Advanced Dementia
Conditions
Keywords
advanced dementia, advance care planning, nursing home
Brief 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). 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.
Interventions
BEHAVIORALAdvance care planning intervention
OTHERControl group
Sponsors
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Hebrew SeniorLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Residents with cognitive impairment due to causes other than dementia (e.g. head trauma) and in short-term, sub-acute SNFs will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Documented Decisions to Forgo Hospitalization | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of Preference for Level of Care | 6 months | 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. |
| Acquisition of Decisions Not to Hospitalize | by 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of Other Documented Advance Care Planning | by 6 months | The proportion of residents who acquired a documented advance directive to forego tube-feeding will be compared in the intervention versus control group. |
| Burdensome Treatments | by 12 months | Burdensome treatments include: Hospitals transfers (hospitalizations or emergency room visits), tube feeding or parenteral therapy. The rate of burdensome treatments per 1000 resident days was compared between the intervention and control arms. |
Countries
United States
Participant flow
Pre-assignment details
Participants are analyzed as dyads; proxies and patients.There are 402 dyads, for a total of 804 participants.
Participants by arm
| Arm | Count |
|---|---|
| Advance Care Planning Intervention Residents Residents with advanced dementia in intervention group | 212 |
| Usual Care (Control Group) Residents Residents with advanced dementia in control group | 190 |
| Advance Care Planning Intervention Proxies Proxies of residents with advanced dementia in intervention group | 212 |
| Usual Care (Control Group) Proxies Proxies of residents with advanced dementia in control group | 190 |
| Total | 804 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Advance Care Planning Intervention Residents | Usual Care (Control Group) Residents | Advance Care Planning Intervention Proxies | Usual Care (Control Group) Proxies | Total |
|---|---|---|---|---|---|
| Age, Continuous | 86.0 years STANDARD_DEVIATION 7.4 | 87.4 years STANDARD_DEVIATION 7.3 | 61.8 years STANDARD_DEVIATION 10.9 | 62.8 years STANDARD_DEVIATION 10.6 | 74.5 years STANDARD_DEVIATION 9.1 |
| Race/Ethnicity, Customized non-white | 34 Participants | 18 Participants | 35 Participants | 17 Participants | 104 Participants |
| Race/Ethnicity, Customized white | 178 Participants | 172 Participants | 177 Participants | 173 Participants | 700 Participants |
| Region of Enrollment United States | 212 participants | 190 participants | 212 participants | 190 participants | 804 participants |
| Sex: Female, Male Female | 167 Participants | 156 Participants | 146 Participants | 120 Participants | 589 Participants |
| Sex: Female, Male Male | 45 Participants | 34 Participants | 66 Participants | 70 Participants | 215 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 86 / 212 | 89 / 190 |
| other Total, other adverse events | 0 / 212 | 0 / 190 |
| serious Total, serious adverse events | 0 / 212 | 0 / 0 |
Outcome results
Primary
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)
Time frame: by six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Advance Care Planning Intervention | Documented Decisions to Forgo Hospitalization | 133 Participants |
| Usual Care | Documented Decisions to Forgo Hospitalization | 119 Participants |
95% CI: [0.69, 1.69]
Secondary
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.
Time frame: by 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Advance Care Planning Intervention | Acquisition of Decisions Not to Hospitalize | 41 Participants |
| Usual Care | Acquisition of Decisions Not to Hospitalize | 30 Participants |
95% CI: [0.66, 2.2]
Secondary
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.
Time frame: 6 months
Population: Missing data are due to missing proxy interviews at certain follow-up time points
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Advance Care Planning Intervention | Acquisition of Preference for Level of Care | 151 Participants |
| Usual Care | Acquisition of Preference for Level of Care | 133 Participants |
95% CI: [0.58, 1.58]
Other Pre-specified
Acquisition of Other Documented Advance Care Planning
The proportion of residents who acquired a documented advance directive to forego tube-feeding will be compared in the intervention versus control group.
Time frame: by 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Advance Care Planning Intervention | Acquisition of Other Documented Advance Care Planning | 148 Participants |
| Usual Care | Acquisition of Other Documented Advance Care Planning | 117 Participants |
95% CI: [1.13, 2.82]
Other Pre-specified
Burdensome Treatments
Burdensome treatments include: Hospitals transfers (hospitalizations or emergency room visits), tube feeding or parenteral therapy. The rate of burdensome treatments per 1000 resident days was compared between the intervention and control arms.
Time frame: by 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Advance Care Planning Intervention | Burdensome Treatments | 33 Participants |
| Usual Care | Burdensome Treatments | 25 Participants |
p-value: 0.32Regression, Linear