Neonatal Abstinence Syndrome
Conditions
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 to rural communities thereby improving access to integrated MAT prenatal care, 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 UK-PATHways program for rural implementation (local group-support vs. 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 the 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 UK-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 or substance use counselor with a peer support specialist (GROUP arm); or, 2) Telemedicine consultation with substance use counselor or perinatal nurse facilitator 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 UK-PATHways program (UK PATHways: Hub) at the University of Kentucky.
Interventions
BEHAVIORALTelemedicine
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.
BEHAVIORALGroup 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.
Sponsors
Wendy F Hansen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment | up to 10 days postpartum | Medical records will be reviewed post-partum 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
| Measure | Time frame | Description |
|---|---|---|
| Participant Quality of Life | 28-32 weeks gestation | WHO-Quality of Life Survey (WHOQoL) will be administered to patients at 28-32 weeks gestation. WHOQoL is a 26 question self administered survey. Each question falls within 1 of 4 domains: physical health, psychological health, social relationships, environment. For purposes of reporting, we are using the first question, How would you rate your quality of life? on a scale of 1-5, with 1 being very poor quality, 2 poor quality, 3 neither poor nor good, 4 good quality, 5 very good quality. |
| Infant Gross Motor Development | Infant at 3 months of age | The Ages & Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 3-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The developmental instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain subsection score only. This domain includes 6 questions. Scores are calculated at 0, 5, or 10 per question. The highest score is 60- the lowest score would be 0. The higher the score the better. For a score greater than 41 development is considered to be on schedule. If the score falls between 38-41- targeted learning activities and monitoring is recommended. If the score falls below 38, concern for lagging infant motor development and further assessment with a professional is recommended. Scores will be presented as the mean +/- standard error compared between group |
| Incidence of Relapse | Up to 60 weeks | Relapse was defined as the use of any illicit substance or misuse of prescribed medications including medication for opioid use disorder. Incidence of relapse was determined by two main methods. Participants were assessed for relapse at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, relapses were determined and confirmed through medical record review, including inappropriate urine drug screens, when possible. Data will be presented in 2 categories: Relapse with opioids and relapse with other substances. The number of relapses is not equal to the number of participants as a single participant may have more than one relapse or polysubstance relapse. Data will be presented as the total number of relapses and compared between groups. |
| Incidence of Opioid Overdose | Up to 60 weeks | The incidence of opioid overdose was determined by two main methods. Participants were assessed for overdose at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, overdoses were determined and confirmed through medical record review when possible. Data will be presented as number of overdoses in each arm. |
| Number of Inappropriate Maternal Drug Screens at Delivery | Up to 10 days post-partum | Maternal urine drug screen (UDS) will be collected at the time of hospital admission for delivery for each participant. A urine drug screen is considered inappropriate when the presence of an illicit drug that is not prescribed for the participant is detected or the prescribed medication for opioid use disorder is not detected. The actual number of inappropriate maternal drug screens will be calculated. Results will be compared between Arms: Telemedicine and Group |
| Prenatal Engagement With Percent of Program Education Sessions Attended | Up to delivery, an average of 19 weeks | Engagement with PATHHome is measured by the number of counseling/education sessions (groups or telemedicine) attended by each participant. Results will be compared between Arms and expressed as percent of interventions attended by participants. |
| Prenatal Engagement With MAT Provider | Up to delivery, an average of 19 weeks | Engagement with MAT provider is measured by the average number of visits attended by each participant with their MAT provider. |
| Prenatal Engagement in Prenatal Care | Up to delivery, an average of 19 weeks | Engagement with Prenatal Care is considered by gestational age of entry. The number of prenatal visits is expressed as a percentage of prenatal visits attended with a denominator of prenatal visits scheduled. The data is provided by patient report and confirmed by medical record review when possible. Results will be compared between Arms. Categories reported are no prenatal visits, 5-50%, 51-100%. |
| Participants With Cigarette Dependency Over Time | Up to 60 weeks | Participants will complete the Fagerstrom Test for Cigarette Dependence 4 times during the course of the study: Intake, 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). This is a 7-question survey with each question scored on a scale of zero to 3 and totaled. Scores greater than 8 are considered high dependency, scores of 5-7 are considered moderately dependent, scores of 3-4 are low to moderate dependence and scores of 1-2 are low dependence. Data will be presented as the number of participants with cigarette dependency over time compared between groups. |
| Participants With Maternal Anxiety Over Time | Up to 60 weeks | Participants will complete the Generalized Anxiety Disorder survey at their intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 7 questions probing the participants burden of anxiety. Each question is scored from 0 to 3, with 3 representing the most severe state. A total score of 1-4 indicates minimal anxiety, 5-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. Data will be presented as the number of participants with anxiety over time compared between groups. |
| Participants With Maternal Depression Over Time | Up to 60 weeks | Participants will complete the Edinburgh Depression Scale at 4 times during the study: Intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 10 questions. Each question is scored between 0-3. An answer of 3 represents a more severe state. A total score of 1-8 falls within a normal range, a score is 9-10 is at risk for depression and a score of 11 or more indicates depression. In general, the higher the score, the more severe the depression. Data will be presented as the number of participants with depression over time compared between groups. |
| Severity of Opioid Use Disorder | Intake visit (between 6-32 weeks gestation) | Participants will complete a Diagnostic and Statistical Manual of Mental Disorders-5-TR, Addiction Severity Scale to assess their opioid dependency at the intake visit (between 6-32 weeks). The survey asks 11 questions. Each question asks about symptoms related to opioid use disorder and are answered in a yes/no format. A mild substance use disorder is diagnosed with 2-3 symptoms, moderate with 4-5 symptoms, and severe is 6 or more symptoms. Data will be presented as the number of participants in each category. |
| Incidence of Hospitalization for Opioid Related Issues During the Study Period | up to 60 weeks | Hospitalizations for opioid related issues were determined by two main methods. Participants were assessed for hospitalization at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, hospitalizations were determined and confirmed through medical record review when possible. Data will be presented as number of hospitalizations in each arm. |
| Change in Physical Condition of Infant Post-delivery by Apgar Score | Up to five minutes | Infant physical condition at birth will be assessed using the Apgar score at 1 minute and 5 minutes after birth. The Apgar score consists of 5 criteria: Appearance (skin color), pulse, grimace (reflex irritability), activity (muscle tone), respiration. Each criteria is scored 0-2. Scores are summed to evaluate a newborns health. A score of 8-10 is considered normal. A score less than 8 requires medical support. The lower the score, the more severely affected the newborn. Data will be presented as the change in Apgar score over time compared between groups. |
| Incidence of Pediatric Emergency Room (ER) Visits | birth-six months | Pediatric emergency room visits will be determined by both in person reporting during a postpartum intervention and by medical record review. Time span starts at discharge from the hospital (after birth) to 6 months postpartum. Data will be presented as the total number of pediarric ER visits compared between groups |
| Adherence to a Vaccine Schedule | Infant 3 months and 6 months of age | Adherence to a vaccine schedule will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; Is your infant up to date on vaccines?. Data will be presented as the total number of infants compliant on their vaccines and compared between groups. |
| Engagement With Pediatric Care | Infant 3 month and 6 months of life | Engagement with pediatric care will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; Does your baby regularly see a pediatrician?. Data will be presented as the total number of infants engaged in pediatric care and compared between groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of Long-term Contraception | Up to 6 months postpartum | Participants will be offered long-acting reversible contraception. Data will be presented as the number of participants per group accepting long term contraception. |
| Change in Household Size | 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. |
| Change in Employment Status | 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. |
Countries
United States
Participant flow
Recruitment details
On 8/30/2019 study design was changed to a non-inferiority and recruitment to 533. Unable to meet 533 within the time frame and budget allotted, 4 secondary outcomes were powered: Urine drug screen at delivery, number of interventions, prenatal visits and MAT visits attended. On 8/2022, recruitment target changed to 256-80 participants in telemedicine, and 176 in group. Final enrollment was 269. Enrollment occurred between 3/13/19-10/16/23 at 13 sites.
Pre-assignment details
Randomization to Group or Telemedicine was at the site level. All enrollments were predetermined by the site which the women enrolled. There was no period between enrollment and assignment. Enrollment and assignment occurred simultaneously. Wash out- periods and Run-in periods are not applicable to this study
Participants by arm
| Arm | Count |
|---|---|
| Telemedicine Education This is a stratified cluster non-inferiority 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.
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. | 82 |
| Group Care Education This is a stratified cluster non-inferiority 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.
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. | 184 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 10 |
| Overall Study | Death | 1 | 3 |
| Overall Study | Did not consent | 0 | 1 |
| Overall Study | Duplicate enrollment | 0 | 1 |
| Overall Study | Lost to Follow-up | 43 | 122 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Telemedicine Education | Group Care Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants | 184 Participants | 266 Participants |
| Age, Continuous | 30.4 years STANDARD_DEVIATION 4.8 | 30.1 years STANDARD_DEVIATION 5.4 | 30.2 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 182 Participants | 260 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 78 Participants | 181 Participants | 259 Participants |
| Region of Enrollment United States | 82 participants | 184 participants | 266 participants |
| Sex: Female, Male Female | 82 Participants | 184 Participants | 266 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 82 | 3 / 184 |
| other Total, other adverse events | 72 / 82 | 166 / 184 |
| serious Total, serious adverse events | 20 / 82 | 46 / 184 |
Outcome results
Primary
Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment
Medical records will be reviewed post-partum 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
Population: Number of participants (infants) available for data analysis per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine Education | Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment | 24.1 % infants requiring medication for NAS |
| Group Care Education | Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment | 33.3 % infants requiring medication for NAS |
Secondary
Adherence to a Vaccine Schedule
Adherence to a vaccine schedule will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; Is your infant up to date on vaccines?. Data will be presented as the total number of infants compliant on their vaccines and compared between groups.
Time frame: Infant 3 months and 6 months of age
Population: Number of infants available for data analysis per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telemedicine Education | Adherence to a Vaccine Schedule | Infant 6 months of age | 22 Number of infants |
| Telemedicine Education | Adherence to a Vaccine Schedule | Infant 3 months of age | 27 Number of infants |
| Group Care Education | Adherence to a Vaccine Schedule | Infant 3 months of age | 45 Number of infants |
| Group Care Education | Adherence to a Vaccine Schedule | Infant 6 months of age | 39 Number of infants |
Secondary
Change in Physical Condition of Infant Post-delivery by Apgar Score
Infant physical condition at birth will be assessed using the Apgar score at 1 minute and 5 minutes after birth. The Apgar score consists of 5 criteria: Appearance (skin color), pulse, grimace (reflex irritability), activity (muscle tone), respiration. Each criteria is scored 0-2. Scores are summed to evaluate a newborns health. A score of 8-10 is considered normal. A score less than 8 requires medical support. The lower the score, the more severely affected the newborn. Data will be presented as the change in Apgar score over time compared between groups.
Time frame: Up to five minutes
Population: Telemedicine arm had one set of twins; Group arm had two sets of twins. Number of participants available for data analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telemedicine Education | Change in Physical Condition of Infant Post-delivery by Apgar Score | 1 minute after birth | 7.89 score on a scale | Standard Error 0.14 |
| Telemedicine Education | Change in Physical Condition of Infant Post-delivery by Apgar Score | 5 minutes after birth | 8.61 score on a scale | Standard Error 0.1 |
| Group Care Education | Change in Physical Condition of Infant Post-delivery by Apgar Score | 1 minute after birth | 7.94 score on a scale | Standard Error 0.11 |
| Group Care Education | Change in Physical Condition of Infant Post-delivery by Apgar Score | 5 minutes after birth | 8.76 score on a scale | Standard Error 0.05 |
Secondary
Engagement With Pediatric Care
Engagement with pediatric care will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; Does your baby regularly see a pediatrician?. Data will be presented as the total number of infants engaged in pediatric care and compared between groups.
Time frame: Infant 3 month and 6 months of life
Population: Number of infants available for data analysis per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telemedicine Education | Engagement With Pediatric Care | Infant 3 months of age | 30 Number of infants adhering |
| Telemedicine Education | Engagement With Pediatric Care | Infant 6 months of age | 26 Number of infants adhering |
| Group Care Education | Engagement With Pediatric Care | Infant 3 months of age | 49 Number of infants adhering |
| Group Care Education | Engagement With Pediatric Care | Infant 6 months of age | 42 Number of infants adhering |
Secondary
Incidence of Hospitalization for Opioid Related Issues During the Study Period
Hospitalizations for opioid related issues were determined by two main methods. Participants were assessed for hospitalization at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, hospitalizations were determined and confirmed through medical record review when possible. Data will be presented as number of hospitalizations in each arm.
Time frame: up to 60 weeks
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine Education | Incidence of Hospitalization for Opioid Related Issues During the Study Period | 2 Numbe of hospitalizations |
| Group Care Education | Incidence of Hospitalization for Opioid Related Issues During the Study Period | 4 Numbe of hospitalizations |
Secondary
Incidence of Opioid Overdose
The incidence of opioid overdose was determined by two main methods. Participants were assessed for overdose at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, overdoses were determined and confirmed through medical record review when possible. Data will be presented as number of overdoses in each arm.
Time frame: Up to 60 weeks
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine Education | Incidence of Opioid Overdose | 0 Number of opioid overdoses |
| Group Care Education | Incidence of Opioid Overdose | 4 Number of opioid overdoses |
Secondary
Incidence of Pediatric Emergency Room (ER) Visits
Pediatric emergency room visits will be determined by both in person reporting during a postpartum intervention and by medical record review. Time span starts at discharge from the hospital (after birth) to 6 months postpartum. Data will be presented as the total number of pediarric ER visits compared between groups
Time frame: birth-six months
Population: Number of infants available for data analysis per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine Education | Incidence of Pediatric Emergency Room (ER) Visits | 10 Number of infants |
| Group Care Education | Incidence of Pediatric Emergency Room (ER) Visits | 11 Number of infants |
Secondary
Incidence of Relapse
Relapse was defined as the use of any illicit substance or misuse of prescribed medications including medication for opioid use disorder. Incidence of relapse was determined by two main methods. Participants were assessed for relapse at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, relapses were determined and confirmed through medical record review, including inappropriate urine drug screens, when possible. Data will be presented in 2 categories: Relapse with opioids and relapse with other substances. The number of relapses is not equal to the number of participants as a single participant may have more than one relapse or polysubstance relapse. Data will be presented as the total number of relapses and compared between groups.
Time frame: Up to 60 weeks
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telemedicine Education | Incidence of Relapse | Relapse with opioids | 10 Number of relapses |
| Telemedicine Education | Incidence of Relapse | Relapse with other substances | 37 Number of relapses |
| Group Care Education | Incidence of Relapse | Relapse with opioids | 29 Number of relapses |
| Group Care Education | Incidence of Relapse | Relapse with other substances | 188 Number of relapses |
Secondary
Infant Gross Motor Development
The Ages & Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 3-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The developmental instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain subsection score only. This domain includes 6 questions. Scores are calculated at 0, 5, or 10 per question. The highest score is 60- the lowest score would be 0. The higher the score the better. For a score greater than 41 development is considered to be on schedule. If the score falls between 38-41- targeted learning activities and monitoring is recommended. If the score falls below 38, concern for lagging infant motor development and further assessment with a professional is recommended. Scores will be presented as the mean +/- standard error compared between group
Time frame: Infant at 3 months of age
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine Education | Infant Gross Motor Development | 53.10 score on a scale | Standard Error 1.52 |
| Group Care Education | Infant Gross Motor Development | 55.22 score on a scale | Standard Error 0.88 |
Secondary
Infant Gross Motor Development
The Ages & Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 6-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The Ages and Stages 6-month survey instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain score only. This domain includes 6 questions, scores are calculated at 0, 5, or 10 per question and a score below 22 is concerning for lagging infant motor development. Scores will be presented as the mean +/- standard error compared between groups.
Time frame: Infant at 6 months of age
Population: Number of infants available for data analysis per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine Education | Infant Gross Motor Development | 50.40 score on a scale | Standard Error 2.71 |
| Group Care Education | Infant Gross Motor Development | 48.71 score on a scale | Standard Error 1.41 |
Secondary
Number of Inappropriate Maternal Drug Screens at Delivery
Maternal urine drug screen (UDS) will be collected at the time of hospital admission for delivery for each participant. A urine drug screen is considered inappropriate when the presence of an illicit drug that is not prescribed for the participant is detected or the prescribed medication for opioid use disorder is not detected. The actual number of inappropriate maternal drug screens will be calculated. Results will be compared between Arms: Telemedicine and Group
Time frame: Up to 10 days post-partum
Population: Participants available for data analysis per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telemedicine Education | Number of Inappropriate Maternal Drug Screens at Delivery | 12 # of inappropriate maternal drug screens |
| Group Care Education | Number of Inappropriate Maternal Drug Screens at Delivery | 29 # of inappropriate maternal drug screens |
Secondary
Participant Quality of Life
WHO-Quality of Life Survey (WHOQoL) will be administered to patients at 28-32 weeks gestation. WHOQoL is a 26 question self administered survey. Each question falls within 1 of 4 domains: physical health, psychological health, social relationships, environment. For purposes of reporting, we are using the first question, How would you rate your quality of life? on a scale of 1-5, with 1 being very poor quality, 2 poor quality, 3 neither poor nor good, 4 good quality, 5 very good quality.
Time frame: 28-32 weeks gestation
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Education | Participant Quality of Life | Good quality of life | 26 Participants |
| Telemedicine Education | Participant Quality of Life | Poor quality of life | 0 Participants |
| Telemedicine Education | Participant Quality of Life | Neither poor nor good quality of life | 2 Participants |
| Telemedicine Education | Participant Quality of Life | Very poor quality of life | 0 Participants |
| Telemedicine Education | Participant Quality of Life | Very Good quality of life | 18 Participants |
| Group Care Education | Participant Quality of Life | Very poor quality of life | 0 Participants |
| Group Care Education | Participant Quality of Life | Very Good quality of life | 29 Participants |
| Group Care Education | Participant Quality of Life | Good quality of life | 55 Participants |
| Group Care Education | Participant Quality of Life | Neither poor nor good quality of life | 6 Participants |
| Group Care Education | Participant Quality of Life | Poor quality of life | 1 Participants |
Secondary
Participants With Cigarette Dependency Over Time
Participants will complete the Fagerstrom Test for Cigarette Dependence 4 times during the course of the study: Intake, 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). This is a 7-question survey with each question scored on a scale of zero to 3 and totaled. Scores greater than 8 are considered high dependency, scores of 5-7 are considered moderately dependent, scores of 3-4 are low to moderate dependence and scores of 1-2 are low dependence. Data will be presented as the number of participants with cigarette dependency over time compared between groups.
Time frame: Up to 60 weeks
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 8-10: High dependency | 8 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 8-10: High dependency | 8 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 3-4: low- moderate dependency | 8 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 0: None; Former or never smoker | 5 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 1-2: Low dependency | 3 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 3-4: low- moderate dependency | 6 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 1-2: Low dependency | 4 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 5-7: Moderate dependency | 8 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 1-2: Low dependency | 2 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 8-10: High dependency | 5 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 5-7: Moderate dependency | 12 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | Intake | 1-2: Low dependency | 7 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | Intake | 0: None; Former or never smoker | 14 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 0: None; Former or never smoker | 4 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 3-4: low- moderate dependency | 4 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | Intake | 3-4: low- moderate dependency | 15 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 0: None; Former or never smoker | 10 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | Intake | 5-7: Moderate dependency | 27 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 5-7: Moderate dependency | 12 Participants |
| Telemedicine Education | Participants With Cigarette Dependency Over Time | Intake | 8-10: High dependency | 12 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 1-2: Low dependency | 6 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | Intake | 8-10: High dependency | 17 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 0: None; Former or never smoker | 23 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 1-2: Low dependency | 10 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 3-4: low- moderate dependency | 23 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 5-7: Moderate dependency | 29 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 28-32weeks | 8-10: High dependency | 4 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 0: None; Former or never smoker | 16 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 1-2: Low dependency | 9 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 3-4: low- moderate dependency | 7 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 5-7: Moderate dependency | 13 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 3 months postpartum | 8-10: High dependency | 4 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 0: None; Former or never smoker | 17 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 3-4: low- moderate dependency | 7 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 5-7: Moderate dependency | 7 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | 6 months postpartum | 8-10: High dependency | 2 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | Intake | 0: None; Former or never smoker | 42 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | Intake | 1-2: Low dependency | 20 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | Intake | 3-4: low- moderate dependency | 28 Participants |
| Group Care Education | Participants With Cigarette Dependency Over Time | Intake | 5-7: Moderate dependency | 64 Participants |
Secondary
Participants With Maternal Anxiety Over Time
Participants will complete the Generalized Anxiety Disorder survey at their intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 7 questions probing the participants burden of anxiety. Each question is scored from 0 to 3, with 3 representing the most severe state. A total score of 1-4 indicates minimal anxiety, 5-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. Data will be presented as the number of participants with anxiety over time compared between groups.
Time frame: Up to 60 weeks
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telemedicine Education | Participants With Maternal Anxiety Over Time | Intake | '0': No anxiety | 7 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | Intake | 5-14 Moderate anxiety | 43 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | Intake | 15-21 Severe anxiety | 11 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | '0': No anxiety | 5 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | 1-4: Minimal anxiety | 11 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | 5-14 Moderate anxiety | 26 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | 15-21 Severe anxiety | 5 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | '0': No anxiety | 6 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | 1-4: Minimal anxiety | 10 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | 5-14 Moderate anxiety | 15 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | 15-21 Severe anxiety | 0 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | '0': No anxiety | 6 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | 1-4: Minimal anxiety | 7 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | 5-14 Moderate anxiety | 11 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | 15-21 Severe anxiety | 2 Participants |
| Telemedicine Education | Participants With Maternal Anxiety Over Time | Intake | 1-4: Minimal anxiety | 16 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | Intake | 1-4: Minimal anxiety | 50 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | Intake | '0': No anxiety | 23 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | 1-4: Minimal anxiety | 13 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | Intake | 5-14 Moderate anxiety | 78 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | 1-4: Minimal anxiety | 10 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | Intake | 15-21 Severe anxiety | 20 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | 5-14 Moderate anxiety | 20 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | '0': No anxiety | 23 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | 15-21 Severe anxiety | 1 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | 1-4: Minimal anxiety | 27 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | 15-21 Severe anxiety | 5 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | 5-14 Moderate anxiety | 34 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | 5-14 Moderate anxiety | 18 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 28-32 weeks | 15-21 Severe anxiety | 7 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 6 months postpartum | '0': No anxiety | 10 Participants |
| Group Care Education | Participants With Maternal Anxiety Over Time | 3 months postpartum | '0': No anxiety | 11 Participants |
Secondary
Participants With Maternal Depression Over Time
Participants will complete the Edinburgh Depression Scale at 4 times during the study: Intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 10 questions. Each question is scored between 0-3. An answer of 3 represents a more severe state. A total score of 1-8 falls within a normal range, a score is 9-10 is at risk for depression and a score of 11 or more indicates depression. In general, the higher the score, the more severe the depression. Data will be presented as the number of participants with depression over time compared between groups.
Time frame: Up to 60 weeks
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telemedicine Education | Participants With Maternal Depression Over Time | Intake | 1-8: Normal | 24 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | Intake | 9-10: At risk for depression | 8 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | Intake | 11-29: Depression | 46 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 28-32 weeks | 1-8: Normal | 21 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 28-32 weeks | 9-10: At risk for depression | 5 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 28-32 weeks | 11-29: Depression | 20 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 3 months postpartum | 1-8: Normal | 20 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 3 months postpartum | 9-10: At risk for depression | 2 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 3 months postpartum | 11-29: Depression | 9 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 6 months postpartum | 1-8: Normal | 13 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 6 months postpartum | 9-10: At risk for depression | 1 Participants |
| Telemedicine Education | Participants With Maternal Depression Over Time | 6 months postpartum | 11-29: Depression | 9 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 6 months postpartum | 9-10: At risk for depression | 7 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | Intake | 1-8: Normal | 60 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 3 months postpartum | 1-8: Normal | 19 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | Intake | 9-10: At risk for depression | 19 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 6 months postpartum | 1-8: Normal | 15 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | Intake | 11-29: Depression | 88 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 3 months postpartum | 9-10: At risk for depression | 10 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 28-32 weeks | 1-8: Normal | 38 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 6 months postpartum | 11-29: Depression | 13 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 28-32 weeks | 9-10: At risk for depression | 10 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 3 months postpartum | 11-29: Depression | 16 Participants |
| Group Care Education | Participants With Maternal Depression Over Time | 28-32 weeks | 11-29: Depression | 37 Participants |
Secondary
Prenatal Engagement in Prenatal Care
Engagement with Prenatal Care is considered by gestational age of entry. The number of prenatal visits is expressed as a percentage of prenatal visits attended with a denominator of prenatal visits scheduled. The data is provided by patient report and confirmed by medical record review when possible. Results will be compared between Arms. Categories reported are no prenatal visits, 5-50%, 51-100%.
Time frame: Up to delivery, an average of 19 weeks
Population: Number of participants available for data analysis per protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Education | Prenatal Engagement in Prenatal Care | No prenatal care visits | 4 Participants |
| Telemedicine Education | Prenatal Engagement in Prenatal Care | 5-50% prenatal care visits | 16 Participants |
| Telemedicine Education | Prenatal Engagement in Prenatal Care | 51-100% prenatal care visits | 59 Participants |
| Group Care Education | Prenatal Engagement in Prenatal Care | No prenatal care visits | 11 Participants |
| Group Care Education | Prenatal Engagement in Prenatal Care | 5-50% prenatal care visits | 35 Participants |
| Group Care Education | Prenatal Engagement in Prenatal Care | 51-100% prenatal care visits | 129 Participants |
Secondary
Prenatal Engagement With MAT Provider
Engagement with MAT provider is measured by the average number of visits attended by each participant with their MAT provider.
Time frame: Up to delivery, an average of 19 weeks
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine Education | Prenatal Engagement With MAT Provider | 12.0 Visits | Standard Error 1.7 |
| Group Care Education | Prenatal Engagement With MAT Provider | 8.40 Visits | Standard Error 0.65 |
Secondary
Prenatal Engagement With Percent of Program Education Sessions Attended
Engagement with PATHHome is measured by the number of counseling/education sessions (groups or telemedicine) attended by each participant. Results will be compared between Arms and expressed as percent of interventions attended by participants.
Time frame: Up to delivery, an average of 19 weeks
Population: Number of participants available for data analysis per protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Education | Prenatal Engagement With Percent of Program Education Sessions Attended | No intervention attended | 12 Participants |
| Telemedicine Education | Prenatal Engagement With Percent of Program Education Sessions Attended | 5-50% interventions attended | 26 Participants |
| Telemedicine Education | Prenatal Engagement With Percent of Program Education Sessions Attended | 51-100% interventions attended | 41 Participants |
| Group Care Education | Prenatal Engagement With Percent of Program Education Sessions Attended | No intervention attended | 36 Participants |
| Group Care Education | Prenatal Engagement With Percent of Program Education Sessions Attended | 5-50% interventions attended | 62 Participants |
| Group Care Education | Prenatal Engagement With Percent of Program Education Sessions Attended | 51-100% interventions attended | 77 Participants |
Secondary
Severity of Opioid Use Disorder
Participants will complete a Diagnostic and Statistical Manual of Mental Disorders-5-TR, Addiction Severity Scale to assess their opioid dependency at the intake visit (between 6-32 weeks). The survey asks 11 questions. Each question asks about symptoms related to opioid use disorder and are answered in a yes/no format. A mild substance use disorder is diagnosed with 2-3 symptoms, moderate with 4-5 symptoms, and severe is 6 or more symptoms. Data will be presented as the number of participants in each category.
Time frame: Intake visit (between 6-32 weeks gestation)
Population: Number of participants available for data analysis per protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Education | Severity of Opioid Use Disorder | 0-1: None/Minimal | 41 Participants |
| Telemedicine Education | Severity of Opioid Use Disorder | 2-3: Mild | 8 Participants |
| Telemedicine Education | Severity of Opioid Use Disorder | 6-11: Severe | 22 Participants |
| Telemedicine Education | Severity of Opioid Use Disorder | 4-5: Moderate | 7 Participants |
| Group Care Education | Severity of Opioid Use Disorder | 6-11: Severe | 63 Participants |
| Group Care Education | Severity of Opioid Use Disorder | 0-1: None/Minimal | 65 Participants |
| Group Care Education | Severity of Opioid Use Disorder | 2-3: Mild | 25 Participants |
| Group Care Education | Severity of Opioid Use Disorder | 4-5: Moderate | 15 Participants |
Other Pre-specified
Acceptance of Long-term Contraception
Participants will be offered long-acting reversible contraception. Data will be presented as the number of participants per group accepting long term contraception.
Time frame: Up to 6 months postpartum
Other Pre-specified
Change in Employment Status
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
Other Pre-specified
Change in Household Size
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