Advance Care PlanningNCT01391429
Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions
A study testing Video Decision Support Tool in people with Advance Care Planning and Palliative Care, run by Boston Medical Center at 1 site in United States.
Trial summary
Subject preferences for care at the end-of-life show wide variability. In the setting of advanced disease, some subjects prefer all life-sustaining care while others forgo such procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advance Care Planning, Palliative Care
- What is being tested?
- Video Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients and their healthcare proxies consulted on by an inpatient palliative care team.
- English-speaking
- Potential patient subjects and/or their healthcare proxies must have the ability to provide informed consent.
- Must be members of the palliative care or primary medical team
Who cannot join
- Potential patient subjects who are identified by the palliative care team as not being appropriate for a goals-of-care discussion will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions With Patients and Surrogates Receiving an Inpatient Palliative Care Consult
Subject preferences for care at the end-of-life show wide variability. In the setting of advanced disease, some subjects prefer all life-sustaining care while others forgo such procedures. The wide variability in preferences may be due to subjects' misconception of the disease condition when using solely verbal descriptions. The failure to participate in effective goals-of-care discussions may lead to overuse of medical interventions and life-sustaining measures that are inconsistent with patients' and families' wishes. Using video images -- in addition to words -- to convey goals-of-care options at end-of-life, adds a sense of verisimilitude to the condition described and may better inform subjects when making their preferences.
Specific Aim: To assess the effect of a video decision support tool on preferences for end-of-life care in patients and surrogate decision makers consulted on by an inpatient palliative care service. The investigators hypothesize that those subjects who view video images as a supplement to a standard palliative care consult will be more likely to opt for comfort oriented care.
In this study, patient subjects and/or their healthcare proxies who are consulted on by an inpatient palliative care team will be surveyed regarding their preferences for end-of-life care following either a standard palliative care consult or one which utilizes a short video to complement verbal descriptions. The primary analysis will involve the proportion of patient subjects/proxies in each group that prefer comfort oriented care and that die in accordance with their stated preferences. The investigators will also study the effect of the video on patient subjects' and/or proxies' uncertainty with regard to treatment preferences and overall satisfaction with the palliative care consult.
Read the detailed description
The investigators research will be conducted as a non-randomized, temporal intervention study. The specific aim of the study is to assess the effect of a video decision support tool on preferences for end-of-life care in patients and surrogate decision makers consulted on by an inpatient palliative care service. The first seven months of the study, or until 25 patient subjects are recruited, will be the observational phase. All participants recruited will receive the usual standard of care provided by an inpatient palliative care service. Using a battery of surveys, data will be collected regarding treatment preferences near the end of life, level of certainty with decision making, pain and symptom management, resource utilization and whether patient subjects die in accordance with their stated preferences. Once the observational phase is complete, the intervention phase of the study will begin. Over the following seven months, or until 25 patient subjects are recruited, all participants will view a six-minute digital video outlining different options for care near the end of life. The same endpoints will then be followed. In addition to the primary analysis involving patient-proxy dyads, an additional exploratory analysis will be performed. This analysis will involve surveying additional medical staff including attendings, residents, interns and nurses regarding their perceptions of patients' symptoms at the time of the palliative care consult. This data will be used to measure concordance between patient subjects' and staffs' ranking of symptoms.
- Conditions
- Advance Care Planning, Palliative Care
- Being tested
- Video Decision Support Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Decision Support ToolBehavioural
Six minute digital video illustrating specific treatments for three different levels of medical care: life-prolonging care, basic care and comfort oriented care.
| Study group | Role | What they receive |
|---|---|---|
| Video decision support tool | Experimental | Video decision support tool for goals-of-care options Receives: Behavioral: Video Decision Support Tool |
| Verbal description | No intervention | Standard verbal description of goals-of-care options provided by an inpatient palliative care team |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in proportions of patient subjects/proxies in each group (observation vs video phase) who prefer comfort oriented care and who die in accordance with their stated preferences.
Measured: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team, as well as 7-14 days, 2-3 months and 5-6 months post-discharge.
Secondary outcomes (4)
The level of uncertainty regarding treatment preferences.
Measured: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.
Satisfaction with pain control and symptom management.
Measured: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team, as well as 7-14 days, 2-3 months and 5-6 months post-discharge.
Healthcare proxy satisfaction with end-of-life care following subjects' death.
Measured: Measured at 7-14 days, 2-3 months or 5-6 months post-discharge.
Concordance between patient subjects' and staffs' ranking of symptoms.
Measured: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Paasche-Orlow, Boston Medical Center
- Investigators
- Michael Paasche-Orlow, MD MA MPH, Principal investigator, Boston UniversityAngelo Volandes, MD MPH, Principal investigator, Massachusetts General HospitalNicole LaRue, MD, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391429
- Sponsor's protocol ID
- H29666
- Status last verified
- Feb 2016
- First submitted
- 21 Jun 2011
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillick MR. A broader role for advance medical planning. Ann Intern Med. 1995 Oct 15;123(8):621-4. doi: 10.7326/0003-4819-123-8-199510150-00009.
PubMed 7677304Emanuel LL, Barry MJ, Stoeckle JD, Ettelson LM, Emanuel EJ. Advance directives for medical care--a case for greater use. N Engl J Med. 1991 Mar 28;324(13):889-95. doi: 10.1056/NEJM199103283241305.
PubMed 2000111A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
PubMed 7474243Hofmann JC, Wenger NS, Davis RB, Teno J, Connors AF Jr, Desbiens N, Lynn J, Phillips RS. Patient preferences for communication with physicians about end-of-life decisions. SUPPORT Investigators. Study to Understand Prognoses and Preference for Outcomes and Risks of Treatment. Ann Intern Med. 1997 Jul 1;127(1):1-12. doi: 10.7326/0003-4819-127-1-199707010-00001.
PubMed 9214246Covinsky KE, Fuller JD, Yaffe K, Johnston CB, Hamel MB, Lynn J, Teno JM, Phillips RS. Communication and decision-making in seriously ill patients: findings of the SUPPORT project. The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Am Geriatr Soc. 2000 May;48(S1):S187-93. doi: 10.1111/j.1532-5415.2000.tb03131.x.
PubMed 10809474Garrett JM, Harris RP, Norburn JK, Patrick DL, Danis M. Life-sustaining treatments during terminal illness: who wants what? J Gen Intern Med. 1993 Jul;8(7):361-8. doi: 10.1007/BF02600073.
PubMed 8410396Forrow L. The green eggs and ham phenomena. Hastings Cent Rep. 1994 Nov-Dec;24(6):S29-32. No abstract available.
PubMed 7860277Tulsky JA, Fischer GS, Rose MR, Arnold RM. Opening the black box: how do physicians communicate about advance directives? Ann Intern Med. 1998 Sep 15;129(6):441-9. doi: 10.7326/0003-4819-129-6-199809150-00003.
PubMed 9735081Volandes AE, Paasche-Orlow MK, Barry MJ, Gillick MR, Minaker KL, Chang Y, Cook EF, Abbo ED, El-Jawahri A, Mitchell SL. Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ. 2009 May 28;338:b2159. doi: 10.1136/bmj.b2159.
PubMed 19477893Volandes AE, Barry MJ, Chang Y, Paasche-Orlow MK. Improving decision making at the end of life with video images. Med Decis Making. 2010 Jan-Feb;30(1):29-34. doi: 10.1177/0272989X09341587. Epub 2009 Aug 12.
PubMed 19675323El-Jawahri A, Podgurski LM, Eichler AF, Plotkin SR, Temel JS, Mitchell SL, Chang Y, Barry MJ, Volandes AE. Use of video to facilitate end-of-life discussions with patients with cancer: a randomized controlled trial. J Clin Oncol. 2010 Jan 10;28(2):305-10. doi: 10.1200/JCO.2009.24.7502. Epub 2009 Nov 30.
PubMed 19949010
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Video Decision Support Tool to Supplement Goals-of-Care Discussions With Patients and Surrogates Receiving an Inpatient Palliative Care Consult
- ClinicalTrials.gov ID
- NCT01391429
- Acronym / sponsor ID
- H29666
- Conditions
- Advance Care Planning, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Jul 2011 (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.
Subject preferences for care at the end-of-life show wide variability. In the setting of advanced disease, some subjects prefer all life-sustaining care while others forgo such procedures. The wide variability in preferences may be due to subjects' misconception of the disease condition when using solely verbal descriptions. The failure to participate in effective goals-of-care discussions may lead to overuse of medical interventions and life-sustaining measures that are inconsistent with patients' and families' wishes. Using video images -- in addition to words -- to convey goals-of-care options at end-of-life, adds a sense of verisimilitude to the condition described and may better inform subjects when making their preferences.
Specific Aim: To assess the effect of a video decision support tool on preferences for end-of-life care in patients and surrogate decision makers consulted on by an inpatient palliative care service. The investigators hypothesize that those subjects who view video images as a supplement to a standard palliative care consult will be more likely to opt for comfort oriented care.
In this study, patient subjects and/or their healthcare proxies who are consulted on by an inpatient palliative care team will be surveyed regarding their preferences for end-of-life care following either a standard palliative care consult or one which utilizes a short video to complement verbal descriptions. The primary analysis will involve the proportion of patient subjects/proxies in each group that prefer comfort oriented care and that die in accordance with their stated preferences. The investigators will also study the effect of the video on patient subjects' and/or proxies' uncertainty with regard to treatment preferences and overall satisfaction with the palliative care consult.
Detailed description
The investigators research will be conducted as a non-randomized, temporal intervention study. The specific aim of the study is to assess the effect of a video decision support tool on preferences for end-of-life care in patients and surrogate decision makers consulted on by an inpatient palliative care service. The first seven months of the study, or until 25 patient subjects are recruited, will be the observational phase. All participants recruited will receive the usual standard of care provided by an inpatient palliative care service. Using a battery of surveys, data will be collected regarding treatment preferences near the end of life, level of certainty with decision making, pain and symptom management, resource utilization and whether patient subjects die in accordance with their stated preferences. Once the observational phase is complete, the intervention phase of the study will begin. Over the following seven months, or until 25 patient subjects are recruited, all participants will view a six-minute digital video outlining different options for care near the end of life. The same endpoints will then be followed. In addition to the primary analysis involving patient-proxy dyads, an additional exploratory analysis will be performed. This analysis will involve surveying additional medical staff including attendings, residents, interns and nurses regarding their perceptions of patients' symptoms at the time of the palliative care consult. This data will be used to measure concordance between patient subjects' and staffs' ranking of symptoms.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video decision support tool | Experimental | Behavioral: Video Decision Support ToolVideo decision support tool for goals-of-care options |
| Verbal description | No intervention | –Standard verbal description of goals-of-care options provided by an inpatient palliative care team |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients and their healthcare proxies consulted on by an inpatient palliative care team.
- English-speaking
- Potential patient subjects and/or their healthcare proxies must have the ability to provide informed consent.
- Must be members of the palliative care or primary medical team
Key exclusion criteria (1 listed)
- Potential patient subjects who are identified by the palliative care team as not being appropriate for a goals-of-care discussion will be excluded.
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 Support ToolSix minute digital video illustrating specific treatments for three different levels of medical care: life-prolonging care, basic care and comfort oriented care. | Behavioural | Video decision support tool |
Primary outcome
The difference in proportions of patient subjects/proxies in each group (observation vs video phase) who prefer comfort oriented care and who die in accordance with their stated preferences.
Time frame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team, as well as 7-14 days, 2-3 months and 5-6 months post-discharge.
4 secondary outcomes
The level of uncertainty regarding treatment preferences.
Time frame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.
Satisfaction with pain control and symptom management.
Time frame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team, as well as 7-14 days, 2-3 months and 5-6 months post-discharge.
Healthcare proxy satisfaction with end-of-life care following subjects' death.
Time frame: Measured at 7-14 days, 2-3 months or 5-6 months post-discharge.
Concordance between patient subjects' and staffs' ranking of symptoms.
Time frame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team.
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 23 Feb 2016.
- Background: PubMed 7677304Gillick MR. A broader role for advance medical planning. Ann Intern Med. 1995 Oct 15;123(8):621-4. doi: 10.7326/0003-4819-123-8-199510150-00009.
- Background: PubMed 2000111Emanuel LL, Barry MJ, Stoeckle JD, Ettelson LM, Emanuel EJ. Advance directives for medical care--a case for greater use. N Engl J Med. 1991 Mar 28;324(13):889-95. doi: 10.1056/NEJM199103283241305.
- Background: PubMed 7474243A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
- Background: PubMed 9214246Hofmann JC, Wenger NS, Davis RB, Teno J, Connors AF Jr, Desbiens N, Lynn J, Phillips RS. Patient preferences for communication with physicians about end-of-life decisions. SUPPORT Investigators. Study to Understand Prognoses and Preference for Outcomes and Risks of Treatment. Ann Intern Med. 1997 Jul 1;127(1):1-12. doi: 10.7326/0003-4819-127-1-199707010-00001.
- Background: PubMed 10809474Covinsky KE, Fuller JD, Yaffe K, Johnston CB, Hamel MB, Lynn J, Teno JM, Phillips RS. Communication and decision-making in seriously ill patients: findings of the SUPPORT project. The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Am Geriatr Soc. 2000 May;48(S1):S187-93. doi: 10.1111/j.1532-5415.2000.tb03131.x.
- Background: PubMed 8410396Garrett JM, Harris RP, Norburn JK, Patrick DL, Danis M. Life-sustaining treatments during terminal illness: who wants what? J Gen Intern Med. 1993 Jul;8(7):361-8. doi: 10.1007/BF02600073.
- Background: PubMed 7860277Forrow L. The green eggs and ham phenomena. Hastings Cent Rep. 1994 Nov-Dec;24(6):S29-32. No abstract available.
- Background: PubMed 9735081Tulsky JA, Fischer GS, Rose MR, Arnold RM. Opening the black box: how do physicians communicate about advance directives? Ann Intern Med. 1998 Sep 15;129(6):441-9. doi: 10.7326/0003-4819-129-6-199809150-00003.
- Background: PubMed 19477893Volandes AE, Paasche-Orlow MK, Barry MJ, Gillick MR, Minaker KL, Chang Y, Cook EF, Abbo ED, El-Jawahri A, Mitchell SL. Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ. 2009 May 28;338:b2159. doi: 10.1136/bmj.b2159.
- Background: PubMed 19675323Volandes AE, Barry MJ, Chang Y, Paasche-Orlow MK. Improving decision making at the end of life with video images. Med Decis Making. 2010 Jan-Feb;30(1):29-34. doi: 10.1177/0272989X09341587. Epub 2009 Aug 12.
- Background: PubMed 19949010El-Jawahri A, Podgurski LM, Eichler AF, Plotkin SR, Temel JS, Mitchell SL, Chang Y, Barry MJ, Volandes AE. Use of video to facilitate end-of-life discussions with patients with cancer: a randomized controlled trial. J Clin Oncol. 2010 Jan 10;28(2):305-10. doi: 10.1200/JCO.2009.24.7502. Epub 2009 Nov 30.
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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.
Michael Paasche-Orlow, MD MA MPH principal investigator
Boston University
Angelo Volandes, MD MPH principal investigator
Massachusetts General Hospital
Nicole LaRue, MD study director
Boston University
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 Support Tool in people with Advance Care Planning and Palliative Care, run by Boston Medical Center 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 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 23 Feb 2016. 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?
The difference in proportions of patient subjects/proxies in each group (observation vs video phase) who prefer comfort oriented care and who die in accordance with their stated preferences. (time frame: Measured on average within 48 hours of the palliative care service's referral of the subject to the research team, as well as 7-14 days, 2-3 months and 5-6 months post-discharge.). 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 NCT01391429, which also lists 11 linked publications.
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 23 Feb 2016.