Feasibility of a Standardized Video for Patient Education... | NCT03213197

Status Module

Record Verification Date

Feb 2019

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

Feb 14, 2017Actual

Primary Completion Date

Mar 22, 2018Actual

Completion Date

Jun 19, 2018Actual

First Submitted Date

Jul 7, 2017

First Submission Date that Met QC Criteria

Jul 7, 2017

First Posted Date

Jul 11, 2017Actual

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

Feb 4, 2019

Last Update Posted Date

Feb 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Caitlin E. Loprinzi Brauer, Principal Investigator, Mayo ClinicPrincipal Investigator

Lead Sponsor

Mayo ClinicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The researchers hypothesize that patients and their families will be comfortable watching standardized CPR informational videos and that they would recommend that others watch the videos. Furthermore, the researchers hypothesize that patients and their families will find the videos helpful in their own end-of-life planning.

Detailed Description

The code status video, produced by experts in palliative medicine and end of life care, has been evaluated in a variety of healthcare settings to allow patients to make more informed decisions based on realistic information about resuscitation status. This video could be used as a supplement for clinical discussions and decision making. It is not meant to replace a careful, individualized discussion by the clinician with patients and their families, but appears to be a helpful tool to help educate patients in order for them to be better informed to make complicated decisions about their code status. The Emergency Department is an ideal setting to evaluate the video because they could improve patient understanding in an environment with inherently limited face-to-face provider time.

Specific Aims

To assess the satisfaction of patients and family members who view the video on cardiopulmonary resuscitation. This will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others.
To assess if watching the standardized video changes patients' code status. This will be measured as what patients' code status was before and after watching the video.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPR video	Experimental	Patient watches a short CPR video	Other: CPR video

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPR video	Other	Patient watches a short CPR video	CPR video

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction of patients and family members in watching videos of cardiopulmonary resuscitation	This will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others.	1 year

Secondary Outcomes

Measure	Description	Time Frame
The number of patients/families who will feel that the video was helpful in the decision regarding code status	To assess if watching the standardized video changes patients' code status. This will be measured as what patients' code status was before and after watching the video.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Any patient in the Emergency Department whose disposition is listed as a full admission to the hospital
Provider willingness to have patient watch the video and be available to answer questions after.
Age > 65
Ability to provide consent

Exclusion Criteria

Does not speak English
Hearing or visually impaired
Prisoner or incarcerated
Inability to provide consent according to attending Physician or Study Coordinator and legal power of attorney is not present

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caitlin E Loprinzi Brauer	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not being shared....

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Intervention Model Description

Feasibility of a Standardized Video for Patient Education and as a Decision Aid on Code Status for Patients in the Emergency Department pending Admission to the Hospital