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Asthma

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Definition of Asthma. Chronic lung disease characterized by: ... Severe persistent asthma. Inhaled corticosteroids (ICS) are 'preferred treatment' for all ... – PowerPoint PPT presentation

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Title: Asthma


1
(No Transcript)
2
Asthma
  • Leslie Boss (CDC)
  • Carlos Camargo
  • Denise Dougherty (AHRQ)
  • Virginia Taggart (NHLBI)
  • Sandra Wilson
  • With Special Thanks to
  • Barbara DeVinney (NIH/OD)
  • Lawrence Fine (NIH/OD)

3
Outline of Presentation
  • Background
  • Measures
  • Design 1
  • Design 2
  • Trade-offs ? Discussion


4
Definition of Asthma
  • Chronic lung disease characterized by
  • Airway narrowing that is reversible (
    completely) either spontaneously or with
    treatment
  • Airway inflammation
  • Airway hyper-responsiveness to a variety of
    stimuli.
  • Episodic dyspnea with wheezing
  • National Asthma Education and Prevention Program
    (NAEPP)

ATS, ARRD 1987
5
NAEPP Guidelines, 1997
  • Classification of chronic asthma
  • Mild intermittent asthma
  • Mild persistent asthma (gt2 days/wk, gt2
    nights/mo)
  • Moderate persistent asthma
  • Severe persistent asthma
  • Inhaled corticosteroids (ICS) are preferred
    treatment for all patients with persistent
    asthma
  • 2002 Update

6
Potential for Improving Asthma
  • ED is often used for asthma care
  • 2 million ED visits per year, especially Sept-Dec
  • Initial PEF 46 of predicted (severe)
  • 20 of patients admitted overnight to hospital
  • Among ED patients (EMNet/MARC data)
  • 74 adults use ED for all problem asthma care
  • 45 adults receive all asthma Rx from ED
  • With PCP 63 for problem care 24 for all Rx
  • High-risk population

www.EMNet-USA.org
7
ED Patients with Acute Asthma
www.EMNet-USA.org
8
ED-Initiated Secondary Prevention
  • High-risk population
  • Use of ED for problem asthma care asthma Rx
  • What interventions are feasible in the ED
    setting?
  • Examples from EMNet
  • ICS initiation at discharge from ED
  • Asthma education programs
  • Other options?

www.EMNet-USA.org
9
Referral from the ED
  • Bridging the gap between ED and primary care
  • Pilot study - how to get patients back to PCP
  • (Baren et al, Ann Emerg Med 2001)
  • Two randomized trials
  • EMNet (9 sites, funded by ACEP/EMF)
  • St Louis (1 site, funded by AHRQ)
  • Next steps?

10
Research Question
  • Does referral of emergency department
  • (ED) patients with acute asthma to asthma
  • centers (i.e., dedicated clinics with asthma
  • specialists, asthma educators, additional
  • resources) improve asthma outcomes in
  • this high-risk population?

11
Overview
  • Intervention would have 3 key elements
  • Facilitated referral to the Asthma Center
  • Asthma Center management (2 visits in 3 months)
  • Shared communication form
  • 40 urban EDs local asthma centers
  • Two study designs
  • Quasi-experimental before/after design
  • Group randomized controlled design

12
Inclusion / Exclusion -- Sites
  • Inclusion
  • Access to an asthma center
  • (with some minimal criteria eg, certified
    educator)
  • Exclusion
  • Current asthma-related quality improvement
    initiative
  • (to avoid co-interventions during trial)

13
Inclusion / Exclusion -- Patients
  • Inclusion
  • Age 18-54
  • Treated in ED, with/without admission to hospital
    for asthma treatment (excludes direct
    admissions)
  • Has sought urgent medical care for their asthma
    at least one other time in past year
  • Exclusion
  • gt 20 pack-year smoking history (to avoid COPD)
  • No telephone or unlikely to be available at 12
    months

14
Measures
  • Outcomes
  • Patient baseline characteristics
  • (including potential effect modifiers)
  • Process measures
  • Key mediators

15
Primary Outcome
  • Proportion of patients with ?1 ED visit during
    one year follow-up period

16
Secondary Outcomes
  • Proportion with ? 1 unscheduled clinic visit
  • Proportion with ? 1 hospitalization
  • Proportion with ? 1 ICS dispensed
  • per Rx of ED or asthma center
  • per Rx of PCP
  • Proportion using an ICS routinely
  • Asthma symptoms
  • Asthma-related Quality of Life
  • Etc.

17
Baseline Characteristics Sitecovariates
potential effect modifiers
  • Characteristics of ED
  • Setting
  • Staffing
  • Patient volume
  • Characteristics of AC
  • Years of operation as an AC
  • Setting
  • Staffing
  • Qualifications of educator(s)

18
Baseline Characteristics Patientcovariates
potential effect modifiers
  • Demographic characteristics
  • Prior healthcare utilization for acute asthma
  • Medication adherence
  • Routine asthma care behavior
  • Environmental exposures
  • Self-management skills
  • (e.g., inhaler use, peak flow meter use)
  • Prior asthma education

19
Measures of Intervention Process
  • Facilitated Referral by ED
  • Contact phone numbers obtained
  • Asthma Center (AC) appointment communicated
    within 48 hours
  • Other assistance given, by type
  • (eg, language, insurance, other)

20
Intervention Process (cont.)
  • 2. Asthma Center (AC) Management
  • AC visits to asthma specialist by patient
  • Asthma education provided to patient
  • (eg, content, duration)
  • Social work services provided to patient

21
Intervention Process (cont.)
  • 3. Communication Form
  • Initiation by ED
  • Completeness (eg, contains services provided,
    treatment plan)
  • Distribution (copied to patient, PCP, AC)
  • Use by AC
  • Completeness (eg, contains services provided,
    treatment plan patient outcomes)
  • Distribution (copied to patient and PCP)

22
Intervention Process (cont.)
  • ED, AC, and Patient perceptions of
  • Data collection procedures (all sites)
  • Communication form (intervention sites only)
  • Plans to continue facilitated referral and use of
    form (intervention sites only)

23
Key Mediators
  • During follow-up period
  • ICS prescription
  • Regular ICS use

24
Study Designs
  • Quasi-experimental before/after trial
  • Group randomized controlled trial

25
Design 1 Quasi-Experimental Before/After Trial
  • Without pretest
  • NR XA O1 O2 O3
  • NR XB O1 O2 O3
  •  
  • With pretest
  • NR O1 XA O2 O3 O4
  • NR O1 XB O2 O3 O4

XA usual care XB intervention
26
Assignment of Patients
  • Non-random assignment based on date of entry into
    study during one fall season
  • For example, at 1 site
  • Sept control group (26 pts)
  • Oct intervention group (26 pts)
  • Both groups followed for 1 year
  • All 40 sites provide usual care (516 patients)
    then intervention (516 patients)

27
Design 2 Group Randomized Controlled Trial
  • Without pretest
  • R XA O1 O2 O3
  • R XB O1 O2 O3
  •  
  • With pretest
  • R O1 XA O2 O3 O4
  • R O1 XB O2 O3 O4

XA usual care XB intervention
28
RCT flow-chart
29
Design Issues
  • Many design issues are same for the two proposed
    studies
  • For RCT, randomize EDs or patients?
  • Randomizing patients risks leakage of
    intervention to controls
  • (e.g., increased referral to asthma center or
    use of communication form)
  • IRB or potential/actual participants may object
    to perceived denial of services

30
Design Issues (cont.)
  • Recruit in peak season or entire year?
  • Peak season recruitment (Sept-Dec) more efficient
    and less costly
  • Peak season recruitment requires ED, AC, and PCP
    cooperation with intervention over shorter time
  • Obtain patient-level pretest data on outcomes vs.
    site characteristics only?
  • Patient-level allows better statistical control
    for pre-intervention site differences in outcomes
  • Incorporates a before-after component into RCT

31
RCT Flow-Chart Pretest
Year prior to RCT
32
Trade-offs -- Advantages
  • Before-After
  • May ? objections to denial of services
  • May ? post-study intervention sustainability
  • More information on variable implementation of
    intervention (40 vs 20 sites)
  • Except for ramp-up at 40 sites (not 20), easier
    to perform study, less costly?
  • Other advantages?
  • Group-RCT
  • ? control for potential co-interventions (eg,
    changes in asthma Tx, ED services)
  • ? control for seasonal patterns of asthma that
    could differentially affect two groups
  • i.e., ? internal validity
  • Other advantages?
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