Enhancing Postpartum Discharge Instructions

NCT ID: NCT03592628

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-07-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Health Literacy Randomized Controlled Trial Postpartum Cesarean Delivery Affecting Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Standard Instructions

Intervention Type OTHER

Standard discharge instructions WITHOUT supplement of visual aid.

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.

Group Type EXPERIMENTAL

Visual Aid

Intervention Type OTHER

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

Interventions

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Visual Aid

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

Intervention Type OTHER

Standard Instructions

Standard discharge instructions WITHOUT supplement of visual aid.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rebecca Lawrence, BS

UNKNOWN

Sponsor Role collaborator

Sarah Cohen, MD

UNKNOWN

Sponsor Role collaborator

Rebecca Newbrander, MD

UNKNOWN

Sponsor Role collaborator

Jason K. Baxter, MD

UNKNOWN

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Rebekah McCurdy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebekah McCurdy, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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16D.794

Identifier Type: -

Identifier Source: org_study_id

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