Trial Outcomes & Findings for Nudge to Drive Transitions of Care (NCT NCT04660032)
NCT ID: NCT04660032
Last Updated: 2024-08-05
Results Overview
The primary outcome measure is documentation of counseling about transitioning care to a continuity care provider (primary care or cardiology) at the postpartum visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
4-12 weeks postpartum
Results posted on
2024-08-05
Participant Flow
Participant milestones
| Measure |
Nudge
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
119
|
|
Overall Study
COMPLETED
|
104
|
118
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Nudge
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Nudge to Drive Transitions of Care
Baseline characteristics by cohort
| Measure |
Nudge
n=104 Participants
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
n=118 Participants
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
32.7 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
32.3 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
222 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latinx
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple races/ethnicities
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=99 Participants
|
118 participants
n=107 Participants
|
222 participants
n=206 Participants
|
|
Public insurance
|
32 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Body mass index at first prenatal visit
|
28.0 kg/m^2
n=99 Participants
|
27.5 kg/m^2
n=107 Participants
|
27.8 kg/m^2
n=206 Participants
|
|
Nulliparity
|
64 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
History of hypertensive disorder of pregnancy
|
22 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Chronic hypertension
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Diabetes
|
7 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Tobacco use
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Gestational age at delivery (weeks)
|
38.5 weeks
n=99 Participants
|
38.5 weeks
n=107 Participants
|
38.5 weeks
n=206 Participants
|
|
Hypertensive disorder of pregnancy
Gestational hypertension or preeclampsia
|
75 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Hypertensive disorder of pregnancy
Preeclampsia with severe features
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Hypertensive disorder of pregnancy
Hemolysis, elevated liver enzymes, and low platelet (HELLP) syndrome
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Hypertensive disorder of pregnancy
Chronic hypertension with superimposed preeclampsia
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4-12 weeks postpartumPopulation: Analyzed for study participants who attended postpartum visit
The primary outcome measure is documentation of counseling about transitioning care to a continuity care provider (primary care or cardiology) at the postpartum visit.
Outcome measures
| Measure |
Nudge
n=98 Participants
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
n=107 Participants
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
|---|---|---|
|
Number of Patients With Documented Counseling on Transitions of Care
|
38 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Prior to postpartum visitPopulation: A nudge was only sent for the intervention group; it was not sent nor measured for usual care. A single nudge message was sent to the scheduled postpartum care provider per patient in the intervention group. A single provider could receive more than 1 nudge if they had more than 1 patient who was included in the study.
Electronic prompts opened by obstetric care providers within 1 week of receipt in the electronic medical record. The nudge (electronic prompt) was sent 1 week prior to the scheduled 4-12 weeks postpartum visit.
Outcome measures
| Measure |
Nudge
n=104 Nudge
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
|---|---|---|
|
Nudge Message Opened Within 1 Week of Receipt
|
104 Nudge
|
0 Nudge
|
SECONDARY outcome
Timeframe: 4-12 weeks postpartumPopulation: 98 of 104 patients in the nudge arm (6 lost to follow-up) and 107 of 118 (11 lost to follow-up) patients in the usual care arm attended a postpartum visit within the health system and could be evaluated for this secondary outcome.
Documentation in the postpartum visit note regarding ongoing cardiovascular risk related to HDP
Outcome measures
| Measure |
Nudge
n=98 Participants
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
n=107 Participants
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
|---|---|---|
|
Number of Patients With Documented Counseling on Cardiovascular Disease (CVD) Risk at the Postpartum Visit
|
21 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 4-12 weeks postpartumPopulation: Attended postpartum visit
Use of scripted dot phrases (available in Epic) for counseling on transitions of care and CVD risk in the postpartum note. These dot phrases were available for all providers and were included in the nudge message.
Outcome measures
| Measure |
Nudge
n=98 Participants
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
n=107 Participants
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
|---|---|---|
|
Number of Participants With Postpartum Visit Notes That Used Example Text
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumPopulation: Entire enrolled population who met inclusion/exclusion criteria
Attendance at a primary care or cardiology visit for preventative care within 6 months of delivery.
Outcome measures
| Measure |
Nudge
n=104 Participants
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
|
Usual Care
n=118 Participants
Usual postpartum follow-up with visit at 4-12 weeks postpartum
|
|---|---|---|
|
Number of Patients With Preventative Care Follow-up
|
23 Participants
|
29 Participants
|
Adverse Events
Nudge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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