CClinicalTrials.gg
CompletedNCT03592628Updated Jul 19, 2018

Enhancing Postpartum Discharge Instructions

An interventional study of Visual Aid and Standard Instructions in Health Literacy, Randomized Controlled Trial and Postpartum, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jun 2017, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Health Literacy
  • Randomized Controlled Trial
  • Postpartum
  • Cesarean Delivery Affecting Newborn
03

In context

Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Placebo comparator
    Standard Instructions

    Subjects enrolled in this arm received standardized teach-back regarding discharge instructions as well as the standard printed discharge instructions regarding post-cesarean wound care.

    Other: Standard Instructions

  • Experimental
    Enhanced Instruction

    Subjects enrolled in this arm received standardized teach-back regarding discharge instructions as well as the standard printed discharge instructions regarding post-cesarean wound care AND they received an additional printed visual diagram.

    Other: Visual Aid

Interventions

  • OtherVisual Aid

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

  • OtherStandard Instructions

    Standard discharge instructions WITHOUT supplement of visual aid.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Two weeks

Secondary outcomes

  1. 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

    Time frame: 15 minutes

07

Study locations

1 site
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03592628
Lead sponsor
Thomas Jefferson University
Collaborators
Rebecca Lawrence, BS, Sarah Cohen, MD, Rebecca Newbrander, MD, Jason K. Baxter, MD
Responsible party
Rebekah McCurdy (Associate Professor, Thomas Jefferson University) — Principal investigator
First posted
Jul 19, 2018
Start date
Jun 1, 2017
Primary completion
Nov 30, 2017
Completion
Jul 3, 2018
Last update
Jul 19, 2018

Study contacts

Rebekah McCurdy, MD
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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