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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Patient Navigation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
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Inclusion Criteria:
Participant Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Cochran, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37859587 | Derived | Cochran G, Smid MC, Krans EE, Yu Z, Carlston K, White A, Abdulla W, Baylis J, Charron E, Okifugi A, Gordon AJ, Lundahl B, Silipigni J, Seliski N, Haaland B, Tarter R. Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Addiction. 2024 Mar;119(3):544-556. doi: 10.1111/add.16364. Epub 2023 Oct 20. | |
| 37103536 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percentage of days | 6 months |
|
Death was the only adverse event collected.
Adverse event collection started at baseline and ended at 6 months post-partum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerald Cochran, PhD | University of Utah | 801-213-0799 | jerry.cochran@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2020 | Dec 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2020 | Dec 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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|
| Salt Lake City |
| Utah |
| 84108 |
| United States |
| Charles JE, Baylis J, Smid MC, Cochran G. Nonfatal Overdoses Among Pregnant Individuals With Opioid Use Disorder. Obstet Gynecol. 2023 May 1;141(5):961-963. doi: 10.1097/AOG.0000000000005129. Epub 2023 Apr 5. |
| 35349380 | Derived | Bryan MA, Mallik D, Cochran G, Lundahl B. Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment. Subst Use Misuse. 2022;57(5):822-826. doi: 10.1080/10826084.2022.2046090. Epub 2022 Mar 10. |
| 31731006 | Derived | Cochran G, Smid MC, Krans EE, Bryan MA, Gordon AJ, Lundahl B, Silipigni J, Haaland B, Tarter R. A pilot multisite study of patient navigation for pregnant women with opioid use disorder. Contemp Clin Trials. 2019 Dec;87:105888. doi: 10.1016/j.cct.2019.105888. Epub 2019 Nov 12. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Location | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Percentage of days of attendance | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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. | 1 | 53 | 0 | 53 | 0 | 53 |
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| D006298 | Health Services Administration |
| Intermediate |
|
| Inadequate |
|