Video Assisted Informed Consent for Lortab to Improve Pat... | NCT01374295

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

NCT01374295

Sponsor

Albany Medical College

Status

Completed

Last Update Posted

Mar 24, 2014Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit

Interventions

video
standard education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Lortab

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jun 7, 2011

First Submission Date that Met QC Criteria

Jun 14, 2011

First Posted Date

Jun 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2014

Last Update Posted Date

Mar 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wayne Triner, Professor Dept. of Emergency Medicine, Albany Medical CollegePrincipal Investigator

Lead Sponsor

Albany Medical CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
video	Experimental	If randomized to this arm patient watches a 3 minute video	Other: video
standard education	Active Comparator	If randomized to this arm patient receives standard verbal education from healthcare provider.	Other: standard education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
video	Other	watch a 3 minute video	video
standard education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient satisfaction and knowledge	comparison of patient completed survey following education via standard format or 3 minute video	survey is completed immediately after education, estimated time to complete survey is 5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albany Medical Center		Albany	New York	12208	United States

Intervention Browse Module

MeSH Terms

ID	Term
D014743	Videotape Recording

Ancestor Terms

ID	Term
D013637	Tape Recording
D001296	Audiovisual Aids
D018961	Educational Technology
D013672	Technology

Browse Leaves

Not provided

Browse Branches

Not provided