Abstract
Importance
Better advance care planning (ACP) can help promote goal-directed care in advanced dementia.
Objectives
To test whether an ACP video (versus usual care) impacted documented advance directives, level of care preferences, goals-of-care discussions, and burdensome treatments among nursing home residents with advanced dementia.
Design
Educational Video to Improve Nursing home Care in End-stage dementia was a cluster randomized clinical trial conducted between February, 2013 and July, 2017.
Setting
64 Boston-area nursing homes (32 facilities/arm)
Participants
402 residents with advanced dementia and their proxies (intervention, N=212; control N=190) assessed quarterly for 12 months.
Interventions
12-minute ACP video for proxies with written communication of their preferred level of care (comfort, basic, or intensive) to the primary care team.
Main Outcomes and Measures
The primary outcome was the proportion of residents with do-not-hospitalize (DNH) directives by 6 months. Secondary outcomes included: preference for comfort care, documented directives to withhold tube-feeding and intravenous hydration, documented goals-of-care discussions, and burdensome treatments (hospital transfers, tube-feeding, or parenteral therapy)/1000 resident-days. Exploratory analyses examined associations between trial arm and documented advance directives when comfort care was preferred.
Results
The proportion of residents (mean age, 86.7; White, 87.1%; and female, 81.5%) with DNH directives by 6 months did not differ between arms (63% in both arms; adjusted odds ratio (AOR)=1.08, 95% confidence interval (CI)=0.69-1.69). Preferences for comfort care, directives to withhold intravenous hydration, and burdensome treatments did not differ between arms. Residents in intervention versus control facilities were more likely to have directives for no tube-feeding at 6 months (70.1% versus 61.9%, AOR=1.79, 95% CI=1.13-2.82) and all other time periods, and documented goals-of-care discussions at 3 months (16.1% versus 7.9%, AOR=2.58, 95% CI=1.20-5.54). When comfort was preferred, residents in the intervention arm were more likely to have both DNH and no tube-feeding directives (72.2% versus 52.8%, AOR=2.68, 95% CI=2.68-5.85).
Conclusions and Relevance
An ACP video did not impact preferences, DNH status, or burdensome treatments among residents with advanced dementia, but increased directives to withhold tube-feeding. When proxies preferred comfort care, advance directives of residents in the intervention arm were more likely to align with that preference.
INTRODUCTION
Advanced dementia patients commonly receive burdensome treatments that may be of little clinical benefit and inconsistent with care preferences.1–5 Advance care planning (ACP) offers an opportunity to promote goal-directed care.2,3,6–10 However, current ACP is often inadequate; proxy counseling is inconsistent, preferences are not routinely ascertained, and advance directives may not reflect the goals of care.1,2,6,8,11–16
Traditional ACP discussions are limited because of challenges envisioning complex scenarios, inconsistent provider counseling, and literacy and language barriers. Video decision support tools aim to address these shortcomings.17–25 Prior randomized clinical trials (RCTs) by our group found that healthy adults randomized to watch videos about ACP in advanced dementia, compared to those read verbal descriptions, were more likely to want comfort-focused care when they imagined having this condition.18,21,22 However, these trials did not investigate the effect of ACP videos on preferences or clinical outcomes among actual advanced dementia patients.
We conducted a cluster RCT, Educational Video to Improve Nursing home Care in End-stage dementia (EVINCE), in 64 Boston-area nursing homes (NHs). At baseline, proxies of residents with advanced dementia in intervention facilities viewed an updated version of an ACP video.18,19,21,22 Proxies in control facilities experienced usual ACP practices. Residents were followed for 12 months. The primary outcome was documented advance directives to forgo hospitalization by 6 months. Secondary outcomes included preferences for comfort care, directives to withhold other treatments, goals-of-care discussions, and burdensome treatments. Exploratory analyses examined associations between trial arm and advance directives, stratified by level of care preference.
METHODS
Design
EVINCE was a cluster RCT conducted in 64 Boston-area NHs (32 facilities/arm). Participant enrollment began February 15, 2013. Data collection was completed July 12, 2017. The Hebrew SeniorLife Institutional Review Board approved this study’s conduct.
Facilities and Randomization
Eligible facilities had over 45 beds and were within 60 miles of Boston. A research assistant (RA) mailed information to senior administrators at 181 eligible facilities and telephoned them one week later to solicit their facilities’ participation.
Facilities were enrolled and randomized as pairs matched on profit status; a factor associated with ACP.4,6,16 Once a pair was recruited, facilities were assigned de-identified labels that the statistician used to randomly assign one NH to each arm using a computer-generated algorithm. Approximately one matched pair was randomized and began the trial every two months between February 1, 2013 and May 1, 2016.
Participants
Resident eligibility criteria included: age ≥ 65; dementia (any type); Global Deterioration Scale (GDS) score of 7 (range 1–7, higher scores indicate worse dementia);26 length of stay >90 days; and English-speaking proxy was available for an in-person interview within two weeks. At GDS=7, dementia patients have profound memory deficits (cannot recognize family), speak < five words, are incontinent of urine and stool, and non-ambulatory.26 The proxy was the resident’s formally or informally designated medical decision-maker.
At the time of NH recruitment and quarterly thereafter, RAs asked nurses to identify residents with dementia, GDS=7, and available proxies. Age and dementia diagnosis were confirmed by chart review. Proxies of eligible residents were mailed information and telephoned two weeks later to solicit their participation. Proxies provided consent for themselves and the residents, and were only informed about conditions of participation in the arm to which their facility was randomized.
Intervention
The intervention included an ACP video for proxies (Video) and provision of a form to the residents’ primary care team indicating the proxy’s preferred level of care after viewing the video. The 12-minute video was developed by geriatricians and palliative care specialists with earlier versions refined for EVINCE.18,19,21,22 Proxies were shown the video on tablets by an RA during a baseline in-person interview.
The video first described the typical features of advanced dementia accompanied by images of an individual with this condition. Next, three level of care options were presented: intensive, basic, and comfort care. Intensive medical care was described as potentially including “all medical treatments available, such as cardiopulmonary resuscitation (CPR), breathing machines, tube-feeding, and hospitalization including the intensive care unit (ICU).” Images included a simulated resuscitation on a mannequin, a ventilated patient, and a tube-fed NH resident.
Basic medical care was described as “somewhere between wanting to live as long as possible and maximizing comfort,” with possible treatments including antibiotics, parenteral therapy, and hospitalization, but not CPR, intubation, tube-feeding, or ICU care. Visual images included a hospitalized older patient receiving intravenous antibiotics and oxygen via nasal cannula.
Comfort care was described as including only treatments to promote comfort. Hospitalization would be avoided except when needed for comfort. Patients would receive assistance eating but not tube-feeding or intravenous fluids. The video depicted an advanced dementia patient getting hand-fed, assistance with personal care, and oxygen.
The proxy’s preferred level of care after viewing the video was documented on a form that was emailed/mailed to the residents’ medical providers (physician, nurse practitioner, or physician assistant), nursing units, and social worker, and placed in their charts. At baseline, proxies in control facilities were read descriptions of the levels of care (eMethods) and asked their preferences. Their choice was not communicated to providers and they otherwise experienced usual ACP practices.
Data Collection and Elements
Resident data were collected at baseline and quarterly up to 12 months from their charts, except for baseline measures of functional and cognitive status. Proxy data were collected at baseline in-person interviews and quarterly telephone interviews for up to 12 months. Charts reviews were done within 14 days of a resident’s death.
Four RAs collected data. One RA conducted all baseline in-person interviews when the video was also shown, and therefore was not masked. Three other RAs who conducted chart abstractions and follow-up proxy interviews, which included all outcome data, were masked. The investigators, statistician, and data programmers were masked.
Baseline resident data from the chart included: demographics (age, gender, and race (White versus other)), and dementia type (Alzheimer's disease versus other). Nurses quantified functional status using the Bedford Alzheimer’s Nursing Severity-Subscale (range 7–28; higher scores indicate greater disability).27 The RAs administered the Test for Severe Impairment (range 0–24, lower scores indicate greater impairment; dichotomized to ≤0) to residents.28
Variables abstracted from charts at each assessment included advance directives to forgo hospital transfers (DNH), tube-feeding, and intravenous hydration, as indicated by either medical orders or other provider documentation (e.g., progress notes). Documented goals-of-care discussions between providers and proxies in the prior 3 months was ascertained. Finally, feeding tube insertions, parenteral therapy (hydration or medications), and hospital transfers (admission or emergency room) were abstracted.
During in-person baseline and quarterly telephone interviews, proxies were read descriptions of intensive, basic, and comfort care (eMethods), and asked which level they felt the resident should receive. At baseline, proxies in intervention facilities were asked their preferences before and immediately after viewing the video; proxies in control facilities were only asked their preferences once. After viewing the video, proxies were asked whether the video was helpful (very, somewhat, a little, or not), and whether they would recommend it to others (definitely, probably, probably not, or definitely not).
Additional proxy data ascertained at baseline included: age, gender, race, (White versus other), education level, relationship to resident (spouse, child, or other), and whether NH providers had asked their opinion regarding goals of care.
Outcomes
The primary outcome was the cumulative proportion of residents with documented DNH directives by 6 months. Secondary outcomes included the cumulative proportion of residents who had DNH directives by 3, 9, and 12 months, and directives to forgo other treatments (tube-feeding, intravenous hydration) and documented goals-of-care discussions by 3, 6, 9, and 12 months. Acquisition of new directives to withhold specific treatments and goals-of-care discussions over follow-up among residents who lacked them at baseline was also examined.
Additional secondary outcomes included proportions of proxies preferring comfort care (versus basic or intensive care) at baseline (post-video in the intervention arm) and cumulatively at each follow-up interview. Finally, burdensome treatments/1000 resident-days which included any hospital transfers, feeding tube insertions, or parenteral therapy.
Two exploratory analyses were conducted. The first examined the association between trial arm and directives for DNH and no tube-feeding (the two most aggressive interventions) stratified by level of care preference. The second examined the association between level of care preferences among proxies in the intervention arm before watching the video and whether or not they found the video helpful.
Analysis
Analyses were done at the resident/proxy level (unless otherwise noted) and followed intention-to-treat principles. Variables were described using means with standard deviations (SDs) and frequencies for continuous and categorical variables, respectively. All models comparing outcomes between arms were adjusted for resident age and race (White versus other) and clustering at the facility-level using generalized estimating equations (GEE) for logistic regression models and robust variance estimates for Cox proportional hazards and Poisson hurdle models. Adjusted odds ratios (AORs) or hazard ratios (AHRs) with 95% confidence intervals (CIs) were generated. Analyses were performed using SAS Version 9.4 and Stata Version 13.1.
Logistic regression compared the proportion of proxies in each arm opting for comfort care at baseline (post-video in intervention group) and cumulatively at 3, 6, 9, and 12 months. For example, proxies were considered to prefer comfort care by 6 months if they stated that preference at either baseline, 3 months, or 6 months.
Logistic regression compared cumulative proportions of residents in the intervention versus control arms with each advance directive at 3, 6, 9, and 12 months. The proportion of residents with each directive were considered cumulatively up until each time point, including those who died (e.g., residents were considered to have DNH directives by 6 months if it was documented at the 3 month, 6 month or death assessment (if they died before 6 months)). Baseline advance directives were excluded. The cumulative incidences of acquiring an advance directive over follow-up, among those who lacked the directive at baseline, were compared between the two arms using Cox proportional hazards regression. Time to acquisition was calculated from baseline assessment dates to follow-up assessment dates when the directive was first noted. Residents who never acquired the directive were censored.
Burdensome treatments/1000 resident-days was compared between trial arms using Poisson hurdle models which compared the odds of having at least one burdensome treatment, and then conditional on having at least one intervention, the number of interventions received. A joint test of effect on both model components was conducted generating a P value.
Exploratory analyses examining associations between trial arm and documented directives stratified by level of care preferences were conducted at the assessment level (i.e., care preference and directive status were derived from the same assessment period) using logistic regression with GEEs to adjust for clustering at the proxy/dyad and facility levels. The baseline period was excluded. Logistic regression was used to examine the association between level of care preferences among proxies in the intervention arm before watching the video and whether they found the video unhelpful.
The sample size was calculated as 360 dyads from 20 matched facilities (180 dyads from 10 facilities/arm) to provide at least 95% power to detect an absolute difference of 25% between arms for the primary outcome and 80% power to detect a 20% difference. The sample size calculation assumed two-sided testing, 5% type I error rate, intra-class correlation coefficient within facilities of 0.05, and 18 dyads per facility. As resident/proxy recruitment yielded fewer dyads per facility than anticipated, 64 facilities (32 facilities/arm) were ultimately enrolled to achieve the target sample size.
RESULTS
Recruitment and Follow-up
Among the 181 eligible NHs, 48 administrators could not be contacted and 69 declined to participate (Figure 1). The remaining 64 facilities were enrolled and randomized (32 facilities/arm). A total of 36% (N=212/546) and 38% (N=190/528) of eligible dyads were recruited in the intervention and control arms, respectively. Mean age and gender distribution of non-participating and participating eligible residents did not significantly differ. Proxy refusal was the sole reason for non-participation.
Figure 1.
Consort diagram of nursing homes and participants. a Unable to contact proxy (n=163), resident did not have dementia (n=56), resident died before consent obtained (n=47), proxy could not meet (n=24), resident GDS score <7 (n=17), proxy did not speak English (n=9), resident in coma (n=4), no proxy (n=1); b Unable to contact proxy (n=158), resident died before consent obtained (n=53), resident did not have dementia (n=49), proxy could not meet (n=20), resident in coma (n=13), resident GDS score <7 (n=8), proxy did not speak English (n=5), no proxy (n=1); c All participants at nursing home completed follow-up either before the facility closed or at another study facility and were included in the primary outcome analysis; d Discharged from nursing home after baseline assessment (n=1), 3 month assessment (n=1); e Discharged from nursing home after: baseline assessment (n-1), 9 month assessment (n=2); f Proxy unstable and could not continue to provide consent for resident; g Unable to contact after: baseline assessment (n=4), 3 month assessment (n=2), 6 month assessment (n=3); h Unable to contact after: baseline assessment (n=3), 3 month assessment (n=2); i Excluded 1 resident with only baseline data, included all residents with ≥1 follow-up assessment.
Six residents (intervention, N=3; control, N=3) were lost during follow-up, 14 proxies (intervention, N=9; control, N=5) stopped responding to phone calls, and 2 proxies (intervention, N=1; control, N=1) withdrew. The final sample size for the primary outcome analysis, which required at least one follow-up resident assessment, included 211 and 189 residents in the intervention and control arms, respectively.
Baseline Characteristics
Baseline resident characteristics were similar between arms (Table 1), except residents in intervention facilities were younger (intervention, mean=86.0 ± 7.4 (SD) years; control, mean=87.4 ± 7.3 (SD) years; P=0.07) and a lower proportion were White (intervention, N=178/212 (84.0%); control, N=172/190 (90.5%); P=0.05). Baseline characteristics of proxies were similar in both arms.
Table 1.
Baseline Resident and Health Care Proxy Characteristics
| Resident Characteristics | Intervention (n=212) | Control (n=190) |
|---|---|---|
| No. (%) or Mean ± Standard Deviation | ||
| Age (Years) | 86.0 ± 7.4 | 87.4 ± 7.3 |
| Male | 45 (21.2) | 34 (17.9) |
| White (vs. Other) | 178 (84.0) | 172 (90.5) |
| Alzheimer’s Dementia (vs. Other Dementia) | 146 (68.9) | 137 (72.1) |
| Bedford Alzheimer’s Nursing Severity-Subscalea | 19.9 ± 2.8 | 20.4 ± 2.6 |
| Test for Severe Impairment = 0b | 101 (47.6) | 89 (46.8) |
| Percutaneous Endoscopic Gastrostomy Tube | 3 (1.4) | 4 (2.1) |
| Documented Advance Directivesc | ||
| No hospitalization | 103 (48.6) | 97 (51.1) |
| No Tube-feeding | 122 (57.5) | 101 (53.2) |
| No Intravenous Hydration | 61 (28.8) | 44 (23.2) |
| Goals-of-care Discussion in Prior 3 months | 27 (12.7) | 29 (15.3) |
| Proxy Characteristics | ||
| Age (Years) | 61.8 ± 10.9 | 62.8 ± 10.6 |
| Male | 66 (31.1) | 70 (36.8) |
| White (vs. Other) | 177 (83.5) | 173 (91.0) |
| ≥ High School Completion | 208 (98.1) | 188 (98.9) |
| Relation to Resident | ||
| Child | 137 (64.6) | 119 (62.6) |
| Spouse | 30 (14.2) | 21 (11.0) |
| Other | 45 (21.2) | 50 (26.3) |
| Provider Asked About Goals-of-care for Resident | 148 (69.8) | 127 (68.4) |
| Baseline level of Care Preferencec | ||
| Comfort | 132 (62.3) | 118 (62.1) |
| Basic | 63 (29.7) | 63 (33.1) |
| Intensive | 17 (8.0) | 9 (4.7) |
Bedford Alzheimer’s Nursing Severity-Subscale, range 7–28, higher scores indicate more functional disability
Test for Severe Impairment, range 0–24, lower scores indicate greater cognitive impairment
Data reflects status prior to the proxies’ exposure to the video in intervention arm
Care Preferences
Proxies’ baseline preferences were similarly distributed in the control (intensive, N=9/190 (4.7%); basic, N=63/190 (33.1%); comfort, N=118/190 (62.1%)) and intervention arms (before watching the video) (intensive, N=17/212 (8.0%); basic, N=63/212 (29.7%); comfort, N=132/212 (62.3%)). Proxies’ preferences in intervention facilities immediately after watching the video were: intensive, N=9/212 (4.2%); basic, N=64/212 (30.2%); comfort, N=138/212 (65.1%); refused to answer, N=1/212 (0.5%). The proportion of proxies preferring comfort care did not differ between arms at baseline (post-video in intervention arm), or cumulatively at any follow-up interview (Table 2).
Table 2.
Cumulative Prevalence of Preferences for Comfort Care Among Residents in Intervention versus Control Arm
| Care Preference |
Baseline | 3 months | 6 months | 9 months | 12 months | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Interventiona n=212 |
Control n=190 |
Intervention n=209b |
Control n=186b |
Intervention n=209b |
Control n=182b |
Intervention n=206b |
Control n=184b |
Intervention n=209b |
Control n=184b |
|
| Comfort Care No. (%)c | 138 (65.1) | 118 (62.1) | 151 (72.2) | 133 (75.1) | 153 (73.2) | 140 (76.9) | 155 (75.2) | 149 (81.0) | 159 (76.1) | 151 (82.1) |
| Adjusted Odds Ratiod (95% Confidence Interval) | 1.28 (0.85–1.94) | 1.21 (0.76–1.94) | 0.96 (0.58–1.58) | 0.68 (0.38–1.23) | 0.72 (0.38–1.38) | |||||
Baseline in intervention arm is post-video preference
Missing data are due to missing proxy interviews at specific time points
Cumulative No. (%) of proxies stating comfort care as preference at any time prior to or at assessment period
Compares intervention to control arm, adjusted for resident race (White), resident age, and clustering at the facility level
Advance Directives and Goals-of-Care Discussions
The proportion of residents with DNH directives by 6 months (primary outcome) did not differ between arms (AOR=1.08, 95% CI=0.69–1.69) or any other time (Table 3). Directives to forgo tube-feeding were significantly more likely in the intervention versus control arm at all assessments (3 months, AOR=1.78, 95% CI=1.14–2.76; 6 months, AOR=1.79, 95% CI=1.13–2.82; 9 months, AOR=1.97, 95% CI=1.22–3.17; 12 months, AOR=2.32, 95% CI=1.38–3.91). Documented goals-of-care discussions at 3 months were significantly more likely in the intervention versus control arm (AOR=2.58, 95% CI=1.20–5.54), but not other periods. Directives to forgo intravenous hydration did not differ between arms. The cumulative incidence of acquiring a decision for no tube-feeding over the follow-up period was significantly higher in the intervention arm (AHR=1.99; 95% CI=1.08–3.66) (Table 4), but did not differ for other directives.
Table 3.
Cumulative Prevalence of Documented Advance Care Planning Among Residents in Intervention (n=211) versus Control (n=189) Arm
| Documented Advance Care Planning | 3 Months | 6 Months | 9 Months | 12 Months | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention No. (%)a |
Control No. (%)a |
Adjusted Odds Ratio (95% Confidence Interval)b |
Intervention No. (%)a |
Control No. (%)a |
Adjusted Odds Ratio (95% Confidence Interval)b |
Intervention No. (%)a |
Control No. (%)a |
Adjusted Odds Ratio (95% Confidence Interval)b |
Intervention No. (%)a |
Control No. (%)a |
Adjusted Odds Ratio (95% Confidence Interval)b |
|
| No Hospitalization | 127 (60.2) | 110 (58.2) | 1.15 (0.74–1.77) | 133 (63.0) | 119 (63.0) | 1.08c (0.69–1.69) | 140 (66.4) | 125 (66.1) | 1.06 (0.66–1.69) | 144 (68.2) | 126 (66.7) | 1.07 (0.66–1.72) |
| No Tube-Feeding | 142 (67.3) | 109 (57.7) | 1.78 (1.14–2.76) | 148 (70.1) | 117 (61.9) | 1.79 (1.13–2.82) | 152 (72.0) | 119 (63.0) | 1.97 (1.22–3.17) | 161 (76.3) | 121 (64.0) | 2.32 (1.38–3.91) |
| No Intravenous Hydration | 77 (36.5) | 53 (28.0) | 1.46 (0.91–2.34) | 79 (37.4) | 60 (31.7) | 1.32 (0.83–2.12) | 84 (39.8) | 66 (34.9) | 1.34 (0.83–2.16) | 91 (43.1) | 68 (36.0) | 1.51 (0.93–2.44) |
| Goals-of-care Discussion | 34 (16.1) | 15 (7.9) | 2.58 (1.20–5.54) | 49 (23.2) | 29 (15.3) | 1.70 (0.94–3.07) | 63 (29.9) | 42 (22.2) | 1.49 (0.87–2.54) | 72 (34.1) | 48 (25.4) | 1.46 (0.86–2.70) |
Cumulative No. (%) of residents with advance care planning variable documented in their chart as ascertained from any assessment prior to or at the time-point including from death assessments of residents who died prior to the time-point. Data from baseline residents’ assessments were excluded as they reflect advance care planning prior to exposure to the intervention.
Compares intervention to control arm, adjusted for resident age and race (White), and clustering at the facility level
Primary trial outcome
Table 4.
Cumulative Incidence of Documented Advance Care Planning Among Residents in Intervention versus Control Arma
| Documented Advance Care Planning |
Intervention No. (%) |
Control No. (%) |
Adjusted Hazard Ratio with 95% Confidence Intervalb |
|---|---|---|---|
| No Hospitalization | 41/108 (38.0) | 30/92 (32.6) | 1.20 (0.66–2.20) |
| No Tube-Feeding | 39/89 (43.8) | 22/89 (24.7) | 1.99 (1.08–3.66) |
| No Intravenous Hydration | 31/150 (20.7) | 25/145 (17.2) | 1.13 (0.67–1.90) |
| Goals-of-care Discussion | 61/184 (33.2) | 38/160 (23.8) | 1.40 (0.92–2.13) |
Analyses examines the cumulative incidence of residents who acquired the advance care planning variable at any time during follow-up among those who did not have the variable at baseline
Compares intervention to control arm, adjusted for resident age, resident race, and clustering within facility
In exploratory analyses, when comfort care was preferred, residents in the intervention versus control arm were significantly more likely to have directives for no tube-feeding (AOR=3.39, 95%CI=1.62, 7.11), both DNH and no tube-feeding together (AOR=2.68, 95% CI=2.68–5.85), but not DNH alone (eTable 1a). Associations between trial arm and advance directives when basic or intensive care was preferred were not significant, albeit some associations involved too few events to analyze.
Burdensome Treatments
Residents experiencing burdensome treatments over follow-up were: hospital transfers, intervention, N=20/211 (9.5%), control, N=21/189 (11.1%); feeding tube insertions, intervention, N=4/211 (1.9%), control, N=4/189 (2.1%); parenteral therapy, intervention, N=17/211 (8.1%), control, N=10/189 (5.3%); and any, intervention, N=33/211 (15.6%), control, N=25/189 (13.2%). The rate of burdensome treatments/1000 resident-days did not differ significantly between arms (intervention, mean=1.23 ± 2.31 (SD); control, mean=1.42 ± 5.03 (SD); P=0.32).
Proxy’s Opinion of the Video
Proxies rated the videos as very or somewhat helpful, 68.0%; a little helpful 8.5%; and unhelpful, 23.6%. A total of 97.1% of proxies stated they would definitely or probably recommend the video to others. Proxies who preferred comfort care (N=131) (versus basic or intensive (N=80)) before watching the video were significantly more likely to find the video unhelpful (30.5% (N=40/131) versus 11.3% (N=9/80); OR=3.47 95% CI=1.58–7.62).
DISCUSSION
In this cluster RCT, the proportion of proxies preferring comfort care for NH residents with advanced dementia did not differ between those who did and did not view an ACP video. The primary outcome, DNH directives by 6 months, also did not differ between arms. Secondary outcomes revealed that residents in intervention facilities were more likely to have documented directives for no tube-feeding throughout follow-up and goals-of-care discussions at 3 months. Burdensome treatments did not differ between arms. In exploratory analyses, when proxies preferred comfort care, residents in the intervention arm were more likely to have advance directives reflecting that preference.
This study corroborates and furthers what is known about proxies’ preferences in advanced dementia and how video decision aids impact those preferences. The Goals-of-Care trial, the only other cluster RCT of a video decision aid for proxies of NH residents with advanced dementia,29 also found that approximately 60% of proxies preferred comfort care at baseline, and that this proportion increased over time but never differed between intervention versus control arms. In contrast, prior studies conducted among patients with other diseases,17,20,24,25 and healthy adults asked to imagine they had advanced dementia, 18,21,22 found that ACP videos increased preferences for comfort care. Through visual images, these videos are intended to promote a better understanding of future health states that are difficult to imagine. The residents in EVINCE already had advanced dementia, which presumably developed over some time. It is conceivable that the video did not impact preferences because proxies were already well-aware of the illness experience and had had ample opportunity to establish preferences. This possibility is supported by the observation that proxies in the intervention arm who already had comfort as their preference before viewing the video, were more likely to rate the video as unhelpful. Taken together, ACP videos may have a greater impact on preferences if shown to proxies earlier in the course of dementia before they have a clear understanding of what to expect in late-stage disease.
In contrast to many earlier trials,17,18,20–22,24,25 EVINCE examined not only the ACP video’s impact on preferences, but also clinical outcomes. Findings were mixed. DNH directives were unaffected, but documented directives to withhold tube-feeding were consistently higher in intervention facilities. The video’s explicit images and explanations regarding tube-feeding may have been particularly informative for proxies, whereas depictions of hospitalizations were more nuanced. The few prior RCTs reporting the impact of ACP videos on clinical outcomes also had mixed findings.24,29,30 The Goals-of-Care trial intervention, which combined a goals-of-care video with a semi-structured care planning meeting,29 improved family ratings of communication, reduced hospitalizations, but had no effect on documented advance directives. There are several possible reasons why the EVINCE intervention did not impact DNH status and burdensome treatments. First, as discussed, the video did not change proxy preferences. Second, DNH directives were well-established in approximately half the residents prior to the study and burdensome treatments were rare. DNH orders, hospital transfer rates, and feeding tube insertions are less common in Boston-area NHs compared to other US regions.4,8,29,31,32 The intervention may have greater impact on clinical outcomes in settings that, at baseline, have a more aggressive approach to advanced dementia care. Finally, the efficacy of the EVINCE intervention may have been hindered by the fact that, unlike the Goals-of-Care trial, there was no integration of the video into actual NH care processes and no direct engagement with the resident’s providers.
A recent expert consensus panel ranked “care consistent with goals” as the top-rated outcome to evaluate the success of an ACP initiative.33 Exploratory analyses suggest the ACP video promoted better alignment of goals with care; when proxies preferred comfort care, residents in the intervention arm were more likely to have documented directives (i.e., DNH and no tube-feeding) consistent with that preference. Insufficient power precluded similar analyses of the effect of the intervention on the concordance between preferences and burdensome treatments.
Several limitations warrant discussion. The participation rate was similar in both arms and comparable studies.2,29,34 However, our findings cannot be generalized to eligible non-participants as proxies’ decisions not to participate may be related to their care preferences. Generalizability is further limited to a mostly white cohort in Boston. The effect of the intervention may differ in other populations and regions, particularly those with a more aggressive approach to advanced dementia care.4,8,29,31,32 Power may have been insufficient to detect significant differences for some secondary outcomes, particularly burdensome treatments.
EVINCE has several important implications for future RCTs of ACP video interventions in advanced dementia. In accordance with the recent consensus report,33 trials should be designed such that the primary outcome reflects concordance between preferences and care delivered. A logical next step would also include testing the impact of the video on clinical outcomes among proxies of patients with less advanced dementia and in settings where comfort-focused care is less prevalent. Finally, future interventions should include the integration of these videos into a broader ACP program within the clinical setting, as they would be used in practice.
Supplementary Material
Advance Care Planning: Making Decisions for People with Dementia: The 12-minute video (File Format mp4) is designed to assist health care proxies choose which level of care (intensive, basic, and comfort care) they feel is most appropriate for a patient with advanced dementia.
KEY POINTS.
Question
Can an advance care planning (ACP) video impact advance directives, preferences, and burdensome treatments among nursing home residents with advanced dementia?
Findings
In this cluster randomized clinical trial of 402 advanced dementia residents, do-not-hospitalize directives, care preferences, and burdensome treatments did not significantly differ between trial arms. In intervention facilities, residents were more likely to have directives to withhold tube-feeding, and when comfort care was preferred, to have do-not-hospitalize and no tube-feeding directives.
Meaning
In advanced dementia, an ACP video did not impact do-not-hospitalize directives, care preferences, or burdensome treatments, but may promote alignment of preferences with advance directives.
Acknowledgments
The investigators wish to thank the EVINCE data collection and management team (Elaine Bergman, Ruth Carroll, Sara Hooley, Maliaka Lindsay, Linda Klein, and Holly Giampetro), the staff at the participant nursing homes, and the residents and families who have generously given their time to this study.
Funding/Support: This research was supported by the following grants: NIH-NIA R01 AG043440 and NIH-NIA K24AG033640 (Mitchell).
Role of the Sponsors: The funding sources for this study played no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Footnotes
Trial Registration: ClinicalTrials.gov Identifier: NCT01774799
Author contributions: Drs. Mitchell and Shaffer had full access to all data in the study and take responsibility for the integrity of the data and the accuracy of the data analyses.
Study concept and design: Mitchell, Shaffer, Hanson, Volandes
Acquisition of data: Mitchell, Volandes
Analyses and interpretation of data: Mitchell, Shaffer, Hanson, Cohen, Habtemariam, Volandes
Drafting of manuscript: Mitchell, Cohen
Critical revision of manuscript for important intellectual content: Mitchell, Shaffer, Cohen, Hanson, Habtemariam, Volandes
Statistical analyses: Mitchell, Shaffer, Habtemariam
Administrative, technical or material support: Mitchell, Volandes
Study supervision: Mitchell, Volandes
Financial Disclosures: None
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Advance Care Planning: Making Decisions for People with Dementia: The 12-minute video (File Format mp4) is designed to assist health care proxies choose which level of care (intensive, basic, and comfort care) they feel is most appropriate for a patient with advanced dementia.