Postpartum Visit Timing and the Effect on Visit Attendance

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression; Satisfaction, Patient; Breastfeeding; Postpartum Disorder; Postpartum Weight Retention; Trust
• Intervention / Treatment: Behavioral: Early postpartum visit; Behavioral: Standard postpartum visit

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early & Often Postpartum Care; Visit at 2-3 and 6 weeks postpartum.	Behavioral: Early postpartum visit; The early postpartum visit will be an in-person visit with a medical provider at 14-21 days postpartum.; Behavioral: Standard postpartum visit; The standard postpartum visit will occur at 35 to 56 days postpartum.
Placebo Comparator: Standard Postpartum Care; Visit at 6 weeks postpartum.	Behavioral: Standard postpartum visit; The standard postpartum visit will occur at 35 to 56 days postpartum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Martha B Kole-White, MD, Women & Infants Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Body Weight; Pregnancy Complications; Body Weight Changes; Depressive Disorder; Weight Gain; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression, Postpartum; Puerperal Disorders; Gestational Weight Gain
• Other Study ID Numbers: Kole_ConstanceHowesGrant_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No