MARC30: Bronchiolitis

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MARC-30 Bronchiolitis

• Carlos Camargo, MD, DrPH
• Ashley Sullivan, MPH (Project Director)
• Massachusetts General Hospital, Boston, MA
• Jonathan Mansbach, MD
• Childrens Hospital, Boston, MA
• Tony Piedra, MD
• Baylor College of Medicine, Houston, TX

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NIAID
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Outline of Presentation

• Overview of MARC-30
• Inclusion/exclusion criteria
• Forms and examples
• NPA specimen collection

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Outline of Presentation

• Overview of MARC-30
• Inclusion/exclusion criteria
• Forms and examples
• NPA specimen collection

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Objectives

• To elucidate the role of multiple (versus single)
  pathogen infections in bronchiolitis
• Determine the utility of PCR-testing for an
  infectious etiology
• To create clinical rules to predict reliably
  those children who require CPAP or intubation
• To develop/test a hospital discharge guideline
  that encourages earlier, but safe, discharges and
  that fosters family-centered care

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Overview

• 15 North American hospitals
• 2,250 patients age lt2 years with bronchiolitis
• Over the enrollment period (November to March),
  each site is expected to enroll, perform chart
  review and follow-up for at least 6-8 ward
  patients 2-4 ICU patients each month
• of ICU patients minimum of 2 with a flexible
  cap of 4 per month

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Hospitalized Child
Consent
No Consent (Refusal short admit)
Visit Form (NPA)
Repeat Visit (no forms)
Provider Form
MC Form
Daily Inpatient Form(s)
Follow-up Form
Registry
EMNet Coordinating Center (send all data
registry Excel file)
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Study Design
Time Form(s) Hospital Visit Consent
Form Provider Form Visit Form or MC
Form Daily Inpatient Form 1 week
post-visit Follow-up Form Ongoing Excel
Registry April Registry Form
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Outline of Presentation

• Overview of MARC-30
• Inclusion/exclusion criteria
• Forms and examples
• NPA specimen collection

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Inclusion Criteria

• Physician diagnosis of bronchiolitis
• Age lt2 years
• Parental ability to give informed consent

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Exclusion Criteria

• Interviewed for bronchiolitis study during an
  earlier visit
• Parents do not agree to the collection of the NPA
  specimen or to possible future use of the
  specimen
• Patient transferred to your hospital gt48 hours
  after the time of admission at another hospital

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Language Barriers

• Patients with insurmountable language barriers
  are excluded
• No interview, but complete Missed Case Form and
  include in registry
• Spanish translations as tools

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Subject Enrollment

• Monthly enrollment goals
• 8-11 ward patients
• 2-4 ICU patients
• If there are eligible subjects in both the
  hospital ward and ICU, enroll the ICU patient

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Outline of Presentation

• Overview of MARC-30
• Inclusion/exclusion criteria
• Forms and examples
• NPA specimen collection

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Completing Forms

• Coding
• 1 yes
• 0 no
• 8 when Q does not apply
• 9 when response is missing
• When interviewing patients, please read questions
  as written
• Follow skip patterns carefully

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MARC-30 Forms

• MC Form
• Follow-up Form
• Registry (Excel)
• Registry Form
• Letter to Parents and
• PCP

• Consent Form
• Visit Form
• Provider Form
• Daily Inpatient Form(s)

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Consent Form

• Obtain consent from parent/guardian (All consent
  forms used should have the IRB stamp of approval)
• If consent Complete Provider Form and interview
  portion of Visit Form
• If no consent Complete Missed Case (MC) Form
• Parent must be interviewed within 18 hours of the
  patients arrival on the medical floor

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Visit Form

• Complete Visit Form for all eligible patients
• Ask the parent questions 10 - 47
• Questions 48 - 71 are chart review

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Points of Interest

• Q6-7
• Ethnicity and Race
• Q31
• Breastfeeding duration
• Q34
• Two-part eczema question please ask both
  questions
• Q46-47
• Results of virology testing sent to PCP and
  parent

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Other Points of Interest (cont.)
Ask for multiple follow-up phone numbers!
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Provider Form

• Interview the primary physician caring for the
  patient and family to answer these questions.
• Timing of the questions
• Pertussis questions - beginning of admission
• Factors that affect the decision to discharge -
  before discharge (if possible)

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Provider Form (cont.)

• For Pertussis, children stratified into groups
  based on the probability of infection (clinical,
  probable, and possible)
• If the child has clinical or probable B.
  pertussis infection
• Interviewer will notify clinical team
• Encourage team to send appropriate pertussis
  tests, begin treatment, and place the child on
  droplet precautions.

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Daily Inpatient Form(s)

• Completed daily
• Record hospital day number
• Example
• The child is admitted on 2/15/08 at 1110 and the
  form is completed on 2/16/08 at 0835. Enter 1
  as the hospital day number
• Official response to Q4-8 should be completed on
  final days form

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Other Points of Interest

• Vital sign trends
• Retractions (Q17)
• Today?
• None
• Compared to yesterday?
• Improved Worsened Stable

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Missed Case (MC) Form

• Used for otherwise eligible patients who are
  missed by study investigators
• Completed entirely by chart review (e.g. the
  patient was missed, no consent obtained).

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Follow-up Form

• 10-minute follow-up phone call with parent 1 week
  after hospital discharge (i.e., 8 to 14 days
  after hospital visit)
• Try calling at least 5 times over at least 3 days
• Always record attempted calls on the Follow-up
  Form

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Follow-up Form

• Follow-up Form (1 Week)
• Be careful of skip pattern for Q7

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Excel Registry

• Use an independent administrative source to
  complete the registry
• During the enrollment period, compile a list of
  all bronchiolitis visits for children lt2 years in
  the MARC-30 Registry
• This includes missed/refused cases and repeat
  visits, even though they will not be interviewed
  for the study

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Excel Registry

• Record the required information using the
  variable definitions given on the registry form
  (e.g. Sex 1. Male 2. Female)
• Record 1 (yes) for all for forms that were
  completed, 0 (no) if not completed (e.g. if visit
  form completed, vform 1)

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Examples
3-digit site number then 3-digit patient number
Please delete name
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Please delete MRN
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Make sure all forms are accounted for
Record ICU Info
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Missed cases are also recorded in the registry
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Repeat Visits

Fill in all info through discharge date and then
enter in 8s in all other cells
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Registry Form

• Different than the actual registry (Excel
  worksheet)
• Describes how to code the Bronchiolitis Registry
• Please calculate questions a-g at bottom of
  form when study complete

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Sending Data

• Data due the last day of the month following
  enrollment (all of these data are entered using
  web-based data entry)
• Visit Form
• Provider Form
• Daily Inpatient Form
• Follow-up Form
• Missed Case Form

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Web-Based Data Entry

• Logging In
• How to Navigate
• Error Messages
• How to Save / Send Forms

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Website/Logging In
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After Hitting Submit

• Please be sure to enter information carefully and
  SAVE frequently
• After you submit the forms changes can NO longer
  be made.
• You will be able to view all of the forms even
  after submission.

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Sending Data

• ALL data are due at the end of April
• Copy of IRB Approval Letter (as soon as
  available)
• Copy of one blank, approved consent form
• Please send the Excel Registry as an email
  attachment send the Registry Form via fax or
  mail

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Sending Data (cont.)

• Send materials to
• Ashley Sullivan, MPH, MS
• Emergency Medicine Network
• Massachusetts General Hospital
• 326 Cambridge Street, Suite 410
• Boston, MA 02114

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Outline of Presentation

• Overview of MARC-30
• Inclusion/exclusion criteria
• Forms and examples
• NPA specimen collection

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Overview

• All subjects enrolled in the study require the
  collection of a nasopharyngeal aspirate (NPA)
  specimen
• All specimens shipped to Baylor College of
  Medicine

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NPA Collection Kit

• Mucus trap
• Sterile container
• Three 5mL syringes
• One 10 mL cryovial
• Suction catheter (8 French tubing)
• Two normal saline bullets (5 mL NS solution pH
  7.0)
• Virus stabilizer (15 glycerol in Iscoves media)
• Labels Specimen NPA label, Visit Form NPA label
• Bio-hazardous ziploc bags

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NPA Collection

• Visit website (www.emnet-usa.org) for complete
  collection instructions (including the NPA
  collection video) and handling instructions
• Reminders
• All NPA specimens will be collected through the
  nose, even for children intubated or on CPAP. 
• Load both 5 ml syringes with exactly 2 mL of
  normal saline
• DO NOT start suctioning while catheter is going
  into the nostril
• Remove catheter with a swirling motion
• Rinse the suction catheter with saline solution
• Label Mucus trap and Visit form
• Write the NPA Sample ID number and collection
  date on the NPA Shipment List

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NPA Labeling

• NPA Sample ID will be pre-assigned and
  pre-printed on a NPA Sample Label.
• Write the collection date (mm/yr) and time
  (hhmm) on the NPA Sample Label
• On specimen - 1 NPA Sample Label
• On visit form - 1 NPA Sample Label with the same
  ID number

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Labeling the Visit Form
Sample ID 011 301 Date _______ Time ____
12/01/09 0523
Sample Visit Form NPA Label
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NPA Shipment List (after NPA collection)
0 1 1
11/01/09
0523
011 301
011 302
11/02/09
2256
11/04/09
1805
011 303
011 304
11/05/09
0331
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NPA Specimen Timeline

• Time Step(s)
• Hospital Visit Collection of NPA on ice
• lt1 hour post-collection Storage at 4ºC
• lt24 hours post-collection Storage at -80ºC
• Day of shipment NPA Shipment List
• Ongoing Excel Registry
• April Registry Form

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NPA Storage

• Immediately following collection, the nasal
  specimen must be transported, on ice, to a 4ºC
  refrigerator
• Always transport the specimen on ice
• Specimen must be transferred to -80ºC freezer no
  later than 24 hours after it is collected

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NPA Shipping
Only lab personnel certified in preparing
diagnostic shipments, according to the IATA
guidelines, should package and ship the specimens!
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NPA Shipment List (when packaging)
0 1 1
11/01/09
0523
?
011 301
?
2256
011 302
11/02/09
?
011 303
11/04/09
1805
011 304
?
11/05/09
0331
011 305
?
11/05/09
1019
?
011 306
1615
11/05/09
2359
?
011 307
11/06/09
0001
?
011 308
11/07/09
0736
?
11/07/09
011 309
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NPA Shipping (cont.)

• Specimens must be shipped (overnight) to
• Pedro A. Piedra, M.D.
• Attention Alan Jewell
• Baylor College of Medicine
• Department of Molecular Virology and
  Microbiology
• Mail stop code BCM 280, Room 248E
• One Baylor Plaza
• Houston, Texas 77030
• Lab Tel [phone]
• Only ship specimens Mon, Tue, or Wed!

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Stipend Information

• Each site will receive
• 125 per patient with completed Visit form and
  follow-up interview
• Sites will not be compensated for enrollment of
  subjects without Daily Inpatient Forms.
• If enrollment is complete, but one cannot reach
  the subject for follow-up, then sites will
  receive 75 per patient for their efforts

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Manuscripts by Site PIs

• Investigators are encouraged to publish
  manuscripts using MARC-30 data
• EMNet staff members provide
• data management
• statistical support
• scientific input
• editorial advice
• Check www.emnet-usa.org, Publications

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Manuscripts by Site PIs (cont.)
http//www.emnet-usa.org/coordinating_center/SAPF.
cfm
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Conclusion

• Detailed information on form completion can be
  found in the Manual of Procedures on the website
  www.emnet-usa.org
• If you have any questions, please contact
  617-724-9712

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Questions?
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Contact Info

• Emergency Medicine Network
• Massachusetts General Hospital
• 326 Cambridge Street, Suite 410
• Boston, MA 02114
• P 617-726-5276
• F 617-724-4050
• emnet_at_partners.org
• www.emnet-usa.org