The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky

Maternal urine drug screen (UDS) will be collected at the time of hospital admission for delivery for each participant. A urine drug screen is considered inappropriate when the presence of an illicit drug that is not prescribed for the participant is detected or the prescribed medication for opioid use disorder is not detected. The actual number of inappropriate maternal drug screens will be calculated. Results will be compared between Arms: Telemedicine and Group

Engagement with PATHHome is measured by the number of counseling/education sessions (groups or telemedicine) attended by each participant. Results will be compared between Arms and expressed as percent of interventions attended by participants.

Engagement with MAT provider is measured by the average number of visits attended by each participant with their MAT provider.

Engagement with Prenatal Care is considered by gestational age of entry. The number of prenatal visits is expressed as a percentage of prenatal visits attended with a denominator of prenatal visits scheduled. The data is provided by patient report and confirmed by medical record review when possible. Results will be compared between Arms. Categories reported are no prenatal visits, 5-50%, 51-100%.

Participants will complete the Fagerstrom Test for Cigarette Dependence 4 times during the course of the study: Intake, 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). This is a 7-question survey with each question scored on a scale of zero to 3 and totaled. Scores greater than 8 are considered high dependency, scores of 5-7 are considered moderately dependent, scores of 3-4 are low to moderate dependence and scores of 1-2 are low dependence. Data will be presented as the number of participants with cigarette dependency over time compared between groups.

Participants will complete the Generalized Anxiety Disorder survey at their intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 7 questions probing the participants burden of anxiety. Each question is scored from 0 to 3, with 3 representing the most severe state. A total score of 1-4 indicates minimal anxiety, 5-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. Data will be presented as the number of participants with anxiety over time compared between groups.

Participants will complete the Edinburgh Depression Scale at 4 times during the study: Intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 10 questions. Each question is scored between 0-3. An answer of 3 represents a more severe state. A total score of 1-8 falls within a normal range, a score is 9-10 is at risk for depression and a score of 11 or more indicates depression. In general, the higher the score, the more severe the depression. Data will be presented as the number of participants with depression over time compared between groups.

WHO-Quality of Life Survey (WHOQoL) will be administered to patients at 28-32 weeks gestation. WHOQoL is a 26 question self administered survey. Each question falls within 1 of 4 "domains": physical health, psychological health, social relationships, environment. For purposes of reporting, we are using the first question, "How would you rate your quality of life?" on a scale of 1-5, with 1 being very poor quality, 2 poor quality, 3 neither poor nor good, 4 good quality, 5 very good quality.

Participants will complete a Diagnostic and Statistical Manual of Mental Disorders-5-TR, Addiction Severity Scale to assess their opioid dependency at the intake visit (between 6-32 weeks). The survey asks 11 questions. Each question asks about symptoms related to opioid use disorder and are answered in a yes/no format. A mild substance use disorder is diagnosed with 2-3 symptoms, moderate with 4-5 symptoms, and severe is 6 or more symptoms. Data will be presented as the number of participants in each category.

Hospitalizations for opioid related issues were determined by two main methods. Participants were assessed for hospitalization at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, hospitalizations were determined and confirmed through medical record review when possible. Data will be presented as number of hospitalizations in each arm.

Infant physical condition at birth will be assessed using the Apgar score at 1 minute and 5 minutes after birth. The Apgar score consists of 5 criteria: Appearance (skin color), pulse, grimace (reflex irritability), activity (muscle tone), respiration. Each criteria is scored 0-2. Scores are summed to evaluate a newborns health. A score of 8-10 is considered normal. A score less than 8 requires medical support. The lower the score, the more severely affected the newborn. Data will be presented as the change in Apgar score over time compared between groups.

Pediatric emergency room visits will be determined by both in person reporting during a postpartum intervention and by medical record review. Time span starts at discharge from the hospital (after birth) to 6 months postpartum. Data will be presented as the total number of pediarric ER visits compared between groups

Adherence to a vaccine schedule will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; "Is your infant up to date on vaccines?". Data will be presented as the total number of infants compliant on their vaccines and compared between groups.

Engagement with pediatric care will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; "Does your baby regularly see a pediatrician?". Data will be presented as the total number of infants engaged in pediatric care and compared between groups.

The Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 3-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The developmental instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain subsection score only. This domain includes 6 questions. Scores are calculated at 0, 5, or 10 per question. The highest score is 60- the lowest score would be 0. The higher the score the better. For a score greater than 41 development is considered to be on schedule. If the score falls between 38-41- targeted learning activities and monitoring is recommended. If the score falls below 38, concern for lagging infant motor development and further assessment with a professional is recommended. Scores will be presented as the mean +/- standard error compared between group

The Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 6-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The Ages and Stages 6-month survey instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain score only. This domain includes 6 questions, scores are calculated at 0, 5, or 10 per question and a score below 22 is concerning for lagging infant motor development. Scores will be presented as the mean +/- standard error compared between groups.

Relapse was defined as the use of any illicit substance or misuse of prescribed medications including medication for opioid use disorder. Incidence of relapse was determined by two main methods. Participants were assessed for relapse at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, relapses were determined and confirmed through medical record review, including inappropriate urine drug screens, when possible. Data will be presented in 2 categories: Relapse with opioids and relapse with other substances. The number of relapses is not equal to the number of participants as a single participant may have more than one relapse or polysubstance relapse. Data will be presented as the total number of relapses and compared between groups.

The incidence of opioid overdose was determined by two main methods. Participants were assessed for overdose at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, overdoses were determined and confirmed through medical record review when possible. Data will be presented as number of overdoses in each arm.