Interconception Care at the University of Mississippi Medical Center

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.

Inclusion Criteria:

1. Pediatric Primary Care Providers and Family Medicine Providers at UMMC

2. Mothers of young infants/toddlers who present with their children for well child
visits to UMC primary clinics -

Exclusion Criteria:

1. Specialists at UMMC

2. Fathers, grandparents, legal guardians - this screening only applies to mothers of
young infants and toddlers -