<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267563</url>
  </required_header>
  <id_info>
    <org_study_id>MichiganSUROSE</org_study_id>
    <nct_id>NCT03267563</nct_id>
  </id_info>
  <brief_title>Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women</brief_title>
  <acronym>ROSE</acronym>
  <official_title>Implementing to Sustain: Determining the Minimum Necessary Intervention to Maintain a Postpartum Depression Prevention Program (ROSE) in Clinics Providing Prenatal Services to Low-income Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michigan State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Butler Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Palo Alto Veterans Institute for Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pacific Institute for Research and Evaluation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Michigan State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postpartum depression (PPD) is common and can have lasting consequences for mother and child.&#xD;
      ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal&#xD;
      settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized&#xD;
      trials in community prenatal settings with racially and ethnically diverse low-income&#xD;
      pregnant women. Requests for ROSE training and recent policy changes supporting payment for&#xD;
      comprehensive perinatal services to underserved populations suggest a context ripe for&#xD;
      embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies&#xD;
      about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART)&#xD;
      Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of&#xD;
      ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance&#xD;
      in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU;&#xD;
      initial training + tools for sustainment). At the first time at which a clinic is determined&#xD;
      to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be&#xD;
      randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or&#xD;
      (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to&#xD;
      be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only,&#xD;
      or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews&#xD;
      will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18&#xD;
      months. Outcomes include: 1. Sustainment of core program elements at each time point and&#xD;
      total length of time ROSE services were provided and were provided with at least moderate&#xD;
      fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs,&#xD;
      cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms&#xD;
      include sustainment of clinical and organizational capacity to deliver core elements, and&#xD;
      engagement/ownership. The study will also examine predictors, tailoring variables, and&#xD;
      implementation processes to determine which kinds of clinics need which level of sustainment&#xD;
      support and when. To our knowledge, this study will be the first randomized trial evaluating&#xD;
      the ROI of a stepped approach to sustainment, a critical unanswered question in&#xD;
      implementation science.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A recent expert consensus report concluded that, &quot;Little is known about how well or under&#xD;
      what conditions health innovations are sustained and their gains maintained once they are put&#xD;
      into practice. Implementation science typically focuses on uptake by early adopters. The&#xD;
      later-stage challenges of sustaining evidence-supported interventions receive too little&#xD;
      attention.&quot; This report placed high priority on conducting return on investment (ROI) studies&#xD;
      to determine how much is gained when effective programs are sustained, and cost-benefit&#xD;
      trade-offs for effort required to sustain.1 Information is especially needed for preventive&#xD;
      behavioral health interventions for adults in outpatient medical (e.g., primary care; OBGYN)&#xD;
      settings.&#xD;
&#xD;
      Postpartum depression (PPD) is common and can have serious and lasting consequences for&#xD;
      mother and child, including maternal increased risk for suicide, compromised functional&#xD;
      status, and adverse infant developmental outcomes. Prevalence of PPD is ~13% in the 12 weeks&#xD;
      after childbirth, with rates up to 50% among low-income women, who are especially vulnerable&#xD;
      to the consequences of PPD. Outpatient clinics offering prenatal care are an opportune place&#xD;
      to deliver PPD prevention services because most women will visit while pregnant. Recent&#xD;
      guidelines suggest that prenatal clinics should screen for PPD after birth and refer once it&#xD;
      is identified. Unfortunately, prenatal clinics do not routinely do anything to prevent PPD&#xD;
      from occurring.&#xD;
&#xD;
      The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of newborns) is a&#xD;
      small-group intervention to prevent PPD that is delivered during pregnancy in outpatient&#xD;
      prenatal settings. ROSE is the only PPD preventative intervention that (1) has been found to&#xD;
      significantly reduce cases of PPD in multiple randomized trials, and (2) has been tested in&#xD;
      community prenatal settings with racially and ethnically diverse low income pregnant women.&#xD;
      ROSE consists of four 90-minute group sessions and a 50-minute individual booster session&#xD;
      after delivery. Requests for ROSE training in Philadelphia and nationwide in Japan, and&#xD;
      recent policy changes supporting payment for comprehensive perinatal services (including&#xD;
      behavioral health care) to underserved populations all suggest a context ripe for embedding&#xD;
      ROSE in prenatal clinics long-term. Given the need for ROI studies about sustainment efforts&#xD;
      and that ROSE is well-positioned for implementation and sustainment research, we propose a&#xD;
      Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and&#xD;
      cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics&#xD;
      providing prenatal care to pregnant women on public assistance accross the US. Our conceptual&#xD;
      framework comes from RE-AIM and a review on sustainment by Co-I Wiltsey-Stirman,3 with&#xD;
      sustainment strategies based on the Replicating Effective Programs (REP) framework. All&#xD;
      clinics will receive enhanced implementation as usual (EIAU; initial training + tools for&#xD;
      sustainment). Clinics will be assessed using surveys and qualitative interviews 9 times over&#xD;
      2.5 years after receiving EIAU. Clinics at risk for failure to sustain operationally (defined&#xD;
      as no ROSE intervention in 3 months and none planned) and/or clinically (defined as low&#xD;
      fidelity to ROSE core elements) will be randomized to receive additional sustainment support&#xD;
      for up to 18 months after baseline. At the first time period at which a clinic is determined&#xD;
      to be at risk (i.e., at 3, 6, 9, 12, or 15 months), that clinic will be randomized to receive&#xD;
      either: (1) no additional implementation support (EIAU only), or (2) EIAU plus low-intensity&#xD;
      (every 3 months) coaching and feedback (LICF). If clinics receiving LICF are still at risk at&#xD;
      subsequent monitoring periods, they will be randomized to (1) EIAU + LICF only, or (2) EIAU +&#xD;
      LICF + high-intensity (monthly) coaching and feedback (HICF). Additional study follow-up&#xD;
      interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur&#xD;
      after 18 months. We will assess costs and benefits of sustainment strategies. Aims are to:&#xD;
&#xD;
      Compare effectiveness of each sustainment step for the following final and proximal OUTCOMES:&#xD;
&#xD;
        1. Sustainment of core program elements at each time point, and total length of time in&#xD;
           weeks that: (i) any ROSE services were provided, and (ii) were provided with adequate&#xD;
           fidelity to core elements (primary).&#xD;
&#xD;
        2. Health impact (e.g., PPD rates over time at each clinic) and reach (number of patients&#xD;
           enrolled in and completing the ROSE program).&#xD;
&#xD;
        3. Return on Investment (costs and cost-effectiveness of each sustainment step).&#xD;
&#xD;
        4. Hypothesized mechanisms include sustainment of: (a) clinical and organizational capacity&#xD;
           to deliver core elements, and (b) a sense of engagement/ownership by key clinic staff,&#xD;
           Examine predictors and processes to determine which kinds of clinics need which level of&#xD;
           support.&#xD;
&#xD;
        5. Explore which clinic characteristics (e.g., organizational and state policy contexts)&#xD;
           and hypothesized mechanisms (Aim 4) are associated with best sustainment to determine&#xD;
           tailoring variables for choosing/sequencing EIAU, LICF, HICF in the future.&#xD;
&#xD;
        6. Document implementation/sustainment effort processes, their timing relative to desired&#xD;
           outcomes, critical incidents to explore factors most related to sustainment after&#xD;
           accounting for hypothesized mechanisms.&#xD;
&#xD;
      To our knowledge, this study will be the first randomized trial evaluating the ROI of a&#xD;
      stepped approach to sustainment, a critical unanswered question in implementation science.&#xD;
      The study will also examine a set of strategies to promote sustainment of an effective PPD&#xD;
      prevention intervention for low-income women, reducing negative consequences for mother and&#xD;
      child. The proposal directly addresses the goal of PAR-16-238 to conduct longitudinal studies&#xD;
      on &quot;factors that contribute to the sustainability of evidence-based interventions,&quot; to test&#xD;
      strategies to improve quality of care among underserved populations, examine mediators and&#xD;
      moderators, and examine cost-effectiveness or other economic outcomes. Thus, the study will&#xD;
      advance implementation science, knowledge of implementation science mechanisms, and clinical&#xD;
      care for an at-risk population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 12, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Sequential, multiple assignment, randomized trial (SMART) design</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustainment of core program elements</measure>
    <time_frame>Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline</time_frame>
    <description>The total length of time that ROSE services were provided with adequate (75% or more) fidelity to core elements. The ROSE Session-by-Session Adherence Scale, a self-rated intervention fidelity scale completed by ROSE interventionists after each session. The outcome for each time point (i.e., quarter) will be the mean % of core elements delivered that should have been delivered at each ROSE session (mean [# of core elements delivered/# core elements should have been delivered] at each session; zero if no sessions were completed).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total length of time any ROSE services were offered</measure>
    <time_frame>Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline</time_frame>
    <description>The total length of time any ROSE services were provided will be tracked using a monthly calendar method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health impact: Postpartum depression (PPD) rates over time at each clinic</measure>
    <time_frame>Quarterly over 30 months</time_frame>
    <description>Quarterly, we will ask each clinic to report the following overall numbers: (1) # of women who should have come for their 6-week postpartum appointment; (2) # who came; (3) # that were screened for PPD; (4) # who screened positive for PPD. We will also collect this information for 4 quarters (12 months) prior to baseline. We will use these numbers to calculate PPD rates for each time period. Although though not every woman in the clinic will receive ROSE, we chose to track overall PPD rates at each clinic because: (1) the study examines larger-scale sustainment aimed at clinic-wide (and eventually population-wide) outcomes; and (2) the clinic-level outcomes are primary; not consenting individual patients makes the needed sample size (90 clinics) feasible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROSE Intervention reach</measure>
    <time_frame>Quarterly over 30 months</time_frame>
    <description># patients receiving ROSE and # of patients who complete at least 3 of 5 sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline</time_frame>
    <description>We will analyze 4 cost-effectiveness (CE) outcome measures: (1) a primary clinical outcome, number of PPD cases averted, estimated as the change in PPD rate at the clinic (post-pre)*(clinic's caseload), (2) another clinical outcome, number of quality-adjusted life years (QALYs) saved, computed from the primary outcome using Morrell et al.'s model, (3) an implementation process outcome, number of clients served with fidelity, and (4) a sustainment outcome, months of additional service delivery. The latter 2 measures have little measurement error.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hypothesized mechanism: Sustainment of clinical and organizational capacity to deliver core elements</measure>
    <time_frame>Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline</time_frame>
    <description>Organizational Capacity subscale of the Program Assessment Sustainability Tool (PSAT). Secondary measures of this construct include number of people trained who have time to deliver ROSE and clinic's ability to manage space, scheduling, and reimbursement for ROSE</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypothesized mechanism: Sustainment of a sense of engagement/ownership by key clinic staff.</measure>
    <time_frame>Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline</time_frame>
    <description>The sum of 4 PSAT subscales: Political Support, Partnerships, Communications, and Strategic Planning. The Staff section of the NHS's Sustainability Model and Guide and investment in addressing PPD will be secondary measures</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Depression, Postpartum</condition>
  <arm_group>
    <arm_group_label>Enhanced implementation as usual (EIAU)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All clinics will receive enhanced implementation as usual (EIAU) that is initial clinical and operational training + tools for sustainment. This occurs once at the beginning of the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-intensity coaching and feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinics will receive enhanced implementation as usual (EIAU) plus low-intensity (every 3 months) implementation coaching and feedback (LICF). LICF consists of quarterly clinical and operational coaching and feedback calls, as well as quarterly participation in an implementation collaborative board.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-intensity coaching and feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinics will receive enhanced implementation as usual (EIAU) plus high-intensity (every month) implementation coaching and feedback (HICF). HICF consists of monthly clinical and operational coaching and feedback calls, monthly participation in an implementation collaborative board, and on call technical assistance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EIAU</intervention_name>
    <description>Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment,</description>
    <arm_group_label>Enhanced implementation as usual (EIAU)</arm_group_label>
    <arm_group_label>High-intensity coaching and feedback</arm_group_label>
    <arm_group_label>Low-intensity coaching and feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LICF</intervention_name>
    <description>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 &quot;booster&quot; meeting.</description>
    <arm_group_label>High-intensity coaching and feedback</arm_group_label>
    <arm_group_label>Low-intensity coaching and feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HICF</intervention_name>
    <description>Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.</description>
    <arm_group_label>High-intensity coaching and feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Study enrollment and randomization takes place at the clinic level. Study participants will&#xD;
        be clinical and operational staff representatives of participating clinics.&#xD;
&#xD;
        To be included in the study, clinics will:&#xD;
&#xD;
          -  provide outpatient prenatal services&#xD;
&#xD;
          -  estimate that at least 50% of their pregnant patients receive some kind of public&#xD;
             assistance (such as federal or state assistance in the form of cash assistance such as&#xD;
             Temporary Assistance for Needy Families [TANF], food stamps, subsidized housing,&#xD;
             and/or health care such as Medicaid)&#xD;
&#xD;
          -  have at least 10 new pregnant women per month on average (i.e., enough patient flow to&#xD;
             run ROSE)&#xD;
&#xD;
          -  agree to study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer E Johnson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raven Miller, M.A.</last_name>
    <role>Study Director</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Michigan State University</investigator_affiliation>
    <investigator_full_name>Jennifer E. Johnson</investigator_full_name>
    <investigator_title>C. S. Mott Endowed Professor of Public Health, Professor of OBGYN, Professor of Psychiatry and Behavioral Medicine</investigator_title>
  </responsible_party>
  <keyword>prevention</keyword>
  <keyword>implementation</keyword>
  <keyword>sustainment</keyword>
  <keyword>perinatal</keyword>
  <keyword>pregnancy</keyword>
  <keyword>postpartum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.&#xD;
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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>After publication of the main results</ipd_time_frame>
    <ipd_access_criteria>De-identified data will be made available for scientific inquiry</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267563
org study id: MichiganSUROSE
nct id: NCT03267563
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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:

        1. Sustainment of core program elements at each time point, and total length of time in
           weeks that: (i) any ROSE services were provided, and (ii) were provided with adequate
           fidelity to core elements (primary).

        2. Health impact (e.g., PPD rates over time at each clinic) and reach (number of patients
           enrolled in and completing the ROSE program).

        3. Return on Investment (costs and cost-effectiveness of each sustainment step).

        4. Hypothesized mechanisms include sustainment of: (a) clinical and organizational capacity
           to deliver core elements, and (b) a sense of engagement/ownership by key clinic staff,
           Examine predictors and processes to determine which kinds of clinics need which level of
           support.

        5. Explore which clinic characteristics (e.g., organizational and state policy contexts)
           and hypothesized mechanisms (Aim 4) are associated with best sustainment to determine
           tailoring variables for choosing/sequencing EIAU, LICF, HICF in the future.

        6. Document implementation/sustainment effort processes, their timing relative to desired
           outcomes, critical incidents to explore factors most related to sustainment after
           accounting for hypothesized mechanisms.

      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.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Sequential, multiple assignment, randomized trial (SMART) design
primary purpose: Health Services Research
masking: None (Open Label)
measure: Sustainment of core program elements
time frame: Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
description: The total length of time that ROSE services were provided with adequate (75% or more) fidelity to core elements. The ROSE Session-by-Session Adherence Scale, a self-rated intervention fidelity scale completed by ROSE interventionists after each session. The outcome for each time point (i.e., quarter) will be the mean % of core elements delivered that should have been delivered at each ROSE session (mean [# of core elements delivered/# core elements should have been delivered] at each session; zero if no sessions were completed).
measure: Total length of time any ROSE services were offered
time frame: Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
description: The total length of time any ROSE services were provided will be tracked using a monthly calendar method
measure: Health impact: Postpartum depression (PPD) rates over time at each clinic
time frame: Quarterly over 30 months
description: Quarterly, we will ask each clinic to report the following overall numbers: (1) # of women who should have come for their 6-week postpartum appointment; (2) # who came; (3) # that were screened for PPD; (4) # who screened positive for PPD. We will also collect this information for 4 quarters (12 months) prior to baseline. We will use these numbers to calculate PPD rates for each time period. Although though not every woman in the clinic will receive ROSE, we chose to track overall PPD rates at each clinic because: (1) the study examines larger-scale sustainment aimed at clinic-wide (and eventually population-wide) outcomes; and (2) the clinic-level outcomes are primary; not consenting individual patients makes the needed sample size (90 clinics) feasible.
measure: ROSE Intervention reach
time frame: Quarterly over 30 months
description: # patients receiving ROSE and # of patients who complete at least 3 of 5 sessions
measure: Cost-effectiveness
time frame: Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
description: We will analyze 4 cost-effectiveness (CE) outcome measures: (1) a primary clinical outcome, number of PPD cases averted, estimated as the change in PPD rate at the clinic (post-pre)*(clinic's caseload), (2) another clinical outcome, number of quality-adjusted life years (QALYs) saved, computed from the primary outcome using Morrell et al.'s model, (3) an implementation process outcome, number of clients served with fidelity, and (4) a sustainment outcome, months of additional service delivery. The latter 2 measures have little measurement error.
measure: Hypothesized mechanism: Sustainment of clinical and organizational capacity to deliver core elements
time frame: Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
description: Organizational Capacity subscale of the Program Assessment Sustainability Tool (PSAT). Secondary measures of this construct include number of people trained who have time to deliver ROSE and clinic's ability to manage space, scheduling, and reimbursement for ROSE
measure: Hypothesized mechanism: Sustainment of a sense of engagement/ownership by key clinic staff.
time frame: Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
description: The sum of 4 PSAT subscales: Political Support, Partnerships, Communications, and Strategic Planning. The Staff section of the NHS's Sustainability Model and Guide and investment in addressing PPD will be secondary measures
arm group label: Enhanced implementation as usual (EIAU)
arm group type: Experimental
description: All clinics will receive enhanced implementation as usual (EIAU) that is initial clinical and operational training + tools for sustainment. This occurs once at the beginning of the trial.
arm group label: Low-intensity coaching and feedback
arm group type: Experimental
description: Clinics will receive enhanced implementation as usual (EIAU) plus low-intensity (every 3 months) implementation coaching and feedback (LICF). LICF consists of quarterly clinical and operational coaching and feedback calls, as well as quarterly participation in an implementation collaborative board.
arm group label: High-intensity coaching and feedback
arm group type: Experimental
description: Clinics will receive enhanced implementation as usual (EIAU) plus high-intensity (every month) implementation coaching and feedback (HICF). HICF consists of monthly clinical and operational coaching and feedback calls, monthly participation in an implementation collaborative board, and on call technical assistance.
intervention type: Behavioral
intervention name: EIAU
description: Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment,
arm group label: Enhanced implementation as usual (EIAU)
arm group label: High-intensity coaching and feedback
arm group label: Low-intensity coaching and feedback
intervention type: Behavioral
intervention name: LICF
description: 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.
arm group label: High-intensity coaching and feedback
arm group label: Low-intensity coaching and feedback
intervention type: Behavioral
intervention name: HICF
description: Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.
arm group label: High-intensity coaching and feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer E Johnson, Ph.D.
role: Principal Investigator
affiliation: Michigan State University
last name: Raven Miller, M.A.
role: Study Director
affiliation: Michigan State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Michigan State University
investigator full name: Jennifer E. Johnson
investigator title: C. S. Mott Endowed Professor of Public Health, Professor of OBGYN, Professor of Psychiatry and Behavioral Medicine
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: 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.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: After publication of the main results
ipd access criteria: De-identified data will be made available for scientific inquiry