Respiratory FailureVIDEONCT01776333
A Randomized Controlled Trial of a Video Decision Aid in the ICU
A study testing video decision aid in people with Respiratory Failure and Cardiac Event, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Respiratory Failure, Cardiac Event
- What is being tested?
- video decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to Dec 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge
Who cannot join
- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state
Trial locations and contacts
3 sites in 1 country.
United States3 sites
BMC
Boston, Massachusetts
Michael Paasche-Orlow
Michael Paasche-Orlow
MGH
Boston, Massachusetts
Angelo Volandes
Angelo Volandes
Cedars Sinai Medical Center
Los Angeles, California
Jonas Green
Jonas Green
About this study
Official title: Video Images of Disease for Ethical Outcomes
Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.
- Conditions
- Respiratory Failure, Cardiac Event
- Being tested
- video decision aid
- Keywords
- ICU
- Medical subject headings
- Respiratory Insufficiency, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video decision aidBehavioural
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Not described |
| video arm | Experimental | video decision aid intervention Receives: Behavioral: video decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)
Measured: at baseline admission to the ICU during family meeting up to one week
Secondary outcomes (4)
level of medical care delivered to patient at time of death or discharge from the ICU
Measured: at time of death or discharge from the ICU up to one week
anxiety and depression
Measured: anxiety and depression at follow up phone call at 3 months after ICU death or discharge
satisfaction with ICU experience
Measured: after 3 months from time of death or discharge from ICU
number of medical interventions during ICU stay
Measured: during time period in the ICU up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo E. Volandes, MD, Massachusetts General Hospital
- Investigators
- Angelo Volandes, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776333
- Sponsor's protocol ID
- 2010-P-001820
- Other IDs
- 2010-P-001820
- Acronym
- VIDEO
- Status last verified
- Nov 2020
- First submitted
- 22 Jan 2013
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Images of Disease for Ethical Outcomes
- ClinicalTrials.gov ID
- NCT01776333
- Acronym / sponsor ID
- VIDEO / 2010-P-001820
- Conditions
- Respiratory Failure, Cardiac Event
- Keywords
- ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- First posted
- 28 Jan 2013 (estimated)
- 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.
Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | – |
| video arm | Experimental | Behavioral: video decision aidvideo decision aid intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge
Key exclusion criteria (1 listed)
- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state
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 |
|---|---|---|
| video decision aid | Behavioural | video arm |
Primary outcome
preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)
Time frame: at baseline admission to the ICU during family meeting up to one week
4 secondary outcomes
level of medical care delivered to patient at time of death or discharge from the ICU
Time frame: at time of death or discharge from the ICU up to one week
anxiety and depression
Time frame: anxiety and depression at follow up phone call at 3 months after ICU death or discharge
satisfaction with ICU experience
Time frame: after 3 months from time of death or discharge from ICU
number of medical interventions during ICU stay
Time frame: during time period in the ICU up to one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Angelo Volandes principal investigator
MGH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video decision aid in people with Respiratory Failure and Cardiac Event, run by Massachusetts General Hospital at 3 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelo Volandes (617 726 2000, avolandes@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.) (time frame: at baseline admission to the ICU during family meeting up to one week). 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 18 Nov 2020.