Quality and Safety Case Studies

Editor’s Note: In early 2021, a workgroup of representatives from the ACS Quality Programs was formed to understand the limitations and barriers to the performance of quality improvement (QI) projects. The workgroup created the QI Framework to facilitate more comprehensive and effective projects. The framework includes eight components and 40 specific criteria to guide a project team through the execution and documentation of QI projects. To help familiarize hospitals with the components and criteria of the QI Framework, it has been retroactively applied to the 2022 Best Practices Case Studies featured in the following case study. While this example does not include all 40 criteria of the QI Framework, it demonstrates how eight components compose a successful QI project. For more information on the ACS Quality Framework, contact ACSQualityFramework@facs.org. 

Bariatric surgery inherently is associated with an increased risk of postoperative nausea and vomiting (PONV) compared with other surgical disciplines. In bariatric surgery patients, PONV is cited as one of the most common causes for prolonged lengths of stay (LOS) and unplanned readmissions.¹ A recent position statement published by the American Society for Metabolic and Bariatric Surgery (ASMBS) stated that “there is an urgent need for more research to address the significant problem of PONV in this special population.”² According to the statement, a lack of bariatric specific screening, established management guidelines, and appropriate measurement tools are among the greatest needs.² This situation highlights the need for more research. 

After being involved with the Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY) Project in 2017, and with the implementation of enhanced recovery after surgery (ERAS) protocol at Bon Secours St. Francis Hospital in Charleston, SC, the program observed significant improvement in LOS and drastically decreased use of opioids in inpatient and outpatient settings. As the QI team continued to follow the quality data, there was a noted rise in the incidence of PONV in bariatric surgery patients who were experiencing more of these occurrences than the rest of the hospital’s surgical population. 

A further review of the 2020 data demonstrated a higher rate of PONV and documented emesis in bariatric patients. Patients were having more PONV in the post-anesthesia care unit (PACU) and surgical progressive care unit (SPCU) than other surgery patients. 

The goal of this project was to work toward improving the patient experience and decrease PONV and LOS in the bariatric surgery patient in the PACU and SPCU.

Bon Secours St. Francis Hospital is one of four hospitals in the Roper St. Francis Healthcare system. It is licensed for 190 beds and was the Lowcountry region’s first magnet hospital, designated in 2010 and redesignated in 2015 and 2020. The hospital specializes in neurosurgery, bariatrics, maternity care, and cancer care. Bon Secours St. Francis Hospital is a leader in image-guided, minimally invasive surgeries.

Goal Specification

SMART Goals

Specific: The goal of this project was to decrease PONV in the bariatric surgery patient, both within the PACU and SPCU by December 2021.

Measurable: Data were extracted from a combination of the electronic health records (EHRs) and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database.

Achievable: The necessary staff were available to implement this project. 

Relevant: Eliminating nausea and vomiting should increase patient satisfaction. Decreasing LOS and readmissions would be a cost savings for both patients and the hospital. 

Timely: Project timeline was January 26 through December 31, 2021.

Strategic Planning

Plan Do Check Act (PDCA)

Plan: We identified a subgroup of key stakeholders from the Metabolic and Bariatric Surgery (MBS) committee members and developed a team to evaluate baseline PONV data, review literature, identify opportunities for improvement, and make recommendations for change in our current process. Our team consisted of: 

• One general and bariatric surgeon, who was the chief of the Department of Surgery at Bon Secours St. Francis Hospital and medical director of Roper St. Francis Bariatric Surgery and Metabolic Weight Loss Division
• One bariatric surgeon from Bon Secours St. Francis Hospital
• One lead certified registered nurse anesthetist (CRNA) of bariatric and metabolic surgery, Bon Secours St. Francis Hospital 
• One bariatric coordinator from Bon Secours St. Francis Hospital
• One pharmacy clinical specialist from Bon Secours St. Francis Hospital
• One quality specialist and metabolic and bariatric surgery clinical reviewer from Bon Secours St. Francis Hospital
• One quality specialist and research nurse scientist from the Department of Nursing Excellence

In addition to our project team, we have an interdisciplinary MBS committee that meets monthly. 

The MBS committee consists of two bariatric surgeons; two obesity medicine physicians; four advanced practice providers; one program coordinator; five dietitians; four representatives from the quality department; four representatives from administration; five anesthesia providers; one pharmacist; one clinical psychologist; representatives from endoscopy, imaging, physical therapy, respiratory therapy, infusion center, physician office, preoperative area, PACU, and the inpatient nursing unit; two representatives from the OR; and four clinical educators.

Do: The CRNA reviewed all charts for patients undergoing bariatric surgery from October to December 2020 who had PONV in the PACU and SPCU. The presence of the PONV was determined by chart review of rescue antiemetics received (ondansetron or promethazine). A literature review also was completed. 

The Fourth Consensus Guidelines for the Management of PONV, published by the American Society of Enhanced Recovery and Perioperative Medicine (ASER) and Society for Ambulatory Anesthesia (SAMBA), highlights the importance of a multimodal approach.³ Several therapies with various mechanisms of action are cited but there is a significant lack of evidence highlighting the single best approach.⁴ 

Fosaprepitant and aprepitant are Neurokinin-1 (NK-1) receptor antagonists and carry a Category A Level 1 recommendation for PONV prophylaxis.³ The decision to trial fosaprepitant over alternative antiemetics with similar quality of evidence stemmed from NK-1 receptor antagonists’ proven ability to reduce acute and delayed emesis. In a prospective, double-blind placebo-controlled study of 125 patients undergoing bariatric surgery with Apfel scores ≥2, use of aprepitant was associated with an absolute risk reduction in incidence of vomiting of 11.9%.⁵ 

In a retrospective chart review of 338 female patients undergoing bariatric surgery, aprepitant was associated with a cumulative reduction in vomiting episodes at 48 hours (p = 0.04).⁶ In a retrospective database analysis of four identically designed, double-blind, randomized controlled studies of 171 female patients with Apfel scores ≥2, use of fosaprepitant demonstrated statistically significant reductions in vomiting episodes at 0–2 hours (p = 0.002), 0–24 hours (p<0.001), and 0–48 hours (p<0.001) after surgery.⁷ The ASER/SAMBA guidelines suggest “NK-1 receptor antagonists may be useful when postoperative emesis is highly undesirable, such as in gastric surgery.”³ 

Findings: All bariatric surgical patients are high risk for PONV as several variables—such as surgical site, mechanical manipulation of stomach, length of surgery, female predominance, and preoperative smoking cessation requirement—make up this risk category.^8,9 

Process Evaluation

Proposal: Anesthesia proposed the addition of fosaprepitant to our established ERAS PONV prophylaxis protocol. This consisted of preoperative application of a scopolamine patch, IV dexamethasone 8 mg prior to induction of anesthesia, and IV ondansetron 4 mg within 30 minutes of emergence. After literature review and discussion with pharmacy leadership, fosaprepitant use for bariatric cases was implemented in January 2021 with plans for formal review and approval by the pharmacy and therapeutics (P&T) committee after a 3-month trial period. The PONV subgroup met biweekly to review data in preparation for an April 6, 2021, P&T committee meeting, where key stakeholders were granted formal approval to continue use of fosaprepitant. It was added to the preoperative medication order set and given to all bariatric surgery patients. On December 7, 2021, fosaprepitant was brought back to the P&T committee as a follow-up item to review 6 months of internal data since its implementation as part of the bariatric surgery ERAS protocol.

The QI team created an Excel spreadsheet for data collection. Metrics included postoperative nausea in the PACU and/or SPCU, documented emesis, and drinking within 8 hours of surgery. 

• An encounter form was developed to interview each patient. Starting on postoperative day (POD) 1, a PACU nurse would evaluate the patient’s PACU experience via interview. On POD 2, an anesthesia provider would perform a follow-up interview to assess for any painful or noxious stimuli throughout the perioperative period. 
• Additional follow-up interviews were performed by phone, typically 24 to 48 hours after discharge, to assess the patient’s oral intake tolerance. 
• All data collected were maintained in an Excel spreadsheet and updated periodically. Members of the PONV project team developed a handout highlighting key components within our ERAS protocol and in-services were provided in May 2021 to the ambulatory surgery unit, PACU, and SPCU staff on the overall goals and performance improvement (PI) initiatives. 

Several changes were made throughout the project period that could influence outcomes. Effective June 1, 2021, use of a preoperative scopolamine patch was discontinued. This decision stemmed from concerns that scopolamine’s anticholinergic effects could pose as a barrier to early ambulation, thus contributing more risk than benefit considering fosaprepitant’s implementation. Additional changes included use of an 8 mg dose of ondansetron in the OR rather than 4 mg. 

In the early stages of data collection, the team noted that several patients were receiving an additional 4 mg dose in the PACU and decided to optimize initial ondansetron dose and provide a different drug class in the PACU as a rescue antiemetic. Other changes effective June 1, 2021, included implementation of QueaseEASE aromatherapy in the PACU and SPCU, and adjustment of goal time for postoperative ambulation and oral fluid intake from 8 to 6 hours. 

Nurses documented the time that patients left the PACU on the SPCU whiteboard as a visual cue to optimize achievement of time-dependent goals. The QI team worked with pharmacy to develop a bariatric-specific Anesthesia Phase 1 order set for the PACU. It provided guidance for first- and second-line treatment of postoperative pain to decrease opioid use and treatment of postoperative nausea. Components included ketorolac 15 mg IV for pain management, as well as QueaseEASE, promethazine 6.25 mg IV, and lorazepam 0.5 mg IV for nausea management.

Outcome Evaluation

Check: PONV was measured using the documented administration of a rescue antiemetic in the PACU or on the inpatient unit in the EHR. Emesis was measured based on documented emesis volume or occurrences in the EHR. Percentage was calculated based on the number of patients that received a rescue antiemetic or had emesis documented divided by the overall bariatric surgical cases each month multiplied by 100. 

PONV data were reviewed at the monthly MBS committee meetings. With the implementation of these process changes, the QI team observed a decrease in PONV in the patient population from an average of 45% in 2020 to an average of 24% in 2021, and a decrease in documented emesis from an average of 16% in 2020 to an average of 4% in 2021 (see Figure 1 and Figure 2). 

One surgeon scheduled postoperative ondansetron on the SPCU instead of as needed, which affected the data; as of December 2021, both surgeons prescribed scheduled postoperative ondansetron, and only promethazine was considered a rescue medication. 

The addition of fosaprepitant and other interventions described has positively contributed to improved patient outcomes. 

Act: We continued to review monthly PONV data at the MBS committee meetings in 2022 and assess for improvement opportunities. We shared data with the units, posting results and showing the success of our interventions. 

Setbacks

One anesthesiologist was resistant to the strategy to minimize opioids and continued to pursue use. All providers are tracked on an Excel spreadsheet. It was decided to exclude this provider from the analysis.

Two physicians prescribed promethazine as PRN. We will perform further analyses to determine which orders were given as needed and given to treat breakthrough.

Throughout this PI project, reeducation was performed to address noncompliance with the PONV protocol. One PACU nurse was providing aromatherapy and administering IV rescue antiemetics concomitantly. Some staff members also did not retrieve preoperative orders, which prompted repeat education.

There was a delay to updating the order sets in our EHRs. This potentially served as a barrier since our order sets were not reflective of our PONV protocol when we began our intervention. To prevent a delay in our go-live, we provided education to the PACU nurses and anesthesia on the protocol. This allowed us to begin implementation before the official order set was established in the system.

Gold standard assessment of postoperative pain or nausea relies on direct patient communication.³ Assessing pain and nausea can be challenging due to its subjective nature as well as the varying degrees of sedation seen in the perioperative period. In review of the baseline data, most patients reported high numeric scores on the pain rating scale and the documentation of an antiemetic to track PONV, which prompted us to evaluate the process. However, the reliability of these data does serve as a limitation.

The timing of our PONV PI project and the implementation of the da Vinci robotic cases also could have served as a limitation, as this procedure can be associated with increased nausea, vomiting, intraoperative time, and anesthesia requirements. Use of da Vinci technology for robotic-assisted surgery began in January. Patients did not experience increased vomiting despite the longer cases and the implementation of robotic surgery, so there was no observed change in the data.

It cannot be confidently stated that fosaprepitant caused the change or if it was one of the other variables implemented during the project. The use of aromatherapy also was implemented in June 2021. In review, it would have been better if the project was organized differently, with consistent gaps between each intervention.

Cost Evaluation

With an average cost of an RSFH general acute care inpatient day at $880, by cutting LOS from 2 days to 1 day, there was a potential cost savings in 2021 (332 patients) of $292,160—or $880 per patient. While LOS was not reduced to the 1-day goal, LOS was reduced from 2020 to 2021. Using the same volume of patients from 2020 to 2021 (332) with actual LOS data, the potential cost savings from 2020 to 2021 is as follows:

• Roux-en-Y gastric bypass cases: $20,451.20
• Sleeve cases: $90,569.60
• The total potential cost savings: $111,020.80

Cost of Fosaprepitant Implementation

Financial summary: Annual medication cost with implementation of fosaprepitant is approximately $15,000 annually.

In selecting a NK-1 receptor antagonist for the Bariatric PONV prophylaxis protocol, the parenteral prodrug formulation, fosaprepitant, was chosen over the active oral formulation, aprepitant, to optimize adherence and avoid potential cost constraints that would be incurred directly by the patient. Since administration recommendations for PONV prophylaxis is 3 hours prior to induction, aprepitant would require the patient to purchase as an outpatient and self-administer before presenting to the facility for their procedure.

The additional costs associated with PONV were up to 100 times more expensive compared with prophylaxis with generic antiemetic. The cost of treating vomiting was three times more than the cost of treating nausea.

There was no additional funding for this project.

Knowledge Acquisition

Lessons Learned

It is beneficial to have a committed team. For example, the anesthesia team was very involved; they spoke with patients and physically went to the PACU and talked to the nurses. One of the team members previously worked in the PACU and was helpful as she knew many of the staff members. The team worked directly with a PharmD, who was integral to the success of this project, a key stakeholder, and part of the committee.

It is important to have a consistent care team. A core set of floor nurses took care of the bariatric patients. While they did not experience any issues on this project, the cohesiveness of the team was addressed early on to make sure the project was being implemented across the board in the same way.

Monitoring data is important for continuous improvement. If an issue is found, dig further to determine the cause. For example, did an anesthesia provider go off protocol? Is it a one-off or a trend?

This project was unique because the team already was involved in bariatric patient care and available, so they did not need to pull in outside resources. The stakeholders were engaged and monthly interdisciplinary meetings were well attended. The data and committee feedback helped inform the process. It is always encouraging when you are trying to make a change and you have interest in and support for the change.

End of Project Decision-Making

The process still is under adjustment, and postoperative preventative pain medication was recently added, which may influence future data.

The research team is reviewing the project process, removing steps, and simplifying the data while ensuring the project is still on track. 

The QI team plans to share its results with other service lines. Information about the program has been shared by word of mouth, and this has helped others with an interest in implementation in their programs. The team will continue to monitor and review data on a monthly basis and look for opportunities for improvement. 

Ginny Ledbetter is the bariatrics program manager at Bon Secours St. Francis Hospital in Charleston, SC. 

References 

1. Berger ER, Huffman KM, Fraker T, et al. Prevalence and risk factors for bariatric surgery readmissions: Findings from 130,007 admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Ann Surg. 2018;267(1):122-131. 
2. Schumann R, Ziemann-Gimmel P, Sultana A, et al. Postoperative nausea and vomiting in bariatric surgery: A position statement endorsed by the ASMBS and the ISPCOP. Surg Obes Relat Dis. 2021;17(11):1829-1833. 
3. Gan TJ, Belani KG, Bergese S, et al. Fourth consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2020;131(2):411-448.
4. Naeem Z, Chen IL, Pryor AD, et al. Antiemetic prophylaxis and anesthetic approaches to reduce postoperative nausea and vomiting in bariatric surgery patients: A systematic review. Obes Surg. 2020;30(8):3188-3200.
5. Sinha AC, Singh PM, Williams NW, et al. Aprepitant’s prophylactic efficacy in decreasing postoperative nausea and vomiting in morbidly obese patients undergoing bariatric surgery. Obes Surg. 2014;24(2):225-231. 
6. Therneau IW, Martin EE, Sprung J, et al. The role of aprepitant in prevention of postoperative nausea and vomiting after bariatric surgery. Obes Surg. 2018;28(1):37-43.
7. Murakami C, Kakuta N, Kume K, et al. A comparison of fosaprepitant and ondansetron for preventing postoperative nausea and vomiting in moderate to high-risk patients: A retrospective database analysis. Biomed Res Int. 2017;2017:5703528.
8. Apfel CC, Kranke P, Eberhart LH. Comparison of surgical site and patient’s history with a simplified risk score for the prediction of postoperative nausea and vomiting. Anaesthesia. 2004;59(11):1078-1082. 
9. Koivuranta M, Läärä E, Snåre L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997;52(5):443-449.