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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630965
• Other study ID #: PULM-AV-CPR
• Secondary ID: PRO00029203
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: May 30, 2020

Study information

• Verified date: February 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin/Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 years
Secondary	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.	3 years
Secondary	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.	3 years