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Sharon VanRiper is the quality improvement specialist for the Blue Cross/Blue Shield Michigan Cardiovascular Consortium at the University of Michigan Hospitals and Health Centers in Ann Arbor.
Eva Kline-Rogers is the project coordinator for the Blue Cross/Blue Shield Michigan Cardiovascular Consortium at the University of Michigan Hospitals and Health Centers in Ann Arbor. She oversees the entire coordinating center for the consortium.
To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 809-2273 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints{at}aacn.org.
Corresponding author: Sharon VanRiper, University of Michigan Hospitals and Health System, 2929 Plymoth Rd, Suite 210, Ann Arbor, MI 48105 (e-mail: sharonv{at}umich.edu).
Most patients walk successfully after the prescribed bed rest, are given instructions on self-care, and are discharged within 24 hours. However, a small group of patients have serious, potentially life-threatening vascular complications after PCIs. These complications can turn a straightforward recovery into a catastrophe in which nurses must use critical assessment skills to detect the problem and provide rapid intervention.
More than 500000 PCIs are performed annually in the United States.1 Although the procedure is generally safe, complications do occur. For example, the incidence of vascular complications ranges from 1% to 14% in reported studies.2 These complications may necessitate longer stays and more complex treatment such as surgical repair or blood transfusions.3 New drugs used to decrease the incidence of restenosis (eg, glycoprotein IIb/IIIa receptor inhibitors) can increase the risk of bleeding through their inhibitory effect on platelet aggregation. The rate of vascular complications is higher in patients with PCIs involving stents, atherectomies, or thrombolytic therapy than in other PCI patients.4–8
Many studies have been done to determine the risk factors for vascular complications. The most common factors are older age, female sex, and low body weight. In addition, other factors may increase the risk, such as chronic illnesses, type of procedure, and types of drugs administered during the procedure2,9 (Table 1
). Every complication has the potential to increase patients’ pain, length of stay, cost, further morbidity, and the rate of mortality.
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Crossing Boundaries: Regional Quality Improvement |
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Specific interventions based on benchmark data are used to improve care outcomes. Quarterly reports are generated that include data from the collaborative, data from each site, and data on the performance of individual physicians. Each site and each physician are assigned a number that is known only to the study coordinator at each site, and data are reported in a blinded fashion. Data accuracy is ensured by audits on a biannual basis through a review of 4% of randomly selected cases.11
Designated cardiologist leaders and nurse coordinators participate in consortium-wide quarterly meetings of working groups. During these meetings, quality improvement goals of each hospital are discussed. Each hospital has a physician-nurse coordinator team that provides leadership in quality assessment and improvement efforts at the team’s institution. Data on each PCI are collected by the nurse study coordinator on a form provided by the consortium. Data are submitted quarterly to the coordinating center, where the data are analyzed and a report is generated to compare data for the entire collaborative with data for each site.
Consortium performance reports offer a continual source of benchmark data for these improvement initiatives at the hospital level. Staff at each hospital can view their hospital’s own complication rates, performance measures, and risk-adjusted mortality rates. Data from the consortium report allow analysis of demographics, therapies provided in the periprocedural time frame, case mix, patients’ outcomes during and after the procedure, and specific data on lesions and devices at each hospital. Once quality improvement projects are under way, the consortium data can be used as both a benchmark to set goals and a yardstick to measure progress toward the goals. Examples of quality improvement goals include decreasing the frequency of contrast nephropathy, decreasing the number of blood transfusions needed, or decreasing vascular complication rates.
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Quality Improvement in Action |
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). The standard definition of hematoma within the BMC2 consortium was hematoma at the access site with blood loss that required a transfusion, caused a decrease in hemoglobin level greater than 3.0 g/dL (30 g/L), or prolonged length of stay.11 Our nurse study coordinator analyzed our processes closely and, along with the nurse manager of the catheterization laboratory, led the change process.
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We identified the practice patterns that were contributing to our high complication rates and selected 2 major areas on which to focus our improvement efforts: training for VCD deployment and implementing a weight-based anticoagulation protocol during the PCI procedure. Our process improvement team was co-led by the nurse study coordinator and the medical director in partnership with the catheterization laboratory leaders, interventional physicians, nurses, and technicians, and in collaboration with the nursing staff from the inpatient telemetry unit. This group led the change process by closely examining our practices and clinical outcomes and comparing them with benchmark data from other institutions in the consortium.
VCDs have been used since the early 1990s in an effort to maximize effective hemostasis and decrease recovery time after femoral artery puncture.13 Although initial hopes for VCDs included decreasing the frequency of vascular complications, in fact, that goal has not been uniformly reached. The reasons the complication rate has not decreased include the learning curve required for each of the many devices, the use of more anticoagulants during complex interventions, and the shift toward performing interventions in sicker and older patients.8
Our hospital and physician leaders were committed to using VCDs for a number of reasons, including the desire to have patients walk sooner, decrease manual compression time, and minimize recovery time in our rapidly growing interventional program, which has a limited number of beds. In addition, our patients reported markedly greater satisfaction with the VCDs than with manual compression in terms of comfort and decreased time required for bed rest. Before 2001, a variety of VCDs from 4 manufacturers were used. Training was often done by the vendors at the time of deployment or was "demonstrated" by one staff member to another (see Sidebar).
As we analyzed our use of VCDs after sheath removal, we noted that nursing and cardiovascular technicians in the catheterization laboratories were not uniformly trained or certified in either sheath removal or techniques for deploying VCDs. (Although sheath removal was primarily done by cardiovascular technicians or physicians, nurses were trained in the skill because they shared off-hours on-call responsibilities.) VCDs were becoming more commonly used, and each device required specific training, but we had no uniform education plan or certification process in place. Training was provided either by the vendor at the time of deployment or by one technician demonstrating use of the device to another. Finally, an inpatient staff nurse often had to provide care to a patient with a "new" VCD, without benefit of specific training on the device. This situation was an important concern for the inpatient nursing staff with respect to patients’ safety.
Compared with others in the consortium, our hospital had a high frequency of vascular complications: our highest rate was 6.5% at the end of 2001, compared with a mean rate for the consortium of 3.1%. Our rates were among the highest for vascular complications, transfusions, and morbidity associated with vascular complications (surgical repair, length of stay). Notably, we also had the highest use of VCDs (90% of our patients had VCDs). The range of VCD use in the consortium was from 0% to 90% (mean 20%). Once this information was shared with our interventional team, the decision to improve was strongly supported.
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VCDs: The Intervention |
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We developed a certification process that required each new staff member (physicians and technicians) to demonstrate a number of successful VCD deployments before the member was allowed to manage VCDs independently. Further, we had our cardiovascular technicians do all VCD deployments, and the technicians are recertified annually via a written assessment of competency. The assessment covers selection of appropriate patients for VCDs and how to manage complications during and after deployment of the VCD. By limiting the number of personnel who had to be certified and allowing those who were certified to become expert at the process through repeated performance of the skill, we were able to decrease risks related to selection of patients for VCDs and complications during deployment of VCDs.
| Vascular Closure Devices Vascular closure devices have been developed for dual purposes: to achieve hemostasis reliably and rapidly, thereby allowing the patient to walk again sooner, and to provide an alternative to the current reference standard (manual compression), which is physically taxing and labor intensive for caregivers and uncomfortable for patients. Many types of devices that use a variety of approaches are available to achieve hemostasis. Some anchor a collagen plug within the artery; others place an extravascular collagen plug. Some devices use a suture or a staple, a sealant gel, or a procoagulant. One device has a balloon catheter that initiates hemostasis and delivers a mixture of procoagulant to the puncture site. Each device comes with a specific delivery system that requires operator training.12 A number of devices are currently approved by the Food and Drug Administration. However, no clear evidence of the superiority of any device in terms of effectiveness and safety is apparent at this time. Complications associated with vascular closure devices include hematoma, retroperitoneal bleeding, pseudoaneurysm, late bleeding, and, occasionally, death. These complications are the same as those reported with manual compression.12 General guidelines for the use of any vascular closure device include the following12
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Next we expanded our educational efforts to the entire staff. Each physician was given complication rates on the physician’s own patients, and all nurses and technicians in the catheterization laboratory were given the most recent evidence-based information on the VCDs. This information helped the staff select appropriate patients on whom to use the VCDs, thus avoiding some of the more high-risk patients. Each physician’s complication rate included all VCDs that were deployed by technicians. Each physician was responsible for determining the appropriateness of the VCD in each patient and for informing the assigned technician of any anticipated difficulties in the deployment of the device.
Finally, we identified an educational need of the nurses in the inpatient unit where the PCI patients were recovering. Nurses needed to know which VCD was used, and what specific observations were needed after the entire procedure. Nurses also needed to know what to teach patients at discharge about groin care. The nurse managers and educators from the catheterization laboratory and the inpatient telemetry unit partnered to provide a thorough educational effort for the nursing unit. This training included a review of all types of vascular complications with the appropriate nursing assessment and interventions, plus information about VCDs: how they work, what to assess for in terms of impending complications, and how to provide groin care after a VCD is deployed. Staff feedback after the educational effort was positive, with most nurses indicating an increased comfort level in providing groin care after VCD deployment and detecting and managing vascular complications after PCI.
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Anticoagulation |
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When we assessed our practice, we found variation in the amount of heparin administered as a bolus during the PCI. For example, some physicians would use a bolus of 10000 units of heparin on every patient and would follow the initial bolus with subsequent boluses during the PCI. In our catheterization laboratory, we used activated clotting time (ACT), a point-of-care test, to assess the effect of heparin because the ACT test is inexpensive and yields a rapid result. In the inpatient unit, we measured activated partial thromboplastin time (aPTT). Analyses of aPTT for general monitoring of heparin therapy are done in the central laboratory.
Both methods of assessing anticoagulation are clinically useful.15 Although ACT testing was readily available in our catheterization laboratory, we did not routinely check the ACT at specified intervals. In fact, the femoral sheaths were routinely removed at the end of the procedure without ACT being checked.
On the basis of the recently published evidence, we determined that our practice of giving heparin was not up to current standards, which recommend that heparin dosing be weight based.16,17 We retrospectively reviewed cases in which PCI was done. A weight-based calculation of heparin dose was done for each patient and compared with the actual dose given. ACTs were tracked, and patients who had received heparin before the PCI were identified. This quality analysis yielded 3 specific areas for improvement: changing heparin administration to follow national guidelines, improving communication between inpatient and laboratory nursing personnel about current heparin administration/discontinuation, and closely monitoring ACT to ensure it is within specific ranges acceptable for sheath removal.18
The Intervention
Over the course of several months, the nurse study coordinator presented the findings of our quality analysis to our physicians during the physicians’ staff meetings. The lead physician for the consortium also provided data from recent research trials indicating that heparin dose should be based on the patient’s weight and closely monitored by measuring ACTs. Physicians agreed to follow a standard protocol that we developed in our multidisciplinary improvement work group. As part of the consortium, our physicians were aware that our hospital had the highest rate of vascular complications, and this was a motivating factor for helping us make change.
Our protocol was simple. Using a Plan, Do, Study, Act (PDSA) quality improvement process, we began with a standardized dose of heparin as a bolus at a maximum of 70 units per kilogram of weight. Staff in the inpatient units were asked to send the medication administration record to the catheterization laboratory with each patient so that we could see when heparin was discontinued before the procedure. Nurses in the catheterization laboratory checked ACTs at the beginning of the procedure for those patients who were already taking heparin.
Patients who were not already receiving heparin were given a bolus dose once the lesion was visualized and the decision to do an intervention was made. When the ACT was between 200 and 300 seconds, the stent was deployed. A repeat ACT test was done with guidewire removal to determine if the sheath could be removed. If the ACT was greater than 250 seconds, we would retest at 10-minute intervals until it was less than 250 seconds, at which point the sheath was removed and the VCD deployed. In order to help ensure compliance with this new protocol, a PDSA analysis was done. This common quality improvement technique, popularized by W. Edwards Deming, is used to clarify the goals of improvement, test actual interventions, and revise efforts accordingly to achieve the desired results.
Our PDSA cycle was led by the nurses, who recorded the heparin dosages, the ACT at the time of sheath removal, and the time of VCD deployment for each procedure (Table 3). Initially the daily results were given to the study coordinator, who collated them and put them into a report format that was shared with physicians. Physicians who removed sheaths before the ACT level was within the acceptable range were able to see their results along with a reminder about the protocol. Results were also shared with the medical director.
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Finally, as each patient was transferred to the care of the inpatient nurse, a joint inspection of the patient’s groin was done to check for any oozing, hematoma, or discoloration at the insertion site. The nurse from the catheterization laboratory reported to the inpatient telemetry nurse the time and dosage of heparin given during the procedure and the last ACT along with the other pertinent information about the case. Because ACTs were often still elevated, it was important for the receiving nurse to monitor the patient for bleeding. It was the responsibility of the telemetry nurse to maintain the prescribed period of bed rest, assess the patient’s groin before and after the patient walked, and provide discharge instructions.
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Results |
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Continuous Improvement |
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Case Study |
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The patient received a bolus and then a continuous infusion at 2 µg/kg per minute of eptifibatide and 300 mg of clopidogrel by mouth. ACT at the end of the procedure was 198 seconds, and because the ACT was less than 250 seconds (as required by our protocol), the technician removed the sheath and placed a collagen-type VCD. D.J. recovered briefly in the catheterization laboratory’s recovery unit and then was sent to the cardiac unit, where her infusion of eptifibatide was maintained at 2 µg/kg per minute for 18 hours. When she arrived in the inpatient unit, a joint assessment of her groin by the receiving nurse and the nurse from the catheterization laboratory confirmed no bleeding or hematoma. After 4 hours of bed rest, D.J. was able to walk. The groin site remained free of oozing or bleeding. D.J. was discharged the next morning with specific written instructions for groin care, activity, and follow-up appointments, as well as counseling about stopping smoking and a review of all medications.
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Conclusion |
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In the recovery units, training of nurses about VCDs and the careful assessment of the access site in each patient’s groin helped promote communication and continuity of care. A multidisciplinary approach to protocol development and education that used the PDSA process along with providing regular feedback on outcomes to individual physicians increased awareness and attentiveness to protocols. Finally, the advantage of participating in a multihospital consortium provided incentive to the entire staff to strive for excellence in quality performance indicators.
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TopCrossing Boundaries: Regional...Quality Improvement in ActionVCDs: The InterventionAnticoagulationResultsContinuous ImprovementCase StudyConclusionReferences |
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| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
