Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Albany Medical College

ClinicalTrials.gov Identifier:

NCT01374295

First received: June 7, 2011

Last updated: June 14, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 7, 2011
Last Updated Date	June 14, 2011
Start Date ^ICMJE	March 2011
Estimated Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 14, 2011)	patient satisfaction and knowledge [ Time Frame: survey is completed immediately after education, estimated time to complete survey is 5 minutes ] [ Designated as safety issue: No ] comparison of patient completed survey following education via standard format or 3 minute video
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01374295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge
Official Title ^ICMJE	Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge: A Randomized Control Study
Brief 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. 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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver)
Condition ^ICMJE	Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit
Intervention ^ICMJE	Other: video watch a 3 minute video Other: standard education Receives standard verbal education from healthcare provider
Study Arm (s)	Experimental: video If randomized to this arm patient watches a 3 minute video Intervention: Other: video Active Comparator: standard education If randomized to this arm patient receives standard verbal education from healthcare provider. Intervention: Other: standard education
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	January 2012
Estimated Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: non-critical emergency room patients being prescribed Lortab age 18 year or older Exclusion Criteria: emergency room patients not receiving Lortab as their first prescribed medication age less than 18 years
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01374295
Other Study ID Numbers ^ICMJE	2981, Lortab
Has Data Monitoring Committee	Yes
Responsible Party	Wayne Triner, DO, Albany Medical Center
Study Sponsor ^ICMJE	Albany Medical College
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Albany Medical College
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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