InjuryNCT01810523
Stories to Educate Patients With Ankle, Foot, and Knee Injuries
A study testing Narrative in people with Injury, run by University of Pennsylvania at 1 site in United States.
Trial summary
Study will test the use of narratives on patient satisfaction and translation of an evidence-based approach to the use of X-rays for leg injuries in the Emergency Department (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom X-rays are determined to not be needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injury
- What is being tested?
- Narrative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2013
- 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
- Acute traumatic knee, ankle or foot injury presenting to ED
- No indication for X-ray by Ottawa Rules criteria
- ED provider planning to discharge patient
Who cannot join
- X-ray obtained
- Need for X-ray by established Ottawa Rules criteria
- Children
- Pregnant women
- Patient to be admitted to the hospital
- Patient non-English speaking or illiterate
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparative Effectiveness of Descriptive Versus Narrative Emergency Department Discharge Instructions for Patient Education on Unnecessary Testing for Ankle, Foot and Knee Injuries
Study will test the use of narratives on patient satisfaction and translation of an evidence-based approach to the use of X-rays for leg injuries in the Emergency Department (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom X-rays are determined to not be needed. On discharge, patients will receive the current fact-based sheet or that plus a narrative explaining the work-up and treatment of these injuries. Outcomes will be assessed by a survey measuring patient satisfaction and understanding.
- Conditions
- Injury
- Being tested
- Narrative, Control
- Keywords
- Acute, lower, extremity, not requiring, diagnostic, imaging
- Medical subject headings
- Wounds and Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NarrativeBehavioural
Narrative form as described above.
ControlBehavioural
Blank piece of paper
| Study group | Role | What they receive |
|---|---|---|
| Narrative | Experimental | This arm will receive information regarding leg injuries and X-ray usage in narrative form in addition to standard of care discharge information. Receives: Behavioral: Narrative |
| Control | Placebo comparator | This arm will receive a blank piece of paper in addition to the standard of care discharge information. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
To measure patient satisfaction, we will use a validated survey instrument. The survey asks patients 5 questions, which they answer by providing responses on a 5-point scale ranging from "Poor" to "Excellent." The questions include:
- My satisfaction with the amount of time spent with me by the person who evaluated and treated me was....
- The explanation I received of how my illness should be treated was...
- The way the health care provider treated me was...
- My overall satisfaction with my visit was...
- Your care provider determined that you did not need an X-ray for your injury. What is your level of satisfaction with that decision?
Measured: 5 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013 (estimated)
Why it stopped: The study was stopped due to methodological issues that require additional consideration prior to resuming the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810523
- Sponsor's protocol ID
- 817212
- Status last verified
- Aug 2016
- First submitted
- 7 Mar 2013
- Last updated
- 22 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Descriptive Versus Narrative Emergency Department Discharge Instructions for Patient Education on Unnecessary Testing for Ankle, Foot and Knee Injuries
- ClinicalTrials.gov ID
- NCT01810523
- Acronym / sponsor ID
- 817212
- Conditions
- Injury
- Keywords
- Acute, lower, extremity, not requiring, diagnostic, imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to methodological issues that require additional consideration prior to resuming the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (estimated)
- First posted
- 13 Mar 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.
Study will test the use of narratives on patient satisfaction and translation of an evidence-based approach to the use of X-rays for leg injuries in the Emergency Department (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom X-rays are determined to not be needed. On discharge, patients will receive the current fact-based sheet or that plus a narrative explaining the work-up and treatment of these injuries. Outcomes will be assessed by a survey measuring patient satisfaction and understanding.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative | Experimental | Behavioral: NarrativeThis arm will receive information regarding leg injuries and X-ray usage in narrative form in addition to standard of care discharge information. |
| Control | Placebo comparator | Behavioral: ControlThis arm will receive a blank piece of paper in addition to the standard of care discharge information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute traumatic knee, ankle or foot injury presenting to ED
- No indication for X-ray by Ottawa Rules criteria
- ED provider planning to discharge patient
Key exclusion criteria (6 listed)
- X-ray obtained
- Need for X-ray by established Ottawa Rules criteria
- Children
- Pregnant women
- Patient to be admitted to the hospital
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 |
|---|---|---|
| NarrativeNarrative form as described above. | Behavioural | Narrative |
| ControlBlank piece of paper | Behavioural | Control |
Primary outcome
Patient Satisfaction
Time frame: 5 minutes after intervention
To measure patient satisfaction, we will use a validated survey instrument. The survey asks patients 5 questions, which they answer by providing responses on a 5-point scale ranging from "Poor" to "Excellent." The questions include: 1. My satisfaction with the amount of time spent with me by the person who evaluated and treated me was.... 2. The explanation I received of how my illness should be treated was... 3. The way the health care provider treated me was... 4. My overall satisfaction with my visit was... 5. Your care provider determined that you did not need an X-ray for your injury. What is your level of satisfaction with that decision?
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative in people with Injury, run by University of Pennsylvania 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 6 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: withdrawn, as of the sponsor's last update on 22 Aug 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient Satisfaction (time frame: 5 minutes after intervention). 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 22 Aug 2016.