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

Primary Purpose

Neonatal Abstinence Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Group Care
Sponsored by
Wendy F Hansen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Karen's Place Maternity CenterRecruiting
  • The Medical CenterRecruiting
  • Grace Health Women's CareRecruiting
  • University of Kentucky Women's Health OB-GYNRecruiting
  • Primary Care Centers of Eastern KentuckyRecruiting
  • OB/GYN & Women's Health University of LouisvilleRecruiting
  • ARH Women's and Family Health Center - MiddlesboroRecruiting
  • University of Kentucky Morehead Women's HealthcareRecruiting
  • Frontier Behavioral Health CentersRecruiting
  • ARH Women's and Family Health Center - Tug ValleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine Education

Group Care Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 29, 2018
Last Updated
December 1, 2022
Sponsor
Wendy F Hansen
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03725332
Brief Title
The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Acronym
PATH
Official Title
The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wendy F Hansen
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
533 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Care Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of medication requiring neonatal abstinence syndrome (NAS)
Description
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.
Time Frame
up to 10 days postpartum
Secondary Outcome Measure Information:
Title
Change in cigarette dependency
Description
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.
Time Frame
Up to 60 weeks
Title
Change in maternal anxiety over time
Description
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.
Time Frame
Up to 60 weeks
Title
Change in maternal depression over time
Description
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.
Time Frame
Up to 60 weeks
Title
Change in quality of life
Description
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
Time Frame
up to 38 weeks
Title
Opioid Use Disorder
Description
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.
Time Frame
Intake visit (between 6-28 weeks gestation)
Title
Incidence of hospitalization for opioid related issues during the study period
Description
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.
Time Frame
up to 38 weeks
Title
Change in physical condition of infant post delivery
Description
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.
Time Frame
Up to ten minutes
Title
Incidence of pediatric emergency room (ER) visits
Description
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
Time Frame
six months
Title
Adherence to a vaccine schedule
Description
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.
Time Frame
six months
Title
Adherence to a pediatric visit schedule
Description
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.
Time Frame
six months
Title
Infant motor development
Description
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.
Time Frame
3 months postpartum
Title
Infant motor development
Description
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.
Time Frame
6 months postpartum
Title
Incidence of opioid relapse
Description
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.
Time Frame
Up to 60 weeks
Title
Incidence of opioid overdose
Description
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.
Time Frame
Up to 60 weeks
Other Pre-specified Outcome Measures:
Title
Change in employment status
Description
Participants will be asked about employment status 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). Participants will answer "yes" or "no" regarding their employment status. Data will be presented as the change in employment status between groups.
Time Frame
Up to 60 weeks
Title
Change in household size
Description
Participants will be asked to indicate the total number of people sharing their living space during the intake visit, and 6 months postpartum (combined total time of observation is up to 38 weeks). Data will be presented as the change in dwelling occupancy over time compared between groups.
Time Frame
up to 38 weeks
Title
Acceptance of long term contraception
Description
Participants will be offered long acting reversible contraception at time of delivery (up to 34 weeks into the study assuming delivery at 40 weeks gestation). Data will be presented as the number of participants per group accepting long term contraception.
Time Frame
Up to 34 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Fawcett, MPH
Phone
859-257-2321
Email
karen.fawcett@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Hansen, MD
Organizational Affiliation
University of Kentucky, Department of OB-GYN, Division of Maternal Fetal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karen's Place Maternity Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Missy Edens, MA, Ed.
Phone
606-225-5163
Email
missy.edens@arccenters.com
Facility Name
The Medical Center
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shebna Unes-Kunju, MD
Phone
270-783-3573
Facility Name
Grace Health Women's Care
City
Corbin
State/Province
Kentucky
ZIP/Postal Code
40701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misty Thompson, DO
Phone
606-528-5527
Email
misty.thompson@gracehealthky.org
First Name & Middle Initial & Last Name & Degree
Tammy Sizemore, RN
Phone
606-526-9005
Ext
6033
Email
tammy.sizemore@gracehealthky.org
Facility Name
University of Kentucky Women's Health OB-GYN
City
Georgetown
State/Province
Kentucky
ZIP/Postal Code
40324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coy Flowers, MD
Phone
859-323-9333
Email
cafl230@uky.edu
Facility Name
Primary Care Centers of Eastern Kentucky
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin White, MD, FACOG
Phone
606-439-1300
Email
kwhite@pccek.com
First Name & Middle Initial & Last Name & Degree
Sandra Boucher, RN
Phone
(606)476-2274
Ext
133
Email
sboucher@pccek.com
Facility Name
OB/GYN & Women's Health University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Miller, MD
Phone
502-588-4400
Email
edward.miller@uoflhealth.org
Facility Name
ARH Women's and Family Health Center - Middlesboro
City
Middlesboro
State/Province
Kentucky
ZIP/Postal Code
40965
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Akers, APRN
Phone
606-248-3015
Email
rakers@arh.org
Facility Name
University of Kentucky Morehead Women's Healthcare
City
Morehead
State/Province
Kentucky
ZIP/Postal Code
40351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Todd, MD, FACOG
Phone
606-270-2931
Email
rebecca.todd@uky.edu
Facility Name
Frontier Behavioral Health Centers
City
Prestonsburg
State/Province
Kentucky
ZIP/Postal Code
41465
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Bailey, DO
Phone
606-349-7475
Facility Name
ARH Women's and Family Health Center - Tug Valley
City
S. Williamson
State/Province
Kentucky
ZIP/Postal Code
41514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Gaunt, MD
Phone
606-886-3831
Email
tgaunt@ARH.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD at this time

Learn more about this trial

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

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