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

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ClinicalTrials.gov Identifier: NCT03725332
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Wendy F Hansen, University of Kentucky

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 specialist telemedicine)

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Behavioral: Telemedicine Behavioral: Group Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Telemedicine Education
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
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.

Active Comparator: Group Care Education
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
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 Measures :
  1. Incidence of medication requiring neonatal abstinence syndrome (NAS) [ Time Frame: up to 10 days postpartum ]
    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 :
  1. Change in cigarette dependency [ Time Frame: Up to 60 weeks ]
    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.

  2. Change in maternal anxiety over time [ Time Frame: Up to 60 weeks ]
    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.

  3. Change in maternal depression over time [ Time Frame: Up to 60 weeks ]
    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.

  4. Change in quality of life [ Time Frame: up to 38 weeks ]
    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

  5. Opioid Use Disorder [ Time Frame: Intake visit (between 6-28 weeks gestation) ]
    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.

  6. Incidence of hospitalization for opioid related issues during the study period [ Time Frame: up to 38 weeks ]
    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.

  7. Change in physical condition of infant post delivery [ Time Frame: Up to ten minutes ]
    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.

  8. Incidence of pediatric emergency room (ER) visits [ Time Frame: six months ]
    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

  9. Adherence to a vaccine schedule [ Time Frame: six months ]
    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.

  10. Adherence to a pediatric visit schedule [ Time Frame: six months ]
    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.

  11. Infant motor development [ Time Frame: 3 months postpartum ]
    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.

  12. Infant motor development [ Time Frame: 6 months postpartum ]
    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.

  13. Incidence of opioid relapse [ Time Frame: Up to 60 weeks ]
    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.

  14. Incidence of opioid overdose [ Time Frame: Up to 60 weeks ]
    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.


Other Outcome Measures:
  1. Change in employment status [ Time Frame: Up to 60 weeks ]
    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.

  2. Change in household size [ Time Frame: up to 38 weeks ]
    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.

  3. Acceptance of long term contraception [ Time Frame: Up to 34 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725332


Contacts
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Contact: Karen Fawcett, MPH 859-257-2321 karen.fawcett@uky.edu

Locations
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United States, Kentucky
The Medical Center Recruiting
Bowling Green, Kentucky, United States, 42101
Contact: Caitlin Burklow    270-796-2509    BurkCM@MCHealth.net   
Grace Health Women's Care Recruiting
Corbin, Kentucky, United States, 40701
Contact: Tammy Sizemore, RN    606-526-9005 ext 6033    tammy.sizemore@gracehealthky.org   
University of Kentucky Women's Health OB-GYN Recruiting
Georgetown, Kentucky, United States, 40324
Contact: Jennifer Martin, RN    859-323-3316    jdmart3@uky.edu   
Primary Care Centers of Eastern Kentucky Recruiting
Hazard, Kentucky, United States, 41701
Contact: Sandra Boucher, RN    606-435-7692    sboucher@pcck.com   
OB/GYN & Women's Health University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Elaine Stauble    502-588-4310    elaine.tasch@louisville.edu   
Primary Plus Recruiting
Maysville, Kentucky, United States, 41056
Contact: Christen Dickens, RN    606-759-5331    dickenc@primaryplus.net   
ARH Women's and Family Health Center - Middlesboro Recruiting
Middlesboro, Kentucky, United States, 40965
Contact: Rebecca Akers, APRN    606-248-3015    rakers@arh.org   
University of Kentucky Morehead Women's Healthcare Recruiting
Morehead, Kentucky, United States, 40351
Contact: Val Moore    859-323-3903    valeria.moore@uky.edu   
ARH Women's and Family Health Center - Tug Valley Recruiting
S. Williamson, Kentucky, United States, 41514
Contact: Raeanna Charles, RN    606-237-0327    rcharles@arh.org   
Sterling Health Care Recruiting
Winchester, Kentucky, United States, 40390
Contact: Leslie Aslam    859-404-7686    laslam@sterlinghealthky.org   
Sponsors and Collaborators
Wendy F Hansen
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Wendy Hansen, MD University of Kentucky, Department of OB-GYN, Division of Maternal Fetal Medicine
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Responsible Party: Wendy F Hansen, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03725332    
Other Study ID Numbers: 44929
MAT-2017C2-7842 ( Other Identifier: Patients Centered Outcomes Research Institute )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD at this time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders