Contraception, Family Planning, PostPartum
Conditions
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.
Interventions
BEHAVIORALLINCC 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
Sponsors
University of Illinois at Chicago
AllianceChicago
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Effectiveness-Implementation Hybrid Design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Receive Contraception by Two Months Postpartum | 2 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Receive Contraception by Six Months Postpartum | 6 months | 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 |
| Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies | 12 months | Use EHR data to follow up participants for short IPI (subsequent pregnancy before 12 months postpartum) |
Countries
United States
Participant flow
Recruitment details
Recruitment was performed at the Community Health Clinic (CHC) level in this cluster-randomized trial, so all eligible patients at each CHC were included in the analysis of outcome data. No individual patient recruitment was performed.
Pre-assignment details
Seven CHCs were enrolled and all eligible patients from those CHCs were included in the outcome assessment. Randomization occurred at the CHC level, then the stepped wedge design was applied to roll out the intervention in waves according to the sequence. Therefore, patients seen at any given CHC prior to the implementation of the intervention were assigned to the Control condition and those seen at that CHC after the implementation of the intervention were assigned to the Intervention condition
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 1,497 |
| Control - Aim 2 Clinics will schedule postpartum contraception using normal clinic procedures. | 1,021 |
| Total | 2,518 |
Baseline characteristics
| Characteristic | Intervention - Aim 2 | Control - Aim 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 44 Participants | 42 Participants | 86 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1453 Participants | 972 Participants | 2425 Participants |
| Age, Continuous | 28.5 years STANDARD_DEVIATION 6 | 27.8 years STANDARD_DEVIATION 6 | 28.2 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 438 Participants | 490 Participants | 928 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 954 Participants | 481 Participants | 1435 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 105 Participants | 50 Participants | 155 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 70 Participants | 29 Participants | 99 Participants |
| Race (NIH/OMB) Black or African American | 551 Participants | 266 Participants | 817 Participants |
| Race (NIH/OMB) More than one race | 202 Participants | 129 Participants | 331 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 105 Participants | 50 Participants | 155 Participants |
| Race (NIH/OMB) White | 569 Participants | 547 Participants | 1116 Participants |
| Region of Enrollment United States | 1497 participants | 1021 participants | 2518 participants |
| Sex: Female, Male Female | 1497 Participants | 1021 Participants | 2518 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,497 | 0 / 1,021 |
| other Total, other adverse events | 0 / 1,497 | 0 / 1,021 |
| serious Total, serious adverse events | 0 / 1,497 | 0 / 1,021 |
Outcome results
Primary
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
Time frame: 2 months
Population: No difference
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Aim 2 | Number of Patients Who Receive Contraception by Two Months Postpartum | 474 Participants |
| Control - Aim 2 | Number of Patients Who Receive Contraception by Two Months Postpartum | 339 Participants |
Comparison: Please note that there were only 7 units (community health clinics) analyzed at Level 2 of this multilevel study, but due to the crossover design of the study, they were each observed under both the Control and Intervention conditions. Therefore, the Units Analyzed entered above reflect the 7 clinics under both conditions and should not be summed to 14.p-value: 0.1295% CI: [0.64, 1.05]Mixed Models Analysis
Secondary
Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies
Use EHR data to follow up participants for short IPI (subsequent pregnancy before 12 months postpartum)
Time frame: 12 months
Population: Due to a shortened study period because of interruptions related to the COVID-19 pandemic, this outcome was measured at 12 instead of 18 months postpartum. Two clinical sites changed to a new EHR platform before the end of the 12 month follow up period, disrupting follow up and leading to fewer numbers of participants in the intervention condition.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - Aim 2 | Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies | 67 Participants |
| Control - Aim 2 | Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies | 55 Participants |
p-value: 0.8895% CI: [0.33, 3.73]Mixed Models Analysis
Secondary
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
Time frame: 6 months
Population: The stepped wedge design was interrupted for outcomes measured at six months due to a longer washout period, resulting in slightly different, yet overlapping samples for the primary and secondary outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention - Aim 2 | Number of Patients Who Receive Contraception by Six Months Postpartum | 595 Participants |
| Control - Aim 2 | Number of Patients Who Receive Contraception by Six Months Postpartum | 436 Participants |
p-value: 0.3395% CI: [0.7, 1.13]Mixed Models Analysis