NCT01610076

Brief Summary

This is a single-center, randomized control trial of a code status video as an educational tool in the intensive care unit. Subjects are stratified by patient or surrogate and are randomized to either watch an educational video on code status or not watch the video. They are then asked knowledge base questions regarding code status as well as questions pertaining to comfort regarding code status. Participants randomized to watch the video are also asked questions related to acceptance of the video.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
Last Updated

May 13, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

January 31, 2012

Results QC Date

August 22, 2015

Last Update Submit

April 7, 2016

Conditions

Keywords

Code StatusDo not resuscitate (DNR)Do not intubate (DNI)CPRCardiopulmonary resuscitationvideoadvanced directives

Outcome Measures

Primary Outcomes (1)

  • 12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)

    12 question (question 4 has 4 sub-questions) survey previously validated to determine knowledge level about resuscitation status with total score on the scale of 0-15. Possible scores ranged from 0 to 15, with higher scores representing increased medical knowledge. The CPR knowledge survey assesses a participants basic understanding of cardiopulmonary resuscitation (CPR). The survey consisted of 12 questions with one point being awarded for each correct response. Question four had a total of four possible correct answers. Thus the scores on the scale of 0-15 points is designed, with higher scores representing increased knowledge.

    after admission to ICU, approx one hour

Secondary Outcomes (3)

  • Participant Reported Comfort With Video Intervention

    immediately after intervention

  • Perception of Utility of Video

    immediately after intervention

  • Willingness to Recommend Video to Other Patients

    immediately after intervention

Study Arms (2)

No Video - Control

NO INTERVENTION

This group does not watch the 10 minute "code status" video before having the knowledge base video administered.

Code Status Video

EXPERIMENTAL

This group views a 10 minute video about "code status" prior to knowledge base survey administration

Other: Code Status Video

Interventions

10 minute video about "Code Status"

Code Status Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ages 18 and older admitted to the medical intensive care unit

You may not qualify if:

  • Institutionalized status (prisoners)
  • Pregnancy
  • A priori decided comfort care measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

  • Hofmann JC, Wenger NS, Davis RB, Teno J, Connors AF Jr, Desbiens N, Lynn J, Phillips RS. Patient preferences for communication with physicians about end-of-life decisions. SUPPORT Investigators. Study to Understand Prognoses and Preference for Outcomes and Risks of Treatment. Ann Intern Med. 1997 Jul 1;127(1):1-12. doi: 10.7326/0003-4819-127-1-199707010-00001.

    PMID: 9214246BACKGROUND
  • Wenger NS, Phillips RS, Teno JM, Oye RK, Dawson NV, Liu H, Califf R, Layde P, Hakim R, Lynn J. Physician understanding of patient resuscitation preferences: insights and clinical implications. J Am Geriatr Soc. 2000 May;48(S1):S44-51. doi: 10.1111/j.1532-5415.2000.tb03140.x.

    PMID: 10809456BACKGROUND
  • Teno JM, Hakim RB, Knaus WA, Wenger NS, Phillips RS, Wu AW, Layde P, Connors AF Jr, Dawson NV, Lynn J. Preferences for cardiopulmonary resuscitation: physician-patient agreement and hospital resource use. The SUPPORT Investigators. J Gen Intern Med. 1995 Apr;10(4):179-86. doi: 10.1007/BF02600252.

    PMID: 7790978BACKGROUND
  • von Gunten CF, Ferris FD, Emanuel LL. The patient-physician relationship. Ensuring competency in end-of-life care: communication and relational skills. JAMA. 2000 Dec 20;284(23):3051-7. doi: 10.1001/jama.284.23.3051.

    PMID: 11122596BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

In this study the patient outcomes were not addressed as the primary outcome was patient and family knowledge of CPR.

Results Point of Contact

Title
Kianoush Kashani; Principal Investigator
Organization
Mayo Clinic

Study Officials

  • Kianoush B Kashani, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 31, 2012

First Posted

June 1, 2012

Study Start

November 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 13, 2016

Results First Posted

April 4, 2016

Record last verified: 2016-04

Locations