CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.

August 31, 2020 updated by: Tirsa M. Ferrer Marrero, Medical College of Wisconsin

Audiovisual Tool Use in the ICU, to Impact the Anxiety Level of Patients' Surrogates While Deciding on Cardiopulmonary Resuscitation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Designated surrogate decision makers of 30 medical intensive care unit patients will be consented and enrolled to receive either a video describing CPR and it's outcomes after standard of care code discussions versus standard of care code discussions alone. All participants will complete a short questionnaire to determine their knowledge level regarding CPR and to assess their anxiety levels. Patients who view the video will also rate their comfort level while watching the video on a 5 point Likert scale.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Medical College of Wisconsin/Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A
No CPR video
Experimental: Group B
CPR video
Other: CPR Video

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 2.5 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the impact of CPR video on patients' surrogate's knowledge about CPR, when compared to the No intervention group.
Time Frame: 3 years
Knowledge assessment will be performed with a 5 questions (1 point each) questionnaire.
3 years
Analyze the surrogates' comfort when watching the video.
Time Frame: 3 years
Surrogate in the intervention group will be asked if he or she if feeling comfortable watching the video. This will be a single question that will be answered using a Likert Scale.
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.
Time Frame: 3 years
Will calculate patients' SOFA score which is the Sequential Organ Failure Assessment (SOFA) score. It is used to grade patients' severity of organs dysfunction and mortality. The SOFA Score is on a scale of 0-24, with higher numbers correlating with higher organs dysfunction and mortality.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Tirsa Ferrer Marrero, MD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2017

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULM-AV-CPR
  • PRO00029203 (Medical College of Wisconsin)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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