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41st Multicenter Airway Research Collaboration (MARC-41)

Investigators:
Kohei Hasegawa, MD, MPH (Principal Investigator)
Carlos A. Camargo, Jr., MD, DrPH (Co-Investigator)
Erin Crocker, MPH (Project Coordinator)

Funding Source:
Funded by a grant from Novartis Pharmaceuticals to MGH (Kohei Hasegawa, PI). Novartis has no role in the conduct of the study nor collection, management, or analysis of data.

Aims:

  • Aim 1: To determine the feasibility of implementation of hospital-initiated care bundle in patients hospitalized for asthma exacerbation.
  • Aim 2: To determine the effectiveness of the care bundle on post-hospitalization asthma care.
  • Aim 3:To determine the effectiveness of the care bundle on post-hospitalization patient’s clinical outcomes.

Design and Setting: This is a multicenter “before-after” study to investigate the feasibility and effectiveness of the hospital-initiated care bundle in adult patients hospitalized for asthma exacerbation. In this self-controlled cohort study, each participant’s rate of outcomes will be compared over a 3-year period (i.e., the 2 years before and 1 year after the implementation of the care bundle). The asthma care bundle will consist of several core elements across all participating sites and optional elements based on the available resources at each site. The core bundle elements are based on the national and international asthma guidelines, systematic literature review, and input from the multidisciplinary project team. The hospital-initiated care bundle will not differ from standard asthma care.

MARC-41 will build on the success of the MARC-36 and -37 studies by implementing an evidenced-based hospital-initiated care bundle and evaluating its effectiveness at five geographically-diverse US sites. Site research staff will enroll participants from October 1, 2017 through September 30, 2018; each site will need to enroll 36 participants to meet the overall enrollment goal of 180 participants. All patients will be managed at the discretion of the treating physician

Study Population:Adults 18 to 54 years of age hospitalized for asthma exacerbation, with a history of asthma diagnoses and severe exacerbations before the index hospitalization, currently treated with inhaled corticosteroids, and the ability to give informed consent.

Study Period: 12 months; starting approximately October 1, 2017 and ending approximately September 30, 2018.

Study Endpoints:

  • Outcome for Aim 1 is concordance to the bundled care (overall and item-by-item).
  • Outcome for Aim 2 is chronic asthma care, including laboratory testing (e.g., environmental allergen skin testing) and adjustment to long-term controller medications (e.g., initiation of omalizumab) in the chronic care setting (e.g., specialist clinic) in the pre- and post-implementation periods.
  • Outcome for Aim 3 is annualized incidence of severe asthma exacerbation (use of systemic corticosteroids for at least 3 days, emergency department (ED) visit, or hospitalization for asthma exacerbation) during the pre- and post-implementation periods.

©2017 EMNet Last Updated:09/29/17 va