Opioid-Related Disorders, Pregnancy, High Risk, Pregnancy Related
Conditions
Brief summary
The US opioid epidemic continues to result in serious health consequences for pregnant and postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year reported past month opioid misuse. This study aims to provide rapid and targeted primary prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to become linked to and retained in treatment in order to reduce harms to them (including overdose) and their offspring.
Detailed description
Age adjusted rates for overdose among women in the US increased more than six-fold from 1.4 in 1999 to 8.5 in 2016. Examining Pennsylvania (PA) and Utah (UT; the states where recruitment will happen in this study), these states have some of the highest rates of overdose among women compared to other US states. Specifically, PA's overdose rate among women surpassed the national average in 2016, and rates of overdose death in UT among women have ranged 2-9 times higher than the national rate between 2009 to 2016. Both PA and Utah are among the states with the highest opioid prescribing to pregnant women, with Utah being the highest in the nation (41.6%). Prenatal opioid use disorder (OUD) in the US has brought serious health consequences for mother and infant-including preterm delivery, low birth weight, NAS, and poor breastfeeding, and includes substantial expenditures of health care resources. Chances for HIV (OR=20.3, 95% CI = 13.8-29.7) and hepatitis C virus (OR=150.2. 95% CI = 120.9-186.6) infection among women with OUD are markedly higher than for those without OUD. Pregnant women with OUD have high rates of psychiatric illnesses, such as depression and anxiety, and other substance use disorders (SUDs), with particularly high rates of smoking (\>80%). Neonatal abstinence syndrome (NAS), an opioid withdrawal syndrome among neonates, has also increased substantially from 3.4/1000 births in 2009 to 5.8/1000 births in 2012. Poly-substance use among pregnant women with OUD has also been associated with higher levels of needed medications to treat NAS and longer duration of NAS treatment. Smoking combined with opioid use during pregnancy has likewise been related to longer duration of NAS treatment, greater NAS severity, and higher levels of medication needed to treat NAS symptomology. Any prenatal opioid use also has been associated with birth defects, including neural tube defects, conoventricular septal defects, atrioventricular septal defects, hypoplastic left heart syndrome, and gastroschisis. Compared with women without any SUDs, children born to mothers with OUD or OUD plus other SUDs also have been documented to have lower cognitive functioning as they mature. Problems resulting from illicit and prescription OUD also result in significant social issues. Pregnant women with OUD have been observed to have financial and housing instability, challenges related to employment, and involvement with the legal system.
Interventions
BEHAVIORALPatient Navigation
The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact.
Sponsors
University of Pittsburgh
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥18 years) * English speaking * Pregnant women (pregnancy status verified by gestational age \>6 weeks from last menstrual period confirmed by ultrasound) * OUD verified by examination of medical records for an OUD diagnosis, urine toxicology, and the Diagnostic and Statistical Manual of Mental Disorders (DSM) Checklist (modified from the DSM-IV to confirm current diagnosis for substance use disorders) * Plan to carry their babies to delivery verified by patient self report Participant
Exclusion criteria
* Experienced a psychotic or a manic episode in the last 30 days documented in their medical record * Beyond the 25th week of gestation * Cannot provide collateral contact information of 2 persons, * Cannot provide a reliable phone number, * Plan to move from the area within 2 months of their delivery will or 6 months after not be included in the study * Inability or unwillingness of subject or legal guardian/representative to give written informed consent. * Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention | 6 months | Percentage of days of days of attending outpatient and inpatient Substance Use Disorder treatment. |
| Adherence to Medication-Assisted Treatment (MAT) Medication Use Section | 6 months | Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section defined by percentage days of attendance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of Prenatal Care | 1 week | Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Navigation The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention.
Patient Navigation: The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact. | 53 |
| Usual Care The standard care condition includes brief case management and referral. The brief case management involves the participant speaking to a hospital social worker who conducts a patient needs assessment in the areas of behavioral health and social services. All patients will be referred to MAT and any identified behavioral health or social service needs. | 49 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Total | Patient Navigation |
|---|---|---|---|
| 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 | 49 Participants | 102 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 95 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Location Pennsylvania | 28 Participants | 57 Participants | 29 Participants |
| Location Utah | 21 Participants | 45 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 40 Participants | 85 Participants | 45 Participants |
| Region of Enrollment United States | 49 participants | 102 participants | 53 participants |
| Sex: Female, Male Female | 49 Participants | 102 Participants | 53 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 | 0 / 49 | 1 / 53 |
| other Total, other adverse events | 0 / 49 | 0 / 53 |
| serious Total, serious adverse events | 0 / 49 | 0 / 53 |
Outcome results
Primary
Adherence to Medication-Assisted Treatment (MAT) Medication Use Section
Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section defined by percentage days of attendance.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Adherence to Medication-Assisted Treatment (MAT) Medication Use Section | 30.7 Percentage of days of attendance | Standard Deviation 43.8 |
| Patient Navigation | Adherence to Medication-Assisted Treatment (MAT) Medication Use Section | 40.4 Percentage of days of attendance | Standard Deviation 53.6 |
Primary
Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention
Percentage of days of days of attending outpatient and inpatient Substance Use Disorder treatment.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention | -1.5 Percentage of days | Standard Deviation 50.2 |
| Patient Navigation | Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention | -8.8 Percentage of days | Standard Deviation 46.7 |
Secondary
Adequacy of Prenatal Care
Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received.
Time frame: 1 week
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Adequacy of Prenatal Care | Adequate plus | 10 Participants |
| Control | Adequacy of Prenatal Care | Adequate | 13 Participants |
| Control | Adequacy of Prenatal Care | Intermediate | 11 Participants |
| Control | Adequacy of Prenatal Care | Inadequate | 9 Participants |
| Patient Navigation | Adequacy of Prenatal Care | Inadequate | 11 Participants |
| Patient Navigation | Adequacy of Prenatal Care | Adequate plus | 12 Participants |
| Patient Navigation | Adequacy of Prenatal Care | Intermediate | 11 Participants |
| Patient Navigation | Adequacy of Prenatal Care | Adequate | 15 Participants |