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 (>2 days/wk, >2 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: 1.ICS initiation at discharge from ED 2.Asthma education programs 3.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: –> 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 – Site covariates & 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 – Patient covariates & 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 1.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 1. Quasi-experimental before/after trial 2. Group randomized controlled trial

25. Design 1: Quasi-Experimental Before/After Trial Without pretest: NR X A O 1 O 2 O 3 NR X B O 1 O 2 O 3 With pretest: NR O 1 X A O 2 O 3 O 4 NR O 1 X B O 2 O 3 O 4 X A = usual care X B = 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 X A O 1 O 2 O 3 R X B O 1 O 2 O 3 With pretest: R O 1 X A O 2 O 3 O 4 R O 1 X B O 2 O 3 O 4 X A = usual care X B = 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?