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Enhancing Postpartum Discharge Instructions

Sponsor
Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT03592628
Collaborator
Rebecca Lawrence, BS (Other), Sarah Cohen, MD (Other), Rebecca Newbrander, MD (Other), Jason K. Baxter, MD (Other)
50
Enrollment
1
Location
2
Arms
13
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Visual Aid
  • Other: Standard Instructions
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Enhancing Postpartum Discharge Instructions for Cesarean Incision Care With Assessment of Comprehension: A Pilot Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Nov 30, 2017
Actual Study Completion Date :
Jul 3, 2018

Arms and Interventions

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.

Other: Standard Instructions
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.

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

Outcome Measures

Primary Outcome Measures

  1. Comprehension Score Two Weeks Post-Discharge [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 Outcome Measures

  1. Immediate Comprehension [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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:

  • Non-English speaking

  • Declined to participate

  • Required a translator for communication

  • Intellectual disability (as self-identified or as determined by healthcare provider)

  • Currently incarcerated

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Rebekah McCurdy, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rebekah McCurdy, Associate Professor, Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT03592628
Other Study ID Numbers:
  • 16D.794
First Posted:
Jul 19, 2018
Last Update Posted:
Jul 19, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 19, 2018