Use of a Reproductive Life Planning Tool at the Pediatric Well-Baby Visit With Postpartum Women
Condition: Postpartum Period; Contraception Behavior; Women's Health; Primary Health Care
Study type: Interventional

Summary: 
      Improved access to timely health care and contraception in the postpartum (PP) period is
      needed to reduce unintended pregnancies and help women achieve desired birth spacing. While
      the routine 6-week visit has historically been considered the place for women to discuss and
      receive contraception, many women, particularly low-income women, do not attend the
      postpartum visit. A novel approach to increasing receipt of PP care and contraception is the
      adoption of a reproductive life planning tool. Explorations of the use of a self-administered
      Reproductive Life Plan Tool (RLPT) by pediatricians in the context of the Well-Baby Visit
      (WBV) with postpartum mothers, holds great promise.

      The objective of this study is to determine whether use of a simple self-administered
      Reproductive Life Plan Tool at the 2-month WBV increases the proportion of postpartum women
      receiving woman's health care and contraception at 6-months PP, compared to women not exposed
      to such an intervention. The two specific aims of the project are: 1) To determine if
      introducing a self-administered Reproductive Life Planning Tool (RLPT) with postpartum
      mothers during the 2-month WBV will increase the proportion of women receiving a well-woman
      primary care health visit by 6 months postpartum; and if introducing a self-administered
      Reproductive Life Planning Tool (RLPT) will increase utilization rates of contraception by 6
      months postpartum. 2) To assess patient-, provider-, and systems-level barriers and
      facilitators to integrating a self-administered Reproductive Life Planning Tool (RLPT)
      designed to facilitate referral of postpartum women for primary well-woman care in the
      context of a pediatric clinic.

      The investigators hypothesize that exposure to a self-administered RLPT combined with a
      conversation with a pediatrician during a 2-month WBV will increase use of well-woman primary
      health care during the postpartum period as well as receipt of contraception, by 6-months
      postpartum. If successful, the results of this study have great potential to inform clinical
      and public health practice to increase women's use of health care and contraception in the
      postpartum period.
    

Detailed description: 
      Specific Aims Aim I. To determine if introducing a self-administered Reproductive Life
      Planning Tool (RLPT) with postpartum mothers during the 2-month WBV will increase the
      proportion of women receiving a well-woman primary care health visit by 6 months postpartum.

      Aim Ia. To determine if introducing a self-administered Reproductive Life Planning Tool
      (RLPT) with postpartum mothers during the 2-month WBV will increase utilization rates of
      contraception by 6 months postpartum.

      Aim II: To assess the extent of system adoption as well as patient-, provider-, and
      systems-level barriers and facilitators to integrating a self-administered Reproductive Life
      Planning Tool designed to facilitate referral of postpartum women for primary well-woman care
      within the context of a pediatric clinic.

      Study Design and Intervention This is a single-site system-level pilot study to measure the
      impact of a self-administered RLPT during the 2-month WBV on PP women's subsequent receipt of
      primary health care and contraception, compared to usual care. To facilitate women's uptake
      of a referral for well-woman primary care, mothers will be offered the opportunity to
      schedule a well-woman visit on the same day as their infant's next WBV or the first available
      visit if the participant needs more immediate care. This study will have two phases: phase 1
      is enrollment of a control or baseline group, followed by a washout period; phase 2 is
      enrollment of the intervention group (intervention).

      During phase 2 (intervention), the self-administered RLPT will be implemented in the Child
      and Youth Center (CYC, the general pediatric clinic) and the Primary Care Adolescent and
      Child Clinic (PCAC) at UIH with all PP women bringing infants for the 2-month WBV. The
      intervention leverages an existing system designed to screen all PP women (through 6-months)
      for depression.

      During the WBV, physicians will review the information provided by the woman on the RLPT
      about general health, reproductive plans, and use of contraception. The pediatrician will use
      the RLPT to initiate a brief conversation with mothers about the need for a referral for
      well-woman primary care. The investigators will create a referral process to the UIH Primary
      Care Plus clinic (internal medicine) through the electronic medical record. At the close of
      the WBV, if the mother desires a referral the pediatrician can request the referral during
      the infant's check-out process. Research staff will routinely review all referral needs and
      initiate scheduling based on the mother's preference. Mothers will be asked for a preference
      of the next available appointment or an appointment on the same day as the infant's next WBV.
      For women who desire their health care visit on the same day as their infant's next WBV (the
      4-month visit), a research assistant will schedule both visits on the same day. To the extent
      possible, the mother's appointment will be earlier the same day (ideally 2 hours before) of
      the infant's scheduled visit, to promote attendance.

      Participant Recruitment into the Research Study: The intervention is planned as a
      system-level intervention, thus, all women whose infants are scheduled for a 2-month WBV
      during the intervention period will have the opportunity to be exposed to the RLPT
      intervention. On study recruitment days (randomly selected half-days during phase 2), women
      whose infants are scheduled for a 2-month WBV will be approached by a research assistant (RA)
      who will screen for eligibility. Recruitment into the study will occur before, during or
      after the WBV, baseline surveys will be completed during or after the WBV to avoid biasing
      women's responses on the RLPT, which is administered prior to the WBV. If a woman is eligible
      and interested in participating, the subject will be consented and asked to complete a
      baseline survey.

      After consent is obtained, the RA will cross-check the participant list using a secure
      network on a tablet device to ensure that the woman is not already enrolled. Each RLPT will
      be linked to the infant by medical record number and date of birth. Limited physician
      characteristics (male/female, trainee/faculty) will be recorded; no physician names will be
      collected. The RLPTs for women who are consented and enrolled in the study will remain intact
      and all data will be collected from the tool and linked to the enrolled mother. The RLPTs for
      women who are not enrolled into the study will be de-identified after the Edinburgh tool is
      scanned by removing and shredding the patient sticker so no identifying information remains
      on the form. This will allow the investigators to calculate clinic-specific adoption rates
      and examine the extent to which provider and system characteristics, such as the type of
      physician (e.g., attending versus resident), demographic characteristics of the physician
      (e.g., sex), and clinic operational factors (e.g., morning versus afternoon clinic; day of
      the week), influences adoption of the intervention.

      Consent for Intervention Group: Informed consent will be obtained for: 1) a baseline survey;
      2) a phone survey at 6 months PP; and 3) access to a woman's medical records to document
      receipt of health care services. Women will be will reimbursed for their time with gift cards
      [$10 at baseline and $10 at follow-up (6-month WBV)]. The RA will log the recruitment
      process, including number of women approached and if women accepted or refused,
      participation.

      Selection of Control Group: The control group will be enrolled during phase 1 (first 4
      months) using similar procedures as the Intervention Group, but prior to the introduction of
      the intervention. After enrollment of the control group, a 6-week washout period prior to
      phase 2 (intervention) will ensure women are not enrolled into both arms of the study.

      Pediatrician Training: Pediatricians (faculty and resident physicians) will all receive a
      1-hour formal training on using the RLPT prior to the start of the study, offered at three
      different times to accommodate physician schedules. Research staff will touch-base with
      pediatricians weekly during the first 4 weeks of the study, and monthly thereafter, to answer
      questions and encourage consistent provider use of the tool. The researchers will schedule a
      'refresher' training 3 months after the start of the study to reinforce appropriate use of
      the tool. During the training, physicians will be instructed on how to start a conversation
      with women, what to document on the tool, and how to initiate a referral if needed.
      Physicians are not expected to provide contraceptive counseling to mothers, only to engage
      women in a discussion about their health care needs. An information sheet about the study
      will be given to all pediatric providers who are trained.

      Sample: This pilot study will enroll at least 50 women per group. This sample size will
      provide a stable estimate of the intervention's effect on primary care receipt by 6 months
      postpartum for power calculations for a larger, subsequent study of intervention
      effectiveness.

      Data Sources and Collection Surveys of Women: All participants will complete a baseline
      survey (English or Spanish) at the time of enrollment in the study (during or after the WBV)
      and will receive a phone call at 6 months PP for the follow-up survey. During the baseline
      survey, in addition to demographic information, women will be asked about their general
      health status and health behaviors, and current contraception type and use. Those in
      intervention arm will be asked about their experience completing the RLPT during the WBV,
      referral to well-woman primary care (if applicable). For the follow-up survey the researchers
      will try to reach each participant as close to 6 months as possible, but no later than 9
      months PP. Structured phone interviews with women will include questions from the following
      domains: 1) use of health care services; 2) use and type(s) of contraception; and 3) known
      pregnancy status. The intervention group interviews will also include experience completing
      the RLPT during the WBV; and, the process of getting care (for those who chose to do so) (SA
      II). To verify RLPT exposure at the individual level, the RLPT tool will be linked to the
      mother using the patient sticker placed on the tool.

      Medical Records: Medical records will be reviewed at baseline and at 6 months PP to determine
      receipt of health care services and contraception. The investigators recognize that some
      women may receive additional health care outside the UIC system; for this group, the
      researchers will not be able to confirm medical visits outside the UIC system.

      Focus Groups with Providers: The investigators will conduct two in-depth qualitative focus
      groups with physicians (residents and faculty) after the intervention is complete during
      study year 2. The focus group guide will include questions from the following domains: 1)
      Experience implementing the RLPT; and, 2) barriers and facilitators to implementation of RLPT
      (SA II). In addition, study investigators will keep a running log of barriers and
      facilitators experienced throughout the intervention implementation period.

      Data Management All survey data will be directly entered into REDcap web-based data capture
      screens that will be programmed and tested prior to the study. Data will be imported to SAS
      for analysis. Variables will be merged across time point by study ID and cleaned and recoded.
      Focus groups will be recorded, transcribed, and uploaded to DeDoose qualitative analysis
      software. Completion of the Grey Box (physician section of the tool) will be a measure of
      provider "adoption" of the intervention; completion rates will be tracked by comparing
      completed forms with completed clinic visits for 2-month WBVs. Completed clinic visit data
      are available in the existing medical record scheduling system.

      Analysis Specific Aim I and Ia: Baseline characteristics will be assessed for equivalency
      across groups using chi-square tests for categorical and t-tests for continuous variables.
      Unbalanced characteristics will be adjusted for in further analyses. An intent-to-treat
      analysis will be performed for SA I and Ia. A crude relative risk (RR) and risk difference
      (RD) will be calculated with 95% confidence intervals to estimate the effect of the
      intervention on primary outcomes. If adjustment is needed for covariates, RRs and RDs will be
      estimated using the average marginal predictions from a fitted logistic regression model with
      the following form:41

      logit(y) = β0 + β1x1 + β2x2 + …+ βkxk , where: y = SA 1: Woman's primary care visit by 6
      months (1 = Yes/0 = No) SA 1a: Use of contraception at 6 months (1 = Yes/0 = No) x1 = RLPT
      Intervention (1 = Intervention/0 = Control) x2 - xk = Unbalanced covariates

      Although the findings of this study will reflect the experiences of low-income women at one
      large medical center in Chicago, the experiences are likely to be relevant to those of many
      low-income women. While a hospital outpatient clinic is a unique health care setting, the
      experience of having a pediatrician discuss new mothers' health needs and refer mothers for
      their own care is likely to be similar across pediatric practices. This study will add to the
      emerging literature related to a dual care focus for mother and infant. If this intervention
      is successful, this work will provide evidence of the feasibility of introducing a
      system-level intervention related to women's health into pediatric practice. This information
      can inform changes in payment and policy to support the ability of pediatricians to discuss
      women's health needs and facilitate referral with mothers at their infants' WBV, with the
      ultimate goal of increasing women's use of primary care and PP contraception, preventing
      rapid repeat and unintended pregnancies, and ultimately decreasing adverse pregnancy
      outcomes.
    

Intervention name(s): RLPT
Intervention type(s): Behavioral
Intervention description(s): The Reproductive Life Plan Tool (RLPT) will be self-administered. Pediatricians will use the RLPT to assess women's need for well-woman primary care.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The control group will be enrolled during phase 1 (first 4 months) prior to the introduction of the intervention. After enrollment of the control group, a 6-week washout period prior to phase 2 (intervention) will ensure women are not enrolled into both arms of the study.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Postpartum; Contraception