Peak Expiratory Flow Rate (PEFR) for ED Management of Acute Asthma Exacerbation PI: Brian Driver, MD Checklist Reviewed Inclusion and Exclusion Criteria Confirm pertinent exclusion criteria with PMP Engage in consent discussion with patient (and PMP). Ensure he/she is willing to discuss health status in about 3 days. Entered patient information into electronic REDCap Screening and Enrollment Log (Coordinators will assign subject number later) Date of Enrollment - - REDCap Screening ID: Subject Number (Assigned by Coordinator): RA Name(s) Patient Label Here Chief complaint: Inclusion Criteria: Presumed diagnosis of asthma Presenting with asthma exacerbation Enrolled within 15 minutes of first nebulizer treatment or of arrival if given nebulizers by EMS Working phone number and willing to be called in 3 days Patients is between the ages of 16 and 55 Exclusion Criteria: Prisoner or in custody Pregnant Diagnosis of COPD Being treated for a co-morbid condition No longer need asthma treatment Non-English speaking Unable to provide informed consent In the stabilization room or on bi-pap HSR# 17-4459 Updated January 17, 2018
Patient Label Here Peak Expiratory Flow Rate (PEFR) for ED Management of Acute Asthma Exacerbation: A Randomized-Controlled Trial Primary Data Collection Worksheet Screening Criteria Inclusion Criteria All answers should be yes for enrolled subjects. 1. Presenting to the ED with acute asthma exacerbation* Yes No *Defined as progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combination of these symptoms 2. Enrollment within 15 minutes of first nebulizer treatment or arrival if given pre-hospital nebulizer treatments by EMS Yes No 3. Working phone number or email address and willing to discuss health status in 72 hours (3 days) via phone or email Yes No 4. Patient is between the ages of 16 and 55 Yes No Exclusion Criteria All answers should be no for enrolled subjects. 1. Received pre-hospital nebs and no longer requires treatment Yes No 2. COPD diagnosis (ask patient) Yes No 3. Non-English speaking Yes No 4. Altered mental status or encephalopathy Yes No 5. Critically ill, as determined by the treating physician (including use of BiPAP) Yes No 6. Unable to provide informed consent Yes No 7. Prisoner or in custody Yes No 8. Pregnant woman (ask patient Yes No Enrollment Is the patient eligible to be enrolled? Yes No If yes, of Randomization (real time, 24-hour clock) : Date of Randomization (MM/DD/YYYY) / / Patient s phone number: ( ) - Randomization Envelope Subject ID: Treatment Assignment (circle one): Patient s email address: Patient s height: ft in Randomization label here PEFR guided therapy Non-PEFR guided therapy Page 1 of 8
Baseline Information: Obtain via EPIC and asking patient, may have to complete near the end of encounter or when patient is more comfortable. 1. Age: 2. Gender: M F 3. Chief Complaint(s) on EPIC: Shortness of breath Dyspnea Cough Wheezing Chest pain URI Other: 4. Race, ask patient: Asian Black/African American Hispanic Native American White/Caucasian Other: 5. Classification of asthma severity: (circle one for each question)- a. Prior to this asthma attack, how often do you have symptoms of asthma? < 2 days/week > 2 days/week daily throughout the day b. Prior to this asthma attack, how often do you have nighttime awakenings due to asthma? < 2x/month 3-4x/month >1x/week nightly c. Prior to this asthma attack, how often do you use your rescue inhaler (SABA) for symptom control? < 2 days/week > 2 days/week daily several times per day d. Prior to this asthma attack, how much does your asthma interfere with your daily activities? none minor limitation some limitation extreme limitation e. How many asthma exacerbations requiring oral steroids have you had over the last year? Page 2 of 8
Data Collection Initial Presentation: Page 3 of 8 Obtain peak flow reading, take two readings and record the higher value: ***Find expected PEF (L/min) using age, height and sex on the back of this packet*** : Peak Expiratory Flow = % measured expected Adequate Effort (Y/N) Patient Position (Sitting/standing/laying) Obtain vital signs from monitor: HR RR SpO2 **For vital signs: please place pulse oximeter on patient and record HR, RR and SpO2, you don t need the nurse Is the patient on oxygen? Yes- nasal cannula or Yes- non-rebreather or No Ask patient: 1. Please rate the severity of your asthma right now: Fill out asthma evaluation sheet and hand to PMP, include peak flow results if in the peak flow group Ask PMP: 1. Is there wheezing present on exam? or Not assessed 2. Will the patient be admitted to the hospital? or Pending Clinical Course Re-assessment #1 (30 mins after initial +/- 5 mins): Obtain peak flow reading, take two readings and record the higher value: ***Find expected PEF (L/min) using age, height and sex on the back of this packet*** Adequate Peak Expiratory Flow Patient Position Effort (Y/N) (Sitting/standing/laying) : = % measured expected Obtain vital signs from monitor: HR RR SpO2 Is the patient on oxygen? Yes- nasal cannula or Yes- non-rebreather or No Ask patient: 1. Please rate the severity of your asthma right now: 2. For non-pefr group only: Would you like more nebulized treatments? 3. Do you feel your asthma symptoms have improved to the point you are ready to go home? Fill out asthma evaluation sheet and hand to PMP, include peak flow results if in the peak flow group Ask PMP: 1. Is there wheezing present on exam? or Not assessed 2. Will the patient be admitted to the hospital? or Pending Clinical Course Study is complete when patient meets criteria below (circle one if complete): None or mild symptoms Decision to Admit Patient is discharged **Note: if patient starts the study with mild symptoms, continue the study until they report none**
Re-assessment #2 (60 mins after initial +/- 5 mins): Page 4 of 8 Obtain peak flow reading, take two readings and record the higher value: Adequate Peak Expiratory Flow Patient Position Effort (Y/N) (Sitting/standing/laying) : Obtain vital signs from monitor: HR RR SpO2 Is the patient on oxygen? Yes- nasal cannula or Yes- non-rebreather or No Ask patient: 1. Please rate the severity of your asthma right now: 2. For non-pefr group only: Would you like more nebulized treatments? 3. Do you feel your asthma symptoms have improved to the point you are ready to go home? Fill out asthma evaluation sheet and hand to PMP, include peak flow results if in the peak flow group Ask PMP: 1. Is there wheezing present on exam? or Not assessed 2. Will the patient be admitted to the hospital? or Pending Clinical Course Study is complete when patient meets criteria below (circle one if complete): Re-assessment #3 (90 mins after initial +/- 5 mins): Obtain peak flow reading, take two readings and record the higher value: : = % measured expected Peak Expiratory Flow = % measured expected Adequate Effort (Y/N) Patient Position (Sitting/standing/laying) Obtain vital signs from monitor: HR RR SpO2 Is the patient on oxygen? Yes- nasal cannula or Yes- non-rebreather or No Ask patient: 1. Please rate the severity of your asthma right now: 2. For non-pefr group only: Would you like more nebulized treatments? 3. Do you feel your asthma symptoms have improved to the point you are ready to go home? Fill out asthma evaluation sheet and hand to PMP, include peak flow results if in the peak flow group Ask PMP: 1. Is there wheezing present on exam? or Not assessed 2. Will the patient be admitted to the hospital? or Pending Clinical Course Study is complete when patient meets criteria below (circle one if complete):
Re-assessment #4 (120 mins after initial +/- 5 mins): Obtain peak flow reading, take two readings and record the higher value: Adequate Patient Position Peak Expiratory Flow Effort (Y/N) (Sitting/standing/laying) : Obtain vital signs from monitor: HR RR SpO2 Is the patient on oxygen? Yes- nasal cannula or Yes- non-rebreather or No Ask patient: 1. Please rate the severity of your asthma right now: 2. For non-pefr group only: Would you like more nebulized treatments? 3. Do you feel your asthma symptoms have improved to the point you are ready to go home? Fill out asthma evaluation sheet and hand to PMP, include peak flow results if in the peak flow group Ask PMP: 1. Is there wheezing present on exam? or Not assessed 2. Will the patient be admitted to the hospital? or Pending Clinical Course Study is complete when patient meets criteria below (circle one if complete): Re-assessment #5 (150 mins after initial +/- 5 mins): Obtain peak flow reading, take two readings and record the higher value: : = % measured expected Peak Expiratory Flow = % measured expected Adequate Effort (Y/N) Patient Position (Sitting/standing/laying) Obtain vital signs from monitor: HR RR SpO2 Is the patient on oxygen? Yes- nasal cannula or Yes- non-rebreather or No Ask patient: 1. Please rate the severity of your asthma right now: 2. For non-pefr group only: Would you like more nebulized treatments? 3. Do you feel your asthma symptoms have improved to the point you are ready to go home? Fill out asthma evaluation sheet and hand to PMP, include peak flow results if in the peak flow group Ask PMP: 1. Is there wheezing present on exam? or Not assessed 2. Will the patient be admitted to the hospital? or Pending Clinical Course Study is complete when patient meets criteria below (circle one if complete): Page 5 of 8
Re-assessment #6 (30 mins later): or Pending Clinical Course 3. Study is complete when patient meets criteria below (circle one if complete): Re-assessment #7 (30 mins later): or Pending Clinical Course 3. Study is complete when patient meets criteria below (circle one if complete): Re-assessment #8 (30 mins later): or Pending Clinical Course 3. Study is complete when patient meets criteria below (circle one if complete): Re-assessment #9 (30 mins later): or Pending Clinical Course 3. Study is complete when patient meets criteria below (circle one if complete): Page 6 of 8
Re-assessment #10 (30 mins later): or Pending Clinical Course 3. Study is complete when patient meets criteria below (circle one if complete): Re-assessment #11 (30 mins later): or Pending Clinical Course 3. Study is complete when patient meets criteria below (circle one if complete): Re-assessment #12 (30 mins later): or Pending Clinical Course 3. Study is complete regardless of patient status. Have PMP fill out discharge/admission questions. Discharge/Admission: 1. Was the PMP or any other team member given peak flow results during the course of the encounter? 2. Were there any protocol deviations during the course of the study? If yes, describe: Page 7 of 8
Peak Expiratory Flow (PEF) Calculation Chart ***Round patient s age and height to nearest value*** Page 8 of 8
Asthma Peak Flow PMP Data Collection Sheet (PMP to fill out) PMP name: *** RVs, do not forget to also fill out Discharge/Admit questions*** 1. Baseline Outpatient therapy, check all that apply: Common Short-acting beta-agonist SABA inhaler PRN (albuterol, levalbuterol) Inhaled corticosteroid- ICS (budesonide, fluticasone, beclomethasone) Combination ICS + LABA (Advair, Symbicort, Dulera) Less Common Systemic corticosteroids (predisone, methylprednisone) Long- acting beta-antagonist- LABA ( formoterol, salmeterol, indacaterol, arformoterol) Antileukotriene (montelukast, zafirlukast, zileuton) Other: 2. Did this patient receive any prehospital treatments? If so, list treatments: 3. Treatment plan: Is the patient being admitted to the hospital? If admitted, reason for admission: If discharged, plan for follow-up: 4. At the time of discharge/admission, is wheezing present on exam? 5. What discharge prescriptions for asthma were ordered from the ED? Common Short-acting beta-agonists (albuterol, levalbuterol) Systemic corticosteroids (prednisone, methylprednisone) Inhaled corticosteroid- ICS (budesonide, fluticasone, beclomethasone) dose: Less Common Combination ICS + LABA (Advair, Symbicort, Dulera) Long- acting beta-antagonist- LABA ( formoterol, salmeterol, indacaterol, arformoterol) Antileukotriene (montelukast, zafirlukast, zileuton) Other: Version Date: January 9, 2018 Page 1 of 1
RV Discharge/Admission: 1. Was the PMP or any other team member given peak flow results during the course of the encounter? 2. Were there any protocol deviations during the course of the study? If yes, describe: Version Date: January 9, 2018 Page 1 of 1
PMP: Peak Flow Results for PMP ***Only for patients randomized to peak flow guided group*** Room Number: Patient label here Reassessment Peak Expiratory Flow (%) Guideline Recommendation (Green/Yellow/ Red) Adequate Effort? (Y/N) Patient Position (laying/sitting/ standing) Initial #1 #2 #3 #4 #5 National Asthma Education and Prevention Program Guidelines PEF 70% = Good Response: Sustained 60 mins, normal exam, no distress Discharge Home: Continue inhaled SABA, course of oral systemic corticosteroids, consider ICS, patient education PEF 40-69% = Incomplete Response: mild to moderate symptoms, use clinician discretion Admit to Hospital: oxygen, inhaled SABA, systemic corticosteroid, adjunct therapies, monitor vitals PEF < 40% = Poor Response: severe symptoms, drowsy, confused, pco2 42 Admit to ICU: oxygen, inhaled SABA hourly or continuously, IV corticosteroid, adjunct therapies, possible intubation/ventilation Page 1 of 1
PMP: Room Number: Asthma Evaluation ***Only for patients randomized to non-peak flow guided group*** Patient label here Reassessment Patient s rating of their asthma severity (none/mild/ moderate/severe) Does the patient request additional nebs Does the patient feel ready for discharge Initial n/a n/a #1 #2 #3 #4 #5 Page 1 of 1