Clinical trial NCT05399784: Postpartum Visit Timing and the Effect on Visit Attendance
Official title: Postpartum Visit Timing and the Effect on Visit Attendance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Disorder
Postpartum Depression
Postpartum Weight Retention
Breastfeeding
Satisfaction, Patient
Trust
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 162
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess if the addition of an early postpartum visit improves attendance at postpartum visits. We seek to evaluate if an additional early postpartum visit improves patient education, satisfaction, or trust in the clinicians during the postpartum period; all of which may ultimately facilitate improved outcomes. Additionally, we seek to explore patient preferences for postpartum care delivery.

Detailed description: Maternal mortality in the United States is currently at a record high of 17 deaths per 100,000 live births and the majority of pregnancy related deaths occur in the postpartum period due to complications from chronic disease exacerbation, pregnancy-related hypertension, or psychiatric conditions that lead to suicide. Optimal postpartum care would reduce mortality risk, but numerous studies have demonstrated current care is inadequate. Up to 40% of women do not attend their postpartum visit at 4-6 weeks after delivery and the 15-minute visit is too short to achieve the comprehensive goals that the American College of Obstetricians and Gynecologists (ACOG) sets for this visit: a full assessment of physical, social, and psychological well-being. In addressing the current gap between optimal and actual care, ACOG recently recommended that practitioners shift from the standard, single six-week postpartum visit to two postpartum visits, the first within three weeks of delivery. While this change is intended to address current sub-optimal outcomes, the effects of this change are entirely unknown.

The long term goal of our program is to improve postpartum care for women in Rhode Island. The primary objective of this project is to determine if the ACOG proposed additional postpartum visit within three weeks of delivery improves attendance to postpartum appointments compared to routine postpartum care. Additionally, we intend to examine whether having two scheduled postpartum visits (one within three weeks and the other at the standard 4-6 week postpartum time point) which we describe as "early and often" postpartum care-improves patient knowledge, satisfaction and trust in clinicians compared to routine care as well as explore patient preferences for postpartum care. Our central hypothesis is that early and often postpartum care will lead to improved patient visit attendance compared to routine care.

Eligibility criteria: Inclusion Criteria:

* age 13 to 50 years old
* literacy in English or Spanish
* receipt of prenatal care at the Obstetrics and Gynecology Care Center of Women \& Infants Hospital
* delivery at Women \& Infants Hospital during the study time period

Exclusion Criteria:

High risk pregnancy defined as one or more of the following:

* chronic hypertension
* gestational hypertension
* preeclampsia
* eclampsia
* third degree perineal laceration
* fourth degree perineal laceration
* blood product transfusion
* intensive care unit admission
* who were prescribed anxiolytic or antidepressant medications in the antepartum period

Primary outcomes:
measure: Number of postpartum visits attended
timeFrame: 3 months
Secondary outcomes:
measure: Number of recommended items covered during postpartum care
timeFrame: 3 months
measure: Trust in physician scale
timeFrame: 3 months
measure: Short Assessment of Patient Satisfaction
timeFrame: 3 months
measure: Number of emergency room visits
timeFrame: 3 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Martha B Kole-White, MD
role: PRINCIPAL_INVESTIGATOR
References: