School-based enhanced hearing screening and specialty telehealth follow-up for hearing loss among children in rural Alaska: study protocol for a hybrid effectiveness-implementation stepped wedge, cluster-randomized controlled trial (North STAR trial)

Administrative information

Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).

Title {1}	School-based enhanced hearing screening and specialty telehealth follow-up for hearing loss among children in rural Alaska: study protocol for a hybrid effectiveness-implementation stepped wedge, cluster-randomized controlled trial (North STAR trial)
Trial registration {2a and 2b}.	NCT05593484—https://clinicaltrials.gov/study/NCT05593484 Supplemental Table 1
Protocol version {3}	North STAR Protocol v1.0
Funding {4}	National Institutes of Health (R01DC020026)
Author details {5a}	1Center for Hearing Health Access, University of Arkansas for Medical Sciences, Little Rock, AR, USA 2Department of Otolaryngology-Head and Neck Surgery, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA 3Duke Global Health Institute, Duke University, Durham, NC, USA 4Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA 5Petersburg Medical Center, Petersburg, AK, USA 6Department of Population Health Sciences, Duke University, Durham, NC, USA 7Harvard Medical School, Boston, MA, USA 8Southcentral Foundation, Anchorage, AK, USA 9Department of Epidemiology, Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences, Little Rock, AR, USA
Name and contact information for the trial sponsor {5b}	University of Arkansas for Medical Sciences Primary Contact: Susan D. Emmett, MD, MPH 4301 W Markham, Slot 543 Little Rock, AR 72205 501–296–1157 [email protected]
Role of sponsor {5c}	The funder has no role in study design, collection, management, analysis, interpretation of data, writing of the report, or the decision to submit the report for publication. The sponsor takes full responsibility for these activities.

Introduction

Background and rationale {6a}

Childhood hearing loss leads to significant speech and language delays [1, 2]. As a result, children with hearing loss perform worse in school, are more likely to drop out, and are 23–39% less likely to attend college [3, 4, 5–6]. Hearing loss also has substantial psychosocial and behavioral implications, and children with even mild losses have lower quality of life and worse behavioral outcomes than peers with normal hearing [7, 8, 9, 10–11]. The World Health Organization estimates up to 60% of childhood hearing loss may be preventable, and this estimate rises to 75% in resource-constrained settings such as rural...