TY - JOUR
T1 - Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy
AU - Trivedi, Michelle
AU - Hoque, Shushmita
AU - Luther, Janki
AU - Spano, Michelle
AU - Shillan, Holly
AU - Pearl, Hallie
AU - Seay, Hannah
AU - Phipatanakul, Wanda
AU - Gerald, Lynn B.
AU - Pbert, Lori
N1 - Funding Information:
Research reported in this publication was supported by the National Center for Advancing Translational Sciences , National Institutes of Health , through Grant UL1TR001453-01 , KL2TR001455 as well as the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number K23HL150341 and the National Institute of Allergy and Infectious Diseases under Award Number K24AI106822 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding sources played no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/9
Y1 - 2021/9
N2 - Rationale: Few evidence-based public health interventions are adopted in practice, in part due to a disconnect between the outcomes measured in clinical trials and the outcomes important to stakeholders that determine implementation in real-world practice. AsthmaLink is a school-supervised asthma therapy program which partners pediatric providers, school nurses, and families. To inform the design of a cluster randomized controlled trial of AsthmaLink, we elicited systems-level stakeholder input. Methods: Maximum variation sampling was used to recruit 18 stakeholders to participate in semi-structured interviews that were recorded, transcribed, and open coded: Department of Public Health officials (n = 4), school officials (n = 4), pediatric practice managers (n = 3), health insurance officials (n = 4), and legislators (n = 3). Thematic analysis was used to identify common themes related to stakeholder priorities for clinical trial design and perceived barriers to AsthmaLink adoption. Results: Stakeholder groups identified common priorities for the clinical trial design, including examination of the extent to which AsthmaLink (1) reduces health care utilization, (2) is cost effective (2) addresses health disparities, (3) reduces school absenteeism, and (4) educates families about asthma. Stakeholder groups reported potential barriers to AsthmaLink adoption, including challenges pertaining to (1) securing resources, staffing, and reimbursement, (2) variability across school districts, and (3) standing out amidst multiple programs vying for resources. Conclusions: Systems-level stakeholder input informed refinements to the clinical trial design of a school-supervised therapy program including outcome and implementation measures and choice of study population. Incorporating systems-level stakeholder perspectives into clinical trial design is critical to achieve adoption of evidence-based interventions into practice.
AB - Rationale: Few evidence-based public health interventions are adopted in practice, in part due to a disconnect between the outcomes measured in clinical trials and the outcomes important to stakeholders that determine implementation in real-world practice. AsthmaLink is a school-supervised asthma therapy program which partners pediatric providers, school nurses, and families. To inform the design of a cluster randomized controlled trial of AsthmaLink, we elicited systems-level stakeholder input. Methods: Maximum variation sampling was used to recruit 18 stakeholders to participate in semi-structured interviews that were recorded, transcribed, and open coded: Department of Public Health officials (n = 4), school officials (n = 4), pediatric practice managers (n = 3), health insurance officials (n = 4), and legislators (n = 3). Thematic analysis was used to identify common themes related to stakeholder priorities for clinical trial design and perceived barriers to AsthmaLink adoption. Results: Stakeholder groups identified common priorities for the clinical trial design, including examination of the extent to which AsthmaLink (1) reduces health care utilization, (2) is cost effective (2) addresses health disparities, (3) reduces school absenteeism, and (4) educates families about asthma. Stakeholder groups reported potential barriers to AsthmaLink adoption, including challenges pertaining to (1) securing resources, staffing, and reimbursement, (2) variability across school districts, and (3) standing out amidst multiple programs vying for resources. Conclusions: Systems-level stakeholder input informed refinements to the clinical trial design of a school-supervised therapy program including outcome and implementation measures and choice of study population. Incorporating systems-level stakeholder perspectives into clinical trial design is critical to achieve adoption of evidence-based interventions into practice.
KW - Childhood asthma
KW - Clinical trial design
KW - Implementation
KW - Stakeholder engagement
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U2 - 10.1016/j.cct.2021.106510
DO - 10.1016/j.cct.2021.106510
M3 - Article
C2 - 34280575
AN - SCOPUS:85111179524
VL - 108
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 106510
ER -