Optimizing Pregnancy and Treatment Interventions for Moms 2.0
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|ClinicalTrials.gov Identifier: NCT03833245|
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : April 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy, High Risk Opioid-Related Disorders Pregnancy Related||Behavioral: Patient Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Optimizing Pregnancy and Treatment Interventions for Moms 2.0|
|Actual Study Start Date :||March 11, 2019|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||September 2022|
No Intervention: 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.
Experimental: 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.
Behavioral: 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.
- Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD) Treatment Linkage/Retention [ Time Frame: 36 months ]OUD and other SUD treatment linkage/retention will be assessed through the treatment services review (TSR-6). The TSR-6 is a clinically validated 56-item measure with excellent reliability. We will capture frequency of meetings, sessions, day in OUD and other substance counseling.
- Opioid Abstinence [ Time Frame: 36 months ]Opioid abstinence will be accessed using a 14-panel urine toxicology screening.
- Adherence to Medication-Assisted Treatment (MAT) [ Time Frame: 36 months ]Adherence to MAT will be accessed using a 14-panel urine toxicology screening.
- Adherence to Medication-Assisted Treatment (MAT) [ Time Frame: 36 months ]Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section.
- Linkage/Retention in Psychosocial Services [ Time Frame: 36 months ]Linkage/retention in psychosocial services will be accessed through medical record review.
- Adequacy of Prenatal Care [ Time Frame: 36 months ]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.
- Needle use and safe sex frequency [ Time Frame: 36 months ]The Risk Behavior Survey (RBA) will be used to access HIV/Hepatitis C virus (HCV) risk behaviors. The RBA is a self-report, 22-item assessment provides the highest 30-day reliability among standardized instruments for HIV/HCV-risk behaviors among drug users.
- Incidence of depression and anxiety [ Time Frame: 36 months ]The patient health questionnaire (PHQ) will be used to assess mental health. The PHQ is an 11-item mental health assessment with demonstrated criterion validity and reliability. The PHQ accesses depression, suicide ideation, anxiety, somatoform, eating and alcohol use disorders.
- Child and mother bond following delivery [ Time Frame: 36 months ]Child and mother indicators will be accessed through the Maternal-Fetal Attachment survey.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833245
|Contact: Gerald Cochran, PhDfirstname.lastname@example.org|
|Contact: Kristi Carlston, BSemail@example.com|
|United States, Pennsylvania|
|Magee Women's Hospital||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Walitta Abdullah|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Kristi Carlston, BS 801-213-0799 firstname.lastname@example.org|
|Principal Investigator:||Gerald Cochran, PhD||University of Utah|