CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.
Audiovisual Tool Use in the ICU, to Impact the Anxiety Level of Patients' Surrogates While Deciding on Cardiopulmonary Resuscitation
2 other identifiers
interventional
26
1 country
1
Brief Summary
Video or No Video to decrease HCPOA/LAR anxiety and increase knowledge as it pertains to CPR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2017
CompletedFirst Submitted
Initial submission to the registry
August 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedSeptember 2, 2020
February 1, 2020
3 years
August 10, 2018
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 INTERVENTIONNo CPR video
Group B
EXPERIMENTALCPR 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.
Eligibility Criteria
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
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.
PMID: 33450473DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tirsa Ferrer Marrero, MD
Medical College of Wisconsin
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