Trial Outcomes & Findings for Bridging the Gap From Postpartum to Primary Care (NCT NCT05543265)

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

360 participants

Primary outcome timeframe

4 months after the patient's estimated date of delivery

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Control Routine postpartum care	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
Overall Study STARTED	176	184
Overall Study COMPLETED	173	180
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Routine postpartum care	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
Overall Study Lost to Follow-up	3	3
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Bridging the Gap From Postpartum to Primary Care

Baseline characteristics by cohort

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=5 Participants	34.2 years STANDARD_DEVIATION 4.8 • n=7 Participants	34.1 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	180 Participants n=7 Participants	353 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=5 Participants	139 Participants n=7 Participants	266 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	00 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	115 Participants n=5 Participants	127 Participants n=7 Participants	242 Participants n=5 Participants
Race (NIH/OMB) More than one race	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	173 participants n=5 Participants	180 participants n=7 Participants	353 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months after the patient's estimated date of delivery

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)

Outcome measures

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 delivery

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months after the patient's estimated date of delivery

Health care maintenance visit appointment with the patient's assigned primary care provider

Outcome measures

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 delivery

Health 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 delivery

Any 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 delivery

Any 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 delivery

Contraception 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 delivery

Long-acting contraception use (implant, intrauterine device)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the patient's estimated date of delivery

Long-acting contraception use (implant, intrauterine device)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the patient's estimated date of delivery

Contraception 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 delivery

Postpartum 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 delivery

Postpartum 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 delivery

Weight counseling documentation among those with obesity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the patient's estimated date of delivery

Weight counseling documentation among those with obesity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months after the patient's estimated date of delivery

Blood 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 delivery

Blood 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 delivery

Clinical 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 delivery

Clinical 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 delivery

New or continued antidepressant prescription use

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the patient's estimated date of delivery

New or continued antidepressant prescription use

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months after the patient's estimated date of delivery

New 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 delivery

New 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 delivery

New 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 delivery

New 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 delivery

Laboratory 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 delivery

Laboratory 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 delivery

Primary 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 delivery

Primary care provider visit attendance per patient report

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Facilitated Transition

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

Mark Clapp, MD

Massachusetts General Hospital

Phone: 617-724-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place