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MARC30: Bronchiolitis

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15 North American hospitals. 2,250 patients age 2 years with bronchiolitis: ... Patients with insurmountable language barriers are excluded ... – PowerPoint PPT presentation

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Title: MARC30: Bronchiolitis


1
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

2
NIAID
3
(No Transcript)
4
Outline of Presentation
  • Overview of MARC-30
  • Inclusion/exclusion criteria
  • Forms and examples
  • NPA specimen collection

5
Outline of Presentation
  • Overview of MARC-30
  • Inclusion/exclusion criteria
  • Forms and examples
  • NPA specimen collection

6
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

7
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

8
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)
9
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
10
Outline of Presentation
  • Overview of MARC-30
  • Inclusion/exclusion criteria
  • Forms and examples
  • NPA specimen collection

11
Inclusion Criteria
  • Physician diagnosis of bronchiolitis
  • Age lt2 years
  • Parental ability to give informed consent

12
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

13
Language Barriers
  • Patients with insurmountable language barriers
    are excluded
  • No interview, but complete Missed Case Form and
    include in registry
  • Spanish translations as tools

14
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

15
Outline of Presentation
  • Overview of MARC-30
  • Inclusion/exclusion criteria
  • Forms and examples
  • NPA specimen collection

16
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

17
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)

18
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

19
Visit Form
  • Complete Visit Form for all eligible patients
  • Ask the parent questions 10 - 47
  • Questions 48 - 71 are chart review

20
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

21
Other Points of Interest (cont.)
Ask for multiple follow-up phone numbers!
22
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)

23
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.

24
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

25
Other Points of Interest
  • Vital sign trends
  • Retractions (Q17)
  • Today?
  • None
  • Compared to yesterday?
  • Improved Worsened Stable

26
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).

27
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

28
Follow-up Form
  • Follow-up Form (1 Week)
  • Be careful of skip pattern for Q7

29
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

30
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)

31
Examples
3-digit site number then 3-digit patient number
Please delete name
32
Please delete MRN
33
Make sure all forms are accounted for
Record ICU Info
34
Missed cases are also recorded in the registry
35
Repeat Visits

Fill in all info through discharge date and then
enter in 8s in all other cells
36
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

37
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

38
Web-Based Data Entry
  • Logging In
  • How to Navigate
  • Error Messages
  • How to Save / Send Forms

39
Website/Logging In
40
(No Transcript)
41
(No Transcript)
42
(No Transcript)
43
(No Transcript)
44
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.

45
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

46
Sending Data (cont.)
  • Send materials to
  • Ashley Sullivan, MPH, MS
  • Emergency Medicine Network
  • Massachusetts General Hospital
  • 326 Cambridge Street, Suite 410
  • Boston, MA 02114

47
Outline of Presentation
  • Overview of MARC-30
  • Inclusion/exclusion criteria
  • Forms and examples
  • NPA specimen collection

48
Overview
  • All subjects enrolled in the study require the
    collection of a nasopharyngeal aspirate (NPA)
    specimen
  • All specimens shipped to Baylor College of
    Medicine

49
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

50
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

51
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

52
Labeling the Visit Form
Sample ID 011 301 Date _______ Time ____
12/01/09 0523
Sample Visit Form NPA Label
53
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
54
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

55
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

56
NPA Shipping
Only lab personnel certified in preparing
diagnostic shipments, according to the IATA
guidelines, should package and ship the specimens!
57
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
58
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 713-798-8339
  • Only ship specimens Mon, Tue, or Wed!

59
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

60
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

61
Manuscripts by Site PIs (cont.)
http//www.emnet-usa.org/coordinating_center/SAPF.
cfm
62
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

63
Questions?
64
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
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