Trial Outcomes & Findings for Treatment of Pregnant Women With OUD (NCT NCT04240392)
NCT ID: NCT04240392
Last Updated: 2025-05-21
Results Overview
Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome timeframe
30 days from baseline
Results posted on
2025-05-21
Participant Flow
Recruitment of participants occurred at one of the participating clinical sites. Clinical sites, not participants, were randomized to either CC or ECHO; therefore, all participants recruited from the same clinical site were randomized to the same model, CC or ECHO.
230 pregnant participants were enrolled; however, two participants had their pregnancies end before they could engage in the intervention. Therefore, only 228 participants underwent the intervention.
Unit of analysis: clinical site
Participant milestones
| Measure |
Collaborative Care (CC)
The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures.
Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.
|
Extension for Community Healthcare Outcomes (ECHO)
ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.
Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
126 6
|
102 6
|
|
Overall Study
Completed Baseline
|
113 6
|
90 6
|
|
Overall Study
Completed Week 26
|
102 6
|
81 6
|
|
Overall Study
Completed Week 36
|
96 6
|
77 6
|
|
Overall Study
Completed 3 Month Postpartum
|
102 6
|
86 6
|
|
Overall Study
COMPLETED
|
102 6
|
86 6
|
|
Overall Study
NOT COMPLETED
|
24 0
|
16 0
|
Reasons for withdrawal
| Measure |
Collaborative Care (CC)
The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures.
Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.
|
Extension for Community Healthcare Outcomes (ECHO)
ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.
Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
|
Overall Study
Lost to Follow-up
|
11
|
12
|
Baseline Characteristics
Treatment of Pregnant Women With OUD
Baseline characteristics by cohort
| Measure |
Collaborative Care (CC)
n=126 Participants
The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures.
Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.
|
Extension for Community Healthcare Outcomes (ECHO)
n=102 Participants
ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.
Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=5 Participants
|
102 participants
n=7 Participants
|
228 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days from baselinePopulation: The engagement cohort included individuals who did not enroll in the study.
Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD
Outcome measures
| Measure |
Collaborative Care (CC)
n=187 Participants
The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures.
Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.
|
Extension for Community Healthcare Outcomes (ECHO)
n=156 Participants
ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.
Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
|
|---|---|---|
|
Treatment Engagement
Not engaged
|
78 Participants
|
64 Participants
|
|
Treatment Engagement
Engaged
|
109 Participants
|
92 Participants
|
PRIMARY outcome
Timeframe: delivery and three-month post-partumPopulation: Data presented here is from all participants who completed assessments at each time frame.
Dichotomous- A participant is considered to have been successfully retained in the study if the participant remained in treatment with no stoppage of greater than 1 month. The numbers reported below for 3 months postpartum differ from those in the Participant Flow, as the numbers in the Participant Flow represent only completed REDCap survey assessments. For the retention outcome, we could utilize additional sources of data collection, such as medical records, site reports, and treatment utilization forms (which were done more frequently than survey assessments), thus resulting in a higher N for this outcome.
Outcome measures
| Measure |
Collaborative Care (CC)
n=126 Participants
The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures.
Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.
|
Extension for Community Healthcare Outcomes (ECHO)
n=102 Participants
ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.
Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
|
|---|---|---|
|
Treatment Retention
Delivery · Not retained
|
17 Participants
|
12 Participants
|
|
Treatment Retention
Delivery · Retained
|
99 Participants
|
87 Participants
|
|
Treatment Retention
3 months post partum · Not retained
|
18 Participants
|
11 Participants
|
|
Treatment Retention
3 months post partum · Retained
|
96 Participants
|
84 Participants
|
PRIMARY outcome
Timeframe: baseline, week 26, week 36 and 3-monhts post-partumPopulation: Data presented here is from all participants who completed assessments at each time frame. The numbers 117 and 94 represent the total number of participants with a PAM score recorded at any time point, as they were included in the analysis model. There were 17 participants who did not complete the PAM assessment at any time point.
The PAM is a patient-centered questionnaire that measures health care knowledge, beliefs, skills and confidence in managing illnesses. The PAM has 13 items with a 5-point Likert response scale. The raw scores are summed and transformed to 0-100 metric (0 = lowest activation level, 100 = highest). The Week 26 numbers below are lower than those in the Participant Flow because participants were allowed to enter the study after 26 weeks of pregnancy and did not have a separate baseline and Week 26 PAM assessment; instead, it was counted as their baseline PAM assessment only. However, other study assessments were unique to week 26 and were completed concurrently with baseline assessments, which were counted separately, accounting for the higher N for Week 26 in the Participant Flow. The postpartum ECHO sample size is 85 rather than 86 because one participant skipped the PAM questions during their 3-month postpartum assessment.
Outcome measures
| Measure |
Collaborative Care (CC)
n=117 Participants
The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures.
Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.
|
Extension for Community Healthcare Outcomes (ECHO)
n=94 Participants
ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.
Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
|
|---|---|---|
|
Patient Activation Measure (PAM)
Week 26
|
78.32 score on a scale
Standard Deviation 17.77
|
78.14 score on a scale
Standard Deviation 18.11
|
|
Patient Activation Measure (PAM)
3 months post partum
|
76.62 score on a scale
Standard Deviation 17.26
|
78.25 score on a scale
Standard Deviation 16.52
|
|
Patient Activation Measure (PAM)
Baseline
|
74.77 score on a scale
Standard Deviation 19.03
|
76.6 score on a scale
Standard Deviation 17.75
|
|
Patient Activation Measure (PAM)
Week 36
|
77.37 score on a scale
Standard Deviation 16.35
|
78.55 score on a scale
Standard Deviation 17.47
|
Adverse Events
Collaborative Care (CC)
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Extension for Community Healthcare Outcomes (ECHO)
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Collaborative Care (CC)
n=126 participants at risk
The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures.
Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.
|
Extension for Community Healthcare Outcomes (ECHO)
n=102 participants at risk
ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.
Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
|
|---|---|---|
|
General disorders
Hospitalization for opioid withdrawal
|
3.2%
4/126 • 52 weeks
|
0.00%
0/102 • 52 weeks
|
|
General disorders
Drug overdose
|
1.6%
2/126 • 52 weeks
|
2.0%
2/102 • 52 weeks
|
|
General disorders
Residential treatment admission
|
0.79%
1/126 • 52 weeks
|
2.9%
3/102 • 52 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
10.3%
13/126 • 52 weeks
|
9.8%
10/102 • 52 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Short Cervix effecting pregnancy
|
0.00%
0/126 • 52 weeks
|
0.98%
1/102 • 52 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Fetal demise
|
0.79%
1/126 • 52 weeks
|
0.00%
0/102 • 52 weeks
|
|
Cardiac disorders
Thrombotic stroke
|
0.00%
0/126 • 52 weeks
|
0.98%
1/102 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Necrotizing Pneumonia
|
0.00%
0/126 • 52 weeks
|
0.98%
1/102 • 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.79%
1/126 • 52 weeks
|
0.00%
0/102 • 52 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place