Advanced DementiaEVINCENCT01774799
Educational Video to Improve Nursing Home Care in End-stage Dementia
A study testing Advance care planning intervention in people with Advanced Dementia, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advanced Dementia
- What is being tested?
- Advance care planning intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age > 65
- A diagnosis of dementia (any type)
- Global Deterioration Scale (GDS) score of 7
- Nursing home length of stay > 30 days
- Proxy is available who can speak in English
- Proxy must either live within a 60 mile radius of Boston or be available to come to the residents nursing home within 2 weeks of recruitment in order to conduct the in-person baseline interview.
Who cannot join
- Residents with cognitive impairment due to causes other than dementia (e.g. head trauma) and in short-term, sub-acute SNFs will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Boston, Massachusetts, 02131
About this study
This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly (up to 12-months) regarding goals of care preferences, advance care planning, and treatments received. The primary outcome is decisions not to be hospitalized at 6 months.
Read the detailed description
The over-riding goal of the EVINCE study is to conduct a cluster RCT of a video Advance Care Planning intervention in nursing home residents with advanced dementia. A total of 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control) will be recruited. These residents' proxies with also be recruited for a total sample size of 720 residents and proxies (resident/proxy dyads). Outcomes will be compared between residents in the intervention vs, control nursing homes at baseline and every 3 months up to 12 months. At baseline proxies of residents in the intervention nursing homes will view a 12-minutes video describing three level of care options in advanced dementia (intensive, basic and comfort) and their choice will be communicated to the resident's primary care providers. Residents in the control nursing homes will receive the usual advance care planning practiced in those facilities.
UPDATE SEPT 19, 2014: During the first 18 months of the study, recruitment of resident/proxy dyads was lower per facility than anticipated at the time of study design. Therefore, the number of matched pairs of NH recruited was increased. As of September 19, 2014, 19 NH pairs (38 NHs) were recruited and randomized with a plans to continue to up to 30 pairs as needed.
NHs were originally randomized using a paired approach matched for for-profit status and whether or not the NH had a special care dementia unit (SCU). In March 2014, the state of Massachusetts changed legislation defining an SCU. Many of the changes focused on specifics of staff training. As a result, SCUs in several participating facilities did not meet the new criteria and lost this official designation, although the actual clinical structure of the existing units did not change. Nonetheless, we opted to maintain the initial matching criteria of the first 19 NHs which included SCU based on the definition before the Massachusetts legislation change, but dropped this matching criterion after the legislation change. Thus, beginning with matched pair 20, NHs were matched solely on for-profit status.
UPDATE MARCH 2016 To reach subject recruitment numbers, additional facilities were recruited. As of this date, 60 NHs (30/arm) have been recruited, randomized and have had subject enrolled.
To achieve additional for power for Outcome 2, (aquisition of new decisions to forego hospitalizations) the target sample size was increased to 400.
- Conditions
- Advanced Dementia
- Being tested
- Advance care planning intervention, Control group
- Keywords
- advanced dementia, advance care planning, nursing home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planning interventionBehavioural
Control groupOther
| Study group | Role | What they receive |
|---|---|---|
| Advance care planning intervention | Experimental | At baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. Receives: Behavioral: Advance care planning intervention |
| Usual care | Active comparator | Residents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented Decisions to Forgo Hospitalization
The proportion of residents with this outcome will be considered cumulatively at 6 months, including those who died; i.e., a composite of the percent of residents alive at six months who had a decision not to hospitalize and those who died before six months with this outcome prior to death. This cumulative outcome will only be based on time points following baseline as the baseline chart review data is conducted before the baseline proxy interview (i.e., before the proxy has seen the video in the intervention arm or heard options verbally in the control arm).
(Decisions to forehospitalizations will be examined in a similar fashion at 3, 9, and 12 months, however the six month time frame is the primary trial outcome)
Measured: by six months
Secondary outcomes (2)
Acquisition of Decisions Not to Hospitalize
This is a sub primary outcome. The modified ITT population will be the subgroup of residents who begin the study without a documented decision to forego hospitalization, and the outcome will be acquisition of a documented decision to forego hospitalization over the 12 month follow-up period. The analysis will utilize Cox proportional hazards regression. Results will be summarized using a hazard ratio and associated 95% confidence interval as well as plots of the cumulative incidence by group.
Measured: by 12 months
Acquisition of Preference for Level of Care
The proportion of proxies who have chosen comfort care (versus intermediate or intensive care) based on telephone interviews will be considered cumulatively at each assessment. At 6 months the outcome will include the proportion of proxies choosing comfort care up to and including the 6 month interview. Cumulative proportions will include data from the baseline interview for the control group, and baseline immediate post video interview for intervention group.The proportion of proxies choosing comfort care will be compared between the intervention and control groups using an extension of logistic regression based on general estimating equations (GEE) to account for clustering at the NH level at each time period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced DementiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Susan Mitchell, MD, Hebrew SeniorLife
- Investigators
- Susan L Mitchell, MD, MPH, Principal investigator, Hebrew SeniorLifeAngelo Volandes, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774799
- Sponsor's protocol ID
- 12-013
- Other IDs
- R01AG043440
- Acronym
- EVINCE
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2013
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data form study are available through link porvided
Publications
Mitchell SL, Shaffer ML, Cohen S, Hanson LC, Habtemariam D, Volandes AE. An Advance Care Planning Video Decision Support Tool for Nursing Home Residents With Advanced Dementia: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):961-969. doi: 10.1001/jamainternmed.2018.1506.
PubMed 29868778
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Video to Improve Nursing Home Care in End-stage Dementia
- ClinicalTrials.gov ID
- NCT01774799
- Acronym / sponsor ID
- EVINCE / 12-013
- Conditions
- Advanced Dementia
- Keywords
- advanced dementia, advance care planning, nursing home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- Mar 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly (up to 12-months) regarding goals of care preferences, advance care planning, and treatments received. The primary outcome is decisions not to be hospitalized at 6 months.
Detailed description
The over-riding goal of the EVINCE study is to conduct a cluster RCT of a video Advance Care Planning intervention in nursing home residents with advanced dementia. A total of 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control) will be recruited. These residents' proxies with also be recruited for a total sample size of 720 residents and proxies (resident/proxy dyads). Outcomes will be compared between residents in the intervention vs, control nursing homes at baseline and every 3 months up to 12 months. At baseline proxies of residents in the intervention nursing homes will view a 12-minutes video describing three level of care options in advanced dementia (intensive, basic and comfort) and their choice will be communicated to the resident's primary care providers. Residents in the control nursing homes will receive the usual advance care planning practiced in those facilities.
UPDATE SEPT 19, 2014: During the first 18 months of the study, recruitment of resident/proxy dyads was lower per facility than anticipated at the time of study design. Therefore, the number of matched pairs of NH recruited was increased. As of September 19, 2014, 19 NH pairs (38 NHs) were recruited and randomized with a plans to continue to up to 30 pairs as needed.
NHs were originally randomized using a paired approach matched for for-profit status and whether or not the NH had a special care dementia unit (SCU). In March 2014, the state of Massachusetts changed legislation defining an SCU. Many of the changes focused on specifics of staff training. As a result, SCUs in several participating facilities did not meet the new criteria and lost this official designation, although the actual clinical structure of the existing units did not change. Nonetheless, we opted to maintain the initial matching criteria of the first 19 NHs which included SCU based on the definition before the Massachusetts legislation change, but dropped this matching criterion after the legislation change. Thus, beginning with matched pair 20, NHs were matched solely on for-profit status.
UPDATE MARCH 2016 To reach subject recruitment numbers, additional facilities were recruited. As of this date, 60 NHs (30/arm) have been recruited, randomized and have had subject enrolled.
To achieve additional for power for Outcome 2, (aquisition of new decisions to forego hospitalizations) the target sample size was increased to 400.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance care planning intervention | Experimental | Behavioral: Advance care planning interventionAt baseline, health care proxies in the intervention arm will be shown a 12-minute Advance Care planning video that describes 3 levels of treatment in advanced dementia: comfort basic and intensive. After viewing the video, the proxies will be asked their preferred level of care for the resident and this choice will be communicated to the residents primary care team in a written form. |
| Usual care | Active comparator | Other: Control groupResidents in control nursing homes with receive the usual advance care planning that occurs in their nursing home. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age > 65
- A diagnosis of dementia (any type)
- Global Deterioration Scale (GDS) score of 7
- Nursing home length of stay > 30 days
- Proxy is available who can speak in English
Key exclusion criteria (1 listed)
- Residents with cognitive impairment due to causes other than dementia (e.g. head trauma) and in short-term, sub-acute SNFs 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 |
|---|---|---|
| Advance care planning intervention | Behavioural | Advance care planning intervention |
| Control group | Other | Usual care |
Primary outcome
Documented Decisions to Forgo Hospitalization
Time frame: by six months
The proportion of residents with this outcome will be considered cumulatively at 6 months, including those who died; i.e., a composite of the percent of residents alive at six months who had a decision not to hospitalize and those who died before six months with this outcome prior to death. This cumulative outcome will only be based on time points following baseline as the baseline chart review data is conducted before the baseline proxy interview (i.e., before the proxy has seen the video in the intervention arm or heard options verbally in the control arm). (Decisions to forehospitalizations will be examined in a similar fashion at 3, 9, and 12 months, however the six month time frame is the primary trial outcome)
2 secondary outcomes
Acquisition of Decisions Not to Hospitalize
Time frame: by 12 months
Acquisition of Preference for Level of Care
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29868778Mitchell SL, Shaffer ML, Cohen S, Hanson LC, Habtemariam D, Volandes AE. An Advance Care Planning Video Decision Support Tool for Nursing Home Residents With Advanced Dementia: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):961-969. doi: 10.1001/jamainternmed.2018.1506.
- Individual participant dataSharing planned: Yes. De-identified data form study are available through link porvided
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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.
Susan L Mitchell, MD, MPH principal investigator
Hebrew SeniorLife
Angelo Volandes, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance care planning intervention in people with Advanced Dementia, run by Hebrew SeniorLife 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 6 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 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Documented Decisions to Forgo Hospitalization (time frame: by six months). 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 NCT01774799, 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 23 Oct 2019.