Triggers
Definition and purpose
Triggers can be used prospectively or retrospectively. Prospectively, a “trigger” is used to identify an event or condition that mandates further action by the health care team. This action is designed to facilitate timely intervention and reduce practice variation to improve efficiency and safety. While “notify MD if” orders are commonplace, triggers not only notify the maternal care provider, but also require further action by the entire health care team. Retrospectively, a “trigger tool” is a list of predefined occurrences likely to indicate an action or potential adverse event and are generally used for retrospective internal quality monitoring and improvement.
Examples
Examples of prospective triggers include patient agitation, new onset of difficulty of movement, or specific thresholds for abnormal vital signs. While utilized for >20 years in the nonobstetric population, early warning systems for abnormal vital signs have been less commonly utilized in obstetrics.
Effective early warning systems include an expectation for surveillance, defined criteria for abnormalities, and a protocol for direct provider assessment after an abnormality is detected. An early warning system can serve as both a diagnostic and communication tool, highlighting an increased risk for compromise prior to clinical decompensation, so that care can be escalated to limit the severity of morbidity. Thus, triggers can help to identify patients at risk of decompensation and prevent morbidity by facilitating the escalation of care. Recently, several early warning systems have been either created specifically for pregnancy or adapted for use in the obstetric context and are termed “maternal” or “modified” obstetric early warning systems. While a comprehensive review of modified obstetric early warning systems is beyond the scope of this discussion, it is notable that this type of early warning system has been broadly implemented by the United Kingdom’s National Health Service.
In the United States, the National Partnership for Maternal Safety was formed in response to the rising maternal mortality rate and evidence demonstrating the contribution to this rate of delays in recognition and treatment of hemorrhage and hypertension as well as prevention of thromboembolism. This collaborative initiative included the American Congress of Obstetricians and Gynecologists (ACOG); Society for Maternal-Fetal Medicine; American Academy of Family Physicians; American College of Nurse-Midwives; and Association of Women’s Health, Obstetric and Neonatal Nurses, among others. It has proposed an early warning system–maternal early warning criteria (MEWC)–that incorporates aspects of the United Kingdom’s early warning system. In the MEWC system, any one abnormal value should trigger a response by the health care team, including bedside assessment by a clinician ( Figure 1 ). This system, ideally incorporated into the electronic medical record, provides a practical tool to facilitate timely recognition of and response to acute maternal illness and may serve as a framework for quality improvement on obstetric units. Figure 2 graphically depicts one health system’s individual early warning system along with a guide to assist physicians in the initial evaluation and management of abnormal vital signs.
Since only 10-20% of errors are reported through the traditional ad-hoc chart and outcome review, a more effective method to accurately identify adverse events is needed. Retrospective obstetric trigger tools, such as the Adverse Outcome Index (AOI) illustrated in the Table or an algorithm for severe maternal morbidity during delivery hospitalizations, can assist clinicians and administrators in analyzing rates of complications, guiding further in-depth review, and monitoring the impact of quality improvement programs.
| Indicator |
|---|
| Blood transfusion |
| Maternal death |
| Maternal ICU admission |
| Maternal return to operating room or labor and delivery |
| Uterine rupture |
| Third- or fourth-degree laceration |
| Apgar score <7 at 5 min |
| Fetal traumatic birth injury |
| Intrapartum or neonatal death >2500 g |
| Unexpected admission to neonatal ICU >2500 g and for >24 h |
Supporting evidence
Outside of obstetrics, early warning systems have demonstrated an ability to identify pediatric patients who are more likely to need intensive care unit (ICU) admission from the emergency department and to lessen the chance of readmission after colorectal surgery. In a systematic review of 13 unique early warning system models, the predictive capability, as quantified by the area under the receiver-operating characteristic curve, for cardiac arrest models ranged from 0.74-0.86 and for death ranged from 0.88-0.93, suggesting high predictive values for both. In the obstetrical literature, while validation studies are underway for the MEWC, the use of other modified obstetric early warning systems has been associated with improvement in mortality rates in maternal ICUs, and also improvement in the recording of vital signs in the clinical setting of maternal bacteremia. The utilization of trigger tools such as the AOI to improve system policies also has been associated with a reduction in the occurrence of adverse events.
Bundles
Definition and purpose
The Institute for Healthcare Improvement (IHI) defines bundles as small sets of evidence-based, independent interventions that when implemented together in an all-or-none fashion result in significantly improved outcomes compared to when they are implemented individually. The power of the bundle is the synergistic effect of each evidence-based component, so that the summative increase in quality of care is greater than would be realized with individual interventions. The Safe Motherhood Initiative from ACOG District II uses the term, “bundle” to signify a collection of materials (eg, checklists, protocols, educational materials) that is targeted toward a particular morbidity such as hemorrhage or severe hypertension in a multifaceted and comprehensive approach.
Examples
The IHI has advanced several perinatal bundles including those for the use of oxytocin in labor induction and augmentation and for operative vaginal deliveries with vacuum. In its labor induction bundle, the IHI recommends that there is clear delineation of the following 4 elements: (1) the approach to assessment of gestational age, (2) the standard recognition and management of fetal heart rate tracings, (3) the performance of pelvic assessment, and (4) the recognition and appropriate management of tachysystole.
The Council on Patient Safety in Women’s Health Care, a larger umbrella initiative over the National Partnership for Maternal Safety, has developed a 4-phase bundle concerned with obstetric hemorrhage: (1) readiness, (2) recognition and prevention, (3) response, and (4) reporting/systems learning. The Safe Motherhood Initiative proposed a hypertension bundle that details the differential diagnosis of hypertension in pregnancy; defines triggers to prompt further evaluation and treatment; and provides algorithms for common antihypertensive medication administration, checklists for eclampsia management, and educational material for providers regarding quality improvement.
Supporting evidence
In an evidence report for the Agency for Healthcare Research and Quality, an expert panel recommended that the IHI 5-item bundle regarding the approach to central line–associated bloodstream infections should have a high level of support for universal adoption given the sustained and cost-effective reduction of central line–associated bloodstream infections from 7.7-1.6 per 1000 per catheter day after implementation. Similarly, for those undergoing emergency laparotomy, a surgical bundle that includes early antibiotics, goal-directed fluid therapy, and reduction of the time to surgery has been associated with a reduction in mortality from 15.6-9.6%. In obstetrics, neither the IHI perinatal bundle nor the one proposed by the Greater New York Hospital Association’s Perinatal Safety Committee on fetal monitoring have specifically demonstrated improved maternal safety. However, given that each component of these bundles has been shown to correlate with improved outcomes independently, it stands to reason that this series of individual clinical steps grouped together could also be associated with improved care, though evaluation after implementation is necessary. Certain aspects of these bundles, such as checklists on management of hypertension or hemorrhage, were based, in part, on the approaches that in some studies have demonstrated to improve maternal morbidity and mortality. Furthermore, early data after implementation of the Council on Patient Safety in Women’s Health Care’s maternal hypertension bundle are associated with a reduction in severe maternal morbidity.
Bundles
Definition and purpose
The Institute for Healthcare Improvement (IHI) defines bundles as small sets of evidence-based, independent interventions that when implemented together in an all-or-none fashion result in significantly improved outcomes compared to when they are implemented individually. The power of the bundle is the synergistic effect of each evidence-based component, so that the summative increase in quality of care is greater than would be realized with individual interventions. The Safe Motherhood Initiative from ACOG District II uses the term, “bundle” to signify a collection of materials (eg, checklists, protocols, educational materials) that is targeted toward a particular morbidity such as hemorrhage or severe hypertension in a multifaceted and comprehensive approach.
Examples
The IHI has advanced several perinatal bundles including those for the use of oxytocin in labor induction and augmentation and for operative vaginal deliveries with vacuum. In its labor induction bundle, the IHI recommends that there is clear delineation of the following 4 elements: (1) the approach to assessment of gestational age, (2) the standard recognition and management of fetal heart rate tracings, (3) the performance of pelvic assessment, and (4) the recognition and appropriate management of tachysystole.
The Council on Patient Safety in Women’s Health Care, a larger umbrella initiative over the National Partnership for Maternal Safety, has developed a 4-phase bundle concerned with obstetric hemorrhage: (1) readiness, (2) recognition and prevention, (3) response, and (4) reporting/systems learning. The Safe Motherhood Initiative proposed a hypertension bundle that details the differential diagnosis of hypertension in pregnancy; defines triggers to prompt further evaluation and treatment; and provides algorithms for common antihypertensive medication administration, checklists for eclampsia management, and educational material for providers regarding quality improvement.
Supporting evidence
In an evidence report for the Agency for Healthcare Research and Quality, an expert panel recommended that the IHI 5-item bundle regarding the approach to central line–associated bloodstream infections should have a high level of support for universal adoption given the sustained and cost-effective reduction of central line–associated bloodstream infections from 7.7-1.6 per 1000 per catheter day after implementation. Similarly, for those undergoing emergency laparotomy, a surgical bundle that includes early antibiotics, goal-directed fluid therapy, and reduction of the time to surgery has been associated with a reduction in mortality from 15.6-9.6%. In obstetrics, neither the IHI perinatal bundle nor the one proposed by the Greater New York Hospital Association’s Perinatal Safety Committee on fetal monitoring have specifically demonstrated improved maternal safety. However, given that each component of these bundles has been shown to correlate with improved outcomes independently, it stands to reason that this series of individual clinical steps grouped together could also be associated with improved care, though evaluation after implementation is necessary. Certain aspects of these bundles, such as checklists on management of hypertension or hemorrhage, were based, in part, on the approaches that in some studies have demonstrated to improve maternal morbidity and mortality. Furthermore, early data after implementation of the Council on Patient Safety in Women’s Health Care’s maternal hypertension bundle are associated with a reduction in severe maternal morbidity.
Protocols and Checklists
Definition and purpose
Protocols and checklists serve to augment memory and limit the chance of human error. Such tools are particularly useful in highly stressful environments such as labor and delivery units. By improving communication and standardizing responses, these tools allow for necessary clinical variation in practices, while reducing unnecessary clinical variation that can lead to medical errors. Protocols and checklists help to remind clinicians of details that form baseline expectations of actions even when the care pathway is complex. Protocols are precise and rigid plans of action for a specific problem or clinical scenario, while checklists are informational aids that ensure consistency and completeness.
Examples
ACOG, the IHI, and others have focused on common clinical presentations in which protocols and checklists can lead to improved quality of care. One example is a protocol for the diagnosis and management of severe hypertension in pregnancy, with the specific goal that an intravenous antihypertensive agent be administered in a timely fashion after identification of a severe blood pressure elevation (systolic blood pressure >160 mm Hg or diastolic blood pressure >110 mm Hg). Another example is a postpartum hemorrhage protocol that includes early blood product transfusion and escalation of care (an example of a published protocol is illustrated in Figure 3 ). A formalized delineation of steps for the management of a shoulder dystocia represents another example. A fourth example is the use of a checklist prior to the performance of an operative vaginal delivery to ensure that a team time-out is performed, the bladder is drained, and fetal position and station are confirmed. Finally, the success surgical time-outs prior to surgery to verify laterality and preoperative antibiotic prophylaxis at cesarean delivery represent examples of improvements in clinical care due to standardization of actions through the implementation of protocols and checklists.
