Trial Outcomes & Findings for Bridging the Gap From Postpartum to Primary Care (NCT NCT05543265)
NCT ID: NCT05543265
Last Updated: 2024-09-19
Results Overview
Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health)
COMPLETED
NA
360 participants
4 months after the patient's estimated date of delivery
2024-09-19
Participant Flow
Participant milestones
| Measure |
Facilitated Transition
Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
Default appointment scheduling: Default primary care appointment scheduling
Targeted messaging: Patient-specific messages about the importance of postpartum care transition
Nudge Reminders: Primary care appointment reminders
|
Control
Routine postpartum care
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
176
|
|
Overall Study
COMPLETED
|
180
|
173
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Facilitated Transition
Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
Default appointment scheduling: Default primary care appointment scheduling
Targeted messaging: Patient-specific messages about the importance of postpartum care transition
Nudge Reminders: Primary care appointment reminders
|
Control
Routine postpartum care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Bridging the Gap From Postpartum to Primary Care
Baseline characteristics by cohort
| Measure |
Control
n=173 Participants
Routine postpartum care
|
Facilitated Transition
n=180 Participants
Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
Default appointment scheduling: Default primary care appointment scheduling
Targeted messaging: Patient-specific messages about the importance of postpartum care transition
Nudge Reminders: Primary care appointment reminders
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
34.2 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
34.1 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=99 Participants
|
180 Participants
n=107 Participants
|
353 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
266 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
00 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
242 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
173 participants
n=99 Participants
|
180 participants
n=107 Participants
|
353 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryAny visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health)
Outcome measures
| Measure |
Control
n=173 Participants
Routine postpartum care
|
Facilitated Transition
n=180 Participants
Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
Default appointment scheduling: Default primary care appointment scheduling
Targeted messaging: Patient-specific messages about the importance of postpartum care transition
Nudge Reminders: Primary care appointment reminders
|
|---|---|---|
|
Rate of Primary Care Provider Visit Attendance
|
38 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryAny visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryHealth care maintenance visit appointment with the patient's assigned primary care provider
Outcome measures
| Measure |
Control
n=173 Participants
Routine postpartum care
|
Facilitated Transition
n=180 Participants
Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
Default appointment scheduling: Default primary care appointment scheduling
Targeted messaging: Patient-specific messages about the importance of postpartum care transition
Nudge Reminders: Primary care appointment reminders
|
|---|---|---|
|
Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health)
|
30 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryHealth care maintenance visit appointment with the patient's assigned primary care provider
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryAny visit to a urgent care or emergency room visit
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryAny visit to a urgent care or emergency room visit
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryContraception plan documented by any provider after delivery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryLong-acting contraception use (implant, intrauterine device)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryLong-acting contraception use (implant, intrauterine device)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryContraception plan documented by any provider after delivery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryPostpartum diabetes screening among those diagnosed with gestational diabetes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryPostpartum diabetes screening among those diagnosed with gestational diabetes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryWeight counseling documentation among those with obesity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryWeight counseling documentation among those with obesity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryBlood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryBlood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryClinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryClinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryNew or continued antidepressant prescription use
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryNew or continued antidepressant prescription use
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryNew or continued antihypertensive medication use among individuals with hypertension
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryNew or continued antihypertensive medication use among individuals with hypertension
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryNew or continued oral or subcutaneous diabetes medication use control among individuals with diabetes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryNew or continued oral or subcutaneous diabetes medication use control among individuals with diabetes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryLaboratory glucose screening test among individuals with or at risk for diabetes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryLaboratory glucose screening test among individuals with or at risk for diabetes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 months after the patient's estimated date of deliveryPrimary care provider visit attendance per patient report
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the patient's estimated date of deliveryPrimary care provider visit attendance per patient report
Outcome measures
Outcome data not reported
Adverse Events
Control
Facilitated Transition
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