PROJECT LEAD(S): Minso Kim, Sandra Staveski, Lori Fineman, Amy McCammond

EXECUTIVE SPONSOR(S):  Shannon Fitzpatrick, MS, RN, CCRN, Patient Care Director, Pediatric Critical Care. University of California San Francisco (UCSF) Benioff Children’s Hospital (BCH) Mission Bay

ABSTRACT (1490 characters): Effective comfort management in children following heart surgery is crucial to successful recovery. Complex symptoms, neurodevelopmental variation, and a diverse care team can contribute to inconsistent care delivery. Further complicating care, important interactions exist among pain, agitation, delirium, and iatrogenic withdrawal syndrome (IWS) and the cardiac system function. A standard approach to pain and sedation following child heart surgery has been shown to improve outcomes, decrease total exposure to opioid and sedative medications, enhance throughput, and reduce hospital length of stay (LOS). Our interprofessional team in the Pediatric Cardiac Intensive Care Unit (PCICU) developed a unique, goal-directed, nurse-implemented pain and sedation algorithm and complementary Advancing Patient-Centered Excellence (APeX) order set, based on published and validated algorithms. Our algorithm aims to improve efficacy in achieving adequate comfort in postoperative child heart surgery patients as measured by clinical outcomes as well as by family feedback. It also aims to reduce children’s total cumulative exposure to opioid and sedative medications. Clinical and pharmacologic data for the 12-month period prior to implementation will be compared to data collected at 6- and 9-months post-implementation. Finally, measures of team communication, performance, and satisfaction related to pain and sedation management will be examined by a pre- and post-implementation survey.

TEAM: Sandra Staveski PhD, RN, CPNP-AC, FAAN; Lori D. Fineman, RN, MS, CNS; Brianna Rojo, RN, MSN, CNS; Tommy Flynn, PhD, RN, CPNP-AC; Minso Kim, MD, Assistant Professor of Pediatrics; Michael Cisco, MD, Associate Professor; Amy McCammond, MD, Associate Professor of Pediatrics; Lulu Jin, Pharm.D., BCPPS, BCPS, Pediatric Clinical Pharmacy Supervisor.

PROBLEM: Lowest effective dose of opioids and sedative agents is a strategic goal in critical care to optimize outcomes. However, ensuring adequate comfort in children with heart disease is complex process and remains elusive.¹ Valentine and colleagues revealed a lack of standardized comfort care and use of sedation protocols in PCICUs including in UCSF BCH PCICU.² There are multiple symptoms such as pain, agitation, under- and over-sedation, delirium, and IWS that overlap with each other. Teasing these symptoms out can be a subjective and challenging process. A pre-implementation survey in our PCICU team showed poor consistency among interprofessional clinicians as multiple team members had differing approaches. Moreover, practice variability among nurses based on expertise, beliefs, and clinical practice can add to the wide range of opioid and sedative use. We identified issues in the categories below:

Patients. Our patient population contains a high percentage of neonates, infants, and neurodevelopmentally divergent patients with impaired verbal communication who require developmentally appropriate approaches to pain and sedation assessment and management. This population benefits the most from evidence-based medication choice to maximize their potential brain development. Exposure to benzodiazepine in infancy is associated with impaired brain development suggested by hippocampal growth alteration implicated in memory processing.³ Use of prolonged continuous ketamine infusions may be associated with increased delirium.⁴ Children who were exposed to higher doses and longer durations of opioid and sedative medications are at a greater risk for IWS and delirium.⁵ Conversely, children exposed to lower doses and shorter durations of sedative medications are at a lower risk for sedation-related complications.⁶ We theorize that our work will not only be fiscally responsible but also add crucial information to the current medical literature. Our algorithm focuses on interprofessional goal setting as well as standardized weaning method for children exposed to opioids, benzodiazepines, and other sedative agents after heart surgery. We hypothesize that these focuses will reduce IWS, subsequently improving parental perception of the pain and sedation management.

Process. Clinical variability impacts infants, children, and adolescents differently. For example, a clinical team may be able to verbally communicate with and support a well-developed adolescent through critical illness in comparison to consoling those who lack verbal communication skills due to their age or neurodivergence. While there is a paucity of unifying practice guidance,⁶ a nurse-implemented, goal-directed, child-centric strategy to improve comfort in PCICU is possible and safe to use.⁷ Similarly, another study of nurse-implemented, goal-directed sedation strategy found a reduction in LOS and cumulative exposure to benzodiazepines.⁸

Systems. Children with agitation, inadequate sedation, poor pain control, delirium or IWS have higher nursing workload and require more 1:1 staffing.⁵ Having sedative medication guidelines is associated with reduced ICU and hospital LOS, decreased occurrence of delirium, shorter length of mechanical ventilation, less exposure to opioid and sedatives, decreased occurrence of IWS, and improved communication and documentation of sedative goals.^1,5 Importantly, these positive changes were without an increase in adverse events.⁷ We hypothesize that financial metrics associated with implementing CICU Comfort Algorithm will decrease total exposure to opioid and sedatives, decrease hours on ventilator, reduce LOS, and improved throughput thereby reducing financial burden and sedation-related complications.

TARGETS: We will evaluate metrics important to each of our goals detailed below, comparing our baseline PCICU data (12-month period pre-implementation) with post-implementation data at 6- and 9-month timepoints (related to 1 year study period).

1. Increase PCICU’s effectiveness in achieving adequate pain relief and appropriate sedation based on acuity for infants and children (0-18 years old) recovering from heart surgery as reflected by clinical outcomes and family feedback. While complex and multidimensional, we plan to evaluate several specific metrics to reflect this. We will evaluate total mechanical ventilation days, ICU LOS and total hospital LOS, aiming for an overall 5% decrease in each endpoint. At baseline, our patients recovering from heart surgery have median 3.2 mechanical ventilation days, median 11.7 ICU LOS, and median 18.0 hospital LOS. There were total 342 heart surgery cases at BCH Mission Bay PCICU in the past 12 calendar months. We will gather comfort scores from our electronic Health Record (EHR) pre- and post-implementation as balancing measures. In addition, we will evaluate post-discharge family survey data (Press Gainey Survey) regarding parental response to the questions “How well your child’s pain was controlled in the first 24 hours following surgery” and “How well your child’s pain was addressed.” We will aim for a 5% increase in families responding “Good” or “Very Good” to these questions at the 6- and 9-month time points. Currently our baseline Press Gainey scores for FY2024 are 95.3 for the question “how well my child’s pain was addressed”.
2. Successfully implement our comfort algorithm in > 75% of children 0-18 years old recovering from heart surgery in the PCICU (excluding those who have undergone ventricular assist device (VAD) placement, heart transplant and/or palliative/comfort care), with equitable application of algorithm in children across all racial and ethnic backgrounds. This will be assessed by auditing utilization of the associated comfort algorithm APeX order set in comparison to unit admission and demographic data. We will further audit compliance with specific components of our algorithm using our audit tool developed in conjunction with UCSF Health regulatory team for appropriateness and sustainability. We will perform subgroup analysis to ensure that our algorithm is being applied equitably to children from all racial and ethnic backgrounds.
3. Reduce total cumulative exposure (both exposure and duration) to opioid and sedation medications by 10% for each medication class. We will collect both pre- and post-implementation data regarding total cumulative exposure and total duration of treatment for all opioid and sedative medications for postoperative children while in our PCICU. Additionally, we will collect data on number of patients continuing to wean from opioid and sedative medications at hospital discharge.
4. Demonstrate a 10 % improvement in our PCICU team’s assessment of our effectiveness, consistency, and communication surrounding pain and sedation management. We have previously conducted an interprofessional survey to assess each team member’s satisfaction with communication and team function related to the assessment and treatment of pain and agitation in children recovering from heart surgery. We will re-administer this survey at 6- and 9-month time points post-implementation. 

GAPS: Analgesia and sedation are important parts of effective postoperative recovery in children after heart surgery ages 0-18 years old. Various system issues, technological boundaries, and educational gaps make the selection and titration of analgesic and sedating agents challenging. Children requiring heart surgery consists of a wide range of ages, developmental, and genetic variations. Their clinical acuities complicate the differentiation between the symptoms of impaired organ function and pain, agitation, delirium, and IWS. Variable clinical staff education, experience, and resource availability create inconsistencies in both the assessment and treatment of comfort from day to day. The lack of a standard approach to guide clinical processes related to ordering and administering analgesics and sedatives is a key gap that, when bridged, has been shown to facilitate improved outcomes as described above.

INTERVENTION:

1. Our interprofessional working group has developed an algorithm to standardize analgesia and sedation in our PCICU. Our algorithm was based upon published analgesia and sedation algorhithms,^7,9 which was modified to reflect local practices and preferences. Briefly, our algorithm provides preferred medication choices, starting dosages, and instructions for increasing or decreasing medication dose as needed based on level of sedation or pain agreed upon during daily rounds. Our algorithm specifies the method of assessing level of sedation to improve consistency; a goal sedation level is set by our medical team, and the medication doses are titrated by our clinical nurses to achieve and maintain that specified comfort level. Additionally, our algorithm includes a standardized approach to weaning from analgesic and sedative medications to prevent IWS. Our algorithm will be applied uniformly to all PCICU surgical patients (0-18 years old) except for VAD placement, heart transplant, or comfort care patients. To ensure there are no equity gaps, we will measure adherence to our algorithm and compare rates among different subgroups.

2. Our algorithm will be implemented in our PCICU at BCH Mission Bay for children between 0-18 years of age. We care for approximately 500 patients per year, ranging in age from newborn to adult. All patients having surgery will be managed with our algorithm. Our medical staff consists of 12 attending physicians, 8 Nurse Practitioners, and fellows from our Pediatric Cardiology and Critical Care fellowship training programs. Approximately 120 nurses staff our unit.

3. We anticipate our largest barrier to implementation will be faculty, trainee, and staff education that are sustained over time. We will approach this using multiple strategies, including electronic dissemination of our algorithm, reviewing our algorithm in person at staff meetings, online training modules, and utilizing staff champions to provide in person assistance.

4. Potential adverse outcomes that we will track include unplanned extubation and hemodynamic instability due to suboptimal sedation or analgesia. Patient/caregiver satisfaction is also tracked in post-discharge surveys. Similar algorithms have been studied in pediatric critical care units, and these studies suggest that an algorithm can provide clinical benefits without significant adverse outcomes.

PROPOSED EHR MODIFICATIONS: Effective and efficient application of technological resources is key to progressive quality improvement projects. Utilizing existing tools and workflows from UCSF Health’s EHR record system (APeX), this project proposal includes development of an algorithm-based order set and an algorithm-specific APeX report. Providers use order sets in APeX to place interdependent orders efficiently while, in this case, consistently adhering to algorithm directives. APeX reports are generated from existing data in our EHR and can be used to monitor various clinical processes and phenomena. We have been working with EHR leaders to modify orders.

RETURN ON INVESTMENT: In 2024, patients who were admitted under pediatric cardiothoracic surgical service had an average 5.5 day of ICU LOS. The direct cost portion of ICU LOS is estimated at $5,500 per day. We aim to decrease the ICU LOS by 5% (0.3 days) by implementing our project. Our estimated annual surgical volume is 300 patients excluding VAD placement or heart transplant patients. If we successfully implement CICU Comfort Algorithm in 75% of this population, this will equate to 225 patients. This will translate to direct cost savings of $371,250 per year. Additionally, this decreased ICU LOS will open up 56 ICU patient days per year to admit more patients for cardiac surgery, which will further generate revenue in return.

SUSTAINABILITY: Our algorithm will be embedded in our broader PCICU management of postoperative children and will involve ongoing annual re-education, mandatory orientation and maintenance of competencies. Longitudinal interprofessional working group will continue to monitor our project and outcomes moving forward.

BUDGET:

• We request $10,000 for data extraction by Clinical Translation Science Institute (CTSI) [including medication duration, cumulative doses of opioid, benzodiazepine, dexmedetomidine, propofol, ketamine, total ventilator days, LOS, discharge home on methadone, lorazepam, or clonidine, and parent satisfaction measures.
• We wish for $10,000 for our PCICU Pharmacist salary and fringe for supervising data verification and analysis by School of Pharmacy graduate research students and/or work study students.  
• We request $15,000 for data collection, verification, management, and cleaning by graduate pharmacy, work study students and/or nursing student researcher. Graduate PharmD students will verify 10% of data extracted by CTSI.
• We wish for $5,000 for PCICU clinical nurse champions to aide in staff education and/or implementation support during our study proposal timeframe.
• We request $10,000 salary and fringe support for proposal and study planning, oversight and statistical support by Dr. Staveski and statistical support from UCSF SON statistician and/or graduate research student.

REFERENCES:

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