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Completed

NCT Number: NCT03630965

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

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

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPR video

Other

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 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).

    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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2018
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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