NCT03630965

Brief Summary

Video or No Video to decrease HCPOA/LAR anxiety and increase knowledge as it pertains to CPR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

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

May 8, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

September 2, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

August 10, 2018

Last Update Submit

August 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure the impact of CPR video on the Surrogate's level of anxiety during the decision-making process on code status, in the ICU compared to the control group of surrogates (No intervention group).

    30 surrogates in the ICU (15 in the intervention group and 15 in the No intervention group) will be administered the validated Hamilton Anxiety Rating Scale (HAM-A), to measure the surrogates' anxiety level . The HAM-A questionnaire has been validated to assess for anxiety, and classify anxiety. The Score in HAM-A is on a scale of 0 to 56 total score, when it is less than 17 there is no anxiety or mild; 18-24 is mild to moderate; 25-30 is moderate to severe; and 30-56 is severe anxiety. The HAM-A questionnaire has been validated to assess change in anxiety after an intervention or treatment, with a delta in total score of 8 with a Standard deviation of 1.7.

    2.5 years

Secondary Outcomes (3)

  • Measure the impact of CPR video on patients' surrogate's knowledge about CPR, when compared to the No intervention group.

    3 years

  • Analyze the surrogates' comfort when watching the video.

    3 years

  • Describe if the CPR video's impact on surrogates' anxiety level, is affected by the patient's severity of illness as per the SOFA score.

    3 years

Study Arms (2)

Group A

NO INTERVENTION

No CPR video

Group B

EXPERIMENTAL

CPR video

Other: CPR Video

Interventions

A 7.07 minutes' CPR video will be administered to the ICU patients' surrogates in Group B. After viewing the video, the surrogate will complete the Hamilton Anxiety Rating Scale, a five-question survey about CPR, and a one-question form about comfort using the Likert Scale.

Group B

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Surrogate decision maker or power of attorney identified within the first 48 hours of ICU admission. Surrogates or power of attorney over the age of 18 y/o Secondary Subjects: * Admitted to the ICU * Critically ill to the point of treating team discussing code status with LAR/POA/Family

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53202, United States

Location

Related Publications (1)

  • Ferrer Marrero TM, Barash M, Jaber B, Nothem M, Shah K, Weber MW, Zellner Jones S, Kennedy P, Graf J, Broaddrick S, Garacci Z, Banerjee A, Kryworuchko J, Patel J. The impact of a cardiopulmonary resuscitation video on reducing surrogates' anxiety: A pilot randomized controlled trial. J Crit Care. 2021 Apr;62:235-242. doi: 10.1016/j.jcrc.2020.11.001. Epub 2020 Dec 3.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tirsa Ferrer Marrero, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 15, 2018

Study Start

May 8, 2017

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

September 2, 2020

Record last verified: 2020-02

Locations