Clinical trial NCT04092530: Linking Inter-professional Newborn and Contraception Care
Official title: Linking Inter-professional Newborn and Contraception Care (LINCC) Trial - A Novel Approach to Postpartum Contraception Provision at the Well-Baby Visit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Planning
Contraception
PostPartum
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: AllianceChicago
First posted: 2019-09-17
Enrollment: 2518
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effectiveness-Implementation Hybrid Design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients who receive contraception by two months postpartum
timeFrame: 2 months
Secondary outcomes:
measure: Number of patients who receive contraception by six months postpartum
timeFrame: 6 months
measure: Number of patients who present with a short inter-pregnancy interval pregnancies
timeFrame: 24 months
Other outcomes:
Locations:
city: Wailuku
country: United States
facility: Malama O ke Ola
state: Hawaii
city: Chicago
country: United States
facility: Friend Health
state: Illinois
city: Chicago
country: United States
facility: Heartland Health Centers
state: Illinois
city: Chicago
country: United States
facility: Infant Welfare Society
state: Illinois
city: New York
country: United States
facility: Settlement Health
state: New York
Study officials:
affiliation: Rush University Medical Center
name: Sadia Haider, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Rachel Caskey, MD
role: PRINCIPAL_INVESTIGATOR
References: