The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Sponsor: Wendy F Hansen

Document Coversheet 
 Study Title: The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use 
Disorder in Rural Kentucky 
Institution/Site: 
University of Kentucky 
Document (Approval/Update) Date: 
8/22/2024 
NCT Number: 
NCT03725332 
IRB Number 
44929 
Coversheet created: 
3/3/2025 

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IRB Approval
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IRB # 44929
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Section 9 Page 3 of 5
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Section 10 Page 1 of 4
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Section 22 Page 1 of 1
44929

Statistical Analysis Plan NCT03725332 
To begin, continuous variables (gestational age at birth, neonatal weight, infant hospitalization 
īôĲČťēϙĺċϙŜťÍƅϠϙôťèϟϽϙſĖīīϙæôϙŜŪııÍŘĖƏôîϙſĖťēϙîôŜèŘĖŕťĖŽôϙŜťÍťĖŜťĖèŜϙϼĲϠϙıôÍĲϠϙŜťÍĲîÍŘîϙôŘŘĺŘϠϙƱŘŜťϙÍĲîϙ
third quartiles, and minimum and maximum); categorical variables (NAS treatment required, 
mother-infant dyad status, preterm birth, maternal smoking status, etc.) will be summarized with 
èĺŪĲťŜϙÍĲîϙŕôŘèôĲťÍČôŜϟϙĺϙĖĲŽôŜťĖČÍťôϙîĖƯôŘôĲèôŜϙĖĲϙĺŪťèĺıôŜϙæôťſôôĲϙťŘôÍťıôĲťϙÍŘıŜϠϙÍϙ
generalized linear mixed model wiīīϙæôϙŕôŘċĺŘıôîϟϙaĖƄôîϙıĺîôīŜϙÍīīĺſϙċĺŘϙÍîîĖťĖĺĲÍīϙƲôƄĖæĖīĖťƅϙťĺϙ
control clustering while controlling for covariates such as socioeconomic status, race, age, 
addiction severity, if needed. Results will be presented with means (standard error) by treatment 
arm. Note that the primary outcome requires a noninferiority analysis; the secondary outcomes 
require superiority analysis to identify between-ČŘĺŪŕϙîĖƯôŘôĲèôŜϟϙaĖƄôîϙıĺîôīϙÍŜŜŪıŕťĖĺĲŜϙſĖīīϙ
be assessed using plots of each outcome, diagnostics, and/or residual plots. If deviations from 
îĖŜťŘĖæŪťĖĺĲÍīϙÍŜŜŪıŕťĖĺĲŜϙÍŘôϙĖîôĲťĖƱôîϠϙŘôıôîĖÍīϙıôÍŜŪŘôŜϙſĖīīϙæôϙîôŕīĺƅôîϙÍŜϙĲôôîôîϟϙIĲϙťēôϙ
èÍŜôϙťēÍťϙıôťēĺîŜϙÍŜŜŪıŕťĖĺĲŜϙÍŘôϙĲĺťϙŜÍťĖŜƱôîϠϙŘôıôîĖÍīϙıôÍŜŪŘôŜϙϼôČϠϙŽÍŘĖÍæīôϙťŘÍĲŜċĺŘıÍťĖĺĲŜϠϙ
nonparametric methods) will be employed.