Less Pain, More Gain: Implementing Evidence-Based Practice In Pain And .
Less Pain, More Gain:Implementing Evidence-BasedPractice in Pain and SedationAndrew C. Faust, PharmD, BCPS; LSS Yellow BeltTexas Health Presbyterian Dallas
Objectives Define different quality improvement models and methodsto incorporate evidence-based medicine in the intensive careunit Discuss the most recent iteration of the pain, agitation,delirium, immobility, and sleep guidelines Review implementation of analgo-sedation protocol in themedical ICU to illustrate transformation of guidelines toclinical practice
Audience Survey Students? Residents? Clinical? Administration? Techs? Medical ICU? Surgical? Mixed? Trauma? Have worked on implementing new practice to your practice Have read a neat new RCT in a big journal that you thoughtyou needed to implement in your hospital
What is “Evidence-Based” Practice Thoughtful use of current best available evidence in decision-making Individual case-based Broader delivery of care Supported by varying levels of evidence R, DB, PC, multicentered huge trial Retrospective, single-center studies Expert/Personal opinions Meta-analyses Straightforward, specific treatments vs. highly complex issues on someof our sickest, most vulnerable patients Ex: Universal decolonization with mupirocin/CHG vs. Low-tidal volumeventilation for ARDSQuality Management in Intensive Care: A Practical Guide; Huang, et al. NEJM2013; ARDSNet NEJM 2000
Clinical Practice Guidelines Accumulation of the best practices, current evidence “Provide a current and transparently analyzed review of therelevant research with the aim to guide clinical practice” – 2018PADIS Guidelines “The goal of these clinical practice guidelines is to recommend bestpractice for managing PAD to improve clinical outcomes in adultICU patients.” - 2013 PAD guidelines Guidelines are not cookbooks Ex: DKA/HHS treatment 80 / 20 rule? There will ALWAYS be exceptions to guidelines because patientsare not uniformDevlin J, et al. Crit Care Med 2018; Barr J, et al. Crit Care Med 2013
Ease of Implementing EBP Quality of evidence and impact on patients Was this a RCT? Is the outcome significant? Example: Improved oxygenation vs. improved survival How similar is my institution and practice to the setting in the paper? Was study/trial in a MICU and you practice in CVICU? Is the nursing staff and resources similar to your institution? Example: “No sedation” protocol in ICU – nursing ratio was 1:1 or, ifneeded, an additional HCW could help watch patient Implementation science Field of study dedicated to understanding facilitators and barriers toadopting EBPStrom, et al. Lancet 2010; Weiss CH Curr Opin Crit Care 2017
ARDS Example High quality data demonstrate that low tidal volume ventilationimproves ARDS mortality Given a strong recommendation by clinical practice guidelines Implementation of intervention has been as low at 19% in somepractices WHY? Multiple barriers to implementation Under-recognition of disease statePhysicians not wanting to give up control of ventPerception of contraindicationsEtc. Implementation science has some recommendations on frameworkfor assessing barriersWeiss CH. Curr Opin Crit Care 2017.
Methods for Implementing Change Should think of any change as a process / quality improvementproject ICU care is very interconnected – multiple disciplines anddepartments may be affected by change What worked well in a RCT may not work well in your practice site,especially if there are multiple interventions Ex: ABCDE bundles, sepsis bundles, etc. Consider your implementation a small, pragmatic research study! Different methods for looking at change implementation Step 1 should ALWAYS be to PLAN! Should involve as many of the disciplines as possible Ex: Changing your sedation protocol will influence pharmacy, nursing,physicians .but also RT, PT/OT, nutrition, etc.
Give me six hours to chop down a tree and I will spend the first foursharpening the axe – Abraham Lincoln
Plan, Do, Study, Act Model One method endorsed by AHRQ Plan: What are root causes? Experiment by changing a root cause / conditionStudy: What is the problem?Who can help fix / be affected by change?What data are we going to collect along the way?Do: We LOVE to fix things in ICU care – resist the urge to jump toconclusionsWhat happened when we implemented change? Why?Act: What do we need to change / improve on?
Lean Six Sigma Methods Lean: Relates to the relentless elimination of waste Six Sigma: Relates to elimination of defects / variations in processes that mayresult in undesirable outcomes Many six sigma tools are applicable to implementation of newpractices and evidence based medicine DMAIC (define, measure, analyze, improve, and control) is one tool Too often we go from “there’s a problem/opportunity, let’s implementthis solution” Avoid Cobra Effects!!
Example: Antibiotics in Sepsis “Septic patients in our hospital never get their antibiotics ontime” Some tools to consider: Define the problem and the goal Example: X% of patients get antibiotics within 1 hour now. Ourgoal is to increase this to Y %. Figure out what the process currently is and where the hang upsare Value stream mapping, asking “5 why’s,” Ishikawa diagrams, etc. When you do implement, how are you going to measure andthen sustain the gain?
PADIS Guideline Review
PADIS in 2018 – A very general overview! Pain is first – it should be treated first Opioids remain treatment of choice Management of pain for adult ICU patients should be guided by routinepain assessment and pain should be treated before a sedative agent isconsidered (THD paper included in references) Ask the patient (awake and interactive patients are, generally, a good thing!)Use objective scores when patients cannot report When indicated, use a sedative agent Keep sedation light (when possible) and be objective Minimize benzos (don’t completely eliminate) Especially continuous infusion benzodiazepines, which have been shown toincrease ventilator duration, delirium, etc.Benzos are still acceptable for acute agitation and effect of intermittent use isn’twell known Propofol or dexmedetomidine preferred
PADIS in 2018 – A very general overview! Delirium Is bad – we think Lots of conflicting evidence about both short and long term effects No “magic bullets” for treatment or prevention Multicomponent, nonpharmacological management might be helpful Immobility Get patients moving – either walking on the vent or at least range ofmotion / PT / OT exercises Sleep The ICU is not a great place to get good sleep Implement a sleep-promotion protocol? Likely expanding area of research for sleep hygiene / sleep maintenanceDevlin JW, et al. Crit Care Med 2018
General principles of sedation Use the least amount of analgesia/sedation as is safe for the patient Patients can be on limited/no meds and be totally fine! Analgesia should always be given first Pain is exceedingly common in ICU Usual goal is RASS 0 to -2 If targeting -3 to -5, usually need analgesia sedation If paralyzing, get to RASS -4 to -5 BEFORE paralysis
Risks of Oversedation Shehabi et al. (2012 AJRCCM) Observational cohort study from 25 ICUs in AU/NZ for 3months Patients vented 24 hours RASS q 4 hours with -2 to 1 considered light sedation Compared “light” vs. “deeper sedation” over first 48 hoursShehabiY, et al. AJRCCM 2012; 186: 724
Risks of Oversedation, cont. Shehabi, et al. (cont) 68% of patients during first 48 hours in deep sedation group Of total 2,656 RASS assessments in first 48 hr 62% deep sedation 35.5% light sedation 2.5% agitated Every add’l RASS assessment in “deep” group over first 48hrs Delayed extubation by 12 hrs Inc risk of hospital-assoc death 10% Incr risk of 6 mos death 8%
Time to extubationMortality
Risks of Oversedation, cont. Shehabi, et al. (2013 Intens Care Med) Same authors as prior study (SPICE group) Performed in 11 Malaysian ICUs Similar results to prior study Significantly longer time to extubate 3.95 vs. 6.69 days (P 0.008) Significantly higher risk of death at 6 months HR 1.09; 95% CI, 1.04-1.15 Significantly higher risk of death in hospitalShehabi, et al. Intensive Care Med 2013; 39: 910
Oversedation is Common Survey of 13,000 U.S. intensivists 64% used a sedation protocol 40% employed daily sedation interruption Not any better in Canada Many patients experience oversedation Up to 60% in literature Assoc w/ ADRs, inc LOS and time on vent Protocols to target lighter sedation reduce chance for oversedationTanios et al. J Crit Care 2009; 24: 66Jackson et al. Crit Care 2010; 14: R59
Analgesia/Sedation Goals Be objective! Goal should be “RASS X to Y” not “comfortable” or “pain-free” Weinert and Calvin (2007) 274 MICU/SICU patients on ventilator 32% were minimally arousable/unarousable w/ objective tool (i.e., RASS -4 to -5) 3% of nurses subjectively judged patients to be oversedated Most patients should be RASS 0 to -2 Times for heavier sedation: Paralysis, therapeutic hypothermia, high vent needs, seizures, etc. Since pain is a common source of agitation, should address RASS first and then pain Example: RASS is 0 on fentanyl 75 mcg/hour. Patient should then be assessed for painWeinert, Calvin. Crit Care Med 2007; 35:393
Sedation Scales RASS (Richmond Agitation Sedation Scale) Runs from 4 to -5 Positive numbers agitation ( 4 violent, dangerous to self) Negative numbers sedated (-5 comatose) Goal is usually 0 to -2 SAS (Sedation-Agitation Scale) Runs from 1 to 7 4 is calm/cooperative 7 is dangerous/combative 1 is comatose Any other sedation scale has a lower level of validity and isgenerally not recommended in ICU care
Pain Assessments Best way is to ask the patients Numeric rating scales are best VAS or FACES is a little less validated Even patients on the ventilator can communicate needs!! Family members may serve as proxies If patient unable to participate in care, can use CPOT or BPSto objectively score patients
Achieving Your Goal Start with analgesia Concept is known as “Analgo-Sedation” Realize that just about EVERYTHING done to an ICU patient ispainful Intubation/ET tube Suctioning Lines and Catheters ABGs and Lab Draws Anticipate and pre-medicate prior to painful procedures Ex: Patient getting tPA in chest tube
Pain Commonly experienced in ICU 82% of patients report pain w/ ET tube 77% of patients remember mod-severe pain during ICU Common cause of agitation Poor pain control is a common cause of delirium and long-term PTSD Vital signs should not be used to assess pain Can use a validated tool such as Critical Care Pain ObservationTool (CPOT)Barr et al. CCM 201326
Analgesic Choices IV narcotics are considered first-line All available narcotics are considered equal when given atsimilar potency doses Morphine may not be a great option Low potency Worse pain control More delirium More hypoTN Consider addition of non-opioid drug Acetaminophen, ibuprofen, ketamine27
Analgesic Selection Fentanyl ( 100x more potent than morphine) Assoc with less histamine release less hypoTN Metabolized in liver to inactive metabolites Essentially equivalent to remifentanil Hydromorphone ( 5x more potent than morphine) Likely less hypoTN vs. morphine Less accumulation vs. morphine Morphine Most hypoTN Assoc with increased delirium
What About Sedatives? Sedatives should be used after analgesia addressed, if RASSstill above goal So give fentanyl/hydromorphone before lorazepam/propofol Sedatives are still acceptable for acute, dangerous agitation Threatening self-extubation Sedatives should be used intermittently first, then as acontinuous infusion Accumulation of drugs as CI
Paralytics Use sparingly and only when no other option Refractory hypoxia, difficult to ventilate, shivering, open abdominal wound,etc. NEVER, EVER start a paralytic on a non-sedated patient Impossible to do proper RASS assessment on a paralyzed patient ALWAYS sedate to a RASS -4 to -5 before going down paralytic trail Ideally, should be on fentanyl either propofol or midazolam infusion Once you get to RASS -4 to -5 and still need paralytic, then leave drip ratesalone for duration of paralysis Wean paralytic FIRST, then sedative/analgesia
Weaning Sedation Goal should be least amount of analgesia/sedation as possible In patients with RASS at goal (i.e., RASS 0 to -2), should try to weandown continuous infusion sedation at least q shift For sedation vacations: Refer to unit guidelines on sedation vacations Wean sedatives first, then anaglesia, for goal RASS 0 to 1 Each agent has some general guidelines for weaning Ex: Fentanyl rate 100 mcg/hour – turn off; Rate / 100 mcg/hour –decrease rate by 50% until 50 mcg/hour or less, then turn off Can extubate on certain meds – mostly dexmedetomidine, butoccasionally benzos or analgesics
THD’s Analgosedation Practice Practice changed in 2012 ICU ACM group ACM accountable clinical management Financial incentives to physician group One of the group’s metrics was to implement a new sedation protocol Anticipation of the “soon to be released” SCCM guidelines Increasing interest in using analgesia-first practice Analgesia was mentioned in the prior guidelines (2002) Lots of talk amongst critical care groups and review papers Increasing recognition that our propofol-first attitude was NOTtreating pain .which is exceedingly common And growing tired of the “which sedative is best?” debates when painmanagement may have been the key!Devabhakthuni S, et al. Ann Pharmacother 2012
Planning Multidisciplinary team Lead by clinical pharmacists Included physicians and nursing Reviewed other hospitals protocols, guidelines, review papers, andprimary literature How much of this would apply to a 24 bed MICU at a communityteaching hospital with one group of intensivists? Assessed what current practices already were Already using RASS and CPOT Not great about treating pain (few patients getting continuousinfusion analgesics) Knew we wanted to study this as a process improvement project Used pharmacy resident resources
Planning LOTS of nursing education Planned inservices On-the-fly huddles Newletters (bathrooms work great!) LOTS of physician education Tried to anticipate barriers “Isn’t it bad that patients are more awake?! That seems mean!” Access to medication Went to pre-mixed, outsourced fentanyl bags to load in PYXIS Toyed with the idea of narcotic boxes in the rooms IT / EHR support
Do Implemented in late 2012 Emphasized early, aggressive treatment of pain withintermittent and, if needed, continuous fentanyl Minimized sedation Preferred drug was intermittent benzodiazepine followed bycontinuous propofol RASS goal, daily awakenings/sedation vacation, andventilator weaning guidelines unchanged
Study / Act During implementation period, held weekly meetings Looking at accidental extubations, complications, success stories, barriers, etc. Continually looking to improve process Nursing questionnaire sent to address knowledge deficits but also concerns Quickly learned that bedside RTs were a vital part of our group that we’domitted from planning Ventilator and tubing positioning were changed to prevent inadvertentventilator disconnection Practices of taping ETT were addressed Physical restraints were addressed More use of mittens LOTS of early wins Patients communicating needs with iPads, computers, message boards, etc.
Results Retrospective, pragmatic study in MICU Applicability to SICU, CVICU, etc.? 65 patients in propofol-based protocol (2011 group) vs. 79 patientsin fentanyl-based protocol (2013 group) More male patients in 2011 group Duration of MV reduced with fentanyl-based protocol 138 .3 /- 132.6 vs. 92.9 /- 73.3 hours Difference of 26.6 hours (95% CI, 44.98 to 8.26) in linear regression Lighter sedation and better pain control with fentanyl-basedprotocolFaust AC, et al. Anesth Anal 2016; 123: 903-909.
Medication Use in Study Fentanyl use went up Sedative use Per patient: 1436.2 mcg fent equivalents vs. 7516.8 mcg (p 0.001)Propofol: Per patient: 14,192.3 mg vs. 1503.2 mg (p 0.001)Other sedatives stayed about the sameUse of continuous infusion of any sedative: 92.3% vs. 38.0% (p 0.001)Drug costs decreased 225 per patient
Application of EBP / Guidelines Nowhere in the guidelines does it say exactly how to manage your ICUpatients Realize that you cannot treat every inevitability with a protocol or order set Zebras DO exist Work as a group to come up with your own best practice based onavailable evidence If you are not cohesive in your approach, even the best evidence and bestpractices WILL LIKELY FAIL! Look at implementation of EBP and clinical guidelines as QI/PI projects Texas SCCM is a great place to share your successes and lessons learned Anticipate problems and try to mitigate unintended consequences
THANK YOU!! Andrewfaust@texashealth.org
Clinical Practice Guidelines Accumulation of the best practices, current evidence "Provide a current and transparently analyzed review of the relevant research with the aim to guide clinical practice" -2018 PADIS Guidelines "The goal of these clinical practice guidelines is to recommend best practice for managing PAD to improve clinical outcomes in adult
pain”, “more pain” and “the most pain possible”. Slightly older children can also say how much they are hurting by rating their pain on a 0-10 (or 0-100) scale. Zero is no pain and 10 (or 100) is the worst possible pain. What a child is doing Often children show their pain by crying, making a “pain” face, or by holding or rubbing .
Short-term pain, such as when you suffer a sprained ankle, is called 'acute' pain. Long-term pain, such as back pain that persists for months or years, is called 'chronic' pain. Pain that comes and goes, like a headache, is called 'recurrent' pain. It is not unusual to have more than one sort of pain or to have pain in several places
General discussions of pain often refer simply to three types: 1) Acute (brief that subsides as healing takes place) 2) Cancer 3) Chronic non-malignant pain - "persistent pain" Classification of pain by inferred pathology: 1) Nociceptive Pain 2) Neuropathic Pain (McCaffery & Pasero, 1999) Nociceptive Pain A. Somatic Pain B. Visceral Pain
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based recommendations for management of postopera-tive pain. The target audience is all clinicians who manage postoperative pain. Management of chronic pain, acute nonsurgical pain, dental pain, trauma pain, and periprocedural (nonsurgical) pain are outside the scope of this guideline. Evidence Rev
severe pain. Treatment of acute pain When assessing a patient with acute pain, the nurse should consider: The patient's report of pain or observation of pain (such as the number on a 1 to 10 scale). The patient's functional ability. The patient's level of consciousness. The site of pain and the cause.
Overview of Essentials of Pain Management 1. Assess pain intensity on a 0 ‐10 scale in which 0 no pain at all and 10 the worst pain imaginable. Determine if the pain is mild (1‐4), moderate (5‐6), or severe (7‐10). 3. Assess the character of the patient’s pain and determine whether it is nociceptive, neuropathic, or both.
chronic pain. Musculoskeletal pain, particularly related to joints and the back, is the most common type of chronic . pain. 2,8. This systematic review thus focuses on five of the most common causes of musculoskeletal pain: chronic low back pain, chronic neck pain, osteoarthritis, fibromyalgia and chronic tension headache. Rationale for This .
