Trial Outcomes & Findings for PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics (NCT NCT02760004)
NCT ID: NCT02760004
Last Updated: 2024-06-10
Results Overview
EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
312 participants
Primary outcome timeframe
Baseline up to 13 months postpartum
Results posted on
2024-06-10
Participant Flow
Participants were enrolled from the 10 participating OB/Gyn practices from October 2017 to November 2020. The 10 obstetric practices were randomized to one of the two interventions (5 each) and patient participants from these practices provided data for evaluating the effectiveness of each intervention. Individual patient participant data were analyzed to assess effectiveness.
Of the 1265 screened, 312 met the inclusion criteria. The practices were randomized to the 2 intervention arms of the study.
Unit of analysis: OB Practices
Participant milestones
| Measure |
PRISM Intervention
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms
* PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
|
MCPAP for Moms
MCPAP for Moms
Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
|
|---|---|---|
|
Overall Study
STARTED
|
150 5
|
162 5
|
|
Overall Study
COMPLETED
|
137 5
|
140 5
|
|
Overall Study
NOT COMPLETED
|
13 0
|
22 0
|
Reasons for withdrawal
| Measure |
PRISM Intervention
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms
* PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
|
MCPAP for Moms
MCPAP for Moms
Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
22
|
Baseline Characteristics
PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
Baseline characteristics by cohort
| Measure |
PRISM Intervention
n=150 Participants
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms
* PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
|
MCPAP for Moms
n=162 Participants
MCPAP for Moms
Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 6 • n=5 Participants
|
33 years
STANDARD_DEVIATION 6 • n=7 Participants
|
32 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
312 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
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
162 participants
n=7 Participants
|
312 participants
n=5 Participants
|
|
Education
Grade school/Some high school
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Education
High school diplomaor GED equivalent
|
46 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Education
Some college no degree
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Education
Associate degree
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Education
Bachelor's degree
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Education
Master's degree
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Education
Doctoral degree or equivalent
|
0 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Education
Other - Missing data
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Primary source of payment for prenatal care
Tricare/Self-pay/Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Primary source of payment for prenatal care
Private or Commercial
|
61 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Primary source of payment for prenatal care
Medicaid/Mass Health/Other public
|
86 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Primary source of payment for prenatal care
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 13 months postpartumPopulation: Out of the participants enrolled in the study, data was obtained and analyzed for 118 participants in the PRISM Intervention and 117 in the MCPAP for Moms for this outcome measure. These subgroups are based on the number of Participants who had both the baseline EPDS score and a final 11-13 months postpartum EPDS score. Participants can enter at \[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.
EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).
Outcome measures
| Measure |
PRISM Intervention
n=118 Participants
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM): • PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
|
MCPAP for Moms
n=117 Participants
MCPAP for Moms
* 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
|
|---|---|---|
|
Change in Edinburgh Postnatal Depression Scale Score (EPDS)
|
-4.3 score on a scale
Standard Deviation 4.5
|
-4.2 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline to up to 13 months postpartumPopulation: Participants can enter at \[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.
Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Outcome measures
| Measure |
PRISM Intervention
n=150 Participants
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM): • PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
|
MCPAP for Moms
n=162 Participants
MCPAP for Moms
* 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
|
|---|---|---|
|
Participants Initiating Treatment
|
78 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to 13 months postpartumPopulation: Participants can enter at \[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.
Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Outcome measures
| Measure |
PRISM Intervention
n=150 Participants
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM): • PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
|
MCPAP for Moms
n=162 Participants
MCPAP for Moms
* 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
|
|---|---|---|
|
Participants Sustaining Mental Health Treatment
|
38 Participants
|
32 Participants
|
Adverse Events
PRISM Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MCPAP for Moms
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRISM Intervention
n=150 participants at risk
PRogram In Support of Moms (PRISM)
PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms
* PRogram In Support of Moms Toolkit with Stepped Care Algorithms
* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
* Customization of depression screening for each practice
* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
* Employ psychoeducation and Motivational Interviewing to engage patients with depression
* medical assistant champion and psychiatrist contact bi-weekly to review cases
* Stepped care treatment to depression screening/assessment
|
MCPAP for Moms
n=162 participants at risk
MCPAP for Moms
Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression
* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
* Access to assessment and treatment protocols in Provider Toolkit
* Resource provision/referrals
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for suicidal risk
|
0.00%
0/150 • 37 months - throughout the enrollment period
|
0.62%
1/162 • 37 months - throughout the enrollment period
|
Additional Information
Nancy Byatt, Tenured Professor of Psychiatry, ObGyn, and Population & Quantitative Health Sciences
UMass Chan Medical School / UMass Memorial Health
Phone: 508.856.5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place