ComplianceNCT01543438
Using Point-of-Care Video Prescriptions to Improve Aftercare Following Discharge From a Pediatric Emergency Department
A study testing Video Prescription (additional education) in people with Compliance and Emergency Department Aftercare, run by healthEworks LLC at 1 site in United States.
Trial summary
The goal of this project is to develop the content and delivery platform that electronically distributes mobile video discharge education for underserved populations and to demonstrate utilization, satisfaction, and improved health outcomes. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Compliance, Emergency Department Aftercare, Emergency Department Utilization
- What is being tested?
- Video Prescription (additional education)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- fits one of diagnostic criteria
- not previously enrolled in past week
Who cannot join
- primary language other than english or spanish
- does not consent to receive email communication
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's National Medical Center (UMC and SZ campuses)
Washington D.C., District of Columbia, 20010
David J Mathison, MD MBA, dmathiso@childrensnational.org
David J Mathison, MD MBA
About this study
Official title: Optimizing Emergency Aftercare With Mobile Video Prescriptions
The goal of this project is to develop the content and delivery platform that electronically distributes mobile video discharge education for underserved populations and to demonstrate utilization, satisfaction, and improved health outcomes.
Read the detailed description
Emergency department (ED) visits have increased by 25% over the past decade. 85% of these patients are discharged, and the standard of care is to provide each patient/caregiver with written instructions that highlight how to care for a particular illness at home and signs to return to the hospital. Compliance with such ED discharge instructions is limited, leading to suboptimal medical care and unnecessary return visits to the ED. Inadequate health literacy, language disparities, and poor comprehension of written discharge information contribute to this problem. This health gap is more prevalent in children of young parents, low-income families, and minority populations where a disproportionate number of patients visit the ED for non-emergent care, often because of a lack of health education. The ED environment is chaotic and distracting and suboptimal to educate patients. Such education is best accomplished where aftercare occurs-in the home, but many patients lack direction and motivation to seek reliable sources of focused health education.
healthEworks LLC has developed Video Prescriptions™ - concise 3-5 minute video modules specific to the most common discharge diagnoses that patients receive in the ED. Further work is needed to develop a professional, diagnosis-specific product. These videos will feature Dr. Christina Johns, an emergency physician who specializes in delivering health information on camera. Each video will be interactive, high definition, designed for small screen size, such as for a smartphone or laptop computer. Each video prescription™ will highlight the transition from hospital to home and focuses on what the diagnosis means, how to treat it at home, and which signs should prompt the patient to return to the ED or seek urgent care. A HIPAA-compliant tablet-based platform will link ED patients with their personalized video education, establishing an innovative system of post-discharge information sharing.
The use of video prescriptions™ will improve patient health education for the 100 million patients who are discharged from U.S. ED's annually. This technology is particularly applicable for hospitals that face increasing pressures to provide performance measures for hospital discharge.
Video prescriptions™ will be utilized by ED patients, regardless of socioeconomic status, will improve patient satisfaction and reduce unnecessary ED return visits.
- Specific Aim 1: Demonstrate patient utilization of video prescriptions Criteria for acceptance: a hyperlink click rate of greater than 70%
- Specific Aim 2: Demonstrate improved health outcomes. Criteria for acceptance: a reduction in return visits by 10%
- Specific Aim 3: Demonstrate quality of video content by showing improved patient satisfaction scores. Criteria for acceptance: improvement in patient satisfaction scores by 20%
- Being tested
- Video Prescription (additional education)
- Keywords
- ED utilization, video education, mobile health, streaming media, underserved populations
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Prescription (additional education)Other
receives video prescriptions
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | current standard of care |
| Intervention Group | Experimental | receives video prescription Receives: Other: Video Prescription (additional education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video Prescription Utilization Rate
measured with hyperlink click rate and successful streaming verification
Measured: 6 months
Secondary outcomes (1)
ED Return Visit Rate
ED return visits within 72 hrs and one week. Will also be stratified into 'unnecessary' return visits by assessing resource use and billing data.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplianceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- healthEworks LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, David J Mathison, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543438
- Sponsor's protocol ID
- R41MD006695-01
- Status last verified
- Jan 2013
- First submitted
- 22 Feb 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Emergency Aftercare With Mobile Video Prescriptions
- ClinicalTrials.gov ID
- NCT01543438
- Acronym / sponsor ID
- R41MD006695-01
- Keywords
- ED utilization, video education, mobile health, streaming media, underserved populations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- healthEworks LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Mar 2012 (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 goal of this project is to develop the content and delivery platform that electronically distributes mobile video discharge education for underserved populations and to demonstrate utilization, satisfaction, and improved health outcomes.
Detailed description
Emergency department (ED) visits have increased by 25% over the past decade. 85% of these patients are discharged, and the standard of care is to provide each patient/caregiver with written instructions that highlight how to care for a particular illness at home and signs to return to the hospital. Compliance with such ED discharge instructions is limited, leading to suboptimal medical care and unnecessary return visits to the ED. Inadequate health literacy, language disparities, and poor comprehension of written discharge information contribute to this problem. This health gap is more prevalent in children of young parents, low-income families, and minority populations where a disproportionate number of patients visit the ED for non-emergent care, often because of a lack of health education. The ED environment is chaotic and distracting and suboptimal to educate patients. Such education is best accomplished where aftercare occurs-in the home, but many patients lack direction and motivation to seek reliable sources of focused health education.
healthEworks LLC has developed Video Prescriptions™ - concise 3-5 minute video modules specific to the most common discharge diagnoses that patients receive in the ED. Further work is needed to develop a professional, diagnosis-specific product. These videos will feature Dr. Christina Johns, an emergency physician who specializes in delivering health information on camera. Each video will be interactive, high definition, designed for small screen size, such as for a smartphone or laptop computer. Each video prescription™ will highlight the transition from hospital to home and focuses on what the diagnosis means, how to treat it at home, and which signs should prompt the patient to return to the ED or seek urgent care. A HIPAA-compliant tablet-based platform will link ED patients with their personalized video education, establishing an innovative system of post-discharge information sharing.
The use of video prescriptions™ will improve patient health education for the 100 million patients who are discharged from U.S. ED's annually. This technology is particularly applicable for hospitals that face increasing pressures to provide performance measures for hospital discharge.
Video prescriptions™ will be utilized by ED patients, regardless of socioeconomic status, will improve patient satisfaction and reduce unnecessary ED return visits.
- Specific Aim 1: Demonstrate patient utilization of video prescriptions Criteria for acceptance: a hyperlink click rate of greater than 70%
- Specific Aim 2: Demonstrate improved health outcomes. Criteria for acceptance: a reduction in return visits by 10%
- Specific Aim 3: Demonstrate quality of video content by showing improved patient satisfaction scores. Criteria for acceptance: improvement in patient satisfaction scores by 20%
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –current standard of care |
| Intervention Group | Experimental | Other: Video Prescription (additional education)receives video prescription |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- fits one of diagnostic criteria
- not previously enrolled in past week
Key exclusion criteria (2 listed)
- primary language other than english or spanish
- does not consent to receive email communication
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 |
|---|---|---|
| Video Prescription (additional education)receives video prescriptions | Other | Intervention Group |
Primary outcome
Video Prescription Utilization Rate
Time frame: 6 months
measured with hyperlink click rate and successful streaming verification
1 secondary outcome
ED Return Visit Rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 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.
Children's National Medical Center (UMC and SZ campuses)
Washington D.C., United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Prescription (additional education) in people with Compliance and Emergency Department Aftercare, run by healthEworks LLC 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 2 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: status not confirmed, as of the sponsor's last update on 4 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video Prescription Utilization Rate (time frame: 6 months). 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 4 Jan 2013.