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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH130948 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Butler Hospital | OTHER |
| Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | OTHER |
| Palo Alto Veterans Institute for Research | OTHER |
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Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenatal settings with racially and ethnically diverse low-income pregnant women. Requests for ROSE training and recent policy changes supporting payment for comprehensive perinatal services to underserved populations suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). At the first time at which a clinic is determined to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include: 1. Sustainment of core program elements at each time point and total length of time ROSE services were provided and were provided with at least moderate fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs, cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of clinical and organizational capacity to deliver core elements, and engagement/ownership. The study will also examine predictors, tailoring variables, and implementation processes to determine which kinds of clinics need which level of sustainment support and when. To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science.
A recent expert consensus report concluded that, "Little is known about how well or under what conditions health innovations are sustained and their gains maintained once they are put into practice. Implementation science typically focuses on uptake by early adopters. The later-stage challenges of sustaining evidence-supported interventions receive too little attention." This report placed high priority on conducting return on investment (ROI) studies to determine how much is gained when effective programs are sustained, and cost-benefit trade-offs for effort required to sustain.1 Information is especially needed for preventive behavioral health interventions for adults in outpatient medical (e.g., primary care; OBGYN) settings.
Postpartum depression (PPD) is common and can have serious and lasting consequences for mother and child, including maternal increased risk for suicide, compromised functional status, and adverse infant developmental outcomes. Prevalence of PPD is ~13% in the 12 weeks after childbirth, with rates up to 50% among low-income women, who are especially vulnerable to the consequences of PPD. Outpatient clinics offering prenatal care are an opportune place to deliver PPD prevention services because most women will visit while pregnant. Recent guidelines suggest that prenatal clinics should screen for PPD after birth and refer once it is identified. Unfortunately, prenatal clinics do not routinely do anything to prevent PPD from occurring.
The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of newborns) is a small-group intervention to prevent PPD that is delivered during pregnancy in outpatient prenatal settings. ROSE is the only PPD preventative intervention that (1) has been found to significantly reduce cases of PPD in multiple randomized trials, and (2) has been tested in community prenatal settings with racially and ethnically diverse low income pregnant women. ROSE consists of four 90-minute group sessions and a 50-minute individual booster session after delivery. Requests for ROSE training in Philadelphia and nationwide in Japan, and recent policy changes supporting payment for comprehensive perinatal services (including behavioral health care) to underserved populations all suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for ROI studies about sustainment efforts and that ROSE is well-positioned for implementation and sustainment research, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance accross the US. Our conceptual framework comes from RE-AIM and a review on sustainment by Co-I Wiltsey-Stirman,3 with sustainment strategies based on the Replicating Effective Programs (REP) framework. All clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). Clinics will be assessed using surveys and qualitative interviews 9 times over 2.5 years after receiving EIAU. Clinics at risk for failure to sustain operationally (defined as no ROSE intervention in 3 months and none planned) and/or clinically (defined as low fidelity to ROSE core elements) will be randomized to receive additional sustainment support for up to 18 months after baseline. At the first time period at which a clinic is determined to be at risk (i.e., at 3, 6, 9, 12, or 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (EIAU only), or (2) EIAU plus low-intensity (every 3 months) coaching and feedback (LICF). If clinics receiving LICF are still at risk at subsequent monitoring periods, they will be randomized to (1) EIAU + LICF only, or (2) EIAU + LICF + high-intensity (monthly) coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. We will assess costs and benefits of sustainment strategies. Aims are to:
Compare effectiveness of each sustainment step for the following final and proximal OUTCOMES:
To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science. The study will also examine a set of strategies to promote sustainment of an effective PPD prevention intervention for low-income women, reducing negative consequences for mother and child. The proposal directly addresses the goal of PAR-16-238 to conduct longitudinal studies on "factors that contribute to the sustainability of evidence-based interventions," to test strategies to improve quality of care among underserved populations, examine mediators and moderators, and examine cost-effectiveness or other economic outcomes. Thus, the study will advance implementation science, knowledge of implementation science mechanisms, and clinical care for an at-risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced implementation as usual (EIAU) | Experimental | EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment. |
|
| Low-intensity coaching and feedback (LICF) | Experimental | Low-intensity (every 3 months) coaching and feedback (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 coaching and feedback (HICF) | Experimental | High-intensity (every month) coaching and feedback (HICF): Enhanced implementation plus high intensity will have received initial training and problem-solving plus planning for sustainment and after that every month will receive one clinical and one operational telephone "booster" meeting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIAU | Behavioral | Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Sustainment of Core Program Elements | 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. | Average over months 3, 6, 9, 12, 15, 18, 24, and 30 after baseline |
| Number of Months of Sustained ROSE Delivery | Number of months when ROSE was delivered was tracked using calendar method. Potential range is 0 to 30 months, higher score reflects better outcome. | Summary of total number of months over 30 month study period. |
| Number of Months of Sustained ROSE Delivery With Fidelity | 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. | Summary of total number of months over 30 month study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Percent of Pregnant People Attending at Least One ROSE Session Over 30 Months | 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. |
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Study enrollment began with enrollment of clinics. Inclusion criteria for clinics were:
Participants were clinic personnel, and they were enrolled within clinic. Their inclusion criteria were:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer E Johnson, Ph.D. | Michigan State University | Principal Investigator |
| Raven Miller, M.A. | Michigan State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan State University | Flint | Michigan | 48502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39930503 | Derived | Johnson JE, Wiltsey-Stirman S, Sikorskii A, Miller T, Poleshuck E, Simas TAM, Carravallah L, Miller R, Zlotnick C. Outcomes of the ROSE Sustainment (ROSES) Study, a sequential multiple assignment randomized implementation trial to determine the minimum necessary intervention to sustain a postpartum depression prevention program in agencies serving low-income pregnant people. Implement Sci. 2025 Feb 10;20(1):9. doi: 10.1186/s13012-025-01420-z. | |
| 30134941 |
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After data have been collected and study results published, de-identified data will be made available to other qualified researchers upon request, on a CD or other electronic means compatible with our systems. The request will be evaluated by the PIs to ensure that it meets reasonable standards of scientific integrity.
We have use standard measures where possible in order to promote data sharing and integration into larger databases and to allow other researchers to analyze the data, including conducting meta-analyses. We will work on the data dictionary throughout the study. Data checking will occur regularly. We will submit primary results for publication by the end of the project period, and will have final de-identified datasets and data dictionaries available by CD within the required time frame.
After publication of the main results
De-identified data will be made available for scientific inquiry
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| ID | Title | Description |
|---|---|---|
| FG000 | EIAU Only Responders | EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment, |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Clinic personnel from each clinic provided data on their demographic characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: Responders to EIAU in 41 Clinics | 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. |
| BG001 | Phase II: Non-responders to EIAU, Continued EIAU in 12 Clinics |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion Sustainment of Core Program Elements | 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. | 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. | Posted | Least Squares Mean | Standard Error | proportion of sessions | Average over months 3, 6, 9, 12, 15, 18, 24, and 30 after baseline | Clinics | Clinics |
|
Each clinic was in the study for 30 months, and adverse event data were collected over 30 months for participants in each clinic.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants in 54 Clinics Receiving EIAU Training Only | EIAU: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment, |
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The study period included COVID-19 pandemic with a temporary pause in randomizations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Johnson | Michigan State University | 810-600-5669 | jjohns@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2023 | Mar 26, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2023 | Mar 26, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| University of Rochester |
| OTHER |
| University of Massachusetts, Worcester | OTHER |
| Pacific Institute for Research and Evaluation | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Sequential, multiple assignment, randomized trial (SMART) design. Three interventions were sequenced.
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| LICF | Behavioral | 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. |
|
| HICF | Behavioral | Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity. |
|
| Summary over 30 month study period. |
| Annualized Percent of Pregnant People Attending at Least Three ROSE Sessions (of Five) Over 30 Months | 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. | Summary over 30 month study period. |
| Johnson JE, Wiltsey-Stirman S, Sikorskii A, Miller T, King A, Blume JL, Pham X, Moore Simas TA, Poleshuck E, Weinberg R, Zlotnick C. Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women. Implement Sci. 2018 Aug 22;13(1):115. doi: 10.1186/s13012-018-0807-9. |
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. |
| BG002 | Phase II: Non-responders to EIAU, Responders to Added LICF in 14 Clinics | 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. |
| BG003 | Phase III: Non-responders to LICF+EIAU, Continued LICF | 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. |
| BG004 | Phase III: Non-responders to LICF+EIAU, HICF Added | 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). |
| BG005 | Phase II: LICF After Non-response to EIAU, Dropout Before Response to LICF Can be Determined | 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. |
| BG006 | Phase I: EIAU, Dropout Before Response to EIAU Can be Determined | 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 |
| BG007 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Clinic FQHC status | Participants reported whether the clinic where they worked was a Federally Qualified Health Center. | Count of Participants | Participants |
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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. |
| OG001 | First Randomization: Participants in 12 Clinics Not Responding to EIAU, Continued With EIAU | 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. |
| OG002 | Second Randomization: Participants in 15 Clinics Not Responding to LICF+EIAU and Had HICF Added | 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). |
| OG003 | Second Randomization: Participants in 14 Clinics Not Responding to LICF+EIAU, 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. Non-response to EIAU+LICF is not delivering ROSE sessions with fidelity. Non-responders in this arm continued with EIAU+LICF. |
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| Primary | Number of Months of Sustained ROSE Delivery | Number of months when ROSE was delivered was tracked using calendar method. Potential range is 0 to 30 months, higher score reflects better outcome. | 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. | Posted | Least Squares Mean | Standard Error | months | Summary of total number of months over 30 month study period. | Clinics | Clinics |
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| Primary | Number of Months of Sustained ROSE Delivery With Fidelity | 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. | 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). | Posted | Least Squares Mean | Standard Error | months | Summary of total number of months over 30 month study period. | Clinics | Clinics |
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| Secondary | Annualized Percent of Pregnant People Attending at Least One ROSE Session Over 30 Months | 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of pregnant people | Summary over 30 month study period. | Clinics | Clinics |
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| Secondary | Annualized Percent of Pregnant People Attending at Least Three ROSE Sessions (of Five) Over 30 Months | 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of pregnant people | Summary over 30 month study period. | Clinics | Clinics |
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| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | Participants in 29 Clinics Receiving LICF Training After Non-response to EIAU | 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. | 0 | 46 | 0 | 46 | 0 | 46 |
| EG002 | Participants in 15 Clinics Receiving HICF Training After Non-response to LICF+EIAU | 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 LICF+EIAU is not delivering ROE with fidelity. In this arm, non-responder clinics also received 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 (monthly). | 0 | 24 | 0 | 24 | 0 | 24 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| Clinics |
|
Key parameter was the coefficient in the model reflecting difference between arms created by the first randomization. A priori we planned to randomize 54 clinics to EIAU+LICF and 15 clinics to continued EIAU alone to have power of .89 to detect adjusted effect size Cohen's d=0.48. |
| The null hypothesis was that the means of two groups created by the second randomization were equal. The alternative hypothesis was that mean were not equal. | Regression, Linear | Month of entry into randomization was included as a covariate. | .17 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Mean Difference (Final Values) | 3.73 | Standard Error of the Mean | 2.68 | 2-Sided | 95 | -1.65 | 9.10 | Difference mean of EIAU+LICF+HICF minus mean of EIAU+LICF. | Superiority | Key parameter was the coefficient in the model reflecting difference between arms created by the second randomization (average over time). A priori we planned to randomize 19 clinics to EIAU+LICF+HICF and 19 clinics to continued EIAU+LICF to have power of .80 to detect adjusted effect size Cohen's d=0.48. |
| Clinics |
|
Key parameter was the coefficient in the model reflecting difference between arms created by the first randomization (average over time). A priori we planned to randomize 54 clinics to EIAU+LICF and 15 clinics to continued EIAU alone to have power of .89 to detect adjusted effect size Cohen's d=0.48. |
| The null hypothesis was that the means of two groups created by the second randomization were equal. The alternative hypothesis was that mean were not equal. | Regression, Linear | Month of entry into randomization was included as a covariate. | .04 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Mean Difference (Final Values) | 4.48 | Standard Error of the Mean | 2.15 | 2-Sided | 95 | 0.16 | 8.79 | Difference mean of EIAU+LICF+HICF minus mean of EIAU+LICF. | Superiority | Key parameter was the coefficient in the model reflecting difference between arms created by the second randomization (average over time). A priori we planned to randomize 19 clinics to EIAU+LICF+HICF and 19 clinics to continued EIAU+LICF to have power of .80 to detect adjusted effect size Cohen's d=0.48. |
| Clinics |
|
This statistical test was non-parametric. Power was determined for the primary outcomes. |
| The null hypothesis was that the distributions in two groups created by the first randomization were the same. The alternative hypothesis was that they were not the same. | Wilcoxon (Mann-Whitney) | .08 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Median Difference (Final Values) | 1.62 | 2-Sided | Difference of distributions of EIAU+LICF+HICF versus EIAU+LICF. Difference of medians is reported, but the test is non-parametric (comparison of the two distributions and not just medians). | Superiority | This statistical test was non-parametric. Power was determined for the primary outcomes. |
| Clinics |
|
This statistical test was non-parametric. Power was determined for the primary outcomes. |
| The null hypothesis was that the distributions in two groups created by the first randomization were the same. The alternative hypothesis was that they were not the same. | Wilcoxon (Mann-Whitney) | .03 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Median Difference (Final Values) | 0.38 | 2-Sided | Difference of distributions of EIAU+LICF+HICF versus EIAU+LICF. Difference of medians is reported, but the test is non-parametric (comparison of the two distributions and not just medians). | Superiority | This statistical test was non-parametric. Power was determined for the primary outcomes. |