Linking Inter-professional Newborn and Contraception Care (LINCC)

Linking Inter-professional Newborn and Contraception Care (LINCC) Trial - A Novel Approach to Postpartum Contraception Provision at the Well-Baby Visit

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes and affect nearly one third of women in the U.S. Rates of postpartum (PP) contraception use remain low, particularly among low-income minority women, leading to high rates of short IPI pregnancies. This proposed study aims to address the gap in the current model of PP contraception care, by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care with the goal of improving access to timely PP contraception.

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception; Family Planning; PostPartum
• Intervention / Treatment: Behavioral: LINCC intervention - enable co-schedule feature

Detailed Description

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes including pre-eclampsia, anemia, and preterm birth. Despite these negative health consequences, nearly one third of women experience a short IPI, highlighting a significant public health problem in the U.S. A critical approach to preventing short IPIs is to provide postpartum (PP) women with timely access to contraception. The current standard clinical practice is to have women return six weeks after delivery for a postpartum visit, at which time contraceptive needs are addressed. However, many women resume sexual activity prior to six weeks PP, and many women, particularly low-income minority women, do not present for this visit. Low rates of postpartum contraception uptake leave women vulnerable to an unplanned pregnancy and significant negative health consequences. Thus, there is an urgent need for alternative approaches to increase timely access to PP contraception to improve outcomes for women and children.

The proposed study aims to:

1. develop a comprehensive implementation plan to link PP contraception and newborn care through co-scheduling visits in community health centers (CHC);
2. use an effectiveness- implementation hybrid design to evaluate this novel system-level approach to linking maternal and newborn care at CHCs served by our partner organization, AllianceChicago and;
3. assess implementation of linked PP contraception and newborn care and report on key barriers and facilitators related to successful implementation of the intervention.

Increasing access to timely contraception is a promising strategy to help women plan their families and, in turn, reduce the poor health sequela associated with short IPI pregnancies. The long-term impact of this study is to reduce negative health outcomes among PP women and infants by increasing access to patient-oriented PP contraceptive care. Findings may provide evidence supporting a paradigm shift for linked PP care and identify important insights to facilitate successful implementation of this model of care in CHCs across the nation.

• Study Type: Interventional
• Enrollment (Estimated): 2667
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Wailuku, Hawaii, United States, 96793
      • Malama O ke Ola
  • Illinois
    • Chicago, Illinois, United States, 60615
      • Friend Health
    • Chicago, Illinois, United States, 60640
      • Heartland Health Centers
    • Chicago, Illinois, United States, 60647
      • Infant Welfare Society
  • New York
    • New York, New York, United States, 10029
      • Settlement Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Eligible participants include women presenting with their infants at one of the 7 chosen CHC sites for their first WBV (typically 3-5 days after delivery).

Exclusion Criteria:

• Women will be excluded if they had a tubal ligation or a long acting reversible contraception planned immediately after delivery. Additionally, women will be excluded if they needed an emergency hysterectomy due to life threatening bleeding during delivery. Any male patients will be excluded from the study because the study outcomes of contraceptive method use and pregnancy status are not applicable to males.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - Aim 2; During the intervention period, staff will capture women during the first well-baby visit (WBV) and offer to have the next visit co-scheduled for infant and contraception care. Appointments are scheduled during the discharge process at the end of each WBV. During the discharge process all women 0-6 months postpartum will be identified by clerical staff through review of each pediatric clinic beforehand and through an electronic flag alert in the infant's electronic medical record. The pre-review of pediatric clinic schedules and the use of the flag will remind staff to offer the mother a co-scheduled visit for newborn and contraceptive care at the time of the next newborn visit.	Behavioral: LINCC intervention - enable co-schedule feature; Clinics will offer postpartum contraception appointments earlier and the opportunity to co-schedule these appointments with their infant's next well-baby visit
No Intervention: Control - Aim 2; Clinics will schedule postpartum contraception using normal clinic procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who receive contraception by two months postpartum	Using de-identified patient data collected through clinic's Electronic Health Record (EHR) system (i.e., visit type attended, billing codes for contraception) we will measure receipt of all methods of contraception by two months postpartum	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who receive contraception by six months postpartum	Using de-identified patient data collected through clinic's Electronic Medical Record system (i.e., visit type attended, billing codes for contraception) we will measure receipt of all methods of contraception by six months postpartum	6 months
Number of patients who present with a short inter-pregnancy interval pregnancies	Use data to estimate clinic-level rate of incoming prenatal patients presenting with short IPI	24 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: University of Illinois at Chicago; AllianceChicago
• Investigators: Principal Investigator: Sadia Haider, MD, Rush University Medical Center; Principal Investigator: Rachel Caskey, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): February 21, 2025

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1R01HD097171 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No