The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Behavioral: TelemedicineBehavioral: Group Care
- Registration Number
- NCT03725332
- Lead Sponsor
- Wendy F Hansen
- Brief Summary
Perinatal opioid use disorder (OUD) is a major health concern in the U.S. with significant impact on mothers, infants, and communities. Investigators at the University of Kentucky/UK HealthCare (UK) have developed a comprehensive clinical care model for perinatal OUD (known as UK-PATHways) that has demonstrated success in maternal and neonatal outcomes. The overreaching goals of the proposed project are to: 1) expand the reach of this successful clinical program to rural communities thereby improving access to integrated MAT prenatal care, 2) to reduce the impact of perinatal OUD in underserved rural areas of our state, and 3) to compare the relative effectiveness methods of delivery active elements of the UK-PATHways program for rural implementation (local group-support vs. telemedicine).
- Detailed Description
The UK-PATHways program preliminary successes during the first three years are clear: enrolled mothers (n\>200) have reduced relapse, increased treatment compliance, and improved neonatal outcomes when compared to non-enrolled OUD mothers. However, at this time, UK-PATHways is only available at the main healthcare campus in Lexington, KY. Many eligible patients reside great distances from our clinical home and some current patients travel hours to access this valuable resource. While Medication Assisted Therapy (MAT) has become increasingly available in our region, many of the components of the UK-PATHways program are not readily accessible in rural Central and Eastern Kentucky and the quality of programming with MAT treatment is not standardized in these locations. Furthermore, rural patients continue to face challenges related to stigma of their OUD and transportation difficulties if they desire more comprehensive services. The proposed study will evaluate the introduction of essential components of the UK-PATHways program into rural communities and identify the optimal intervention strategies for expansion of services and to improve the treatment of OUD for rural patients. Specific aims include the following: Aim 1) Conduct a randomized cluster trial using a 'hub and spoke' study design, comparing two delivery modes (local GROUP care vs TELEMEDICINE) for the delivery of a UK-PATHways based patient education curriculum at participating rural regional sites. Each regional site will be randomized to support one of two study arms: 1) Prenatal group care led by a perinatal nurse facilitator or substance use counselor with a peer support specialist (GROUP arm); or, 2) Telemedicine consultation with substance use counselor or perinatal nurse facilitator based at the 'hub' site (TELEMEDICINE arm); and Aim 2) Evaluate the relative effectiveness of each study arm on primary and secondary maternal and neonatal outcomes as compared to the established UK-PATHways program (UK PATHways: Hub) at the University of Kentucky.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 269
- Pregnant women at 6 to 32 weeks' gestational age
- History of Opioid Use Disorder
- Receiving Medication Assisted Therapy (buprenorphine products or methadone)
- Obtaining prenatal care at one of eleven study sites located throughout Central and Eastern Kentucky
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine Education Telemedicine This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Group Care Education Group Care This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff.
- Primary Outcome Measures
Name Time Method Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment up to 10 days postpartum Medical records will be reviewed post-partum for treatment for NAS. Diagnosis of NAS will be made within 10 days of birth and treatment started based on standard of care. Data will be presented as the percent of infants born requiring therapy in each group.
- Secondary Outcome Measures
Name Time Method Prenatal Engagement in Prenatal Care Up to delivery, an average of 19 weeks 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 With Cigarette Dependency Over Time Up to 60 weeks 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 With Maternal Anxiety Over Time Up to 60 weeks 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.
Participant Quality of Life 28-32 weeks gestation 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.
Number of Inappropriate Maternal Drug Screens at Delivery Up to 10 days post-partum 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
Prenatal Engagement With Percent of Program Education Sessions Attended Up to delivery, an average of 19 weeks 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.
Prenatal Engagement With MAT Provider Up to delivery, an average of 19 weeks Engagement with MAT provider is measured by the average number of visits attended by each participant with their MAT provider.
Participants With Maternal Depression Over Time Up to 60 weeks 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.
Severity of Opioid Use Disorder Intake visit (between 6-32 weeks gestation) 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.
Incidence of Hospitalization for Opioid Related Issues During the Study Period up to 60 weeks 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.
Change in Physical Condition of Infant Post-delivery by Apgar Score Up to five minutes 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.
Incidence of Pediatric Emergency Room (ER) Visits birth-six months 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 Infant 3 months and 6 months of age 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 Infant 3 month and 6 months of life 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.
Infant Gross Motor Development Infant at 6 months of age 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.
Incidence of Relapse Up to 60 weeks 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.
Incidence of Opioid Overdose Up to 60 weeks 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.
Trial Locations
- Locations (11)
Karen's Place Maternity Center
🇺🇸Ashland, Kentucky, United States
Primary Care Centers of Eastern Kentucky
🇺🇸Hazard, Kentucky, United States
ARH Women's and Family Health Center - Middlesboro
🇺🇸Middlesboro, Kentucky, United States
Frontier Behavioral Health Centers
🇺🇸Prestonsburg, Kentucky, United States
The Medical Center
🇺🇸Bowling Green, Kentucky, United States
BrightView
🇺🇸Georgetown, Kentucky, United States
University of Kentucky Women's Health OB-GYN
🇺🇸Georgetown, Kentucky, United States
ARH Women's and Family Health Center - Tug Valley
🇺🇸S. Williamson, Kentucky, United States
Grace Health Women's Care
🇺🇸Corbin, Kentucky, United States
OB/GYN & Women's Health University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Kentucky Morehead Women's Healthcare
🇺🇸Morehead, Kentucky, United States