NCT03592628

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

July 5, 2018

Last Update Submit

July 17, 2018

Conditions

Outcome Measures

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

    Two weeks

Secondary Outcomes (1)

  • Immediate Comprehension

    15 minutes

Study Arms (2)

Standard Instructions

PLACEBO COMPARATOR

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

Enhanced Instruction

EXPERIMENTAL

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

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

Enhanced Instruction

Standard discharge instructions WITHOUT supplement of visual aid.

Standard Instructions

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll participants were in-hospital status post a cesarean delivery for delivery of their newborn.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to consent
  • Identified as English speaking
  • Had a cesarean delivery during the index hospitalization for delivery of their living newborn

You may not qualify if:

  • Non-English speaking
  • Declined to participate
  • Required a translator for communication
  • Intellectual disability (as self-identified or as determined by healthcare provider)
  • Currently incarcerated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Audiovisual Aids

Intervention Hierarchy (Ancestors)

Educational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Rebekah McCurdy, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 19, 2018

Study Start

June 1, 2017

Primary Completion

November 30, 2017

Study Completion

July 3, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations