ElderlyNCT01233973
Using Videos to Improve Understanding of the Delivery of End-of-life Medical Care in Non-hospital Settings
A study testing video decision aid in people with Elderly, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To compare the decision making of elderly subjects having a verbal advance care planning discussion compared to subjects using a video. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- video decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2011
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- over age of 64
- have decision making capacity
Who cannot join
- do not speak English
Trial locations and contacts
1 site in 1 country.
About this study
To compare the decision making of elderly subjects having a verbal advance care planning discussion compared to subjects using a video.
Read the detailed description
A.1. Aim 1: To recruit 101 subjects over the age of 64 who are newly admitted to a nursing home facility and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting the Goals of Care (Life Prolonging Care, Limited Care, and Comfort Care) (intervention) or 2. a verbal narrative describing the Goals of Care (control) encountered if the subject becomes very ill.
Hypothesis 1: It is feasible to recruit and randomize newly admitted elderly subjects to each of the ACP modalities.
A.2. Aim 2: To compare the care preferences for their primary goal of care (i.e., life-prolonging care, limited care, or comfort care) among 101 subjects randomized to video vs. verbal narrative intervention for ACP.
Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt for comfort care (vs. life-prolonging or limited care) as the primary goal of care compared to those randomized to the verbal narrative.
A.3. Aim 3: To compare knowledge assessment of the Goals of Care of 101 subjects randomized to video vs. verbal narrative intervention for ACP.
Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of the Goals of Care.
- Conditions
- Elderly
- Being tested
- video decision aid
- Keywords
- nursing home, advance care planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video decision aidOther
Also called decision aid, film
video
| Study group | Role | What they receive |
|---|---|---|
| control subjects | No intervention | verbal narrative of advance care planning |
| intervention group | Experimental | video decision aid viewed by subjects Receives: Other: video decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
preference for medical care
preference for care at the end of life
Measured: 5 minutes after the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 ElderlyStudies 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
- 101 participants (actual)
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
- NCT01233973
- Sponsor's protocol ID
- 2010-P-000180
- Status last verified
- Apr 2012
- First submitted
- 1 Nov 2010
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Volandes AE, Brandeis GH, Davis AD, Paasche-Orlow MK, Gillick MR, Chang Y, Walker-Corkery ES, Mann E, Mitchell SL. A randomized controlled trial of a goals-of-care video for elderly patients admitted to skilled nursing facilities. J Palliat Med. 2012 Jul;15(7):805-11. doi: 10.1089/jpm.2011.0505. Epub 2012 May 4.
PubMed 22559905
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Videos to Improve Understanding of the Delivery of End-of-life Medical Care in Non-hospital Settings
- ClinicalTrials.gov ID
- NCT01233973
- Acronym / sponsor ID
- 2010-P-000180
- Conditions
- Elderly
- Keywords
- nursing home, advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Nov 2010 (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 compare the decision making of elderly subjects having a verbal advance care planning discussion compared to subjects using a video.
Detailed description
A.1. Aim 1: To recruit 101 subjects over the age of 64 who are newly admitted to a nursing home facility and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting the Goals of Care (Life Prolonging Care, Limited Care, and Comfort Care) (intervention) or 2. a verbal narrative describing the Goals of Care (control) encountered if the subject becomes very ill.
Hypothesis 1: It is feasible to recruit and randomize newly admitted elderly subjects to each of the ACP modalities.
A.2. Aim 2: To compare the care preferences for their primary goal of care (i.e., life-prolonging care, limited care, or comfort care) among 101 subjects randomized to video vs. verbal narrative intervention for ACP.
Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt for comfort care (vs. life-prolonging or limited care) as the primary goal of care compared to those randomized to the verbal narrative.
A.3. Aim 3: To compare knowledge assessment of the Goals of Care of 101 subjects randomized to video vs. verbal narrative intervention for ACP.
Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of the Goals of Care.
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 subjects | No intervention | –verbal narrative of advance care planning |
| intervention group | Experimental | Other: video decision aidvideo decision aid viewed by subjects |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- over age of 64
- have decision making capacity
Key exclusion criteria (1 listed)
- do not speak English
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 aidAlso: decision aid, filmvideo | Other | intervention group |
Primary outcome
preference for medical care
Time frame: 5 minutes after the survey
preference for care at the end of life
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 1 May 2012.
- Derived from this study: PubMed 22559905Volandes AE, Brandeis GH, Davis AD, Paasche-Orlow MK, Gillick MR, Chang Y, Walker-Corkery ES, Mann E, Mitchell SL. A randomized controlled trial of a goals-of-care video for elderly patients admitted to skilled nursing facilities. J Palliat Med. 2012 Jul;15(7):805-11. doi: 10.1089/jpm.2011.0505. Epub 2012 May 4.
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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 Elderly, 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 2 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: finished, as of the sponsor's last update on 1 May 2012. 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?
preference for medical care (time frame: 5 minutes after the survey). 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 NCT01233973, 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 1 May 2012.