Critical IllnessNCT03630965
CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.
A study testing CPR Video in people with Critical Illness, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Video or No Video to decrease HCPOA/LAR anxiety and increase knowledge as it pertains to CPR. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- CPR Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53202
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- CPR Video
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR VideoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | No CPR video |
| Group B | Experimental | CPR video Receives: Other: CPR Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Knowledge assessment will be performed with a 5 questions (1 point each) questionnaire.
Measured: 3 years
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.
Measured: 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.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start8 May 2017
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tirsa M. Ferrer Marrero, Medical College of Wisconsin
- Investigators
- Tirsa Ferrer Marrero, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630965
- Sponsor's protocol ID
- PULM-AV-CPR
- Other IDs
- PRO00029203
- Status last verified
- Feb 2020
- First submitted
- 10 Aug 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33450473
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovisual Tool Use in the ICU, to Impact the Anxiety Level of Patients' Surrogates While Deciding on Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT03630965
- Acronym / sponsor ID
- PULM-AV-CPR
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –No CPR video |
| Group B | Experimental | Other: CPR VideoCPR video |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPR VideoA 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. | Other | Group B |
Primary outcome
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.
3 secondary outcomes
Measure the impact of CPR video on patients' surrogate's knowledge about CPR, when compared to the No intervention group.
Time frame: 3 years
Analyze the surrogates' comfort when watching the video.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 33450473Ferrer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirsa Ferrer Marrero, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPR Video in people with Critical Illness, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.