We See You When You're Sleeping

We See You When You're Sleeping Addressing Patient Safety Risks Surrounding Opioid-Induced Sedation Jeanne J. Venella DNP, MS, CEN, CPEN November 30 th, 2016 1

Objectives Review the current state of opioids and impact on your practice Define the clinical problem and regulatory guidelines that support increased inventions for enhancing patient monitoring and patient safety while receiving opioids Analyze the effectiveness of continuous vital signs and spot monitoring to detect early patient deterioration Identify the biggest challenges to overcome when implementing continuous monitoring 2

Background January 1, 2001 The Joint Commission (TJC) introduced the standards that require pain assessment and treatment of pain Know as Pain as the 5th vital sign While patient satisfaction increased- the incidence of opioid over sedation adverse drug reactions doubled The use of patient-controlled analgesia (PCA) devices introduced opportunities for adverse drug events Then in 2012 The Joint Commission (TJC) issued their 49th Sentinel event alert Safe use of opioids in hospitals 3

State of the Union Drugs now kill more Americans than cars Cocaine used to be the leading killer, not anymore (Heroin) Opioid prescriptions have tripled over 20 years 76 million / 216 million The epidemic has hit nearly everyone, regardless of race Opioids and the NFL 4

Heroin and Opioids 369% 439% www.pbs.org/wgbh/frontline/article/how-bad-is-the-opioid-epidemic/

Opioid Related Deaths in the Hospital The opioid-related adverse drug events including deaths that occurred in hospitals and were reported to The Joint Commission s Sentinel Event database (2004-2011) Opioids are involved in almost half of all deaths attributed to medication errors 11 % were related to other factors, including excessive dosing, medication interactions and adverse drug reactions 47 % were wrong dose medication errors 29 % were related to improper monitoring 6

Clinical Problem Hospital systems are increasingly caring for complex, co-morbid patients who require surgical procedures or joint replacement and the use of Patient-Controlled Analgesia (PCA) post operatively Preventable deaths and anoxic brain injury from unrecognized opioid related sedation and respiratory depression remain a serious and growing patient safety concern Opioid analgesics rank among the drugs most frequently associated with adverse drug events The incidence of respiratory depression among post-operative patients is reported to average about 0.5% 7

Significance Patient Descriptions: Age 60 or older, BMI >35 More and more patients with multi- factorial risks factors Patients with significant o Organ system dysfunction i.e. COPD, O2 dependent, CHF, Emphysema Concomitant use of CNS depressant medications (Benzodiazepine) Patients with known increased sensitivity to narcotics making them opioid naive Patients with history of chronic high doses of narcotics making them opioid tolerant Patients requiring escalating doses of PCA, bolus or basal 8

Adverse Events Causes are: Lack of knowledge about potency differences among opioids Improper prescribing and administration of multiple opioids and modalities of opioid administration (i.e., oral, parenteral and transdermal patches) Inadequate monitoring of patients on opioids 9

Why We Monitor 3 patterns of unexpected hospital deaths Sepsis Opioid induced carbon dioxide narcosis Drug induced arousal failure with sleep apnea 10

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Who to Monitor Selective monitoring or universal monitoring Risk stratification- can lead to misses of patients with undiagnosed sleep apnea (25-30%) Telemetry guidelines 12

When to Monitor According to the McCarter study-at Main Line Health Most respiratory depression events occurred within the first 24 hrs. of initiating PCA therapy With a mean time of 3.4 hrs., excluding an outlier with 23.5 hrs. The median time from initiation of PCA therapy to the onset of respiratory events was 3.5 hrs. The average time was 5.6 hrs. In addition, 1 patient had an event 23.5 hrs. after starting PCA When excluding this outlier patient, the average time to a respiratory depression event was 3.4 hrs. 13

How to Monitor Spot Check Tele-Room Continuous Tele-room Direct care team notification Direct care team notification with smart alarms 14

Spot Check Vital Signs Intermittent observation and recording of patient s pulse, breathing rate, and O2 saturation Every 2-4 hours This action typically arouses the patient Patients are left unmonitored 96% of the time www.ncbi.nlm.nih.gov/pmc/articles/pmc4109792 15

Telemetry Remote surveillance Human analytics Relay system Often delayed Dependent on clinical communications tools 16

Continuous Monitoring Detects subtle changes in respirations and trends and provide actionable information prior to deterioration Current methods of detecting and preventing opioid-induced respiratory depression have limitations, but continuous monitoring using available technologies could still prevent a significant number of cases of patient harm Reduce burden the nurses workload, with more technology, but to provide an enhanced level of observation with actionable notifications with data capture through this technology 17

Ideal State Capturing data and monitoring alone is not enough Surveillance with integration into the electronic medical record Embedded analytics would provide a best practice platform for the patient and would assure a highest level of quality and safety 18

Continuous Monitoring with Smart Alarms The most sophisticated category is the use of smart alarms that are transmitted to a device held by direct-care clinical staff. The use of smart alarm technology serves two primary purposes: Smart alarms provide an accurate and real-time picture of a patient s condition, enabling direct-care patient staff and physicians to intervene before a patient begins to deteriorate. Attenuating alarm data achieves the balance between communicating contextual patient-safety specific information and minimizing spurious and non-emergent events that are not indicative of a threat to patient safety. 7 Zaleski JR. Alarm Fatigue. 19

Alarm Fatigue 100 s of alarms/day per patient 1000 s of alarms/day per unit 10,000 s of alarms/day per hospital 20

Alarm Fatigue Alarm Fatigue Overwhelmed by information Desensitized to number of alarms Improper Responses Turn down volume Turn off alarms Adjust settings outside of safe limits Serious or Fatal Consequences Patient falls Delays in treatment Zaleski JR. Alarm Fatigue. 21

Smart Alarms Sustained alarms: Which sets a minimal time threshold that the alarm must be violated prior to sending alarm Consecutive alarms: Which patterns of a consistent alarm detected, occurring over a clinician-defined period of time Combination alarms: Which multiple parameters from different devices occurring simultaneously may together indicate a degraded patient condition Trending alarms: Which expand or contract patient alarm limits on individual devices 22

Achieving Continuous Monitoring Technology needs (middleware, physiologic devices, smart alarms) Workforce needs (training, mobile devices, team-approach to implementation) Business needs (the hidden cost of sentinel events)

Data Delivery, Communication and Integrity Physiologic devices are critical components to continuous patient monitoring and capture a more complete and real-time picture of a patient s condition Recent studies identified capnography, along with continuous pulse oximetry monitoring, as providing a sensitive and early predictor of opioid-induced respiratory depression 24

Safe Administration of Opioids Must include: Effective Processes Safe technology Appropriate education and training A rapid response notification system should be in place to alert staff if the patient is deteriorating. A plan for escalation of rapid response alarm to another staff member should also be in place 25

Effective Processes Human Workflow Distribution of equipment, transport of patients Changes Impacting Clinical Staff Nurse leaders on Medical-Surgical floors must be engaged to encourage staff Include Respiratory Therapists Monitor variations in narcotic ordering 26

Safe Technology Technological Cables, set-up, configuration need to be checked to ensure correct prior to use Assembly association / disassociation from patient Breakage (i.e., regular inspections) Phones: functionality, association of phone to patient room must be easily managed by operational staff 27

Education & Leadership Initial and On-going Didactic, audio-visuals, and simulation Include policies Educate the need for monitoring capacity / capabilities for all nurses, respiratory therapists 28

29 Case Study

Capnography Study Overview o This health system is increasingly caring for complex, co-morbid patients who require surgical procedures or joint replacement and use of Patient-Controlled Analgesia Post-Operatively (PCA) o PCA carries risks for patients who experience difficulty due to obstructive sleep apnea (OSA) and other conditions Physical Environment- single rooms, closed doors, bedside alarms Desired Intervention o Bedside ventilation monitoring & alarming of end-tidal CO2 (Medtronic) o Notifications of trended events to provide indicators of conditions (Bernoulli) o Trended conditions transmitted via Nurse call (hand held devices) o No bedside monitor alerts are impeded 30

Distribution of Parameter Notifications to Study Patient D/C Time to D/C Capnography Min (hours) 2.9 Ave (hours) 22.3 Max (hours) 74.4 Parameter # Notifications # Trended Notifications (30 seconds or more) Respiratory Rate 31,064 25,152 CO2-EX 30,119 23,541 PR 8,459 5,126 SPO2 6,103 1,735 Total: 75,745 55,554 31

Capnography Study Capnography and Post-Operative Patients on PCA- Pulse Oximetry Low Alarms Setting a minimum time threshold that an alarm limit must be violated prior to sounding the alarm Sustained Alarm: Alert staff if limit violation exceeds min. time threshold 32

Patient 25 CO2-EX (mmhg) v Time (minutes) (Total Samples: 16583) 60 50 40 30 20 10 0 800 600 400 200 0 Patient 25 Cumulative Patient 25 CO2-EX (mmhg) Notifications v Time (minutes) (53) (22) Patient 25 CO2-EX (mmhg) CO2-EX Filter (mmhg) (314) 14:1 Notification Reduction Cumulative Raw Notifications <= 15mmHg (22) Cumulative Trended Notifications <= 15mmHg 33

Outcomes Patient bedsides alarms ringing without notice Delayed alarms- fewer alarms- but still get bulk of nuisance alarms Multi-variant alarms / time to event Smart alarms 34

Summary Rules operated as designed reduced single notifications without introducing false negatives o o To mitigate the effect of repetitive trended notifications A protocol to respond after defined period of time would help to mitigate even trended notifications Immediate remediation of all nursing staff in education Engage nursing educators to facilitate and educate nursing Educate respiratory therapy Consult with Pulmonary Physicians Reevaluate the redundant order sets that comes with pulse oximetry to evaluate capnography (i.e., involve tele-techs in pulse oximetry) Key challenge will be implementation workflow o o Stakeholders must include bedside nurses Introduction of this technology must enhance rather than complicate nursing operations 35

Monitoring Success Reduce the chaos and fatigue of non-actionable alarms from the myriad of medical devices Clinical Efficiency + Improved Clinical Outcomes Inform remote/mobile clinicians of critical alarms that require intervention (Patient Safety) Quiet the bedside environment (Patient Satisfaction and Clinical Outcomes) The Threat of Alarm Fatigue on Patient Safety Webinar 36

Return on Investment Include hospital administrative staff who are educated on the topic of preventable harm (Risk, Quality and Safety) Increased costs of monitoring will be offset financially with improved outcomes Reduce rapid response calls Decrease transfers to ICU Reduce ICU staffing burdens Fewer rescues with Narcan (Naloxone HCL) Decrease LOS Improved nursing satisfaction Safety advantage for patients and the community 37

Summary Continuous monitoring should be used for patients receiving post-operative opioids When supplement O2 is not used Pulse Oximetery most reliable and practical monitor available today If O2 is being administered- Capnopraphy is necessary to detect hypoventilation Improved and on-going education Better assessment of sedation levels Continuous monitoring when possible is the best practice Inadequate post-operative monitoring is risky and costly Improving patient outcomes and patient satisfaction 38

Literature Review AAMI. Opioid Safety & Patient Monitoring Conference Compendium. The National Coalition to Promote Continuous Monitoring of Patients on Opioids. November 14, 2014. Available at: http://s3.amazonaws.com/rdcmsaami/files/production/public/filedownloads/foundation/reports/2015_opioid_compen dium.pdf. Accessed October 27, 2016. Capnographic Monitoring of Respiratory Activity Improves Safety of Sedation for Endoscopic Cholangiopancreatography and Ultrasonography (2009). Curry JP, Jungquist CR. A critical assessment of monitoring practices, patient deterioration, and alarm fatigue on inpatient wards: a review. Patient Saf Surg. 2014;8:29. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4109792. Accessed October 27, 2016 39

Literature Review Miner JR, Heegaard W, Plummer D. End-tidal carbon dioxide monitoring during procedural sedation. Acad Emerg Med. 2002;9:275-280. https://www.jointcommission.org/sea_issue_49/ Overdyk FJ, Carter R, Maddox RR, et al. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007;105:412-418. Zaleski JR. Alarm Fatigue? What a Nuisance! [Blog post]. October 4, 2014. Available at: www.medicinfotech.com/2014/10/mathematical-techniques-mitigating-alarmfatigue. 40

Thank you for listening to: Addressing Patient Safety Risks Surrounding Opioid-Induced Sedation Jeanne J. Venella DNP, MS, CEN, CPEN November 30 th, 2016 41