Health LiteracyNCT03592628
Enhancing Postpartum Discharge Instructions
A study testing Visual Aid and Standard Instructions in people with Health Literacy and Randomized Controlled Trial, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Randomized Controlled Trial, Postpartum
- What is being tested?
- Visual Aid and Standard Instructions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 3 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to consent
- Identified as English speaking
- Had a cesarean delivery during the index hospitalization for delivery of their living newborn
Who cannot join
- Non-English speaking
- Declined to participate
- Required a translator for communication
- Intellectual disability (as self-identified or as determined by healthcare provider)
- Currently incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
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.
- Conditions
- Health Literacy, Randomized Controlled Trial, Postpartum, Cesarean Delivery Affecting Newborn
- Being tested
- Visual Aid, Standard Instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AidOther
The visual aid was a one-sheet diagram with illustrations of important features of post-cesarean wound care.
Standard InstructionsOther
Standard discharge instructions WITHOUT supplement of visual aid.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Visual Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jun 2017
- Primary completion30 Nov 2017
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Rebecca Lawrence, BS, Sarah Cohen, MD, Rebecca Newbrander, MD, Jason K. Baxter, MD
- Responsible party
- Principal investigator, Rebekah McCurdy, Thomas Jefferson University
- Investigators
- Rebekah McCurdy, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592628
- Sponsor's protocol ID
- 16D.794
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Postpartum Discharge Instructions for Cesarean Incision Care With Assessment of Comprehension: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03592628
- Acronym / sponsor ID
- 16D.794
- Conditions
- Health Literacy, Randomized Controlled Trial, Postpartum, Cesarean Delivery Affecting Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Rebecca Lawrence, BS, Sarah Cohen, MD, Rebecca Newbrander, MD, Jason K. Baxter, MD
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Instructions | Placebo comparator | Other: Standard InstructionsSubjects enrolled in this arm received standardized teach-back regarding discharge instructions as well as the standard printed discharge instructions regarding post-cesarean wound care. |
| Enhanced Instruction | Experimental | Other: Visual AidSubjects 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to consent
- Identified as English speaking
- Had a cesarean delivery during the index hospitalization for delivery of their living newborn
Key exclusion criteria (5 listed)
- Non-English speaking
- Declined to participate
- Required a translator for communication
- Intellectual disability (as self-identified or as determined by healthcare provider)
- Currently incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual AidThe visual aid was a one-sheet diagram with illustrations of important features of post-cesarean wound care. | Other | Enhanced Instruction |
| Standard InstructionsStandard discharge instructions WITHOUT supplement of visual aid. | Other | Standard Instructions |
Primary outcome
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
1 secondary outcome
Immediate Comprehension
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebekah McCurdy, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Aid and Standard Instructions in people with Health Literacy and Randomized Controlled Trial, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension Score Two Weeks Post-Discharge (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.