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Molloy DW, Guyatt GH, Russo R, et al. Systematic Implementation of an Advance Directive Program in Nursing Homes: A Randomized Controlled Trial. JAMA. 2000;283(11):1437–1444. doi:10.1001/jama.283.11.1437
Author Affiliations: Geriatric Research Group, Department of Medicine (Drs Molloy and Harrison, Mss Russo and Smith, and Messrs Standish and Dubois), Department of Clinical Epidemiology and Biostatistics (Drs Guyatt, O'Brien, and Willan, Mr Goeree, and Ms Watson), and School of Nursing (Ms Patterson), McMaster University, Father Sean O'Sullivan Research Centre (Drs O'Brien and Willan, Messrs Goeree and Bédard, and Ms Watson), and Center For Evaluation of Medicines, St Joseph's Hospital (Drs O'Brien and Willan, Mr Goeree, and Ms Watson), Hamilton, Ontario; Department of Medicine, University of Manitoba, Winnipeg (Dr Strang); and National Ageing Research Institute, University of Melbourne, Australia (Dr Darzins). Dr Bédard is now with Lakehead Psychiatric Hospital in Thunder Bay, Ontario. Dr Harrison is now with the Hospital for Sick Children, Toronto, Ontario.
Context Although advance directives are commonly used in the community, little
is known about the effects of their systematic implementation.
Objectives To examine the effect of systematically implementing an advance directive
in nursing homes on patient and family satisfaction with involvement in decision
making and on health care costs.
Design Randomized controlled trial conducted June 1, 1994, to August 31, 1998.
Setting and Participants A total of 1292 residents in 6 Ontario nursing homes with more than
100 residents each.
Intervention The Let Me Decide advance directive program included educating staff
in local hospitals and nursing homes, residents, and families about advance
directives and offering competent residents or next-of-kin of mentally incompetent
residents an advance directive that provided a range of health care choices
for life-threatening illness, cardiac arrest, and nutrition. The 6 nursing
homes were pair-matched on key characteristics, and 1 home per pair was randomized
to take part in the program. Control nursing homes continued with prior policies
concerning advance directives.
Main Outcome Measures Residents' and families' satisfaction with health care and health care
services utilization over 18 months, compared between intervention and control
Results Of 527 participating residents in intervention nursing homes, 49% of
competent residents and 78% of families of incompetent residents completed
advance directives. Satisfaction was not significantly different in intervention
and control nursing homes. The mean difference (scale, 1-7) between intervention
and control homes was −0.16 (95% confidence interval [CI], −0.41
to 0.10) for competent residents and 0.07 (95% CI, −0.08 to 0.23) for
families of incompetent residents. Intervention nursing homes reported fewer
hospitalizations per resident (mean, 0.27 vs 0.48; P
= .001) and less resource use (average total cost per patient, Can $3490 vs
Can $5239; P = .01) than control nursing homes. Proportion
of deaths in intervention (24%) and control (28%) nursing homes were similar
(P = .20).
Conclusion Our data suggest that systematic implementation of a program to increase
use of advance directives reduces health care services utilization without
affecting satisfaction or mortality.
People complete advance directives before they lose capacity to express
their wishes, extend autonomy, and guide their families and health care workers
to provide care consistent with their choices.1
Despite the promising nature of advance directives, ensuring both their completion
and implementation has proved problematic. Written materials alone fail to
education by health care providers,2 individualized
information and counseling sessions,6 and use
of videos and case scenarios7 result in higher
completion rates. In 1 US community, 2 years after a systematic, community-wide
advance directive program was implemented, 85% of the decedents had advance
directives,8 a significant increase compared
with 15% before the program. Unless there is adequate communication between
patients, health care workers,9,10
advance directives are unlikely to improve the decision-making process. They
may enhance communication of patient preferences between patients and physicians,14,15 or they may not.16
Although advance directives have been used in the community,17,18
nursing homes,19,20 hospitals,9,16,19-24
and physicians' offices,25-34
uncertainty still persists about their effect on patient satisfaction with
health care and health care costs. In particular, while 2 randomized trials
of directives failed to show a reduction in costs,10,35
they recruited critically ill inpatients10
and young outpatients,35 and their small sample
sizes and cost accounting have been criticized.36
We pair-matched 6 nursing homes on key characteristics and randomized
1 of each pair to systematic implementation of an advance directive or to
the continuation of existing policies.
We measured satisfaction with care, costs, and mortality for all eligible
residents in the home at the time of randomization for 18 months. We measured
health care utilization in a cohort of patients who were in the same home
at the beginning of a 1-year period prior to the start of prospective data
collection and controlled for this level of utilization in our cost analysis.
We surveyed 215 Ontario nursing homes with more than 100 residents each;
171 (80%) responded, 150 expressed interest in the study, and 78 had health
care choices documented for less than 25% of residents. We selected pairs
of homes that had differences of less than 10% in the proportion of residents
hospitalized annually, case-mix indexes that defined the level of care residents
received, and differences of 20% or less in the number of residents in the
home and the proportion of deaths occurring in a hospital. We chose 3 pairs
of the homes that best matched these criteria and were geographically distant
from each another.
We visited the candidate pairs of homes to ensure the accuracy of data,
willingness to participate, and the absence of plans for major changes during
the study. Local hospitals provided approval to educate staff about the program
and to provide access to the charts of residents admitted during the study.
When the 3 pairs were chosen, we randomized homes within pairs to receive
the systematic implementation of the advance directive program (intervention
home) or to continue with conventional use of advance directives (control
In 1988, we developed the Let Me Decide advance directive (LMD) and
evaluated its systematic implementation in nursing homes and in the community.17,37,38 We found consistent
support from residents, families, and health care workers for the program.37,38
The program has instructional and proxy components,39
providing a range of health care choices for life-threatening illness, cardiac
arrest, and feeding. Individuals or proxies can choose different levels of
care for life-threatening illness (from intensive to palliative), nutrition
(from intubation to basic), and cardiopulmonary resuscitation (CPR) (resuscitation
or no resuscitation) if they are in a "reversible" condition with an "acceptable"
quality of life or an "irreversible" condition with an "unacceptable" quality
of life. This unacceptable condition is described in a personal statement.
Three registered nurses employed in the program homes attended a 2-day
workshop to train as health care facilitators (HCFs). They learned a specific
approach to educating hospital staff, nursing home staff, residents, and families
about directives and measuring a person's capacity to complete directives.
The HCFs provided educational sessions and in-service training to hospital
staff, with special emphasis on emergency workers, at open information sessions
and through the libraries that provided access to 3 videotapes describing
the LMD program. Refresher sessions throughout the study educated new staff
and maintained awareness of the program among previously trained staff.
Each HCF contacted the president and members of the residents' council,
nursing staff, social workers, and administrators and provided educational
sessions about the implementation process.
Head nurses on each ward used their experience with residents in other
areas of decision making to classify the residents as definitely incompetent
to complete an advance directive or "otherwise." Residents rated as otherwise
completed the Standardized Mini-Mental State Examination (SMMSE).40 Those who scored 16 or more on a scale of 0 to 30
were educated about the LMD.41 If residents
designated otherwise scored 15 or less, we contacted their proxies (court-appointed
guardians for personal care, attorneys for personal care, board-appointed
representatives, family members or partners, or public guardians and trustees)
to complete LMDs on their behalf.
Competent residents and proxies of incompetent residents met with the
HCF to discuss their treatment choices. When they were educated about the
LMD, the HCF assessed the resident's capacity using validated instruments
specific to LMD.41 Competent residents and
proxies for incompetent residents had the opportunity to complete directives.
Physicians reviewed and signed directives, originals remained in the residents'
charts, and residents, families, proxies, and family physicians received copies.
Charts with directives were flagged and extra copies were produced to accompany
residents if they were transferred to hospitals.
One year later, the HCFs contacted competent residents and proxies of
incompetent residents to update the directives.
We provided no specific directions or written material to control institutions.
They continued their usual policies, which did not prescribe any particular
We obtained consent from residents and families for data collection
in intervention and control homes. Competent residents and relatives of incompetent
residents completed satisfaction questionnaires42
at the start of the study and 6, 12, and 18 months thereafter. If residents
became incompetent during the study, families completed the instrument designed
for relatives of an incompetent resident.
These instruments focus on 2 areas: satisfaction with level of health
care received and involvement in decision making. Some patients and relatives
wish to be fully involved in health care decisions,8,9,14,17
while others prefer to leave these decisions to health care providers.43-45 Mean scores of elderly
patients and their relatives were between 75% and 80% of the maximum with
a wide range, and the intraclass correlation for test-retest reliability for
the instruments varied from 0.86 to 0.94.42
Thus, while the mean score of close to 80% of the maximum suggests the possibility
of a ceiling effect, the high intraclass correlation demonstrates that between-respondent
heterogeneity was high, suggesting a good chance of detecting improvement
In the experimental homes and their matched controls, we collected prospective
data for 18 months on the date the first LMD directive was completed and retrospective
data for 12 months prior to that date. In the prospective period, we collected
information on health care utilization for patients and proxies who consented
to participate. Unit cost of hospital tests, procedures, emergency department
visits, and patient days in a hospital by type of ward and type of diagnosis
came from a hospital participating in the Ontario Case Costing Project.46 The Ontario provincial fee schedule for services47 provided cost estimates for physician consultations
and assessments, daily hospital visits, diagnostic procedures, and surgical
operations. The Ontario Ministry of Health price list48
provided data for stock medications cost, while nonstock prescription medication
costs were based on the Ontario Drug Benefit formulary49
plus a 10% pharmacy markup and a standard Can $6.11 dispensing fee for prescriptions.
We surveyed local pharmacies for nonprescription, nonstock drug prices.
We summarized characteristics of the homes and residents at baseline
using means and proportions (Figure 1).
Analyses of intervention effects were based on homes as the unit of randomization,
rather than on individual patients. Detection of the treatment effect in our
analyses was based on the magnitude of differences between homes within pairs
and on the extent to which these differences were large in relation to the
variability in these differences across pairs of homes.
To determine if satisfaction differed between intervention and control
homes, we used a weighted analysis of covariance with the last available satisfaction
score as the dependent variable and baseline satisfaction scores in these
same patients as the covariate. The analysis of covariance was required because
of baseline differences between groups, and the weighting was used to adjust
data for the different number of participants in each home.
The home with the lowest number of residents was assigned a weight of
1. The other 5 homes were assigned a fractional weight determined by dividing
the number of residents in the home with the fewest participants by the number
of participants in each of the other 5 homes.
To compare health care use in intervention and control homes, we calculated
the total cost for each person based on health care use and unit costs of
services. The difference in mean cost per person between each paired nursing
home was compared using an unpaired t test (with
2 df). A logit model, adjusted for clustering, was
used to compare the consent rate, sex composition, death rate, and hospitalization
rate in the directive and control homes. A least squares model (based on the
square root transformation) adjusting for clustering was used to compare the
number of hospital days in the directive and the control home groups.50 A secondary analysis compared the average number
of hospitalizations and hospital days in patients in the intervention homes
who had or had not completed an advance directive.
Institutional review board approval for the study was granted by Hamilton
Health Sciences Corporation.
There were 636 and 656 residents in the intervention and control homes,
respectively, at the start of the prospective data collection period. In the
intervention homes, 228 residents (36%) were competent and 408 (64%) were
incompetent. Of the 228 competent residents, 177 (78%) consented to chart
review and/or to complete baseline assessments, 38 residents (17%) refused
to participate, and 13 (6%) died or left the home before contact. For the
408 incompetent residents, 350 proxies (86%) consented to chart review and/or
to complete baseline assessments, 32 proxies (8%) refused to participate in
the study, 2 (0.5%) were ineligible because they did not have a proxy, and
15 (4%) died or left the home before contact. Three of the residents' families
(0.7%) could not be contacted, and 6 (1.5%) had not made a decision 12 months
after the start of the prospective period.
In the control homes, 267 residents (41%) were competent and 389 (59%)
were incompetent. Of the 267 competent residents, 256 (96%) consented to chart
reviews and/or to complete baseline assessments, 8 (3%) refused to participate
in the study, and 3 (0.8%) died or left the homes before contact. Of the 389
incompetent residents, 350 proxies (90%) consented to chart review and/or
complete baseline assessments, 17 (4%) refused to participate, 4 (1%) had
no proxy to consent, 15 (4%) died or were discharged before contact, and 3
(1%) had not made a decision 12 months after the start of the prospective
In all, 12% in the intervention homes and 4.4% in the control homes
refused chart review or to complete the baseline assessment. The remaining
nonconsenters (5% in the intervention homes and 3.1% in the control homes)
were discharged or deceased before the baseline assessment. Differences in
consent rate between intervention and control homes, within the 3 pairs, were
not significant (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.20
Table 1 describes characteristics
of consenting and nonconsenting residents in intervention and control homes.
There was a higher percentage of men in the intervention (220/636 [35%]) than
in control homes (138/656 [21%]) (OR, 0.51; 95% CI, 0.35 to 0.76).
Of 208 residents who expressed interest in completing advance directives,
23 were deemed incompetent by the HCF, and 90 (49%) of the remaining 185 competent
residents completed advance directives. Of 389 proxies of incompetent residents
who expressed interest in completing advance directives for their relatives,
305 (78%) did so. There was no significant difference between the advance
directive completion rates between males (62%) and females (67%) (OR, 0.79;
95% CI, 0.58 to 1.07).
At the end of the study, 57% of residents in the control homes and 70%
in the intervention homes had completed advance directives; 71% of directives
in the control homes were "do not resuscitate" orders and 89% of directives
in the intervention homes were LMD. The time span between the dates when the
first and last directives were completed for the intervention homes was 1.08,
1.67, and 1.45 years.
In the event of irreversible conditions, 70% of competent residents
chose palliative care, 47% basic feeding, and 91% no CPR. For reversible conditions,
41% chose intensive care, 35% intravenous feeding, and 67% no CPR. For irreversible
conditions, 66% of proxies for incompetent residents chose palliative care,
56% supplemental feeding (additional liquid supplements taken orally), and
97% no CPR. For reversible conditions, 51% chose limited care, 48% supplemental
feeding, and 84% no CPR. Most competent residents and families of incompetent
residents defined the inability to recognize family or communicate as an intolerable/irreversible
Of 395 completed directives, 72 residents and 234 proxies participated
in an annual review, 68 residents had died, and 9 had left the institution.
Residents and proxies made 18 changes to residents' advance directives.
Satisfaction scores ranged from 1 (lowest) to 7 (highest). The mean
(SD) satisfaction score for competent residents in the intervention group
was 4.77 (1.10) at baseline and 5.07 (1.17) following the intervention, and
5.09 (0.98) at baseline and 5.10 (1.11) following intervention for controls.
The postintervention adjusted mean difference, −0.16 (95% CI, −0.41
to 0.10), was not significant (F1,218 = 1.38, P = .24).
The mean (SD) satisfaction score for incompetent residents in intervention
homes was 5.49 (1.04) at baseline and 5.71 (1.03) following the intervention.
For incompetent residents in control homes, the preintervention and postintervention
means (SDs) were 5.44 (1.11) and 5.61 (1.15), respectively. The difference
between the postintervention adjusted means, 0.07 (95% CI of the difference, −0.08
to 0.23), was not significant (F1,459 = 0.82, P = .37).
Table 2 presents hospitalizations,
hospitalized days, deaths, and discharges in the retrospective and prospective
periods. In the retrospective period, hospitalizations and hospital days were
similar in intervention and control homes. The mean number of days of follow-up
in the prospective period averaged 479 for intervention residents and 475
for controls. The death rate in the prospective period, adjusted for death
rate in the retrospective period, was not significantly different between
intervention and control homes (24% vs 28%; P = .20).
In the prospective period, the adjusted risk of hospitalization was lower
in intervention home residents than controls (0.27 vs 0.48 mean hospitalizations
per patient; P = .001). Intervention home residents
had a lower mean number of hospital days than controls (2.61 vs 5.86; P = .01). Residents in the intervention homes who completed
an LMD had similar hospitalizations (0.273 vs 0.267; P
= .93) and mean number of hospitalized days (2.44 vs 3.24; P = .42) compared with those who did not.
Table 3 presents health
care costs. The mean hospital cost per resident was Can $1772 for intervention
homes and Can $3869 for control homes (P = .003).
Total health care and implementation costs were significantly lower for residents
in the intervention homes (Can $3490 vs Can $5239; P
= .01) compared with controls.
The only systematic difference in baseline characteristic between the
2 groups was a greater number of men in the intervention group. However, when
data were pooled across both groups, men showed a greater rate of hospitalizations
than women (0.43 vs 0.36) and a higher number of mean hospital days (4.84
Strengths of this study include the randomized controlled trial design,
use of validated questionnaires to measure satisfaction, and comprehensive
collection of health care resource use.
One major limitation of this study is related to the small sample size,
which increases the likelihood that randomization may fail to balance prognostic
factors between groups.51 This limitation was
ameliorated by our careful matching of the pairs of homes according to a number
of relevant variables. Despite our careful matching strategy, we did find
some imbalance between the groups. First, consent rates to complete satisfaction
questionnaires and collect resource use data collection were different: 83%
and 92% in the control and intervention homes, respectively. However, we observed
substantial differences in consent rate in only 1 home (Table 1) and, overall, the difference in consent rates did not reach
statistical significance. The second imbalance was the higher percentage of
men in the intervention homes. Prior studies have suggested that male residents
are hospitalized more often than female residents.52,53
We also observed a greater rate of hospitalization in men. Any bias from this
imbalance would decrease the difference in hospitalizations and costs between
intervention and control groups, suggesting that our estimate of the difference
is a conservative one.
Another limitation associated with our small sample size has to do with
generalizability. In particular, one may question the extent to which other
countries with different attitudes and differently structured health care
systems could expect a substantial health care cost reduction through systematic
implementation of advance directives in nursing homes.
Although we enrolled only homes with health care choices documented
for less than 25% of their residents, by the end of the study, 70% of residents
in the intervention homes and 57% in the control homes had an advance directive.
Directives in the control homes were generally less specific and comprehensive
than in LMD homes. Systematic implementation of comprehensive, specific directives
may reduce costs in institutions with a high rate of nonspecific directives.
Another possibility is that the educational process in nursing homes and hospitalizations
was responsible for this effect, rather than patients' completion of advance
directives. If this is the case, one might also expect an impact even in homes
where most patients already have some form of advance directive.
The LMD advance directive is a comprehensive and complex document. To
the extent that its complexity deterred residents from completing it, we might
have underestimated the potential impact of systematic implementation of advance
directives. However, the HCFs were trained to provide clear explanations and
answer residents' questions. Patients with SMMSE scores as low as 16 may be
capable of completing an LMD. Therefore, even patients with impaired cognitive
function can, with the aid of trained facilitators, understand and complete
This study confirms that, given the opportunity, competent residents
in nursing homes and the families of incompetent residents are willing to
complete advance directives.37,38
Rates of approximately 50% for directive completion for competent residents
and in families of incompetent residents can be achieved after comprehensive
education of health care workers, patients, and families.
Systematic implementation of LMD in the intervention homes required
an HCF commitment of 100% of a standard work shift for 6 to 8 months, depending
on the size of the home. After initial implementation, HCFs worked half a
day in the small home and a full day in the 2 larger homes to maintain the
program. The percentage of time varied slightly depending on the size of the
home and the admission rate.
We anticipated that systematic application of LMD would decrease overall
resource utilization because staff would follow the wishes of acutely ill
residents and their families and allow these residents to remain in the home.
Without LMD, staff in the control homes would transfer more residents to the
hospital. Increased acknowledgment of patient wishes might also create an
environment in which staff would develop a higher threshold for transferring
patients to hospital. Our results are consistent with at least 1 of these
situations occurring in each of the intervention homes.
We expected that residents transferred to hospital would have lower
mortality than those who remained in the home. However, despite a lower rate
of hospitalization, mortality was similar in the intervention and the control
homes. We did not measure symptom control and quality of life and so cannot
comment on the effect of different hospitalization rates on these outcomes.
Unlike 2 previously conducted randomized trials,10,35
this study explored the effect of advance directives in nursing homes in homogeneous
populations. We also educated health care workers in homes and in hospitals,
and LMD differs from other advance directives used previously. The LMD directive
is more comprehensive and covers life-threatening illness, cardiac arrest,
and feeding options for reversible and irreversible conditions. It has a personal
statement that allows individuals to specify what disability they would accept
or reject, and has a comprehensive education and capacity assessment process
that acts as a quality assurance measure to assure health care providers that
the directives truly reflect the wishes of those who complete them. Our findings
may be a consequence of any or all of these differences.
The cost difference between intervention and control groups was consistent
across all pairs of homes and was statistically significant, suggesting that
we observed a true effect of systematic implementation of advance directives.
The applicability of our results to health care systems internationally depends
on the fact that while reimbursement mechanisms differ, all systems have incentives
to reduce hospitalizations and related costs. While patient populations and
their resulting expectations differ, the movement toward greater patient autonomy
is an international one. We believe that cultures and health care systems
across Canada, the United States, and northern Europe may be sufficiently
similar that the findings could be replicated in other countries.54,55
If these findings are judged both valid and generalizable, the results
may have implications for training of nursing home personnel. The workers
in many nursing homes are not educated about advance directives, and the homes
are not equipped to provide symptom relief and palliative care to residents
at the end of life.56 It is likely that the
systematic application of advance directives will increase the need for effective
palliative care in nursing homes.
Systematic application of LMD in nursing homes can reduce costs substantially
by reducing hospitalizations. Replications of this study, with exploration
of generalizability in different settings, would greatly strengthen the case
for a widespread program of systematic implementation of certain kinds of
advance directives in nursing homes.
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