SurgeryNCT01589107
A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit
A study testing video decision aid in people with Surgery and Trauma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- 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
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical surrogates of the following patients will be eligible to participate in this opinion survey:
- All patients admitted to the SICU and not expected to die within 48 hours.
- Patient has been admitted to the acute care surgical service,
- The patient is over the age of 50 and does not have decision making capacity.
- Subjects must be over the age of 21 and English speaking to participate in the opinion survey.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Angelo Volandes, 617-643-4266, avolandes@partners.org
Angelo Volandes
About this study
To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
Read the detailed description
Specific Aim 1: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
Hypothesis 1: Adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the SICU, will better inform clinical surrogates of incapacitated patients admitted to the SICU regarding decision making when providing consent for medical treatment.
- Being tested
- video decision aid
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video decision aidBehavioural
video decision aid
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | usual care |
| Video Arm | Experimental | Not described Receives: Behavioral: video decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge of risks and benefits of procedures
knowledge of risks and benefits of procedures
Measured: 5 minutes after survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT01589107
- Sponsor's protocol ID
- 2011-P-001731
- Status last verified
- Nov 2020
- First submitted
- 28 Apr 2012
- 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
- A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01589107
- Acronym / sponsor ID
- 2011-P-001731
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 1 May 2012 (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.
To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
Detailed description
Specific Aim 1: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
Hypothesis 1: Adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the SICU, will better inform clinical surrogates of incapacitated patients admitted to the SICU regarding decision making when providing consent for medical treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –usual care |
| Video Arm | Experimental | Behavioral: video decision aid |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical surrogates of the following patients will be eligible to participate in this opinion survey:
- Subjects must be over the age of 21 and English speaking to participate in the opinion survey.
Key exclusion criteria (0 listed)
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 aidvideo decision aid | Behavioural | Video Arm |
Primary outcome
knowledge of risks and benefits of procedures
Time frame: 5 minutes after survey
knowledge of risks and benefits of procedures
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.
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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.
Angelo Volandes principal investigator
MGH
1 site 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 Surgery and Trauma, run by Massachusetts General Hospital 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 5 inclusion and 0 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge of risks and benefits of procedures (time frame: 5 minutes after survey). 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; AzTrials last refreshed its copy on 2 Nov 2026.