Postpartum Visit Timing and the Effect on Visit Attendance

Breastfeeding Clinical Trial

Official title:

Postpartum Visit Timing and the Effect on Visit Attendance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399784
• Other study ID #: Kole_ConstanceHowesGrant_2020
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Depression, Postpartum
• Gestational Weight Gain
• Postpartum Depression
• Postpartum Disorder
• Postpartum Weight Retention
• Puerperal Disorders
• Satisfaction, Patient
• Trust

Intervention

Behavioral:
• Early postpartum visit
The early postpartum visit will be an in-person visit with a medical provider at 14-21 days postpartum.
• Standard postpartum visit
The standard postpartum visit will occur at 35 to 56 days postpartum.

Locations

Country	Name	City	State
United States	Women & Infants Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of postpartum visits attended	The number of times a patient attends a postpartum visit in the first 12 weeks postpartum will be counted	3 months
Secondary	Number of recommended items covered during postpartum care	Patients will complete a survey (created for this study) and identify how many key postpartum items were discussed during their postpartum care.	3 months
Secondary	Trust in physician scale	The Trust in Physicians scale is a reliable and valid measure of a patients trust in their clinician and has been shown to be distinct from patient satisfaction	3 months
Secondary	Short Assessment of Patient Satisfaction	The Short Assessment of Patient Satisfaction (SAPS) is a short, reliable, valid, seven item scale to assess patients satisfaction with medical treatment and care	3 months
Secondary	Number of emergency room visits	Emergency room utilization will be determined via the electronic medical record. The number of visits in the first 3 months postpartum will be recorded.	3 months