Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy.
Childhood asthma
Clinical trial design
Implementation
Stakeholder engagement
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
09 2021
09 2021
Historique:
received:
25
05
2021
revised:
09
07
2021
accepted:
13
07
2021
pubmed:
20
7
2021
medline:
27
10
2021
entrez:
19
7
2021
Statut:
ppublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 34280575
pii: S1551-7144(21)00246-9
doi: 10.1016/j.cct.2021.106510
pmc: PMC8453113
mid: NIHMS1727820
pii:
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106510Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL150341
Pays : United States
Organisme : NIAID NIH HHS
ID : K24 AI106822
Pays : United States
Organisme : NCATS NIH HHS
ID : KL2 TR001455
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001453
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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