Enhancing Postpartum Discharge Instructions

Randomized Controlled Trial Clinical Trial

Official title:

Enhancing Postpartum Discharge Instructions for Cesarean Incision Care With Assessment of Comprehension: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592628
• Other study ID #: 16D.794
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: July 3, 2018

Study information

• Verified date: July 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-cesarean delivery discharge instructions are not currently at an appropriate health literacy level. Enhancing discharge instructions with a visual aid did not improve scores on comprehension quizzes, either immediately or two-weeks post-discharge. However, participants preferred to have access to visual images with discharge instructions.

Description:

Objective:

To evaluate the effect of a visual aid on improving comprehension of hospital discharge instructions for cesarean wound care.

Methods:

A randomized control trial with a 1:1 allocation ratio and an intention to treat analysis was performed at an urban, tertiary care center from June-November 2017. Fifty English-speaking patients ages 18-50 who had undergone a cesarean delivery were randomized to receive either standard or enhanced discharge instructions regarding post-cesarean incision care. Enhanced instructions included a visual aid not present in the standard instructions. Participants completed a comprehension quiz prior to hospital discharge and again 2 weeks after discharge as well as the REALM literacy assessment prior to discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 3, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Able to consent

• Identified as English speaking

• Had a cesarean delivery during the index hospitalization for delivery of their living newborn

Exclusion Criteria:

• Non-English speaking

• Declined to participate

• Required a translator for communication

• Intellectual disability (as self-identified or as determined by healthcare provider)

• Currently incarcerated

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Newborn
• Health Literacy
• Postpartum
• Randomized Controlled Trial

Intervention

Other:
• Visual Aid
The visual aid was a one-sheet diagram with illustrations of important features of post-cesarean wound care.
• Standard Instructions
Standard discharge instructions WITHOUT supplement of visual aid.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Thomas Jefferson University	Jason K. Baxter, MD, Rebecca Lawrence, BS, Rebecca Newbrander, MD, Sarah Cohen, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension Score Two Weeks Post-Discharge	Total score on 11-point quiz (Discharge Instructions Comprehension Quiz) administered via phone two weeks post-discharge, score range 1-11 with one point assigned for each correct answer (no subtractions for incorrect answers); higher scores are favorable indicating answers consistent with higher comprehension	Two weeks
Secondary	Immediate Comprehension	Total score on 11-point quiz (Discharge Instructions Comprehension Quiz) administered immediately after discharge instructions reviewed, score range 1-11 with one point assigned for each correct answer (no subtractions for incorrect answers), higher scores are favorable indicating answers consistent with higher comprehension	15 minutes