Trial Outcomes & Findings for Linking Inter-professional Newborn and Contraception Care (NCT NCT04092530)
NCT ID: NCT04092530
Last Updated: 2025-09-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2518 participants
Primary outcome timeframe
2 months
Results posted on
2025-09-04
Participant Flow
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.
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
Unit of analysis: Clinics
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|
|
Period 1: Months 1-3
STARTED
|
82 1
|
50 1
|
68 1
|
32 1
|
52 1
|
17 1
|
12 1
|
|
Period 1: Months 1-3
COMPLETED
|
82 1
|
50 1
|
68 1
|
32 1
|
52 1
|
17 1
|
12 1
|
|
Period 1: Months 1-3
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 2: Months 4-6
STARTED
|
0 0
|
36 1
|
74 1
|
42 1
|
50 1
|
31 1
|
13 1
|
|
Period 2: Months 4-6
COMPLETED
|
0 0
|
36 1
|
74 1
|
42 1
|
50 1
|
31 1
|
13 1
|
|
Period 2: Months 4-6
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 3: Months 7-9
STARTED
|
78 1
|
0 0
|
74 1
|
29 1
|
59 1
|
30 1
|
15 1
|
|
Period 3: Months 7-9
COMPLETED
|
78 1
|
0 0
|
74 1
|
29 1
|
59 1
|
30 1
|
15 1
|
|
Period 3: Months 7-9
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 4: Months 10-12
STARTED
|
65 1
|
42 1
|
0 0
|
48 1
|
46 1
|
24 1
|
19 1
|
|
Period 4: Months 10-12
COMPLETED
|
65 1
|
42 1
|
0 0
|
48 1
|
46 1
|
24 1
|
19 1
|
|
Period 4: Months 10-12
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 5: Months 13-15
STARTED
|
60 1
|
48 1
|
83 1
|
0 0
|
39 1
|
25 1
|
11 1
|
|
Period 5: Months 13-15
COMPLETED
|
60 1
|
48 1
|
83 1
|
0 0
|
39 1
|
25 1
|
11 1
|
|
Period 5: Months 13-15
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 6: Months 16-18
STARTED
|
46 1
|
48 1
|
91 1
|
47 1
|
0 0
|
27 1
|
6 1
|
|
Period 6: Months 16-18
COMPLETED
|
46 1
|
48 1
|
91 1
|
47 1
|
0 0
|
27 1
|
6 1
|
|
Period 6: Months 16-18
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 7: Months 19-21
STARTED
|
66 1
|
55 1
|
82 1
|
29 1
|
39 1
|
0 0
|
10 1
|
|
Period 7: Months 19-21
COMPLETED
|
66 1
|
55 1
|
82 1
|
29 1
|
39 1
|
0 0
|
10 1
|
|
Period 7: Months 19-21
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 8: Months 22-24
STARTED
|
76 1
|
69 1
|
74 1
|
29 1
|
28 1
|
24 1
|
0 0
|
|
Period 8: Months 22-24
COMPLETED
|
76 1
|
69 1
|
74 1
|
29 1
|
28 1
|
24 1
|
0 0
|
|
Period 8: Months 22-24
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 9: Months 25-27
STARTED
|
71 1
|
57 1
|
75 1
|
38 1
|
48 1
|
19 1
|
10 1
|
|
Period 9: Months 25-27
COMPLETED
|
71 1
|
57 1
|
75 1
|
38 1
|
48 1
|
19 1
|
10 1
|
|
Period 9: Months 25-27
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
Baseline characteristics by cohort
| Measure |
Intervention - Aim 2
n=1497 Participants
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
|
Control - Aim 2
n=1021 Participants
Clinics will schedule postpartum contraception using normal clinic procedures.
|
Total
n=2518 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
44 Participants
n=1497 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
42 Participants
n=1014 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
86 Participants
n=2511 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
|
Age, Categorical
Between 18 and 65 years
|
1453 Participants
n=1497 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
972 Participants
n=1014 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
2425 Participants
n=2511 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1497 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
0 Participants
n=1014 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
0 Participants
n=2511 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 6.0 • n=1497 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
27.8 years
STANDARD_DEVIATION 6.0 • n=1014 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
28.2 years
STANDARD_DEVIATION 6.0 • n=2511 Participants • Seven control participants had invalid values for age after calculating from their dates of birth, so were not analyzed for the age measure .
|
|
Sex: Female, Male
Female
|
1497 Participants
n=1497 Participants
|
1021 Participants
n=1021 Participants
|
2518 Participants
n=2518 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1497 Participants
|
0 Participants
n=1021 Participants
|
0 Participants
n=2518 Participants
|
|
Region of Enrollment
United States
|
1497 participants
n=1497 Participants
|
1021 participants
n=1021 Participants
|
2518 participants
n=2518 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1497 Participants
|
0 Participants
n=1021 Participants
|
0 Participants
n=2518 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=1497 Participants
|
29 Participants
n=1021 Participants
|
99 Participants
n=2518 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1497 Participants
|
0 Participants
n=1021 Participants
|
0 Participants
n=2518 Participants
|
|
Race (NIH/OMB)
Black or African American
|
551 Participants
n=1497 Participants
|
266 Participants
n=1021 Participants
|
817 Participants
n=2518 Participants
|
|
Race (NIH/OMB)
White
|
569 Participants
n=1497 Participants
|
547 Participants
n=1021 Participants
|
1116 Participants
n=2518 Participants
|
|
Race (NIH/OMB)
More than one race
|
202 Participants
n=1497 Participants
|
129 Participants
n=1021 Participants
|
331 Participants
n=2518 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
105 Participants
n=1497 Participants
|
50 Participants
n=1021 Participants
|
155 Participants
n=2518 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
438 Participants
n=1497 Participants
|
490 Participants
n=1021 Participants
|
928 Participants
n=2518 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
954 Participants
n=1497 Participants
|
481 Participants
n=1021 Participants
|
1435 Participants
n=2518 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
105 Participants
n=1497 Participants
|
50 Participants
n=1021 Participants
|
155 Participants
n=2518 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: No difference
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
Outcome measures
| Measure |
Intervention - Aim 2
n=7 Community Health Clinics (CHC)
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
n=7 Community Health Clinics (CHC)
Clinics will schedule postpartum contraception using normal clinic procedures.
|
|---|---|---|
|
Number of Patients Who Receive Contraception by Two Months Postpartum
|
474 Participants
|
339 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
Intervention - Aim 2
n=1461 Participants
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
n=1067 Participants
Clinics will schedule postpartum contraception using normal clinic procedures.
|
|---|---|---|
|
Number of Patients Who Receive Contraception by Six Months Postpartum
|
595 Participants
|
436 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Use EHR data to follow up participants for short IPI (subsequent pregnancy before 12 months postpartum)
Outcome measures
| Measure |
Intervention - Aim 2
n=991 Participants
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
n=1067 Participants
Clinics will schedule postpartum contraception using normal clinic procedures.
|
|---|---|---|
|
Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies
|
67 Participants
|
55 Participants
|
Adverse Events
Experimental: Intervention - Aim 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Aim 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place