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Telemedicine vs Group Care for Opioid Use Disorder During Pregnancy (PATH Trial)

N/A
Waitlist Available
Led By Wendy Hansen, MD
Research Sponsored by Wendy F Hansen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving Medication Assisted Therapy (buprenorphine products or methadone)
Pregnant women at 6 to 32 weeks' gestational age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights

PATH Trial Summary

This trial will compare the effectiveness of two methods of delivering care to rural areas for perinatal opioid use disorder - local group support vs. UK nurse/counselor telemedicine.

Who is the study for?
This trial is for pregnant women between 6 to 32 weeks' gestation in Central and Eastern Kentucky who are on Medication Assisted Therapy (like buprenorphine or methadone) due to a history of Opioid Use Disorder. They must be getting prenatal care at one of the eleven study sites.Check my eligibility
What is being tested?
The PATH Home Trial compares two ways of delivering the UK-PATHways program for perinatal opioid use disorder: local group support versus telemedicine with UK nurses/counselors, aiming to improve outcomes for mothers and infants in rural areas.See study design
What are the potential side effects?
Since this trial focuses on service delivery methods rather than medications, traditional side effects aren't applicable. However, participants may experience differences in satisfaction or effectiveness between the two approaches.

PATH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently on medication-assisted therapy for addiction.
Select...
I am pregnant and between 6 to 32 weeks along.

PATH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of medication requiring neonatal abstinence syndrome (NAS)
Secondary outcome measures
Adherence to a pediatric visit schedule
Vaccines
Change in cigarette dependency
+10 more
Other outcome measures
Acceptance of long term contraception
Change in employment status
Change in household size

PATH Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telemedicine EducationExperimental Treatment1 Intervention
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.
Group II: Group Care EducationActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telemedicine
2008
Completed Phase 4
~3540

Find a Location

Who is running the clinical trial?

Wendy F HansenLead Sponsor
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,996,507 Total Patients Enrolled
Wendy Hansen, MDPrincipal InvestigatorUniversity of Kentucky, Department of OB-GYN, Division of Maternal Fetal Medicine

Media Library

Group Care Clinical Trial Eligibility Overview. Trial Name: NCT03725332 — N/A
Neonatal Abstinence Syndrome Research Study Groups: Telemedicine Education, Group Care Education
Neonatal Abstinence Syndrome Clinical Trial 2023: Group Care Highlights & Side Effects. Trial Name: NCT03725332 — N/A
Group Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT03725332 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this experiment limited to individuals who are over 20 years old?

"According to the study's stated criteria, eligible participants must be within the 18-55 age range. Conversely, there are 32 trials specifically for minors and 244 for elderly patients."

Answered by AI

How many people have been invited to participate in this research?

"Affirmative, clinicaltrials.gov's records confirm that this trial is still open to enrollment; it was first posted on March 13th 2019 and has since had multiple updates with the latest being December 1st 2022. 533 participants from 12 sites need to be recruited for successful completion of this study."

Answered by AI

How widespread is the implementation of this experimental investigation?

"At this time, 12 medical sites are offering enrolment in the study. Primary Plus located in Maysville and Sterling Health Care based Winchester as well University of Kentucky Morehead Women's Healthcare in Morehead are among these locations."

Answered by AI

Is participation in this trial available to individuals at the moment?

"Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting patients; it was created on March 13th 2019 and last updated on December 1st 2022. In total, 533 participants are needed for the trial which will take place in 12 different locations."

Answered by AI

Is there an opportunity for me to participate in this clinical research?

"This trial is looking to enroll 533 individuals suffering from passive addiction within the ages of 18 and 55. Patients must also meet additional criteria: they need to be receiving prenatal care at one of eleven study sites located in Central and Eastern Kentucky, while pregnant between 6-32 weeks' gestation age."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Wendy F Hansen 2019. "The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03725332.
~44 spots leftby Apr 2025
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