Conditions Influencing Health StatusNCT01968291
Use of Teach Back to Improve Comprehension of Discharge Instructions for Emergency Patients With Limited Health Literacy
A study testing Teach-back in people with Conditions Influencing Health Status, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study was to determine whether use of teach-back discharge instructions improve patient satisfaction and patients' self-reported and objective comprehension of discharge instructions in the emergency department when compared to standard discharge instructions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status
- What is being tested?
- Teach-back
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients being discharged from the emergency department
- A score of 6 or less on the Rapid Estimate of Adult Literacy in Medicine, Revised (consistent with Limited Health Literacy)
Who cannot join
- aphasia,
- non-English speaking,
- mental handicap,
- psychiatric chief complaint,
- too high acuity per physician,
- insurmountable communication barrier,
- evaluations for sexual assault,
- clinical intoxication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barnes-Jewish Hospital Emergency Department
St Louis, Missouri, 63110
About this study
Official title: The Impact of Teach-back on Comprehension of Discharge Instructions Among Emergency Patients With Limited Health Literacy: A Randomized, Controlled Study
The purpose of this study was to determine whether use of teach-back discharge instructions improve patient satisfaction and patients' self-reported and objective comprehension of discharge instructions in the emergency department when compared to standard discharge instructions.
- Conditions
- Conditions Influencing Health Status
- Being tested
- Teach-back
- Keywords
- Health Literacy, Teach-back, Emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-backBehavioural
Patients are asked to repeat back in their own words their understanding of the discharge information that was provided to them.
| Study group | Role | What they receive |
|---|---|---|
| Teach-back | Experimental | Patients are prompted to state back in their own words their comprehension of the information given to them at discharge. Receives: Behavioral: Teach-back |
| Standard Discharge Instructions | No intervention | Patient receives usual discharge instructions as administered by the nurse assigned to the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective comprehension
Concordance between audio taped comprehension compared to review of medical record using 5 level scale of concordance
Measured: Questions evaluating comprehension were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).
Secondary outcomes (1)
self-reported comprehension
self reported comprehension of discharge instructions for the following areas: emergency department (ED) course (Tests and treatment); Post-ED care (medication instructions; home instructions; follow-up instructions); Return instructions.
Measured: Questions evaluating self-reported comprehension were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions Influencing Health StatusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Griffey, Washington University School of Medicine
- Investigators
- Richard T Griffey, MD, MPH, Principal investigator, Washington University School of MedicineKim A Kaphingst, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968291
- Sponsor's protocol ID
- 201206011
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Teach-back on Comprehension of Discharge Instructions Among Emergency Patients With Limited Health Literacy: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01968291
- Acronym / sponsor ID
- 201206011
- Conditions
- Conditions Influencing Health Status
- Keywords
- Health Literacy, Teach-back, Emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Oct 2013 (estimated)
- 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.
The purpose of this study was to determine whether use of teach-back discharge instructions improve patient satisfaction and patients' self-reported and objective comprehension of discharge instructions in the emergency department when compared to standard discharge instructions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teach-back | Experimental | Behavioral: Teach-backPatients are prompted to state back in their own words their comprehension of the information given to them at discharge. |
| Standard Discharge Instructions | No intervention | –Patient receives usual discharge instructions as administered by the nurse assigned to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients being discharged from the emergency department
- A score of 6 or less on the Rapid Estimate of Adult Literacy in Medicine, Revised (consistent with Limited Health Literacy)
Key exclusion criteria (8 listed)
- aphasia,
- non-English speaking,
- mental handicap,
- psychiatric chief complaint,
- too high acuity per physician,
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 |
|---|---|---|
| Teach-backPatients are asked to repeat back in their own words their understanding of the discharge information that was provided to them. | Behavioural | Teach-back |
Primary outcome
Objective comprehension
Time frame: Questions evaluating comprehension were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).
Concordance between audio taped comprehension compared to review of medical record using 5 level scale of concordance
1 secondary outcome
self-reported comprehension
Time frame: Questions evaluating self-reported comprehension were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).
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 24 Oct 2013.
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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.
Richard T Griffey, MD, MPH principal investigator
Washington University School of Medicine
Kim A Kaphingst, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-back in people with Conditions Influencing Health Status, run by Washington University School of Medicine 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 2 inclusion and 8 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 24 Oct 2013. 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. 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?
Objective comprehension (time frame: Questions evaluating comprehension were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).). 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 24 Oct 2013.