study, random sample audits were performed among inpatients who were at the medical center for more than 48 hours. The percentage of patients who were on adequate VTE prevention regimens was tracked and rose from 67% at the start of the study to 98% in the most recent 6 months of the study.
"The study was about diligence in evaluating patients," and not about the selection of treatments or agents, Dr. Morris said. There is a range of acceptable pharmacologic choices, with no single agent remarkably superior to another. The important point is to make a conscious decision about prophylaxis, based on an evaluation of risk factors.
Dr. Morris had no disclosures; Dr. Maynard has received speaker honoraria from Sanofi Aventis.
When asked to comment on this article, Dr. Mark D. Morasch, associate professor of surgery, Northwestern University Feinberg School of Medicine, stated: "The UCSD group has shown us that there is significant room for improvement in preventing hospital-acquired VTE. Nevertheless, I believe it is important to point out that even with a state of the art protocol in place, 82 cases of VTE still occurred. CMS is proposing hospital acquired VTE be listed as one of their 'never events'. CMS is proposing that these occurrences not be paid for if and when they happen.
"These data show that even with our very best efforts some VTE events are truly not preventable. Additionally, it is important to remember that although administrative data review showed no rise in complication rates in this study, when automated protocols that include the administration of medications that are not risk free are initiated, complication rates certainly may rise." Dr. Morasch is an associate medical editor of VASCULAR SPECIALIST