Patient EducationNCT03213197
Feasibility of a Standardized Video for Patient Education and as a Decision Aid on Code Status for Patients in the Emergency Department Pending Admission to the Hospital
A study testing CPR video in people with Patient Education, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers hypothesize that patients and their families will be comfortable watching standardized CPR informational videos and that they would recommend that others watch the videos. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Patient Education
- What is being tested?
- CPR video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 19 Jun 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Any patient in the Emergency Department whose disposition is listed as a full admission to the hospital
- Provider willingness to have patient watch the video and be available to answer questions after.
- Age > 65
- Ability to provide consent
Who cannot join
- Does not speak English
- Hearing or visually impaired
- Prisoner or incarcerated
- Inability to provide consent according to attending Physician or Study Coordinator and legal power of attorney is not present
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The researchers hypothesize that patients and their families will be comfortable watching standardized CPR informational videos and that they would recommend that others watch the videos. Furthermore, the researchers hypothesize that patients and their families will find the videos helpful in their own end-of-life planning.
Read the detailed description
The code status video, produced by experts in palliative medicine and end of life care, has been evaluated in a variety of healthcare settings to allow patients to make more informed decisions based on realistic information about resuscitation status. This video could be used as a supplement for clinical discussions and decision making. It is not meant to replace a careful, individualized discussion by the clinician with patients and their families, but appears to be a helpful tool to help educate patients in order for them to be better informed to make complicated decisions about their code status. The Emergency Department is an ideal setting to evaluate the video because they could improve patient understanding in an environment with inherently limited face-to-face provider time.
Specific Aims
- To assess the satisfaction of patients and family members who view the video on cardiopulmonary resuscitation. This will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others.
- To assess if watching the standardized video changes patients' code status. This will be measured as what patients' code status was before and after watching the video.
- Conditions
- Patient Education
- Being tested
- CPR video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR videoOther
Patient watches a short CPR video
| Study group | Role | What they receive |
|---|---|---|
| CPR video | Experimental | Patient watches a short CPR video Receives: Other: CPR video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of patients and family members in watching videos of cardiopulmonary resuscitation
This will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others.
Measured: 1 year
Secondary outcomes (1)
The number of patients/families who will feel that the video was helpful in the decision regarding code status
To assess if watching the standardized video changes patients' code status. This will be measured as what patients' code status was before and after watching the video.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start14 Feb 2017
- Primary completion22 Mar 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EducationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility of a Standardized Video for Patient Education and as a Decision Aid on Code Status for Patients in the Emergency Department pending Admission to the Hospital
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin E. Loprinzi Brauer, Mayo Clinic
- Investigators
- Caitlin E Loprinzi Brauer, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213197
- Sponsor's protocol ID
- 16-009141
- Status last verified
- Feb 2019
- First submitted
- 7 Jul 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not being shared....
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Standardized Video for Patient Education and as a Decision Aid on Code Status for Patients in the Emergency Department Pending Admission to the Hospital
- ClinicalTrials.gov ID
- NCT03213197
- Acronym / sponsor ID
- 16-009141
- Conditions
- Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 11 Jul 2017 (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.
The researchers hypothesize that patients and their families will be comfortable watching standardized CPR informational videos and that they would recommend that others watch the videos. Furthermore, the researchers hypothesize that patients and their families will find the videos helpful in their own end-of-life planning.
Detailed description
The code status video, produced by experts in palliative medicine and end of life care, has been evaluated in a variety of healthcare settings to allow patients to make more informed decisions based on realistic information about resuscitation status. This video could be used as a supplement for clinical discussions and decision making. It is not meant to replace a careful, individualized discussion by the clinician with patients and their families, but appears to be a helpful tool to help educate patients in order for them to be better informed to make complicated decisions about their code status. The Emergency Department is an ideal setting to evaluate the video because they could improve patient understanding in an environment with inherently limited face-to-face provider time.
Specific Aims
- To assess the satisfaction of patients and family members who view the video on cardiopulmonary resuscitation. This will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others.
- To assess if watching the standardized video changes patients' code status. This will be measured as what patients' code status was before and after watching the video.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility of a Standardized Video for Patient Education and as a Decision Aid on Code Status for Patients in the Emergency Department pending Admission to the Hospital
| Arm | Type | Receives |
|---|---|---|
| CPR video | Experimental | Other: CPR videoPatient watches a short CPR video |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Any patient in the Emergency Department whose disposition is listed as a full admission to the hospital
- Provider willingness to have patient watch the video and be available to answer questions after.
- Age > 65
- Ability to provide consent
Key exclusion criteria (4 listed)
- Does not speak English
- Hearing or visually impaired
- Prisoner or incarcerated
- Inability to provide consent according to attending Physician or Study Coordinator and legal power of attorney is not present
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 videoPatient watches a short CPR video | Other | CPR video |
Primary outcome
Satisfaction of patients and family members in watching videos of cardiopulmonary resuscitation
Time frame: 1 year
This will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others.
1 secondary outcome
The number of patients/families who will feel that the video was helpful in the decision regarding code status
Time frame: 1 year
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 5 Feb 2019.
- Individual participant dataSharing planned: No. Not being shared....
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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.
Caitlin E Loprinzi Brauer principal investigator
Mayo Clinic
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 Patient Education, run by Mayo Clinic 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?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 5 Feb 2019. 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?
Satisfaction of patients and family members in watching videos of cardiopulmonary resuscitation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2019.