Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room VisitNCT01374295
Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge
A study testing video and standard education in people with Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit, run by Albany Medical College at 1 site in United States.
Trial summary
In order to compare two different forms of patient education; patients who receive Lortab medication or prescription during their ED visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit
- What is being tested?
- video and standard education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-critical emergency room patients being prescribed Lortab
- age 18 year or older
Who cannot join
- emergency room patients not receiving Lortab as their first prescribed medication
- age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge: A Randomized Control Study
In order to compare two different forms of patient education; patients who receive Lortab medication or prescription during their ED visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. After education, patient completes a survey, estimated to take 5 minutes to complete.
Read the detailed description
The purpose of this study is to compare different methods of teaching patients about their prescription medicines. It is possible that certain teaching methods are better than others at educating patients.
Patients who receive Lortab medication or prescription during their ED visit and agree to the study are randomized to receive either standard patient education (from healthcare provider) or watch a 3 minute video. After the medication teaching has been provided the patient is given the medicine and a asked to complete a ten-question survey. This takes approximately five minutes and asks the patient to rate the quality of the information received.
- Being tested
- video, standard education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoOther
watch a 3 minute video
standard educationOther
Receives standard verbal education from healthcare provider
| Study group | Role | What they receive |
|---|---|---|
| video | Experimental | If randomized to this arm patient watches a 3 minute video Receives: Other: video |
| standard education | Active comparator | If randomized to this arm patient receives standard verbal education from healthcare provider. Receives: Other: standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction and knowledge
comparison of patient completed survey following education via standard format or 3 minute video
Measured: survey is completed immediately after education, estimated time to complete survey is 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room VisitStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Triner, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374295
- Sponsor's protocol ID
- 2981
- Other IDs
- Lortab
- Status last verified
- Jun 2011
- First submitted
- 7 Jun 2011
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT01374295
- Acronym / sponsor ID
- 2981
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Jun 2011 (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.
In order to compare two different forms of patient education; patients who receive Lortab medication or prescription during their ED visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. After education, patient completes a survey, estimated to take 5 minutes to complete.
Detailed description
The purpose of this study is to compare different methods of teaching patients about their prescription medicines. It is possible that certain teaching methods are better than others at educating patients.
Patients who receive Lortab medication or prescription during their ED visit and agree to the study are randomized to receive either standard patient education (from healthcare provider) or watch a 3 minute video. After the medication teaching has been provided the patient is given the medicine and a asked to complete a ten-question survey. This takes approximately five minutes and asks the patient to rate the quality of the information received.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video | Experimental | Other: videoIf randomized to this arm patient watches a 3 minute video |
| standard education | Active comparator | Other: standard educationIf randomized to this arm patient receives standard verbal education from healthcare provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-critical emergency room patients being prescribed Lortab
- age 18 year or older
Key exclusion criteria (2 listed)
- emergency room patients not receiving Lortab as their first prescribed medication
- age less than 18 years
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 |
|---|---|---|
| videowatch a 3 minute video | Other | video |
| standard educationReceives standard verbal education from healthcare provider | Other | standard education |
Primary outcome
patient satisfaction and knowledge
Time frame: survey is completed immediately after education, estimated time to complete survey is 5 minutes
comparison of patient completed survey following education via standard format or 3 minute video
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 Mar 2014.
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 video and standard education in people with Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit, run by Albany Medical College 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: finished, as of the sponsor's last update on 24 Mar 2014. 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?
patient satisfaction and knowledge (time frame: survey is completed immediately after education, estimated time to complete survey is 5 minutes). 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 Mar 2014.