Trial Outcomes & Findings for Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women (NCT NCT03267563)
NCT ID: NCT03267563
Last Updated: 2026-04-15
Results Overview
Proportion sustainment of ROSE's core program elements, assessed using the ROSE Session-by-Session Adherence Scale, was defined as the mean proportion of core elements delivered that should have been delivered at each ROSE session over the time period (zero if no sessions were completed). Potential range is 0 to 1, higher score reflects better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
Average over months 3, 6, 9, 12, 15, 18, 24, and 30 after baseline
Results posted on
2026-04-15
Participant Flow
Unit of analysis: Clinics
Participant milestones
| Measure |
EIAU Followed by LICF for Non-responders to EIAU, Non- Responders to LICF Continued With LICF
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
|
EIAU Followed by LICF for Non-responders to EIAU, Non- Responders to LICF Also Received HICF
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
high-intensity (monthly) coaching and feedback (HICF). HICF: Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.
|
Drop-outs After EIAU+LICF Prior to Determining Response to EIAU+LICF
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
|
EIAU Drop-out Prior to Determining Response to EIAU
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
|
EIAU Only Responders
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment,
|
EIAU Only Followed by Continued EIAU Only for Non-responders to Initial EIAU
Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
|
EIAU Only Followed by LICF for Non-responders to Initial EIAU, Responders to LICF
Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Low-intensity (every 3 months) coaching and feedback (LICF): problem-solving plus planning for sustainment plus one clinical and one operational telephone "booster" meeting.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24 14
|
24 15
|
1 1
|
2 1
|
70 41
|
18 12
|
21 14
|
|
Overall Study
COMPLETED
|
24 14
|
24 15
|
1 1
|
2 1
|
70 41
|
18 12
|
21 14
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women
Baseline characteristics by cohort
| Measure |
Phase I: Responders to EIAU in 41 Clinics
n=70 Participants
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Responders to EIAU are in clinics providing ROSE with fidelity. They did not receive other interventions.
|
Phase II: Non-responders to EIAU, Continued EIAU in 12 Clinics
n=18 Participants
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-responders to EIAU are in clinics not providing ROSE with fidelity. They did not receive other interventions in this arm.
|
Phase II: Non-responders to EIAU, Responders to Added LICF in 14 Clinics
n=21 Participants
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-responders to EIAU are in clinics not providing ROSE with fidelity. Following non-response to EIAU, low-intensity (every 3 months) coaching and feedback (LICF) was added in this arm.
LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months received one clinical and one operational telephone "booster" meeting.
Responders to LICF are clinics providing ROSE with fidelity. They did not receive other interventions in this arm.
|
Phase III: Non-responders to LICF+EIAU, Continued LICF
n=24 Participants
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-responders to EIAU are in clinics not providing ROSE with fidelity. Following non-response to EIAU, low-intensity (every 3 months) coaching and feedback (LICF) was added in this arm.
LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months received one clinical and one operational telephone "booster" meeting.
Non-responders to LICF are clinics not providing ROSE with fidelity. They did not receive other interventions in this arm.
|
Phase III: Non-responders to LICF+EIAU, HICF Added
n=24 Participants
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-responders to EIAU are in clinics not providing ROSE with fidelity. Following non-response to EIAU, low-intensity (every 3 months) coaching and feedback (LICF) was added in this arm.
LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months received one clinical and one operational telephone "booster" meeting.
Non-responders to LICF are in clinics not providing ROSE with fidelity. They received high intensity coaching and feedback (HICF) after non-response to LICF.
HICF: Enhanced implementation plus high intensity will received everything that the clinics in LICF received, but at a higher intensity (monthly).
|
Phase II: LICF After Non-response to EIAU, Dropout Before Response to LICF Can be Determined
n=1 Participants
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-responders to EIAU are in clinics that were not providing ROSE with fidelity. Following non-response to EIAU, low-intensity (every 3 months) coaching and feedback (LICF) was added in this arm.
LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months received one clinical and one operational telephone "booster" meeting.
Responders to LICF are in clinics providing ROSE with fidelity. In this arm, clinic dropped out prior to determination of response.
|
Phase I: EIAU, Dropout Before Response to EIAU Can be Determined
n=2 Participants
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-responders to EIAU are clinics not providing ROSE with fidelity. In this arm, clinic dropped out before response to EIAU can be determined
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
5 Participants
n=13 Participants
|
3 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
38 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=193 Participants
|
18 participants
n=193 Participants
|
21 participants
n=386 Participants
|
24 participants
n=13 Participants
|
24 participants
n=43 Participants
|
1 participants
n=1 Participants
|
2 participants
n=8 Participants
|
160 participants
n=21 Participants
|
|
Clinic FQHC status
Yes
|
6 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
3 Participants
n=13 Participants
|
4 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
17 Participants
n=21 Participants
|
|
Clinic FQHC status
No
|
64 Participants
n=193 Participants
|
14 Participants
n=193 Participants
|
21 Participants
n=386 Participants
|
21 Participants
n=13 Participants
|
20 Participants
n=43 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=8 Participants
|
143 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
68 Participants
n=193 Participants
|
16 Participants
n=193 Participants
|
18 Participants
n=386 Participants
|
24 Participants
n=13 Participants
|
24 Participants
n=43 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
152 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Sex · Unknown
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
3 Participants
n=13 Participants
|
3 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=193 Participants
|
11 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
18 Participants
n=13 Participants
|
18 Participants
n=43 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
102 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
3 Participants
n=13 Participants
|
3 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
4 Participants
n=13 Participants
|
8 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
11 Participants
n=386 Participants
|
14 Participants
n=13 Participants
|
10 Participants
n=43 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
85 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
3 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
41.87 years
STANDARD_DEVIATION 10.69 • n=193 Participants
|
39.47 years
STANDARD_DEVIATION 9.43 • n=193 Participants
|
42.75 years
STANDARD_DEVIATION 10.19 • n=386 Participants
|
44.26 years
STANDARD_DEVIATION 12.16 • n=13 Participants
|
46.86 years
STANDARD_DEVIATION 9.67 • n=43 Participants
|
28.00 years
n=1 Participants
|
44.5 years
STANDARD_DEVIATION 6.36 • n=8 Participants
|
42.82 years
STANDARD_DEVIATION 10.65 • n=21 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Average over months 3, 6, 9, 12, 15, 18, 24, and 30 after baselinePopulation: Participants in clinics that were non-responders to the initial EIAU were randomized at the clinic level to add LICF or continue with EIAU only. Participants in clinics that were non-responders to LICF+EIAU were randomized at the clinic level for the second time to add HICF or continue with EIAU+LICF.
Proportion sustainment of ROSE's core program elements, assessed using the ROSE Session-by-Session Adherence Scale, was defined as the mean proportion of core elements delivered that should have been delivered at each ROSE session over the time period (zero if no sessions were completed). Potential range is 0 to 1, higher score reflects better outcome.
Outcome measures
| Measure |
Second Randomization: Participants in 15 Clinics Not Responding to LICF+EIAU and Had HICF Added
n=15 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
Non-response to EIAU+LICF was not delivering ROSE with fidelity. In this arm, non-responders to EIAU+LICF had HICF added. High-intensity (monthly) coaching and feedback (HICF): Enhanced implementation plus high intensity received will receive everything that the clinics in LICF receive, but at a higher intensity (monthly).
|
First Randomization: Participants in 44 Clinics Not Responding to EIAU and Had LICF Added
n=44 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
|
First Randomization: Participants in 12 Clinics Not Responding to EIAU, Continued With EIAU
n=12 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm received no other interventions.
|
Second Randomization: Participants in 14 Clinics Not Responding to LICF+EIAU, Continued With LICF
n=14 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting. Non-response to EIAU+LICF is not delivering ROSE sessions with fidelity. Non-responders in this arm continued with EIAU+LICF.
|
|---|---|---|---|---|
|
Proportion Sustainment of Core Program Elements
|
0.43 proportion of sessions
Standard Error 0.08
|
0.34 proportion of sessions
Standard Error 0.05
|
0.18 proportion of sessions
Standard Error 0.09
|
0.13 proportion of sessions
Standard Error 0.09
|
PRIMARY outcome
Timeframe: Summary of total number of months over 30 month study period.Population: Participants in clinics that were non-responders to the initial EIAU were randomized at the clinic level to add LICF or continue with EIAU only. Participants in clinics that were non-responders to LICF+EIAU were randomized at the clinic level for the second time to add HICF or continue with EIAU+LICF.
Number of months when ROSE was delivered was tracked using calendar method. Potential range is 0 to 30 months, higher score reflects better outcome.
Outcome measures
| Measure |
Second Randomization: Participants in 15 Clinics Not Responding to LICF+EIAU and Had HICF Added
n=15 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
Non-response to EIAU+LICF was not delivering ROSE with fidelity. In this arm, non-responders to EIAU+LICF had HICF added. High-intensity (monthly) coaching and feedback (HICF): Enhanced implementation plus high intensity received will receive everything that the clinics in LICF receive, but at a higher intensity (monthly).
|
First Randomization: Participants in 44 Clinics Not Responding to EIAU and Had LICF Added
n=44 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
|
First Randomization: Participants in 12 Clinics Not Responding to EIAU, Continued With EIAU
n=12 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm received no other interventions.
|
Second Randomization: Participants in 14 Clinics Not Responding to LICF+EIAU, Continued With LICF
n=14 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting. Non-response to EIAU+LICF is not delivering ROSE sessions with fidelity. Non-responders in this arm continued with EIAU+LICF.
|
|---|---|---|---|---|
|
Number of Months of Sustained ROSE Delivery
|
7.11 months
Standard Error 1.81
|
7.00 months
Standard Error 1.09
|
5.07 months
Standard Error 1.95
|
3.38 months
Standard Error 1.87
|
PRIMARY outcome
Timeframe: Summary of total number of months over 30 month study period.Population: Participants in clinics that were non-responders to the initial EIAU were randomized at the clinic level to add LICF or continue with EIAU only. Participants in clinics that were non-responders to LICF+EIAU were randomized at the clinic level for the second time to add HICF or continue with EIAU+LICF. (n=14).
Number of months when ROSE was delivered with fidelity was tracked using calendar method. Potential range is 0 to 30 months, higher score reflects better outcome.
Outcome measures
| Measure |
Second Randomization: Participants in 15 Clinics Not Responding to LICF+EIAU and Had HICF Added
n=15 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
Non-response to EIAU+LICF was not delivering ROSE with fidelity. In this arm, non-responders to EIAU+LICF had HICF added. High-intensity (monthly) coaching and feedback (HICF): Enhanced implementation plus high intensity received will receive everything that the clinics in LICF receive, but at a higher intensity (monthly).
|
First Randomization: Participants in 44 Clinics Not Responding to EIAU and Had LICF Added
n=44 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
|
First Randomization: Participants in 12 Clinics Not Responding to EIAU, Continued With EIAU
n=12 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm received no other interventions.
|
Second Randomization: Participants in 14 Clinics Not Responding to LICF+EIAU, Continued With LICF
n=14 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting. Non-response to EIAU+LICF is not delivering ROSE sessions with fidelity. Non-responders in this arm continued with EIAU+LICF.
|
|---|---|---|---|---|
|
Number of Months of Sustained ROSE Delivery With Fidelity
|
6.68 months
Standard Error 1.45
|
6.02 months
Standard Error 0.91
|
4.41 months
Standard Error 1.79
|
2.20 months
Standard Error 1.54
|
SECONDARY outcome
Timeframe: Summary over 30 month study period.Population: Participants in clinics that were non-responders to the initial EIAU were randomized at the clinic level to add LICF or continue with EIAU only. Participants in clinics that were non-responders to LICF+EIAU were randomized at the clinic level for the second time to add HICF or continue with EIAU+LICF.
Surveys at each time point included questions for the clinic to report the number of people who attended at least one ROSE session and the number served by the clinic in the past 12 months. Total numbers attending ROSE over 30 months were annualized (divided by 2.5), then divided by number of pregnant people served in the 12 months prior to baseline and multiplied by 100% to estimate percent of pregnant patients at each agency who received ROSE over 30 months. Potential range is 0 to 100 percent. Higher score reflects better outcome.
Outcome measures
| Measure |
Second Randomization: Participants in 15 Clinics Not Responding to LICF+EIAU and Had HICF Added
n=15 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
Non-response to EIAU+LICF was not delivering ROSE with fidelity. In this arm, non-responders to EIAU+LICF had HICF added. High-intensity (monthly) coaching and feedback (HICF): Enhanced implementation plus high intensity received will receive everything that the clinics in LICF receive, but at a higher intensity (monthly).
|
First Randomization: Participants in 44 Clinics Not Responding to EIAU and Had LICF Added
n=44 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
|
First Randomization: Participants in 12 Clinics Not Responding to EIAU, Continued With EIAU
n=12 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm received no other interventions.
|
Second Randomization: Participants in 14 Clinics Not Responding to LICF+EIAU, Continued With LICF
n=14 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting. Non-response to EIAU+LICF is not delivering ROSE sessions with fidelity. Non-responders in this arm continued with EIAU+LICF.
|
|---|---|---|---|---|
|
Annualized Percent of Pregnant People Attending at Least One ROSE Session Over 30 Months
|
1.62 percentage of pregnant people
Interval 0.1 to 7.67
|
1.07 percentage of pregnant people
Interval 0.0 to 4.8
|
0.46 percentage of pregnant people
Interval 0.07 to 11.0
|
0 percentage of pregnant people
Interval 0.0 to 2.07
|
SECONDARY outcome
Timeframe: Summary over 30 month study period.Population: Participants in clinics that were non-responders to the initial EIAU were randomized at the clinic level to add LICF or continue with EIAU only. Participants in clinics that were non-responders to LICF+EIAU were randomized at the clinic level for the second time to add HICF or continue with EIAU+LICF.
Surveys at each time point included questions for the clinic to report the number of people who attended at least three ROSE sessions and the number served by the clinic in the past 12 months. Total numbers attending at least three ROSE sessions over 30 months were annualized (divided by 2.5), then divided by number of pregnant people served in the 12 months prior to baseline and multiplied by 100% to estimate percent of pregnant patients at each agency who received at least three sessions of ROSE over 30 months. Potential range is 0 to 100 percent. Higher score reflects better outcome.
Outcome measures
| Measure |
Second Randomization: Participants in 15 Clinics Not Responding to LICF+EIAU and Had HICF Added
n=15 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
Non-response to EIAU+LICF was not delivering ROSE with fidelity. In this arm, non-responders to EIAU+LICF had HICF added. High-intensity (monthly) coaching and feedback (HICF): Enhanced implementation plus high intensity received will receive everything that the clinics in LICF receive, but at a higher intensity (monthly).
|
First Randomization: Participants in 44 Clinics Not Responding to EIAU and Had LICF Added
n=44 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.
|
First Randomization: Participants in 12 Clinics Not Responding to EIAU, Continued With EIAU
n=12 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm received no other interventions.
|
Second Randomization: Participants in 14 Clinics Not Responding to LICF+EIAU, Continued With LICF
n=14 Clinics
EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment.
Non-response to EIAU is not delivering ROSE with fidelity. Non-responders in this arm also received low-intensity (every 3 months) coaching and feedback (LICF). LICF: Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting. Non-response to EIAU+LICF is not delivering ROSE sessions with fidelity. Non-responders in this arm continued with EIAU+LICF.
|
|---|---|---|---|---|
|
Annualized Percent of Pregnant People Attending at Least Three ROSE Sessions (of Five) Over 30 Months
|
0.38 percentage of pregnant people
Interval 0.0 to 4.27
|
0.10 percentage of pregnant people
Interval 0.0 to 2.88
|
0.06 percentage of pregnant people
Interval 0.0 to 10.0
|
0 percentage of pregnant people
Interval 0.0 to 0.01
|
Adverse Events
Participants in 54 Clinics Receiving EIAU Training Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants in 29 Clinics Receiving LICF Training After Non-response to EIAU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants in 15 Clinics Receiving HICF Training After Non-response to LICF+EIAU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place