NCT03448289

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

February 7, 2018

Last Update Submit

October 23, 2019

Conditions

Keywords

PostpartumContraception

Outcome Measures

Primary Outcomes (2)

  • Change in receipt of primary care services - self report

    Change in receipt of primary care services will be ascertained by self-report on the 2-month and 6-month Postpartum interview.

    2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)

  • Change in receipt of primary care services - EMR review

    Change in receipt of primary care services will be ascertained by electronic medical record review at 2-months and 6-months Postpartum. Evidence of a visit from either source (self-report or EMR review) will be counted as receipt.

    2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)

Secondary Outcomes (3)

  • Contraception utilization

    2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)

  • Participant feasibility and acceptability

    The last half of Year 2

  • Provider feasibility and acceptability

    The last half of Year 2

Study Arms (2)

Control

NO INTERVENTION

This group will not receive the RLPT.

Intervention

EXPERIMENTAL

This group will receive the RLPT.

Behavioral: RLPT

Interventions

RLPTBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Postpartum women 15-49 years
  • Present with infant for a 2-month WBV at the UIC CYC or PCAC
  • Receive healthcare at UIC
  • Speak English or Spanish

You may not qualify if:

  • Pregnant
  • \< 15 years or \> 49 years of age
  • Receive healthcare outside the UIC system
  • Do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • Caskey RN, Olender SE, Zocchi A, Bergo CJ, Uesugi KH, Haider S, Handler AS. Addressing Women's Health Care Needs During Pediatric Care. Womens Health Rep (New Rochelle). 2021 Jul 9;2(1):227-234. doi: 10.1089/whr.2021.0016. eCollection 2021.

  • Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Rachel Caskey, MD, MAPP

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Because we are studying health behaviors, we cannot share the specific aims of the study with control group participants as this could bias behavior. The control group participants will be told that this is a study monitoring women's general health care experiences at UIH.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Academic Internal Medicine

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 28, 2018

Study Start

January 24, 2018

Primary Completion

September 29, 2019

Study Completion

September 29, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations