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

Study Overview
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Brief Summary
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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, 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 PATHways program for rural implementation (local group-support vs. UK nurse/counselor telemedicine)

Detailed Description
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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 our 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 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 and Peer Support Specialist (GROUP arm); or, 2) Telemedicine consultation with substance abuse counselors, perinatal nurse educators, and/or Peer Health Specialists 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 PATHways program (UK-PATHways: Hub) at the University of Kentucky.

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

Conditions
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Neonatal Abstinence Syndrome

Intervention / Treatment
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* Behavioral: Telemedicine
* Behavioral: Group Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine Education<br>This is a stratified cluster 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. | Behavioral: Telemedicine<br>* Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance abuse counselors, perinatal nurse educators, and/or Peer Health Specialists. Consultations will occur every two weeks until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.<br>|
| Active Comparator: Group Care Education<br>This is a stratified cluster 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. | Behavioral: Group Care<br>* Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator and community-based peer support specialist. Small group care meetings will occur every two weeks until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1)Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of medication requiring neonatal abstinence syndrome (NAS) | Medical records will be reviewed at 3 months post-partum visit 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. | up to 10 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cigarette dependency | Participants will complete the Fagerstrom Test For Cigarette Dependence during their intake visit, at 28 weeks gestational age, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey instrument asks seven questions related to cigarette dependency. Responses will be scored on a scale of zero to 3 and totaled. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. | Up to 60 weeks | 
| Change in maternal anxiety over time | Participants will complete the Generalized Anxiety Disorder 7-Item scale during their intake visit, at 28 weeks gestational age, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consisted of 8 questions scored between zero (no anxiety) and 3 (daily anxiety) were a total score of 1-4 indicates minimal anxiety and a score of 15-21 indicates severe anxiety. Data will be presented as the change in anxiety over time compared between groups. | Up to 60 weeks | 
| Change in maternal depression over time | Participants will complete the Edinburgh Depression Scale during their intake visit, at 28 weeks gestational age, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consisted of 10 questions scored between 1 (no depression) and 4 (daily depression) were a total score of 1-8 is normal, a score is 9-10 is at risk for depression and a score of 11 or more indicates severe depression. Data will be presented as the change in depression over time compared between groups. | Up to 60 weeks | 
| Change in quality of life | WHO-Quality of Life Survey (WHOQoL) will be administered to patients at 28 weeks gestation, 3 and 6 months postpartum ( total time frame up to 38 weeks). WHOQoL is a 26 question self administered survey. Each question falls within 1 of 4 domains: physical health, psychological health, social relationships, environment. The four domains are added up to create 4 raw domain scores and means are calculated. These are transformed into transformed scores of 0 - 100. Higher scores indicate higher perceived quality of life in that particular domain. Data will be presented as the change in depression over time compared between groups | up to 38 weeks | 
| Opioid Use Disorder | Participants will complete a survey to assess their opioid dependency during their intake visit (typically between 6-28 weeks gestation). The survey asks 11 questions related to opioid use in a yes/no format. 2-3 yes answers indicates mild opioid use, yes to 4-5 questions indicates moderate use and yes to 6 or more questions indicates severe dependency. Data will be presented as the mean +/-standard error of the dependency scores per group. | Intake visit (between 6-28 weeks gestation) | 
| Incidence of hospitalization for opioid related issues during the study period | Participants will be surveyed for hospitalizations during the study but not related to participation in the study at 28 weeks gestation and 3 and 6 months postpartum (total time frame up to 38 weeks). They will be asked a series of yes or no questions. Data will presented as the total number of yes answers per group over the course of the study. | up to 38 weeks | 
| Change in physical condition of infant post delivery | Infant physical condition at birth with be assessed using the Apgar scale at 1 minute, 5 minutes and 10 minutes after birth. The Apgar scale consists of 5 criteria scored 0-2. Scores are combined for a total score of between 0-10 were 10 is a very healthy infant and 0 is an infant requiring immediate intensive medical care. Data will be presented as the change in Apgar score over time compared between groups. | Up to ten minutes | 
| Incidence of pediatric emergency room (ER) visits | A medical record review will take place to determine if any ER visits took place in the first 6 months of the infants life. Data will be presented as the total number of ER visits compared between groups | six months | 
| Adherence to a vaccine schedule | A medical record review will take place to determine if the infant's vaccine schedule was maintained in the first 6 months of the infants life. Data will be presented as the percent of infants in each group considered compliant and compared between groups. | six months | 
| Adherence to a pediatric visit schedule | A medical record review will take place to determine if the infant's pediatric visit schedule was maintained in the first 6 months of the infants life. Data will be presented as the percent of infants in each group considered compliant and compared between groups. | six months | 
| Infant motor development | At three months of age, infant mom/caregivers will be asked to complete the Ages & Stages Questionnaires®, Third Edition (ASQ®-3), a developmental screening tool designed for use by early educators and health care professionals. The survey collects milestones in infants in five domains; communication, gross motor, fine motor, problem-solving, and personal/social. It takes just 10-15 minutes for parents to complete and 2-3 minutes for professionals to score and highlights results that fall in a monitoring zone, to make it easier to keep track of children at risk. The Ages and Stages 3 month survey instrument is 38 items filled out by the caregiver and scored by the clinic staff. Scores are calculated at 0, 5, or 10 per question, and lower scores are interpreted to support further professional assessment concerning the infant's development. Scale scores will be presented as the mean +/- standard error per group compared between groups. | 3 months postpartum | 
| Infant motor development | At six months of age, infant mom/caregivers will be asked to complete the Ages & Stages Questionnaire, Third Edition to provide a snapshot need to catch delays and celebrate milestones. The survey collects milestones in infants in five domains; communication, gross motor, fine motor, problem-solving, and personal/social. It takes just 10-15 minutes for parents to complete and 2-3 minutes for professionals to score and highlights results that fall in a monitoring zone, to make it easier to keep track of children at risk. The Ages and Stages 6 month survey instrument is 38 items filled out by the infants caregiver and scored by the clinic staff. Scores are calculated at 0, 5, or 10 per question, and lower scores are interpreted to support further professional assessment concerning the infant's development. Scale scores will be presented as the mean +/- standard error per group compared between groups. | 6 months postpartum | 
| Incidence of opioid relapse | A medical record review and patient interview at each visit will be used to determine the number of participants in each group that began using illicit substances after a period of sobriety. Data will be collected at the intake visit, admission for delivery, and 3 and 6 months postpartum (up to 60 weeks). Data will be presented as the total count of relapse events in each group over the course of the study compared between groups. | Up to 60 weeks | 
| Incidence of opioid overdose | A medical record review and patient interview at each visit will be used to determine the number of participants in each group that experienced an opioid overdose. Data will be collected at the intake visit, admission for delivery, and 3 and 6 months postpartum (up to 60 weeks). Data will be presented as the total count of overdose events in each group over the course of the study compared between groups. | Up to 60 weeks |