Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy
Division of Pulmonary Medicine, Department of Pediatrics; Department of Population and Quantitative Health Sciences; School of Medicine; Senior Scholars Program
Michelle Trivedi, MD, MPH
Clinical Trials | Community-Based Research | Medical Education | Pediatrics | Public Health | Pulmonology | Respiratory Tract Diseases
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.
Childhood asthma, Clinical trial design, Implementation, Stakeholder engagement
DOI of Published Version
Trivedi M, Hoque S, Luther J, Spano M, Shillan H, Pearl H, Seay H, Phipatanakul W, Gerald LB, Pbert L. Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy. Contemp Clin Trials. 2021 Sep;108:106510. doi: 10.1016/j.cct.2021.106510. Epub 2021 Jul 16. PMID: 34280575; PMCID: PMC8453113. Link to article on publisher's site
Contemporary clinical trials
Trivedi M, Hoque S, Luther J, Spano M, Shillan H, Pearl H, Seay HL, Phipatanakul W, Gerald LB, Pbert L. (2021). Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy. Senior Scholars Program. https://doi.org/10.1016/j.cct.2021.106510. Retrieved from https://escholarship.umassmed.edu/ssp/305