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

NACompletedINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

March 13, 2019

Primary Completion Date

April 1, 2024

Study Completion Date

November 1, 2024

Conditions
Neonatal Abstinence Syndrome
Interventions
BEHAVIORAL

Telemedicine

Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month 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.

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 or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month 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.

Trial Locations (11)

40202

OB/GYN & Women's Health University of Louisville, Louisville

40324

BrightView, Georgetown

University of Kentucky Women's Health OB-GYN, Georgetown

40351

University of Kentucky Morehead Women's Healthcare, Morehead

40701

Grace Health Women's Care, Corbin

40965

ARH Women's and Family Health Center - Middlesboro, Middlesboro

41101

Karen's Place Maternity Center, Ashland

41465

Frontier Behavioral Health Centers, Prestonsburg

41514

ARH Women's and Family Health Center - Tug Valley, South Williamson

41701

Primary Care Centers of Eastern Kentucky, Hazard

42101

The Medical Center, Bowling Green

All Listed Sponsors
lead

Wendy F Hansen

OTHER

NCT03725332 - The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky | Biotech Hunter | Biotech Hunter