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Completed

NCT Number: NCT03592628

Enhancing Postpartum Discharge Instructions

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.

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Key information

Conditions

Health Literacy Cesarean Delivery Affecting Newborn Postpartum Randomized Controlled Trial

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual aid

Other

The visual aid was a one-sheet diagram with illustrations of important features of post-cesarean wound care.

Standard Instructions

Other

Standard discharge instructions WITHOUT supplement of visual aid.

Primary outcomes

  1. Comprehension Score Two Weeks Post-Discharge

    Time frame: Two weeks

    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

Secondary outcomes

  1. Immediate Comprehension

    Time frame: 15 minutes

    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

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Jason K. Baxter, MD
  • Rebecca Lawrence, BS
  • Rebecca Newbrander, MD
  • Sarah Cohen, MD

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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