Opioid-use Disorder
Conditions
Keywords
opioid, pregnant
Brief summary
The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)
Detailed description
The investigators are proposing a cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with an OUD: 1) a collaborative care (CC) approach based upon the Massachusetts Office-Based-Opioid Treatment (OBOT) Model that would provide onsite training, and support to providers and participants through the use of care managers (CMs) vs 2) a telesupport approach modeled on the Project Extension for Community Healthcare Outcomes (ECHO), a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing.
Interventions
BEHAVIORALCollaborative 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.
BEHAVIORALExtension 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.
Sponsors
Patient-Centered Outcomes Research Institute
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study will use a matched-pair cluster randomized trail design. The investigators will match clinical centers in pairs. The participants in each pair will be randomly assigned to either CC or ECHO using computer generated random numbers.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Females age 18 or older * Documented pregnancy in the medical record at less than 34 weeks gestation * Delivery date no later than July 1, 2024 * Willingness to adhere to the study schedule * Confirmed opioid use disorder by the DSM-5 Opioid Use Disorder questionnaire * Ability to communicate in English * No current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks
Exclusion criteria
* Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent * Current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible * Current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Engagement | 30 days from baseline | Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD |
| Treatment Retention | delivery and three-month post-partum | 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. |
| Patient Activation Measure (PAM) | baseline, week 26, week 36 and 3-monhts post-partum | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 126 |
| 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. | 102 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 12 |
| Overall Study | Withdrawal by Subject | 13 | 4 |
Baseline characteristics
| Characteristic | Collaborative Care (CC) | Total | Extension for Community Healthcare Outcomes (ECHO) |
|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 4.5 | 31.4 years STANDARD_DEVIATION 4.7 | 31.0 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 38 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 182 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 26 Participants | 12 Participants |
| Race (NIH/OMB) White | 98 Participants | 175 Participants | 77 Participants |
| Region of Enrollment United States | 126 participants | 228 participants | 102 participants |
| Sex: Female, Male Female | 126 Participants | 228 Participants | 102 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 / 126 | 0 / 102 |
| other Total, other adverse events | 0 / 126 | 0 / 102 |
| serious Total, serious adverse events | 22 / 126 | 18 / 102 |
Outcome results
Primary
Patient Activation Measure (PAM)
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.
Time frame: baseline, week 26, week 36 and 3-monhts post-partum
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collaborative Care (CC) | Patient Activation Measure (PAM) | Baseline | 74.77 score on a scale | Standard Deviation 19.03 |
| Collaborative Care (CC) | Patient Activation Measure (PAM) | Week 26 | 78.32 score on a scale | Standard Deviation 17.77 |
| Collaborative Care (CC) | Patient Activation Measure (PAM) | Week 36 | 77.37 score on a scale | Standard Deviation 16.35 |
| Collaborative Care (CC) | Patient Activation Measure (PAM) | 3 months post partum | 76.62 score on a scale | Standard Deviation 17.26 |
| Extension for Community Healthcare Outcomes (ECHO) | Patient Activation Measure (PAM) | Week 26 | 78.14 score on a scale | Standard Deviation 18.11 |
| Extension for Community Healthcare Outcomes (ECHO) | Patient Activation Measure (PAM) | 3 months post partum | 78.25 score on a scale | Standard Deviation 16.52 |
| Extension for Community Healthcare Outcomes (ECHO) | Patient Activation Measure (PAM) | Baseline | 76.6 score on a scale | Standard Deviation 17.75 |
| Extension for Community Healthcare Outcomes (ECHO) | Patient Activation Measure (PAM) | Week 36 | 78.55 score on a scale | Standard Deviation 17.47 |
Comparison: At week 36p-value: 0.51895% CI: [-3.13, 6.19]Mixed Models Analysis
Comparison: At 3 months post partump-value: 0.89395% CI: [-4.41, 5.06]Mixed Models Analysis
Primary
Treatment Engagement
Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD
Time frame: 30 days from baseline
Population: The engagement cohort included individuals who did not enroll in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collaborative Care (CC) | Treatment Engagement | Not engaged | 78 Participants |
| Collaborative Care (CC) | Treatment Engagement | Engaged | 109 Participants |
| Extension for Community Healthcare Outcomes (ECHO) | Treatment Engagement | Not engaged | 64 Participants |
| Extension for Community Healthcare Outcomes (ECHO) | Treatment Engagement | Engaged | 92 Participants |
p-value: 0.53495% CI: [0.462, 4.055]Mixed Models Analysis
Primary
Treatment Retention
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.
Time frame: delivery and three-month post-partum
Population: Data presented here is from all participants who completed assessments at each time frame.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Collaborative Care (CC) | Treatment Retention | Delivery | Not retained | 17 Participants |
| Collaborative Care (CC) | Treatment Retention | Delivery | Retained | 99 Participants |
| Collaborative Care (CC) | Treatment Retention | 3 months post partum | Not retained | 18 Participants |
| Collaborative Care (CC) | Treatment Retention | 3 months post partum | Retained | 96 Participants |
| Extension for Community Healthcare Outcomes (ECHO) | Treatment Retention | 3 months post partum | Retained | 84 Participants |
| Extension for Community Healthcare Outcomes (ECHO) | Treatment Retention | Delivery | Not retained | 12 Participants |
| Extension for Community Healthcare Outcomes (ECHO) | Treatment Retention | 3 months post partum | Not retained | 11 Participants |
| Extension for Community Healthcare Outcomes (ECHO) | Treatment Retention | Delivery | Retained | 87 Participants |
Comparison: At deliveryp-value: 0.695% CI: [0.326, 1.979]Mixed Models Analysis
Comparison: At 3 months post partump-value: 0.47195% CI: [0.254, 1.975]Mixed Models Analysis