Michelle Trivedi1, Shushmita Hoque2, Janki Luther3, Michelle Spano4, Holly Shillan2, Hallie Pearl5, Hannah Seay2, Wanda Phipatanakul6, Lynn B Gerald7, Lori Pbert8. 1. Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, USA; Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA. Electronic address: michelle.trivedi@umassmemorial.org. 2. University of Massachusetts Medical School, Worcester, MA, USA. 3. Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA. 4. Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, USA. 5. Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, USA. 6. Division of Asthma, Allergy, and Immunology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. 7. Department of Health Promotion Sciences, University of Arizona Mel and Enid Zuckerman College of Public Health, Tucson, AZ, USA; Asthma and Airway Disease Research Center, University of Arizona, Tucson, AZ, USA. 8. Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.
Abstract
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.
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.
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Authors: Simon Craig; Franz E Babl; Stuart R Dalziel; Charmaine Gray; Colin Powell; Khalid Al Ansari; Mark D Lyttle; Damian Roland; Javier Benito; Roberto Velasco; Julia Hoeffe; Diana Moldovan; Graham Thompson; Suzanne Schuh; Joseph J Zorc; Maria Kwok; Prashant Mahajan; Michael D Johnson; Robert Sapien; Kajal Khanna; Pedro Rino; Javier Prego; Adriana Yock; Ricardo M Fernandes; Indumathy Santhanam; Baljit Cheema; Gene Ong; Shu-Ling Chong; Andis Graudins Journal: Trials Date: 2020-01-13 Impact factor: 2.279
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