<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/NCT03024385</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0116</org_study_id>
    <nct_id>NCT03024385</nct_id>
  </id_info>
  <brief_title>Interconception Care at the University of Mississippi Medical Center</brief_title>
  <official_title>Interconception Care at the University of Mississippi Medical Center: An Innovative and Unique Collaborative Continuous Quality Improvement Project Between the Departments of Pediatrics and Family Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>IMPLICIT Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>March of Dimes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Mississippi Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This model will utilize tools from the IMPLICIT (Interventions to Minimize Preterm and Low&#xD;
      Birth Weight Infant through Continuous Quality Improvement Techniques) Network (collaboration&#xD;
      of academic family medicine providers). The project involves assessing maternal risk&#xD;
      behaviors that significantly affect subsequent birth outcomes: specifically smoking&#xD;
      cessation, maternal depression, family planning and preconception folic acid supplementation&#xD;
      during well child (WCC) visits. There is evidence that screening mothers for depression can&#xD;
      be done at WCC. Data from IMPLCIT network has demonstrated increased screening and referral&#xD;
      rates as well as decreased rates of prematurity. This is the first collaborative effort&#xD;
      between Pediatrics and Family Medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim(s) 1. Determine feasibility of implementing an ICC model as routine standard of&#xD;
      care during well child care visits 2. Assess how often physicians routinely implement this&#xD;
      model into their practice 3. Increase rates of screening for smoking, depression, folic acid&#xD;
      supplementation and family planning during routine visits.&#xD;
&#xD;
      4. Increase rates of referrals for mothers at risk Study Period (inclusive years) This&#xD;
      project will take place over a two year period. It will be re-evaluated at monthly intervals&#xD;
      to make sure that objectives are being met.&#xD;
&#xD;
      Study Design Study Entry: All mothers presenting with their children to an Ambulatory&#xD;
      Pediatric site (North Clinic, Eli Manning and the Pavilion) or Family Medicine (Lakeland and&#xD;
      Flowood) for 2 month, 4 month, 6 month, 9 month, 15 month, 18 month and 24 month well child&#xD;
      (WCC) visits will be screened for smoking, depression, folic acid supplementation and&#xD;
      contraception. Screening will take place at the time of each well child visit. The clinic&#xD;
      nurse will present the mother with the screeners for depression and will also ask whether she&#xD;
      is smoking, using contraception, and using a folic acid supplementation. Screening scores&#xD;
      will be reviewed by the patient's primary care provider. A positive score for PHQ 9 will&#xD;
      elicit a referral to Adolescent Medicine and/or Family Medicine for further evaluation. A&#xD;
      positive screen for smoking will elicit a referral to the ACT Center at UMMC. Negative&#xD;
      responses for contraception use will elicit a referral to Adolescent Medicine and/or Family&#xD;
      Medicine for further management. Primary care providers will provide mothers with information&#xD;
      and recommendations on folic acid use if they are not using a supplementation.&#xD;
&#xD;
      In Ambulatory Pediatrics mothers in need of services will be referred based on age. Mothers&#xD;
      who are 21 years or younger will be referred to Adolescent Medicine. Mothers who are 21 years&#xD;
      or older will be referred to Family Medicine. In Family Medicine, mothers will be referred&#xD;
      only for depression or smoking cessation.&#xD;
&#xD;
      This project is quality improvement hence screening will be offered to all mothers presenting&#xD;
      with their child for well child visits will be screened. Since this project is quality&#xD;
      improvement; examining provider behaviors, an exemption from informed consent is requested.&#xD;
      Foster parents and non-parental legal guardians will not be screened. Mothers presenting with&#xD;
      their child for sick visits will not be screened. Mothers of children older than 2 years of&#xD;
      age will not be screened.&#xD;
&#xD;
      All screening will take place at Pediatric primary care sites and at Family Medicine sites,&#xD;
      Monday through Friday, from 8am-4pm.&#xD;
&#xD;
      During Phase 2 of the project, mothers of NICU infants will be offered screening. Details of&#xD;
      Phase 2 will be presented as an amendment.&#xD;
&#xD;
      Measures: Validated questionnaires will be used to screen depression. Mothers will also be&#xD;
      screened regarding smoking, contraceptive use and folic acid supplementation.&#xD;
&#xD;
      Data will be collected monthly as quality improvement reports. Data will be shared with the&#xD;
      IMPLICIT Network every 6 months as continuous quality improvement throughout the network.&#xD;
&#xD;
      All de-identified data will be uploaded into REDCap, a password and encrypted database. Data&#xD;
      will be shared with March of Dimes to assess progress/process throughout the grant cycle.&#xD;
&#xD;
      On the IMPLICIT REDCap database, site names are listed to facilitate communication and&#xD;
      continuous quality improvement monitoring. The IMPLICIT REDCap is maintained on servers at&#xD;
      Lancaster General Hospital in Lancaster, Pennsylvania.&#xD;
&#xD;
      Depression Screening: The Patient Health Questionnaire is a validated screening tool for&#xD;
      depression. Both forms of the PHQ are graded on a Likert scale, from 0-3 and take just a few&#xD;
      minutes to complete. In adults, the PHQ2 has a 97% sensitivity and 67% specificity; the PHQ9&#xD;
      has a 61% sensitivity and 94% specificity. In youth (aged 13-17), the PHQ 9 has 90%&#xD;
      sensitivity and 78% specificity. A PHQ9 score of 10 or greater has 88% sensitivity and 88%&#xD;
      specificity for major depression. Numeric scoring for PHQ9 is as follows:&#xD;
&#xD;
      Score 5 = Mild Depression Score 10= Moderate Depression Score 15 = Moderately Severe&#xD;
      Depression Score 20 = Severe Depression A two item questionnaire (PHQ2) will be given to all&#xD;
      mothers of children 2 years or younger presenting for well child visits. If the mother&#xD;
      answers yes to either or both of the questions, the screen is scored as positive for&#xD;
      depression. The mother will then be screened further with the Patient Health Questionnaire 9&#xD;
      (PHQ9) - a nine item questionnaire.&#xD;
&#xD;
      If the PHQ9 score is positive for moderate depression (10 or greater) the primary care&#xD;
      provider will further inquire if the mother is actively suicidal. If so, the primary care&#xD;
      provider will send the mother to the Emergency Department for further psychiatric evaluation,&#xD;
      as per standard protocol. If the mother is not suicidal, she will be referred to either&#xD;
      Adolescent Medicine or Family Medicine Behavioral Health for further evaluation.&#xD;
&#xD;
      Smoking, Contraception and Folic Acid Screening: Screening for smoking, contraception and&#xD;
      folic acid supplementation will be &quot;yes or no&quot; items. All scores for mothers will be&#xD;
      documented in the child's progress note in the electronic health record.&#xD;
&#xD;
      Inclusion Criteria Mothers who accompany their infants to routine well child care visits will&#xD;
      be invited to be screened.&#xD;
&#xD;
      Exclusion Criteria Other legal guardians or foster parents of infants. Mothers of children&#xD;
      over 2 years of age will also be excluded.&#xD;
&#xD;
      Number of Subjects (anticipated): This is a feasibility project for quality improvement. It&#xD;
      is anticipated that 89 ambulatory care providers will be trained to use this model of ICC.&#xD;
      Training will include faculty in general ambulatory pediatrics (8 total) and family medicine&#xD;
      (4 total whose practice include pediatric patients). Residents in general pediatrics (47) and&#xD;
      family medicine (30) will also be trained.&#xD;
&#xD;
      These providers will have an estimated 1625 unique encounters with mothers. Estimated number&#xD;
      of WCC visits for target age group is 13000. Assuming each child gets 8 routine visits in the&#xD;
      1st two years of life (13000/8 =1625).&#xD;
&#xD;
      Outcome Measures Screening and referral rates will be collected and recorded as quality&#xD;
      improvement. Current rates of screening and hence referral for these health risks are&#xD;
      minimal. It is anticipated that screening rates will initially increase with a subsequent&#xD;
      increase in referral rates.&#xD;
&#xD;
      Study Endpoints Current screening and hence referral rates are minimal. This is the first&#xD;
      initiative to improve to screening and referral rates. At the end of 2 years, rates of&#xD;
      screening for depression, smoking, folic acid supplementation and family planning will be&#xD;
      increased to at least 80% of encounter for mothers infants aged 0-2 years of age. Mothers in&#xD;
      need of additional intervention will be referred 80% of the time.&#xD;
&#xD;
      Private Health Information Data will be collected in aggregate via chart reviews. Data will&#xD;
      be collected by pulling EPIC electronic health record smart-phrases. Private health&#xD;
      information will be collected in aggregate. Data pulled from EPIC (infant's name, date of&#xD;
      birth, date of visit, ethnicity, medical record number, visit type and demographics) will be&#xD;
      de-identified into an internal file and re-coded with a unique REDCap encounter ID.&#xD;
      De-identified information will be uploaded into REDCap (a HIPAA secure database) every 6&#xD;
      months. Private health information will not be transmitted to the IMPLCIT REDCap database.&#xD;
      REDCap is fully HIPAA compliant.&#xD;
&#xD;
      All 0-2 year well child visits will be pulled and chart review will be done to assess whether&#xD;
      screening for depression, contraception, cigarette and folic acid use was performed. Chart&#xD;
      review will be performed a monthly basis, at the end of the month. Every 6 months, process of&#xD;
      screening will be reviewed and if not at 80% or greater, screening process will be reviewed&#xD;
      with all primary care providers.&#xD;
&#xD;
      Data will be assessed for number of positive PHQ9 scores, number of positive smokers and&#xD;
      number of mothers not using a contraceptive method or folic acid supplementation.&#xD;
&#xD;
      Data will be assessed for the number of referrals offered to mothers with positive PHQ9&#xD;
      scores, positive smokers and no contraceptive use, to Adolescent Medicine, Family Medicine,&#xD;
      Family Medicine Behavioral health or UMMC ACT Center accordingly.&#xD;
&#xD;
      Only de-identified data will be collected (screening rates, questionnaire scores, referral&#xD;
      rates). Only the principal investigators and the data analyst (research assistant; a UMMC&#xD;
      employee) will have access to the data.&#xD;
&#xD;
      Risks: No identifying information will be collected on any of the screening data to reduce&#xD;
      the risk of loss of confidentiality. Mothers are free to withhold any information that they&#xD;
      wish to keep confidential.&#xD;
&#xD;
      There are minor risks or discomforts due to participation in this screening. Completion of&#xD;
      the screen may be associated with mild distress. Certain screening questions may make&#xD;
      participants feel embarrassed or uncomfortable; however, this is a risk that is highly&#xD;
      unlikely to be severe given the voluntary participation in the screening.&#xD;
&#xD;
      If such distress occurs for the mother she can discuss with the primary care physician. For&#xD;
      mothers who screen positive and are under the age of 18; their guardian will be notified of&#xD;
      the recommendation for referral (current standard of care for screening and treatment of&#xD;
      minors with depression).&#xD;
&#xD;
      Benefits of Participation in Study:&#xD;
&#xD;
      Subjects: There is a direct benefit to the mother from the screening. Mothers identified as&#xD;
      depressed or need of contraceptive services or tobacco cessation will be linked to&#xD;
      appropriate services.&#xD;
&#xD;
      Infants/Children: There is an indirect benefit to the children of the mothers screened, such&#xD;
      as improved maternal physical and emotional health, which could lead to improved care of the&#xD;
      infant/child.&#xD;
&#xD;
      Societal benefits: ICC has been demonstrated to decrease pre-terms births, hence this CQI&#xD;
      would ultimately contribute to lower pre-term birth rates in Mississippi&#xD;
&#xD;
      Statistical Methodology Because this is a feasibility study, no formal statistical testing&#xD;
      will be performed. Descriptive statistics along with 95% confidence intervals will be used to&#xD;
      describe rates of provider screening compliance. In examining the feasibility, we will&#xD;
      examine overall rates as well as rates stratified by clinic and age of child.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Can pediatric primary care provider screen mother for maternal health behaviors during routine well child visits using brief questionnaires?</measure>
    <time_frame>2 years</time_frame>
    <description>Pediatric primary care providers (and family medicine providers who care for young infants) will screen mothers for maternal behaviors (smoking status, depression, prenatal multivitamin use, family planning) during routine well child visits of infants aged 0-2 years of age. Mothers will be screened for depression using a validated screening tool (Patient Health Questionnaire or PHQ: the 2 item PHQ-2 will be an initial screen; mothers who have a positive PHQ-2 will be offered the 9-item questionnaire ie the PHQ-9); screening for family planning needs, prenatal multivitamin use and smoking status will be in the form of &quot;yes/no&quot; answers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Can pediatric primary care providers make appropriate recommendations for mothers with at risk behaviors using brief questionnaires?</measure>
    <time_frame>2 years</time_frame>
    <description>Pediatric primary care providers (and family medicine providers who care for young infants) will offer resources for mothers in need of treatment for the following conditions: smoking cessation, depression, multivitamin use, contraception. The Patient Health Questionnaire (PHQ) will be used to screen for depression. The PHQ-2 will be used as an initial screen for depression, mothers who have a positive PHQ-2 will be offered the PHQ-9. Mothers will be screened for suicidal ideation and referred for immediate resources if needed. Mothers who screen positive for depression and not suicidal will be referred to mental health specialists. Mothers will be queried (using &quot;yes/no&quot; responses) with respect to smoking status (mothers will be referred to a smoking cessation program if needed); contraceptive resources will be offered if needed; prenatal vitamins will be recommended if needed. Recommendations will be tracked within the infant's electronic health record.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1625</enrollment>
  <condition>Maternal Behavior</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Mothers of healthy infants</arm_group_label>
    <description>Mothers of young infants presenting for well child visits between the ages of 0-2 years of age</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Well Child Visits</intervention_name>
    <description>Mothers of young infants will be screened for maternal behaviors that affect the outcome of future pregnancies. These behaviors are related to the following: family planning; smoking status, prenatal vitamin use and maternal depression. Mothers with positive screens will be offered appropriate resources. This will all take place during the child's routine well-child visit.</description>
    <arm_group_label>Mothers of healthy infants</arm_group_label>
    <other_name>Screening questions</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a continuous quality improvement project. It has two aims: can providers screen&#xD;
        mothers for health behaviors and can they offer appropriate resources to mothers in need?&#xD;
        Thus the study populations are as follows:&#xD;
&#xD;
          1. Pediatric primary care providers and Family Medicine providers at UMMC&#xD;
&#xD;
          2. Mothers of young infants/toddlers seen in primary care clinics at UMMC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pediatric Primary Care Providers and Family Medicine Providers at UMMC&#xD;
&#xD;
          2. Mothers of young infants/toddlers who present with their children for well child&#xD;
             visits to UMC primary clinics -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Specialists at UMMC&#xD;
&#xD;
          2. Fathers, grandparents, legal guardians - this screening only applies to mothers of&#xD;
             young infants and toddlers -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah MH Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>MacDorman MF, Mathews TJ. Behind international rankings of infant mortality: how the United States compares with Europe. NCHS Data Brief. 2009 Nov;(23):1-8.</citation>
    <PMID>19887034</PMID>
  </reference>
  <reference>
    <citation>Santos IS, Matijasevich A, Silveira MF, Sclowitz IK, Barros AJ, Victora CG, Barros FC. Associated factors and consequences of late preterm births: results from the 2004 Pelotas birth cohort. Paediatr Perinat Epidemiol. 2008 Jul;22(4):350-9. doi: 10.1111/j.1365-3016.2008.00934.x.</citation>
    <PMID>18578748</PMID>
  </reference>
  <reference>
    <citation>Goedhart G, Snijders AC, Hesselink AE, van Poppel MN, Bonsel GJ, Vrijkotte TG. Maternal depressive symptoms in relation to perinatal mortality and morbidity: results from a large multiethnic cohort study. Psychosom Med. 2010 Oct;72(8):769-76. doi: 10.1097/PSY.0b013e3181ee4a62. Epub 2010 Jul 28.</citation>
    <PMID>20668282</PMID>
  </reference>
  <reference>
    <citation>Johnson K, Posner SF, Biermann J, Cordero JF, Atrash HK, Parker CS, Boulet S, Curtis MG; CDC/ATSDR Preconception Care Work Group; Select Panel on Preconception Care. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006 Apr 21;55(RR-6):1-23.</citation>
    <PMID>16617292</PMID>
  </reference>
  <reference>
    <citation>Murin S, Rafii R, Bilello K. Smoking and smoking cessation in pregnancy. Clin Chest Med. 2011 Mar;32(1):75-91. doi: 10.1016/j.ccm.2010.11.004.</citation>
    <PMID>21277451</PMID>
  </reference>
  <reference>
    <citation>Sheeder J, Kabir K, Stafford B. Screening for postpartum depression at well-child visits: is once enough during the first 6 months of life? Pediatrics. 2009 Jun;123(6):e982-8. doi: 10.1542/peds.2008-1160.</citation>
    <PMID>19482749</PMID>
  </reference>
  <reference>
    <citation>Ratcliffe S, Gambler A, Gross M, Horst M, Raff T. Preventing Prematurity: One Woman at a Time. The Journal of Lancaster General Hospital. Fall 2012,(7):3;69-74</citation>
  </reference>
  <reference>
    <citation>2015 Premature Birth Report Cards. march of Dimes. http//:www.marchofdimes.org/mission/prematurity-reportcard.aspx. Accessed 2/18/2016</citation>
  </reference>
  <reference>
    <citation>Maternal, Infant and Child Health. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health.Accessed 2/18/2016</citation>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03024385
org study id: 2016-0116
nct id: NCT03024385
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This model will utilize tools from the IMPLICIT (Interventions to Minimize Preterm and Low
      Birth Weight Infant through Continuous Quality Improvement Techniques) Network (collaboration
      of academic family medicine providers). The project involves assessing maternal risk
      behaviors that significantly affect subsequent birth outcomes: specifically smoking
      cessation, maternal depression, family planning and preconception folic acid supplementation
      during well child (WCC) visits. There is evidence that screening mothers for depression can
      be done at WCC. Data from IMPLCIT network has demonstrated increased screening and referral
      rates as well as decreased rates of prematurity. This is the first collaborative effort
      between Pediatrics and Family Medicine.
Specific Aim(s) 1. Determine feasibility of implementing an ICC model as routine standard of
      care during well child care visits 2. Assess how often physicians routinely implement this
      model into their practice 3. Increase rates of screening for smoking, depression, folic acid
      supplementation and family planning during routine visits.

      4. Increase rates of referrals for mothers at risk Study Period (inclusive years) This
      project will take place over a two year period. It will be re-evaluated at monthly intervals
      to make sure that objectives are being met.

      Study Design Study Entry: All mothers presenting with their children to an Ambulatory
      Pediatric site (North Clinic, Eli Manning and the Pavilion) or Family Medicine (Lakeland and
      Flowood) for 2 month, 4 month, 6 month, 9 month, 15 month, 18 month and 24 month well child
      (WCC) visits will be screened for smoking, depression, folic acid supplementation and
      contraception. Screening will take place at the time of each well child visit. The clinic
      nurse will present the mother with the screeners for depression and will also ask whether she
      is smoking, using contraception, and using a folic acid supplementation. Screening scores
      will be reviewed by the patient's primary care provider. A positive score for PHQ 9 will
      elicit a referral to Adolescent Medicine and/or Family Medicine for further evaluation. A
      positive screen for smoking will elicit a referral to the ACT Center at UMMC. Negative
      responses for contraception use will elicit a referral to Adolescent Medicine and/or Family
      Medicine for further management. Primary care providers will provide mothers with information
      and recommendations on folic acid use if they are not using a supplementation.

      In Ambulatory Pediatrics mothers in need of services will be referred based on age. Mothers
      who are 21 years or younger will be referred to Adolescent Medicine. Mothers who are 21 years
      or older will be referred to Family Medicine. In Family Medicine, mothers will be referred
      only for depression or smoking cessation.

      This project is quality improvement hence screening will be offered to all mothers presenting
      with their child for well child visits will be screened. Since this project is quality
      improvement; examining provider behaviors, an exemption from informed consent is requested.
      Foster parents and non-parental legal guardians will not be screened. Mothers presenting with
      their child for sick visits will not be screened. Mothers of children older than 2 years of
      age will not be screened.

      All screening will take place at Pediatric primary care sites and at Family Medicine sites,
      Monday through Friday, from 8am-4pm.

      During Phase 2 of the project, mothers of NICU infants will be offered screening. Details of
      Phase 2 will be presented as an amendment.

      Measures: Validated questionnaires will be used to screen depression. Mothers will also be
      screened regarding smoking, contraceptive use and folic acid supplementation.

      Data will be collected monthly as quality improvement reports. Data will be shared with the
      IMPLICIT Network every 6 months as continuous quality improvement throughout the network.

      All de-identified data will be uploaded into REDCap, a password and encrypted database. Data
      will be shared with March of Dimes to assess progress/process throughout the grant cycle.

      On the IMPLICIT REDCap database, site names are listed to facilitate communication and
      continuous quality improvement monitoring. The IMPLICIT REDCap is maintained on servers at
      Lancaster General Hospital in Lancaster, Pennsylvania.

      Depression Screening: The Patient Health Questionnaire is a validated screening tool for
      depression. Both forms of the PHQ are graded on a Likert scale, from 0-3 and take just a few
      minutes to complete. In adults, the PHQ2 has a 97% sensitivity and 67% specificity; the PHQ9
      has a 61% sensitivity and 94% specificity. In youth (aged 13-17), the PHQ 9 has 90%
      sensitivity and 78% specificity. A PHQ9 score of 10 or greater has 88% sensitivity and 88%
      specificity for major depression. Numeric scoring for PHQ9 is as follows:

      Score 5 = Mild Depression Score 10= Moderate Depression Score 15 = Moderately Severe
      Depression Score 20 = Severe Depression A two item questionnaire (PHQ2) will be given to all
      mothers of children 2 years or younger presenting for well child visits. If the mother
      answers yes to either or both of the questions, the screen is scored as positive for
      depression. The mother will then be screened further with the Patient Health Questionnaire 9
      (PHQ9) - a nine item questionnaire.

      If the PHQ9 score is positive for moderate depression (10 or greater) the primary care
      provider will further inquire if the mother is actively suicidal. If so, the primary care
      provider will send the mother to the Emergency Department for further psychiatric evaluation,
      as per standard protocol. If the mother is not suicidal, she will be referred to either
      Adolescent Medicine or Family Medicine Behavioral Health for further evaluation.

      Smoking, Contraception and Folic Acid Screening: Screening for smoking, contraception and
      folic acid supplementation will be "yes or no" items. All scores for mothers will be
      documented in the child's progress note in the electronic health record.

      Inclusion Criteria Mothers who accompany their infants to routine well child care visits will
      be invited to be screened.

      Exclusion Criteria Other legal guardians or foster parents of infants. Mothers of children
      over 2 years of age will also be excluded.

      Number of Subjects (anticipated): This is a feasibility project for quality improvement. It
      is anticipated that 89 ambulatory care providers will be trained to use this model of ICC.
      Training will include faculty in general ambulatory pediatrics (8 total) and family medicine
      (4 total whose practice include pediatric patients). Residents in general pediatrics (47) and
      family medicine (30) will also be trained.

      These providers will have an estimated 1625 unique encounters with mothers. Estimated number
      of WCC visits for target age group is 13000. Assuming each child gets 8 routine visits in the
      1st two years of life (13000/8 =1625).

      Outcome Measures Screening and referral rates will be collected and recorded as quality
      improvement. Current rates of screening and hence referral for these health risks are
      minimal. It is anticipated that screening rates will initially increase with a subsequent
      increase in referral rates.

      Study Endpoints Current screening and hence referral rates are minimal. This is the first
      initiative to improve to screening and referral rates. At the end of 2 years, rates of
      screening for depression, smoking, folic acid supplementation and family planning will be
      increased to at least 80% of encounter for mothers infants aged 0-2 years of age. Mothers in
      need of additional intervention will be referred 80% of the time.

      Private Health Information Data will be collected in aggregate via chart reviews. Data will
      be collected by pulling EPIC electronic health record smart-phrases. Private health
      information will be collected in aggregate. Data pulled from EPIC (infant's name, date of
      birth, date of visit, ethnicity, medical record number, visit type and demographics) will be
      de-identified into an internal file and re-coded with a unique REDCap encounter ID.
      De-identified information will be uploaded into REDCap (a HIPAA secure database) every 6
      months. Private health information will not be transmitted to the IMPLCIT REDCap database.
      REDCap is fully HIPAA compliant.

      All 0-2 year well child visits will be pulled and chart review will be done to assess whether
      screening for depression, contraception, cigarette and folic acid use was performed. Chart
      review will be performed a monthly basis, at the end of the month. Every 6 months, process of
      screening will be reviewed and if not at 80% or greater, screening process will be reviewed
      with all primary care providers.

      Data will be assessed for number of positive PHQ9 scores, number of positive smokers and
      number of mothers not using a contraceptive method or folic acid supplementation.

      Data will be assessed for the number of referrals offered to mothers with positive PHQ9
      scores, positive smokers and no contraceptive use, to Adolescent Medicine, Family Medicine,
      Family Medicine Behavioral health or UMMC ACT Center accordingly.

      Only de-identified data will be collected (screening rates, questionnaire scores, referral
      rates). Only the principal investigators and the data analyst (research assistant; a UMMC
      employee) will have access to the data.

      Risks: No identifying information will be collected on any of the screening data to reduce
      the risk of loss of confidentiality. Mothers are free to withhold any information that they
      wish to keep confidential.

      There are minor risks or discomforts due to participation in this screening. Completion of
      the screen may be associated with mild distress. Certain screening questions may make
      participants feel embarrassed or uncomfortable; however, this is a risk that is highly
      unlikely to be severe given the voluntary participation in the screening.

      If such distress occurs for the mother she can discuss with the primary care physician. For
      mothers who screen positive and are under the age of 18; their guardian will be notified of
      the recommendation for referral (current standard of care for screening and treatment of
      minors with depression).

      Benefits of Participation in Study:

      Subjects: There is a direct benefit to the mother from the screening. Mothers identified as
      depressed or need of contraceptive services or tobacco cessation will be linked to
      appropriate services.

      Infants/Children: There is an indirect benefit to the children of the mothers screened, such
      as improved maternal physical and emotional health, which could lead to improved care of the
      infant/child.

      Societal benefits: ICC has been demonstrated to decrease pre-terms births, hence this CQI
      would ultimately contribute to lower pre-term birth rates in Mississippi

      Statistical Methodology Because this is a feasibility study, no formal statistical testing
      will be performed. Descriptive statistics along with 95% confidence intervals will be used to
      describe rates of provider screening compliance. In examining the feasibility, we will
      examine overall rates as well as rates stratified by clinic and age of child.
observational model: Cohort
time perspective: Prospective
measure: Can pediatric primary care provider screen mother for maternal health behaviors during routine well child visits using brief questionnaires?
time frame: 2 years
description: Pediatric primary care providers (and family medicine providers who care for young infants) will screen mothers for maternal behaviors (smoking status, depression, prenatal multivitamin use, family planning) during routine well child visits of infants aged 0-2 years of age. Mothers will be screened for depression using a validated screening tool (Patient Health Questionnaire or PHQ: the 2 item PHQ-2 will be an initial screen; mothers who have a positive PHQ-2 will be offered the 9-item questionnaire ie the PHQ-9); screening for family planning needs, prenatal multivitamin use and smoking status will be in the form of "yes/no" answers.
measure: Can pediatric primary care providers make appropriate recommendations for mothers with at risk behaviors using brief questionnaires?
time frame: 2 years
description: Pediatric primary care providers (and family medicine providers who care for young infants) will offer resources for mothers in need of treatment for the following conditions: smoking cessation, depression, multivitamin use, contraception. The Patient Health Questionnaire (PHQ) will be used to screen for depression. The PHQ-2 will be used as an initial screen for depression, mothers who have a positive PHQ-2 will be offered the PHQ-9. Mothers will be screened for suicidal ideation and referred for immediate resources if needed. Mothers who screen positive for depression and not suicidal will be referred to mental health specialists. Mothers will be queried (using "yes/no" responses) with respect to smoking status (mothers will be referred to a smoking cessation program if needed); contraceptive resources will be offered if needed; prenatal vitamins will be recommended if needed. Recommendations will be tracked within the infant's electronic health record.
arm group label: Mothers of healthy infants
description: Mothers of young infants presenting for well child visits between the ages of 0-2 years of age
intervention type: Behavioral
intervention name: Well Child Visits
description: Mothers of young infants will be screened for maternal behaviors that affect the outcome of future pregnancies. These behaviors are related to the following: family planning; smoking status, prenatal vitamin use and maternal depression. Mothers with positive screens will be offered appropriate resources. This will all take place during the child's routine well-child visit.
arm group label: Mothers of healthy infants
other name: Screening questions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 67 Years
healthy volunteers: No
last name: Sarah MH Jones, MD
role: Principal Investigator
affiliation: University of Mississippi Medical Center
facility: 
country: United States
citation: MacDorman MF, Mathews TJ. Behind international rankings of infant mortality: how the United States compares with Europe. NCHS Data Brief. 2009 Nov;(23):1-8.
PMID: 19887034
citation: Santos IS, Matijasevich A, Silveira MF, Sclowitz IK, Barros AJ, Victora CG, Barros FC. Associated factors and consequences of late preterm births: results from the 2004 Pelotas birth cohort. Paediatr Perinat Epidemiol. 2008 Jul;22(4):350-9. doi: 10.1111/j.1365-3016.2008.00934.x.
PMID: 18578748
citation: Goedhart G, Snijders AC, Hesselink AE, van Poppel MN, Bonsel GJ, Vrijkotte TG. Maternal depressive symptoms in relation to perinatal mortality and morbidity: results from a large multiethnic cohort study. Psychosom Med. 2010 Oct;72(8):769-76. doi: 10.1097/PSY.0b013e3181ee4a62. Epub 2010 Jul 28.
PMID: 20668282
citation: Johnson K, Posner SF, Biermann J, Cordero JF, Atrash HK, Parker CS, Boulet S, Curtis MG; CDC/ATSDR Preconception Care Work Group; Select Panel on Preconception Care. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006 Apr 21;55(RR-6):1-23.
PMID: 16617292
citation: Murin S, Rafii R, Bilello K. Smoking and smoking cessation in pregnancy. Clin Chest Med. 2011 Mar;32(1):75-91. doi: 10.1016/j.ccm.2010.11.004.
PMID: 21277451
citation: Sheeder J, Kabir K, Stafford B. Screening for postpartum depression at well-child visits: is once enough during the first 6 months of life? Pediatrics. 2009 Jun;123(6):e982-8. doi: 10.1542/peds.2008-1160.
PMID: 19482749
citation: Ratcliffe S, Gambler A, Gross M, Horst M, Raff T. Preventing Prematurity: One Woman at a Time. The Journal of Lancaster General Hospital. Fall 2012,(7):3;69-74
citation: 2015 Premature Birth Report Cards. march of Dimes. http//:www.marchofdimes.org/mission/prematurity-reportcard.aspx. Accessed 2/18/2016
citation: Maternal, Infant and Child Health. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health.Accessed 2/18/2016
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No