search
Back to results

Postpartum Visit Timing and the Effect on Visit Attendance

Primary Purpose

Postpartum Disorder, Postpartum Depression, Postpartum Weight Retention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early postpartum visit
Standard postpartum visit
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Disorder

Eligibility Criteria

13 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women & Infants Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Early & Often Postpartum Care

Standard Postpartum Care

Arm Description

Visit at 2-3 and 6 weeks postpartum.

Visit at 6 weeks postpartum.

Outcomes

Primary Outcome Measures

Number of postpartum visits attended
The number of times a patient attends a postpartum visit in the first 12 weeks postpartum will be counted

Secondary Outcome Measures

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.
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
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
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.

Full Information

First Posted
October 20, 2021
Last Updated
July 31, 2023
Sponsor
Women and Infants Hospital of Rhode Island
search

1. Study Identification

Unique Protocol Identification Number
NCT05399784
Brief Title
Postpartum Visit Timing and the Effect on Visit Attendance
Official Title
Postpartum Visit Timing and the Effect on Visit Attendance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women and Infants Hospital of Rhode Island

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Disorder, Postpartum Depression, Postpartum Weight Retention, Breastfeeding, Satisfaction, Patient, Trust

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early & Often Postpartum Care
Arm Type
Experimental
Arm Description
Visit at 2-3 and 6 weeks postpartum.
Arm Title
Standard Postpartum Care
Arm Type
Placebo Comparator
Arm Description
Visit at 6 weeks postpartum.
Intervention Type
Behavioral
Intervention Name(s)
Early postpartum visit
Intervention Description
The early postpartum visit will be an in-person visit with a medical provider at 14-21 days postpartum.
Intervention Type
Behavioral
Intervention Name(s)
Standard postpartum visit
Intervention Description
The standard postpartum visit will occur at 35 to 56 days postpartum.
Primary Outcome Measure Information:
Title
Number of postpartum visits attended
Description
The number of times a patient attends a postpartum visit in the first 12 weeks postpartum will be counted
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of recommended items covered during postpartum care
Description
Patients will complete a survey (created for this study) and identify how many key postpartum items were discussed during their postpartum care.
Time Frame
3 months
Title
Trust in physician scale
Description
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
Time Frame
3 months
Title
Short Assessment of Patient Satisfaction
Description
The Short Assessment of Patient Satisfaction (SAPS) is a short, reliable, valid, seven item scale to assess patients satisfaction with medical treatment and care
Time Frame
3 months
Title
Number of emergency room visits
Description
Emergency room utilization will be determined via the electronic medical record. The number of visits in the first 3 months postpartum will be recorded.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha B Kole-White, MD
Organizational Affiliation
Women & Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postpartum Visit Timing and the Effect on Visit Attendance

We'll reach out to this number within 24 hrs