Enhancing Postpartum Discharge Instructions
July 17, 2018 updated by: Rebekah McCurdy, Thomas Jefferson University
Enhancing Postpartum Discharge Instructions for Cesarean Incision Care With Assessment of Comprehension: A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Standard discharge instructions WITHOUT supplement of visual aid.
|
|
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.
|
The visual aid was a one-sheet diagram with illustrations of important features of post-cesarean wound care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
November 30, 2017
Study Completion (Actual)
July 3, 2018
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
July 17, 2018
First Posted (Actual)
July 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 16D.794
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.