Back to resultsCPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPR Video
Sponsored by
About this trial
This is an interventional other trial for Critical Illness
Eligibility Criteria
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
Sites / Locations
- Medical College of Wisconsin/Froedtert Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group A
Group B
Arm Description
No CPR video
CPR video
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Measure the impact of CPR video on patients' surrogate's knowledge about CPR, when compared to the No intervention group.
Knowledge assessment will be performed with a 5 questions (1 point each) questionnaire.
Analyze the surrogates' comfort when watching the video.
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.
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.
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.
Full Information
NCT ID
NCT03630965
First Posted
August 10, 2018
Last Updated
August 31, 2020
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT03630965
Brief Title
CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.
Official Title
Audiovisual Tool Use in the ICU, to Impact the Anxiety Level of Patients' Surrogates While Deciding on Cardiopulmonary Resuscitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Video or No Video to decrease HCPOA/LAR anxiety and increase knowledge as it pertains to CPR.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
No Intervention
Arm Description
No CPR video
Arm Title
Group B
Arm Type
Experimental
Arm Description
CPR video
Intervention Type
Other
Intervention Name(s)
CPR Video
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Measure the impact of CPR video on patients' surrogate's knowledge about CPR, when compared to the No intervention group.
Description
Knowledge assessment will be performed with a 5 questions (1 point each) questionnaire.
Time Frame
3 years
Title
Analyze the surrogates' comfort when watching the video.
Description
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.
Time Frame
3 years
Title
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.
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tirsa Ferrer Marrero, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33450473
Citation
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.
Results Reference
derived
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CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.
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