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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| AllianceChicago | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Aim 2 | Experimental | 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. |
|
| Control - Aim 2 | No Intervention | Clinics will schedule postpartum contraception using normal clinic procedures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINCC intervention - enable co-schedule feature | Behavioral | Clinics will offer postpartum contraception appointments earlier and the opportunity to co-schedule these appointments with their infant's next well-baby visit |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sadia Haider, MD | Rush University Medical Center | Principal Investigator |
| Rachel Caskey, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malama O ke Ola | Wailuku | Hawaii | 96793 | United States | ||
| Friend Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39121991 | Derived | Haider S, Ott E, Moore A, Rankin K, Campbell R, Mohanty N, Gemkow JW, Caskey R. Linking Inter-professional Newborn and Contraception Care (LINCC) trial: Protocol for a stepped wedge cluster randomized trial to link postpartum contraception care with routine Well-Baby Visits. Contemp Clin Trials. 2024 Oct;145:107659. doi: 10.1016/j.cct.2024.107659. Epub 2024 Aug 8. |
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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
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence/Clinic 1: 3 Months Baseline, 21 Months Intervention | Clinic 1 was randomly assigned to start the clinic-level intervention after 3 months in the baseline period followed by 3 months for training and wash out. The intervention period continued for 21 months at this clinic. During the intervention period, staff approached women during all well-baby visits (WBV) between 0-6 months and offered to have the next visit co-scheduled for infant and contraception care. Appointments were scheduled during the discharge process at the end of each WBV. |
| FG001 | Sequence/Clinic 2: 6 Months Baseline, 18 Months Intervention | Clinic 2 was randomly assigned to start the clinic-level intervention after 6 months in the baseline period followed by 3 months for training and wash out. The intervention period continued for 18 months at this clinic. During the intervention period, staff approached women during all well-baby visits (WBV) between 0-6 months and offered to have the next visit co-scheduled for infant and contraception care. Appointments were scheduled during the discharge process at the end of each WBV. |
| FG002 | Sequence/Clinic 3: 9 Months Baseline, 15 Months Intervention | Clinic 3 was randomly assigned to start the clinic-level intervention after 9 months in the baseline period followed by 3 months for training and wash out. The intervention period continued for 15 months at this clinic. During the intervention period, staff approached women during all well-baby visits (WBV) between 0-6 months and offered to have the next visit co-scheduled for infant and contraception care. Appointments were scheduled during the discharge process at the end of each WBV. |
| FG003 | Sequence/Clinic 4: 12 Months Baseline, 12 Months Intervention | Clinic 4 was randomly assigned to start the clinic-level intervention after 12 months in the baseline period followed by 3 months for training and wash out. The intervention period continued for 12 months at this clinic. During the intervention period, staff approached women during all well-baby visits (WBV) between 0-6 months and offered to have the next visit co-scheduled for infant and contraception care. Appointments were scheduled during the discharge process at the end of each WBV. |
| FG004 | Sequence/Clinic 5: 15 Months Baseline, 9 Months Intervention | Clinic 5 was randomly assigned to start the clinic-level intervention after 15 months in the baseline period followed by 3 months for training and wash out. The intervention period continued for 9 months at this clinic. During the intervention period, staff approached women during all well-baby visits (WBV) between 0-6 months and offered to have the next visit co-scheduled for infant and contraception care. Appointments were scheduled during the discharge process at the end of each WBV. |
| FG005 | Sequence/Clinic 6: 18 Months Baseline, 6 Months Intervention | Clinic 6 was randomly assigned to start the clinic-level intervention after 18 months in the baseline period followed by 3 months for training and wash out. The intervention period continued for 6 months at this clinic. During the intervention period, staff approached women during all well-baby visits (WBV) between 0-6 months and offered to have the next visit co-scheduled for infant and contraception care. Appointments were scheduled during the discharge process at the end of each WBV. |
| FG006 | Sequence/Clinic 7: 21 Months Baseline, 3 Months Intervention | Clinic 7 was randomly assigned to start the clinic-level intervention after 21 months in the baseline period followed by 3 months for training and wash out. The intervention period continued for 3 months at this clinic. During the intervention period, staff approached women during all well-baby visits (WBV) between 0-6 months and offered to have the next visit co-scheduled for infant and contraception care. Appointments were scheduled during the discharge process at the end of each WBV. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Months 1-3 |
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| Period 2: Months 4-6 |
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| Period 3: Months 7-9 |
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| Period 4: Months 10-12 |
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| Period 5: Months 13-15 |
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| Period 6: Months 16-18 |
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| Period 7: Months 19-21 |
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| Period 8: Months 22-24 |
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| Period 9: Months 25-27 |
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Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure only.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure . |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | No difference | Posted | Number | Participants | 2 months | Community Health Clinics (CHC) | Community Health Clinics (CHC) |
|
up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Rankin | University of Illinois at Chicago | 708-710-8411 | krankin@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2024 | Jun 5, 2025 | Prot_SAP_000.pdf |
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Effectiveness-Implementation Hybrid Design
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| 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) |
| 12 months |
| Chicago |
| Illinois |
| 60615 |
| United States |
| Heartland Health Centers | Chicago | Illinois | 60640 | United States |
| Infant Welfare Society | Chicago | Illinois | 60647 | United States |
| Settlement Health | New York | New York | 10029 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Control - Aim 2 | Clinics will schedule postpartum contraception using normal clinic procedures. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure . | Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure . | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control - Aim 2 | Clinics will schedule postpartum contraception using normal clinic procedures. |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
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| 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) | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 0 |
| 1,497 |
| 0 |
| 1,497 |
| 0 |
| 1,497 |
| EG001 | Control - Aim 2 | Clinics will schedule postpartum contraception using normal clinic procedures. | 0 | 1,021 | 0 | 1,021 | 0 | 1,021 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Unknown or Not Reported |
|