CHFVIDEO-HFNCT01589120
Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
A study testing Video decision aid in people with CHF, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare the decision making of subjects with advanced CHF having a verbal discussion about goals of care compared to subjects using a video. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- CHF
- 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
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2014
- 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
- A diagnosis of advanced heart failure as defined by ALL THREE of the following:
- New York Heart Association Class III or IV (NYHA III or IV) (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest).
- AND
- Hospitalization for heart failure within the last six months. AND
- Age greater than or equal to 65.
- Additionally ONE of the following must be met:
Show all 14Show fewer
- According to the attending physician's best judgment the patient's survival is limited to 2 years but may very well be less than 1 year (i.e. the physician would not be surprised if the patient died within one year from any cause) OR
- Three heart failure hospitalizations in the last year OR
- One of the following:
- Two Systolic Blood Pressures < 90 within the last 6 months in the ambulatory setting
- Na < 130 within the last 6 months
- NTproBNP > 3,000
- EGFR < 35
- High diuretic use (160 mg po Lasix or 100 mg po torsemide or equivalent total daily dose)
Who cannot join
- New patient
- A transplant or mechanical circulatory support candidate
- Major psychiatric illness as determined by the attending that would make this study inappropriate.
- Any patient that has been excluded for transplant or mechanical circulatory support due to psychological or psychiatric co-morbidities.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Angelo Volandes, MD
Angelo Volandes, MD
About this study
The purpose of this study is to compare the decision making of subjects with advanced CHF having a verbal discussion about goals of care compared to subjects using a video.
Read the detailed description
Aim #1: To compare the impact of the intervention on the distribution of end-of-life knowledge, decisional conflict, and preferences among 248 subjects with advanced heart failure randomly assigned to one of two ACP modalities: 1. a video visually depicting the goals of care along with a patient checklist (intervention, 124 subjects), or 2. usual care, i.e., verbal narrative (control, 124 subjects).
Hypothesis #1: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have more knowledge about their choices
1b. Have less decisional conflict about their decisions
1c. Opt for comfort care and less likely to choose life-prolonging measures
Aim #2: To compare stability of preferences over time (1, 3, and 6 months), concordance rate of preferences (preferences expressed vs. preferences documented in the medical record - both inpatient and outpatient records), and advance care planning discussions (as reported by the patient), among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124).
Hypothesis #2: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have more stable preferences over time
1b. Higher concordance rates
1c. Have had an advance care planning discussion
Aim #3: To compare quality of life, anxiety and depression, referral to hospice, place of death, after death bereavement (caregiver), and resource utilization after 6 months and 1 year (or death) among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124).
Hypothesis #3: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have a better quality of life (FACIT-Pal, FACIT-Sp-12)
1b. Have earlier referral to hospice in subjects who die
1d. Die at home or hospice (or inpatient hospice setting) in subjects who die
1e. Have better caregiver bereavement score (for caregiver subjects who die).
- Conditions
- CHF
- Being tested
- Video decision aid
- Keywords
- CHF, video decision aid
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 of the goals of care
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Verbal description of goals of care reflecting usual care |
| Video Arm | Experimental | Video intervention group Receives: Behavioral: Video decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge
knowledge of the goals of care for CHF
Measured: 5 minutes after survey
preferences
preferences for goals of care
Measured: 5 minutes after survey
Secondary outcomes (8)
decisional conflict
decisional conflict regarding decision making
Measured: 5 minutes after survey
stability
stability of preferences for goals of care
Measured: 5 minutes after survey and then at 1, 3, and 6 months
concordance of preferences
concordance of stated preferences with documented preferences in the medical record
Measured: by the end of one year
advance care planning discussion
self reported completion of advance care planning discussion
Measured: by 6 months
quality of life
better quality of life using FACIT questionnaire after 6 months
Measured: after 6 months
referral to hospice
referral to hospice for patients who die
Measured: by one year
place of death
place of death for those patients that die
Measured: by one year
caregiver bereavement score
caregiver bereavement score for those subjects that die
Measured: by one year
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 startApr 2012
- Primary completionApr 2014
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 CHFStudies 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
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver, Vanderbilt University, South Shore Hospital, Brigham and Women's Hospital, Boston Medical Center
- Responsible party
- Principal investigator, Angelo E. Volandes, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589120
- Sponsor's protocol ID
- 2012-P-000341
- Other IDs
- 1R01HL107268-01
- Acronym
- VIDEO-HF
- Status last verified
- Nov 2020
- First submitted
- 28 Apr 2012
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Jawahri A, Paasche-Orlow MK, Matlock D, Stevenson LW, Lewis EF, Stewart G, Semigran M, Chang Y, Parks K, Walker-Corkery ES, Temel JS, Bohossian H, Ooi H, Mann E, Volandes AE. Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure. Circulation. 2016 Jul 5;134(1):52-60. doi: 10.1161/CIRCULATIONAHA.116.021937.
PubMed 27358437
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01589120
- Acronym / sponsor ID
- VIDEO-HF / 2012-P-000341
- Conditions
- CHF
- Keywords
- CHF, video decision aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver, Vanderbilt University, South Shore Hospital, Brigham and Women's Hospital, Boston Medical Center
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (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.
The purpose of this study is to compare the decision making of subjects with advanced CHF having a verbal discussion about goals of care compared to subjects using a video.
Detailed description
Aim #1: To compare the impact of the intervention on the distribution of end-of-life knowledge, decisional conflict, and preferences among 248 subjects with advanced heart failure randomly assigned to one of two ACP modalities: 1. a video visually depicting the goals of care along with a patient checklist (intervention, 124 subjects), or 2. usual care, i.e., verbal narrative (control, 124 subjects).
Hypothesis #1: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have more knowledge about their choices
1b. Have less decisional conflict about their decisions
1c. Opt for comfort care and less likely to choose life-prolonging measures
Aim #2: To compare stability of preferences over time (1, 3, and 6 months), concordance rate of preferences (preferences expressed vs. preferences documented in the medical record - both inpatient and outpatient records), and advance care planning discussions (as reported by the patient), among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124).
Hypothesis #2: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have more stable preferences over time
1b. Higher concordance rates
1c. Have had an advance care planning discussion
Aim #3: To compare quality of life, anxiety and depression, referral to hospice, place of death, after death bereavement (caregiver), and resource utilization after 6 months and 1 year (or death) among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124).
Hypothesis #3: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have a better quality of life (FACIT-Pal, FACIT-Sp-12)
1b. Have earlier referral to hospice in subjects who die
1d. Die at home or hospice (or inpatient hospice setting) in subjects who die
1e. Have better caregiver bereavement score (for caregiver subjects who die).
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 | –Verbal description of goals of care reflecting usual care |
| Video Arm | Experimental | Behavioral: Video decision aidVideo intervention group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- A diagnosis of advanced heart failure as defined by ALL THREE of the following:
- AND
- Additionally ONE of the following must be met:
Key exclusion criteria (4 listed)
- New patient
- A transplant or mechanical circulatory support candidate
- Major psychiatric illness as determined by the attending that would make this study inappropriate.
- Any patient that has been excluded for transplant or mechanical circulatory support due to psychological or psychiatric co-morbidities.
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 of the goals of care | Behavioural | Video Arm |
Primary outcome
knowledge
Time frame: 5 minutes after survey
knowledge of the goals of care for CHF
preferences
Time frame: 5 minutes after survey
preferences for goals of care
8 secondary outcomes
decisional conflict
Time frame: 5 minutes after survey
stability
Time frame: 5 minutes after survey and then at 1, 3, and 6 months
concordance of preferences
Time frame: by the end of one year
advance care planning discussion
Time frame: by 6 months
quality of life
Time frame: after 6 months
referral to hospice
Time frame: by one year
place of death
Time frame: by one year
caregiver bereavement score
Time frame: by one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 27358437El-Jawahri A, Paasche-Orlow MK, Matlock D, Stevenson LW, Lewis EF, Stewart G, Semigran M, Chang Y, Parks K, Walker-Corkery ES, Temel JS, Bohossian H, Ooi H, Mann E, Volandes AE. Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure. Circulation. 2016 Jul 5;134(1):52-60. doi: 10.1161/CIRCULATIONAHA.116.021937.
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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.
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 CHF, 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 14 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: status not confirmed, as of the sponsor's last update on 17 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?
Contact Angelo Volandes, MD (617 643 4266, avolandes@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge (time frame: 5 minutes after survey). The study lists 2 primary outcomes in all. 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 NCT01589120, 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 17 Nov 2020.