Deborah Mandel, PhD, RNC-OB, APN Cathy Pirko, BSN, RNC-OB Kelly Grant, BSN, RNC-OB Tasha Kauffman, BSN, RNC-OB Lindsay Williams, RN Jane Schneider,

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1 Deborah Mandel, PhD, RNC-OB, APN Cathy Pirko, BSN, RNC-OB Kelly Grant, BSN, RNC-OB Tasha Kauffman, BSN, RNC-OB Lindsay Williams, RN Jane Schneider, RN

2 A Collaborative Protocol on Oxytocin Administration Bringing Nurses, Midwives and Physicians Together Lack of clear communication among health care providers has been identified as one of the foremost reasons for medical and nursing errors (Cherouny, Federico, Haraden, Leavitt Gullo, & Resar, 2005; Friesen, Farquhar, & Hughes, 2008; Institute for Healthcare Improvement [IHI], 2005; Woolf, Kuzel, Dovey, & Phillips, 2004). It s important for nurses, physicians and midwives to communicate information that is clear, concise and of one meaning.

3 Bottom Line Oxytocin is a high-alert drug for which safety precautions are crucial. Clear communication between nurses, physicians and midwives is vital when oxytocin is used. A collaborative process to updating an oxytocin administration protocol results in trust and respect among health care providers. Fortunately, the adoption and use of the National Institute of Child Health and Human Development (NICHD) recommended terminology for fetal heart rate patterns has provided nurses, physicians and midwives common meaning on terms that describe fetal heart rate patterns. Practice protocols are also important in providing a clear guide to acceptable practice and patient care. Ideally, protocol development should include all stakeholders who will be held accountable for providing care in accordance with the protocol. Unfortunately, protocol development can be a partisan endeavor with each group writing its own protocols that can be contradictory to one and other, causing confusion and conflict among different health care providers. When examining the process of protocol development at our facility and at our campus as a whole, we found that protocol development was a nursing process, rather than a collaborative process among nurses, physicians and midwives. Encouraged to collaborate on an oxytocin protocol, the Labor and Delivery Evidence-Based Practice Committee along with the Labor and Delivery Clinical Practice Council, both composed of bedside nurses, along with the Obstetric Clinical Practice Council, composed of physicians, midwives, nursing leadership, staff nurses private physician practice groups, embarked on their first collaborative protocol. This article describes our journey toward a collaborative protocol on oxytocin administration for induction and augmentation, and the role of research in influencing practice changes. Background Ours is a Magnet organization that practices within a shared governance model. As such, several established nursing committees (Labor and Delivery Evidence-Based Practice Committee, Labor and Delivery Clinical Practice Council, and Labor and Delivery Performance Improvement Committee) work together to address practice issues and patient safety concerns. In Deborah Mandel, PhD, RNC-OB, MSN, is a clinical nurse specialist; Cathy Pirko, BSN, RNC-OB, Kelly Grant, BSN, RNC-OB, Tasha Kauffman, BSN, RNC-OB, Lindsay Williams, RN, and Jane Schneider, RN, are staff nurses; all authors are at Women and Babies Hospital in Lancaster, PA. Address correspondence to: dmandel2@lancastergeneral.org. DOI: /j X x this case of an oxytocin protocol, the committees looked collectively at the current nursing oxytocin protocol and its compliance with current NICHD terminology recommendations along with how oxytocin is administered for inductions and augmentation. Oxytocin is considered a high-alert medication, and the need to ensure that the current protocol was compliant with safe administration guidelines was crucial. After reviewing the current protocol and identifying the need to make changes to comply with current standards, members of the Labor and Delivery Evidence-Based Practice Committee along with the Labor and Delivery Clinical Practice Council began research to revise and update the current oxytocin protocol. A Historically Divided Process Historically, collaboration between disciplines has not been identified as a strength at our hospital. Nursing and medical disciplines have developed separate protocols, procedures and policies for guiding their individual practice. Our approach to the management of oxytocin in laboring patients was no exception. Institutional requirements mandate a yearly nursing protocol review with revisions as indicated. This begins with a search for up-to-date evidence-based literature to aid in protocol revisions. Once research and revisions are completed, the protocol is assessed through various approving bodies, final adjustments are made and approval is granted. At this point, the unit is informed of changes and staff education is provided. The protocol is initiated and posted on the hospital intranet for reference by staff. A New Collaborative Process Our collaborative process began with the Obstetric Performance Improvement Committee noting documentation deficiencies surrounding NICHD and IHI recommendations and the use of oxytocin. These results were shared with the Labor and Delivery Evidence-Based Practice Committee along with the Labor and Delivery Clinical Practice Council. Both groups agreed that the need for improved documentation and the assurance of safe practice was of paramount concern. The staff nurse responsible for nursing protocol development and revision was consulted and she, along with the Labor and Delivery Evidence-Based Practice Committee, began an exhaustive literature review on oxytocin administration so that the current protocol could be updated to reflect both current oxytocin administration recommendations and NICHD terminology. At the same time, the Obstetric Clinical Practice Council along with medical leadership was discussing the need for standardization of oxytocin administration. Taking advantage of the fact that both nurses and physicians/midwives were addressing oxytocin administration at the same time, the administration recommended that both groups collaborate and develop an acceptable evidence-based oxytocin administration protocol. Both groups agreed and collaboration on the oxytocin administration began and became the first collaborative protocol initiated at Women and Babies Hospital (WBH) , AWHONN

4 Ideally, protocol development should include all stakeholders who will be held accountable for providing care in accordance with the protocol Multiple face-to-face discussions and s occurred between members of various units, including Nursing, Obstetrics, Maternal-Fetal Medicine and Nursing Administration. Discussions included questions related to induction criteria and required documentation, NICHD terminology conformity, indications for the high-dose oxytocin regimen (Regimen 2 see Box 1) and how to manage bariatric patients. The protocol underwent numerous revisions as responses were received and incorporated. At the same time, a scheduled conference on legal issues in perinatal documentation was provided for nurses, physicians and midwives at WBH. This provided even more valuable information and generated further questions, discussion and collaboration. From its inception to completion, the protocol development process took 6 months. Research Evidence In a clinical setting, change should be based on current reliable research, clinical expertise and patient preference. Evidencebased practice integrates both clinical expertise and reputable research (Plastow, 2006). According to Brown, Wickline, Ecoff, and Glaser (2008), Evidence-based practice has been recognized by the health care community, as well as by regulatory agencies, as the gold standard for the provision of safe and compassionate health care (p. 372). Members of the Labor and Delivery Evidence-Based Practice Committee began a literature search and were pleased to discover that the literature abounded with new articles, as oxytocin had been named a high-alert medication by the Institute for Safe Medication Practices (ISMP). We also discovered that the IHI had developed bundles for safe practices concerning elective induction and augmentation. A bundle is a concept developed by the IHI that provides a structured way to improve the delivery of care based on research evidence and consists of a group of interventions that when implemented together resulted in better patient outcomes than when implemented individually (IHI, 2006). We also consulted AWHONN s monograph on Cervical Ripening and Induction and Augmentation of Labor (Simpson, 2008). As we continued our research efforts, we discovered that the Hospital Corporation of America (HCA) had developed oxytocin protocol checklists that addressed documentation and patient safety concerns (Clark, Belfort, Byrum, Meyers, & Perlin, 2008). Other articles we used in our research included those by Simpson, James, and Know (2006), Simpson (2005), Simpson and Atterbury (2003) and Simpson and Knox (2003). We also examined current research related to appropriate uterine activity, tachysystole, uterine resting period and tone and fetal outcomes. The importance of appropriate documentation of uterine activity and fetal and maternal assessment was stressed by all involved in the development of the protocol. Appropriate documentation guidelines and terminology was researched and incorporated into the protocol. The importance of using NICHD terminology was supported by the research as well as both professional organizations (ACOG and AWHONN). Fetal heart rate assessment and documentation frequencies were included in the protocol, as were maternal and fetal factors pertaining to initiation of oxytocin administration as well as contraindications and special considerations. Collaboration on a High-Dose Regimen During the protocol development process it was suggested by physicians and midwives that a high-dose oxytocin regimen be included in the protocol. Collaboratively, the group re-examined the current literature and conducted an additional literature review. An article by Hayes and Weinstein (2008) was added to the literature review. These authors examined numerous studies pertaining to various oxytocin administration regimens along with their clinical endpoints (time to delivery, hyperstimulation rates and C-section rates). Information from the Hayes and Weinstein article substantiated information from other research articles on the efficacy and safety of specific alternative oxytocin administration regimens. We also noted that ACOG practice bulletins (ACOG, 2003, 2009) supported December 2009 January 2010 Nursing for Women s Health 483

5 Box 1 Low- and High-Dose Oxytocin Regimens Infuse oxytocin via electronic infusion device programmed at ordered rate: a. Regimen 1: Begin at 2 milliunits/minute and increase by 2 milliunits/minute q30 minutes until 5 contractions lasting 45 to 90 seconds in 10 minutes averaged over 30 minutes. Maximum dose of 20 milliunits/minute. b. Regimen 2: Begin at 4 milliunits/minute and increase by 4 milliunits/minute q30 minutes until 5 contractions lasting 45 to 90 seconds in 10 minutes averaged over 30 minutes. Maximum dose of 20 milliunits. c. Oxytocin may exceed 20 milliunits/minute per provider discretion with provider documentation of rationale for exceeding protocol. the use of both a low- and high-dose oxytocin administration regimen. After analyzing all the information, we developed two oxytocin administration regimens. Research provided the necessary evidence to support changing our current practice and including a low- and high-dose regimen in our oxytocin administration protocol. Box 1 describes our low- and high-dose regimens. Using a multidisciplinary approach, pharmacy was consulted regarding medication pharmacokinetics of oxytocin. More specifically, pharmacy was asked to validate information related to steady plasma levels and to evaluate the new high-dose regimen with consideration to appropriate incremental dose increases. Although they were skeptical of Regimen 2, nurses willingness to include this regimen and place evidence-based research into practice added to the collaborative process. We were pleased that our research efforts provided information on the efficacy and safety of not one but two oxytocin administration regimens. The Finished Product After the eight-page protocol was complete, it was brought to the hospital s OB Care Management Committee for approval. The protocol then went on to our Protocol Subcommittee at Lancaster General Hospital where it was reviewed, discussed and granted final approval on December 17, The protocol went into effect and was posted on the hospital intranet on January 12, All Labor and Delivery staff received inservice by our staff educators the week prior to the official posting, so that staff would be able to initiate the new protocol on the date it went into effect. All OB physicians were informed of the date the new protocol would take effect. A preparatory information binder was made available in both the physician/nurse-midwife call room and the L&D lounge, which included the protocol and all substantiating research for review on November 19, Outcomes To determine use of the protocol by physicians and midwives, the Labor and Delivery Performance Improvement Committee conducted a chart review in March Out of the 416 delivery charts, 159 charts were coded as Induction or Augmentation. Forty charts or 25 percent were randomly selected from the Induction or Augmentation group to review. The committee found 87.5 percent (35 out of 40 charts) of providers used the collaborative oxytocin protocol for induction or augmentation, while 12.5 percent (5 out of 40 charts) of providers were not using the collaborative oxytocin protocol and continuing to write their own orders. It was also noted that only 5 percent (two charts) of providers used Regimen 2 for induction of labor. Nursing adherence to the collaborative protocol was 90 percent (34 out of 40). The reported incidence of tachysystole among patients on oxytocin protocol was 13 percent (4 out of 30 patients). Reported incidence of tachysystole among patients whose providers wrote orders or for those whose nurses who did not follow protocol was 10 percent (1 out of 10 patients). The incidence of Category III fetal heart rate among patients on the oxytocin protocol was 6 percent (2 out of 30 patients). Their were no reports of Category III fetal heart rate among patients whose providers wrote orders or for those nurses who did not follow the protocol. Continued monthly surveillance is in progress to monitor compliance with oxytocin protocol. Nursing Implications When discussing with physicians and/or midwives the need for practice change, it s important for nurses to be knowledgeable of current trends, research and patient needs. Recommendations from research studies, professional organizations and government agencies help in providing substantiating evidence that support the need for change. Working collaboratively provides all stakeholders a voice in the change process and increases the likelihood of all concerned parties accepting and complying with the proposed change. Future Collaborations Future collaborations are planned and currently underway. The next protocols for revision are Magnesium Sulfate Administration, Induction of Labor, and Operative Vaginal Birth. Once again, the Labor and Delivery Evidence-Based Practice Committee along with the Labor and Delivery Clinical Practice Committee and the newly formed OB Care Management Protocol Subcommittee will collaborate on revising these protocols using the most current evidence and recommendations. Conclusion After consulting ACOG and AWHONN recommendations and current research literature, we determined that our oxytocin 484 Nursing for Women s Health Volume 13 Issue 6

6 Working collaboratively provides all stakeholders a voice in the change process and increases the likelihood of all concerned parties accepting and complying with the proposed change administration protocol needed to be revised to reflect current evidence. A collaborative process involving nurses, physicians and midwives was proposed. Concerns regarding maternal-fetal safety in regard to oxytocin administration were addressed collaboratively. This process allowed all stakeholders to share and interpret research findings and critique research evidence. The collaborative process engendered a deep level of trust and respect between nurses and physicians/midwives, and has fostered a safe and positive working environment. Our success can be attributed to a thorough understanding of the relevant literature and oxytocin pharmacokinetics, coupled with our strong commitment to a successful collaboration to ensure best practices and patient safety. NWH References American College of Obtetricians and Gynecologists. (2003). ACOG practice bulletin 49: Dystocia and augmentation of labor. In ACOG 2008 Compendium of Selected Publications, Vol. 2 (pp ). Washington, DC: Author. American College of Obstetricians and Gynecologists. (2009). ACOG practice bulletin 107: Induction of labor. Washington, DC: Author. Retrieved September 27, 2009, from: org/eweb/dynamicpage.aspx?webcode=loginrequired&site=a COG&urlReq=/publications/educational_bulletins/pb107.cfm Brown, C., Wickline, M., Ecoff, L., & Glaser, D. (2008). Nursing practice, knowledge, attitudes, and perceived barriers to evidencebased practice at an academic medical center. Journal of Advanced Nursing, 65(2), Cherouny, P. H., Federico, F. A., Haraden, C., Leavitt Gullo, S., & Resar, R. (2005). Idealized design of perinatal care: IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement. Clark, S., Belfort, M., Byrum, S., Meyers, J., & Perlin, J. (2008). Improved outcomes, fewer cesareans and reduced litigation: Results of a new paradigm in patient safety. American Journal of Obstetrics and Gynecology, 199(2), 105.e1 105.e7. Friesen, M. A., Farquhar, M. B., & Hughes, R. (2008). The nurse s role in promoting a culture of patient safety. American Nurses Association. Retrieved September 21, 2009, from Hayes, E. J., & Weinstein, L. (2008). Obstetrics: Improving patient safety and uniformity of care by a standardized regimen for the use of oxytocin. American Journal of Obstetrics and Gynecology, 198(6), Institute for Healthcare Improvement. (2005). Develop a culture of safety. Retrieved September 21, 2009, from org/ihi/topics/patientsafety/medicationsystems/changes/ Develop+a+Culture+of+Safety.htm Institute for Healthcare Improvement. (2006). What is a bundle? Retrieved September 21, 2009, from Topics/CriticalCare/IntensiveCare/ImprovementStories/WhatIsa Bundle.htm Plastow, N. A. (2006). Implementing evidence-based practice: A model for change. International Journal of Therapy and Rehabilitation, 13(10), Simpson, K. R. (2005). Failure to rescue: Implications for evaluating quality of care during labor and birth. Journal of Perinatal and Neonatal Nursing, 19(1), Simpson, K. R. (2008, updated 2009). Cervical ripening and induction and augmentation of labor (3rd ed.) [Monograph]. Washington, DC: Association of Women s Health, Obstetric and Neonatal Nurses. Simpson, K. R., & Atterbury J. (2003). Trends and issues in labor induction in the United States: Implications for clinical practice. Journal of Perinatal and Neonatal Nursing, 32, Simpson, K. R., James, D., & Know, G. (2006). Nurse-physician communication during labor and birth: Implications for patient safety. Journal of Obstetric, Gynecologic, & Neonatal Nursing, 35(4), Simpson, K. R., & Knox, G. (2003). Common areas of litigation related to care during labor and birth: Recommendations to promote patient safety and decrease risk exposure. Journal of Perinatal and Neonatal Nursing, 17, Woolf, S. H., Kuzel, A. J., Dovey, S. M., & Phillips, R. L., Jr. (2004). A string of mistakes: The importance of cascade analysis in describing, counting, and preventing medical errors. Annals of Family Medicine, 2, December 2009 January 2010 Nursing for Women s Health 485