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Early Intervention in Planning End-of-Life Care With Ambulatory Geriatric Patients
Results of a Pilot Trial
Carolyn E. Schwartz, ScD;
H. Brownell Wheeler, MD;
Bernard Hammes, PhD;
Noreen Basque, RN, MA;
Jean Edmunds, MA;
George Reed, PhD;
Yunsheng Ma, MPH;
Lynn Li, MD;
Patricia Tabloski, PhD, RN;
Julianne Yanko, PhD;
and the UMass End-of-Life Working Group
Arch Intern Med. 2002;162:1611-1618.
ABSTRACT
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Background A large discrepancy exists between the wishes of dying patients and
their actual end-of-life care. However, retrospective clinical experience
suggests that early advance care planning (ACP) can markedly reduce this discrepancy.
This article describes a randomized trial to evaluate the short-term clinical
utility of early ACP. We also assessed the feasibility of performing a larger
prospective study to document long-term outcomes.
Methods Ambulatory geriatric patients (N = 61) were randomized to either a control
group, which received only a Massachusetts Health Care Proxy form to complete,
or an intervention group, in which each patient and health care agent discussed
ACP with a trained nurse facilitator. The benefits and burdens of life-sustaining
treatments were discussed, and patient goals and preferences for these treatments
were documented.
Results Two-month follow-up revealed that the intervention achieved higher congruence
between agents and patients in their understanding of patients' end-of-life
care preferences, with 76% (19/25) in complete agreement vs 55% (12/22) of
the controls (effect size [ES] = -0.43). There was also a greater increase
in patient knowledge about ACP in the intervention group (ES = 0.22). Intervention
patients became less willing to undergo life-sustaining treatments for a new
serious medical problem (ES = -0.25), more willing to undergo such treatments
for an incurable progressive disease (ES = 0.24), and less willing to tolerate
poor health states (ES = -0.78). Practical insights were gained about
how to conduct a larger study more effectively.
Conclusion A facilitated discussion about end-of-life care between patients and
their health care agents helps define and document the patient's wishes for
both patient and agent.
INTRODUCTION
LIFE SUPPORT measures were never intended to prolong the dying process
of patients with incurable conditions. Unfortunately, that outcome is now
common. Many conflicts arise in medical decision making at the end of life.
To address this problem, a concerted effort has been made to promote the use
of advance directives. Despite these efforts, the overall prevalence of advance
directive documents remains 15% to 20%.1-3
Even when completed, advance directives often are not readily available to
physicians or completely understood by loved ones. Frequently they are vague
and incomplete. Without clear documentation of the patient's wishes, the legal
and ethical constraints on health care institutions often force them to use
aggressive life support measures to keep patients alive, although these measures
are not what most patients and their families want.4
There is a wide gap between current practice and the wishes for end-of-life
care expressed by patients, family members, and caregivers alike.5
Research on interventions aimed at increasing awareness and use of advance
directives has generally been disappointing. Perhaps the best-known failure
is the $28 million Robert Wood Johnson Foundation project titled SUPPORT (Study
to Understand Prognoses and Preferences for Outcomes and Risks of Treatment).6 Focused on seriously ill patients who were hospitalized
and had only a 50% probability of long-term survival, this comprehensive observational
and intervention study documented a disturbing prevalence of potentially preventable
adverse or negative end-of-life experiences for patients and no impact of
a nurse-delivered advance care planning (ACP) intervention. The dramatic failure
of the SUPPORT intervention has been attributed to not confronting the lack
of communication between patients and physicians (ie, a nurse implemented
the intervention), not ensuring that patients' wishes were documented in readily
accessible places (eg, the medical record), attempting to intervene at a suboptimal
time (ie, a time of medical crisis) for promoting good communication about
patients' wishes,7 and not addressing the cultural
resistance to discussing end-of-life care that is common to patients and physicians.8-11
Only a few published studies12-16
of ACP have yielded heartening results. The most striking benefit was documented
in a retrospective study of 540 decedents from La Crosse, Wis.12
This study compared the prevalence of and adherence to advance directives
before and after a concerted 2-year intervention called Respecting Choices (Gundersen Lutheran Medical Foundation, La Crosse,
Wis). The intervention included community-based educational outreach efforts
and a facilitated discussion between patient and health care agent. The La
Crosse educational outreach efforts were aimed at changing the reluctance
in our culture to discuss death or dying, including medical decision making
at the end of life. The efforts included educational and promotional materials
(eg, posters, brochures, handouts) that were placed in hospital clinics and
physicians' offices, as well as presentations at civic and church groups and
frequent media exposure (eg, radio, television, newspaper) related to the
importance of ACP. It emphasized coalition building between health care, legal,
civic, and religious organizations.
The facilitated discussion intervention was typically led by a nonphysician
health care professional (eg, medical ethicist, nurse, social worker, pastoral
counselor, or highly selected volunteer). It aimed at helping patients and
their loved ones to discuss the patient's wishes for end-of-life care, explained
the benefits and burdens of medical treatments at the end of life, and focused
on clearly defining and documenting the patient's wishes so as to be readily
available later for the patient's health care agent and attending physician.
Similar to other communities, only 15% of adults in the general population
of La Crosse had advance directives before the intervention. In contrast,
after the intervention, 85% of all patients who died during a 1-year study
had written advance directives.12 Furthermore,
96% of these documents were readily available in the decedent's medical record,
and in 98% of cases, the patient's wishes were followed.12
The La Crosse program has since been recognized as a "best practice" by the
National Coalition on Health Care and the Institute for Health Care Improvement.
The success of the La Crosse study has not previously been documented
in a prospective randomized trial, but the retrospective clinical experience
strongly suggests that the program has had a markedly positive effect on end-of-life
care.12 The Respecting Choices intervention promotes early intervention in ACP rather than waiting
until a medical crisis; provides training to facilitators in ACP and gives
structure to their interviews with patients and agents; specifically encourages
patients to discuss their wishes for medical care at the end of life with
their loved ones and their physicians; and documents such wishes in the medical
records of area hospitals.
Interpretation of the excellent results obtained in the La Crosse study
is somewhat difficult because it was not a randomized trial and it relied
on a historical control to assess the impact of the intervention. The program
has several components, and their relative contributions are unclear. For
example, it is unclear to what extent the good results are owing to the community
educational outreach and to what extent they are owing to the facilitated
interview.
A basic tenet of the La Crosse intervention is that ACP should be revisited
periodically to ascertain any changes in patients' values over time with regard
to what constitutes an acceptable quality of life. However, some patient desires
are relatively consistent. Most people want their treatment preferences known.
They conceive of a "good death" experience as including good symptom management,
good personal care, a sense of trust in their health care professionals, the
ability to make practical preparations for end of life, the ability to complete
personally important life tasks, and being treated as a "whole person."17-18 Other desires may change with time
and progression of disease. When people experience health state changes, they
often change their perceptions of what constitutes an acceptable quality of
life.19-20 For example, patients
may become more tolerant of pain or disability than they had previously imagined
would be acceptable to them. These "response shifts" occur as part of human
adaptation.21 Response shift phenomena have
significant implications for treatment outcomes research22-24
and medical decision making.25 Accordingly,
advance directives created when patients were relatively healthy may no longer
be valid when they are approaching death.26
This shifting of values has significant ramifications for end-of-life care
planning and for ensuring that patients' current wishes are clear to their
health care agents. The present study thus sought to document and investigate
response shifts in patient values and to examine whether facilitating a clearer
understanding of the benefits and burdens of treatment leads to changes in
or clarification of patients' values and concepts regarding what constitutes
an acceptable quality of life.
The primary purpose of the present work was to evaluate the importance
of the facilitated interview portion of the La Crosse intervention in a prospective
randomized trial conducted in a different part of the country and studying
a different patient mix. This work is a pilot study to test the hypothesis
that the facilitated interview used in the La Crosse intervention is effective
in improving short-term outcomes associated with end-of-life care. Specifically,
we studied outcomes such as (1) patient-agent congruence as to patient wishes
for end-of-life care, (2) patient knowledge about the legal and practical
aspects of ACP, and (3) the agent's comfort with his or her role. A secondary
objective of the present work was to examine whether the La Crosse intervention
affected patient preferences by educating the patient about the benefits and
burdens of end-of-life care. In addition, we determined the feasibility of
performing a large randomized clinical trial of the La Crosse intervention
to document long-term outcomes.
PARTICIPANTS AND METHODS
PARTICIPANTS
Ambulatory geriatric participants for this pilot study were recruited
from the patient practices of 2 geriatricians (L.L. and Sarah McGee, MD, MPH)
and from an independent living facility. Eligibility criteria included being
65 years or older with a chronic or life-threatening disease or being 75 years
or older, speaking English, and being mentally competent at the last visit
with the health care provider.
PROCEDURE
Patients were sent letters signed by their primary care physician, a
description of the study, and a request for their participation. In addition,
residents of an independent living facility were informed about the study
via flyers left in their mailboxes and an informal presentation by one of
us and a nurse practitioner (C.E.S. and P.T.). People who were interested
signed up to learn more about the study. These potential participants were
then called by a study representative (J.E. and J.Y.), and the study procedures
were explained. Interested participants were invited to an intake interview,
at which time patients were screened for dementia using the Mini-Mental State
Examination27 and a criterion score of 23 or
higher. The intake interview took place at either the University of Massachusetts
Medical School or the participant's home. During the intake interview, written
informed consent was obtained, and a quality-of-life questionnaire packet
was completed. The packet was completed by the patient as a paper-and-pencil
questionnaire at the beginning of the pilot trial, but we later adopted a
semistructured interview because of feedback from several participants that
visual problems made filling out a questionnaire burdensome.
Participants were then randomized using blinded envelopes. If randomized
to standard care, participants were given a Massachusetts Health Care Proxy
form to take home and complete. If randomized to the Respecting
Choices intervention, participants were given 2 pamphlets that briefly
describe ACP and include questions that prompt patients to consider what factors
affect their personal goals for end-of-life care. The pamphlets also include
vignettes about situations in which ACP would be beneficial. Patients were
encouraged to read the materials, to think about whom they might appoint as
a health care agent, and to discuss the materials with family members or their
health care agent. The facilitator subsequently contacted the patient to schedule
a facilitated discussion with the patient and his or her health care agent.
At least 1 meeting was then held with the facilitator, the patient,
and the patient's health care agent (if identified). In the Respecting Choices intervention, this interview focused on enhancing
patients' understanding of ACP and encouraged them to reflect on their goals
for end-of-life care, to communicate with their loved ones about their wishes,
and to develop a written plan to document those wishes.28
Such a plan included choosing an appropriate agent and specifying decisions
regarding likely scenarios given the patient's health status. Open-ended questions
encouraged patients to raise any issues that are personally important to them.
Facilitators frequently repeated and discussed patients' statements to be
sure that their meaning was clearly understood. Facilitators were trained
to administer the structured interview so that all topics were addressed,
but additional information was also tailored to patients' or agents' needs.
The intervention typically consisted of a 1-hour session, but additional sessions
were offered to patients as necessary to meet individual needs. The content
of the session(s) was recorded on a checklist to ensure that all desired components
of the discussion were included (see Figure
1 for an example of a checklist for progressive chronic disease).
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Figure 1. Respecting Choices
checklist for the advance care planning interview for adults with incurable,
progressive disease. From Gunderson Lutheran Medical Foundation, copyright
2000.28
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Facilitators began each interview by assessing the patient's motivation
to engage in ACP. They elicited information regarding previous experiences
with health care decision making and level of understanding about ACP. Facilitators
assessed patients' perception of their health status and their understanding
of how their condition was likely to progress. Patients who expressed uncertainty
about the course of their illness were encouraged to address questions to
their health care providers. Facilitators next clarified patients' preferences,
asking specific questions about personal goals, including religious and cultural
beliefs. They explained specific treatment options relevant to the individual
patient's health status. The facilitators discussed life support treatments
that might be applicable to the individual patient (eg, cardiopulmonary resuscitation,
mechanical ventilation, artificial nutrition and hydration, antibiotic drugs,
pain medication, and hospitalization). They described the benefits and burdens
of each treatment and encouraged patients to weigh benefits and burdens from
their own perspective. The facilitator then determined specific preferences
for comfort care, such as pain and symptom control, emotional support, and
counseling needs, including financial, legal, psychological, and spiritual
needs. This discussion also directed patients to identify specific activities
and experiences that contribute to, or detract from, quality of life. Finally,
the facilitator assisted the patient in completing a written Statement of
Personal Values for end-of-life care. This statement was appended to the Massachusetts
Health Care Proxy document. (Although an advance directive is not legally
binding in Massachusetts, a Statement of Personal Values can be of great assistance
to both physicians and health care agents when difficult decisions regarding
end-of-life care must be made later.) Copies of these documents were then
given to the patient, the health care agent, and the referring physician and
placed in the study file.
MEASURES
To evaluate the effectiveness of the program, outcomes data were collected
twice from patients (at baseline and 2 months later) and once from the designated
health care agent (2 months after baseline).
The patient packet contained questionnaires to assess knowledge, treatment
preferences, and response shifts in values, conceptualizations, and internal
standards of quality of life. The Knowledge Questionnaire was adapted from
a form used in the La Crosse training manual to test facilitators' and patients'
knowledge of advance directives. The original form listed only misconceptions
about advance directives, but we modified the questionnaire to include some
items that were true and some that were false. The test assesses understanding
of the meaning, legality, and ramifications of advance directives. This 9-item
questionnaire had an  reliability coefficient of .78, and scores at
baseline ranged from 0 to 9 (mean ± SD, 6.1 ± 2.3).
Treatment preferences were assessed using a modified version of the
Emanuel and Emanuel29 Medical Directive. This
form asks patients to consider 4 hypothetical situations: coma, incurable
progressive disease, end-stage terminal illness, and a new serious medical
problem (eg, stroke). It then asks patients to indicate their goals for treatment
(ie, to prolong life or comfort care only) and their preferences for 6 specific
treatments (ie, cardiopulmonary resuscitation, mechanical ventilation, artificial
nutrition and hydration, antibiotic drugs, pain medications, and hospitalization
for treatments to prolong life, such as the intensive care unit). This measure
was used to assess patient-agent congruence (ie, the primary outcome) and
response shifts in values (ie, the secondary outcome).
Response shifts in patient conceptualizations of quality of life were
measured using the Beliefs and Values Questionnaire.30
This 18-item questionnaire asks patients to consider various disabilities
that are not uncommon at the end of life and asks them to rate on a 4-point
scale how strongly they feel that life would or would not be worth living
with this condition.
Three visual analog scale items assessed self-reported pain, anxiety,
and alertness. These items were given in a 10-point Likert scale format and
were also adapted to a "then-test" format in follow-up questionnaires to assess
response shifts in internal standards over time. The then-test asks respondents
at the posttest evaluation to give a renewed judgment about their level of
functioning on a target construct at baseline.31-32
It is subsequently compared with the baseline score to estimate changes in
internal standards of the target construct,20
in this case quality of life.
The health care agent questionnaire packet contained (1) the same Knowledge
Questionnaire as the patient completes, (2) an adaptation of the Medical Directive
questionnaire to query their understanding of the wishes of the patient for
whom they are a health care agent, and (3) the Agent Comfort Questionnaire
(available on request from C.E.S.), a new measure we devised to assess the
agent's level of comfort with the responsibility of making health care decisions
for the patient. This 6-item measure had an reliability coefficient
of .70, and scores ranged from 8 to 24 (mean ± SD, 12.7 ± 2.7).
STATISTICAL ANALYSIS
All analyses were performed by intention to treat,33
as is standard in clinical trials research. Two of the 3 participants who
refused to participate in the Respecting Choices
intervention after randomization provided follow-up data for analysis, and
1 of their health care agents provided data for analysis.
Owing to the small sample sizes of this pilot trial, we did not have
sufficient statistical power to document even a large effect. We thus report
results in terms of effect size (ES) using the formula of Cohen34:
(µ1 - µ2)/ . This approach
summarizes the clinical importance of the detected changes by estimating the
magnitude of change over time in units of standard deviations. An ES of 0.20
to 0.40 is considered small, 0.41 to 0.79 is considered medium, and 0.80 or
greater is considered large. Because the focus of this trial was to determine
the clinical effectiveness of the Respecting Choices
intervention (ie, Does the intervention seem to result in a clinically significant
change?), we computed a clinical ES by dividing the mean change score by the
average SD of the baseline and posttest measurements. These statistics are
not only useful summaries of the magnitude of the detected change but can
also be useful for planning subsequent trials that build on this pilot work
because power calculations rely on a "best guess" of the magnitude of change
anticipated.
The primary outcome in the pilot trial was the congruence between patient
and health care agent in reporting patient goals of treatment in the 4 hypothetical
health state scenarios. To evaluate this outcome, an index of congruence was
created by summing the absolute difference between patient and agent on the
global preference indicator for each hypothetical health state, in which respondents
indicated whether the patient's goal of treatment was "to prolong life, treat
everything" or "comfort care only." The mean congruence index in the 2 groups
was compared initially using a t test. Paired t tests were used to compare change over time in the 2
randomization groups regarding change in patients' and agents' knowledge about
ACP and agents' reported comfort with their role as a health care agent. Results
of these t tests were summarized in terms of ES.
Response shift in patients' values were investigated by examining changes
during follow-up in patients' treatment preferences for each of the 4 hypothetical
end-of-life scenarios. A within-subject congruence score was estimated for
each participant and compared among intervention groups. Response shifts in
patients' quality-of-life conceptualization were determined using a t test comparing a within-subject congruence score on the
Beliefs and Values Questionnaire. Response shifts in internal standards were
assessed using within-group t tests on the difference
scores of the visual analog scale items for pain, anxiety, and alertness.
The difference in then-test values and baseline values (ie, then-test minus
baseline) estimated changes in internal standards.
RESULTS
RECRUITMENT RESPONSE RATE
Of 337 patients who received letters, 61 (18%) agreed to participate
in the trial. Of 11 elderly residents of an independent living facility who
indicated interest in the study after the informational meeting, 5 (45%) were
enrolled in the study and randomized. The most prevalent reasons for refusing
to participate included already having a health care agent, lack of interest
in the topic, and not having transportation.
Five patients dropped out of the study after the intake interview, leaving
a total of 61 (92% of those randomized) with complete baseline and follow-up
data. Of the 61 enrolled patients, 31 were randomized to the Respecting Choices intervention group and 30 to the standard care control
group (ie, simply being given a statutory Massachusetts Health Care Proxy
form to fill out). Five patients who did not have a designated health care
agent at the beginning of the study did not subsequently identify a health
care agent. One of these patients received the Respecting
Choices intervention. Ninety-five percent of the health care agents
provided complete data.
DESCRIPTIVE STATISTICS OF PILOT TRIAL PARTICIPANTS
Of the 61 randomized participants, 51 were women and 10 were men. The
mean age was 80 years (range, 65-92 years). The study sample was predominantly
white, and most had at least some college education. About 85% of the participants
were Christian, and more than half of the participants indicated that spiritual
practice was important to their well-being. The 2 study arms were comparable
on all of the sociodemographic variables examined (Table 1).
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Table 1. Sociodemographic Characteristics of 61 Study Patients*
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IMPACT OF THE INTERVENTION
Patients and health care agents in the Respecting
Choices intervention demonstrated greater congruence in reporting the
patient's goals for treatments at the end of life than did those in the control
group, with 76% of the Respecting Choices group in
complete agreement vs 55% of the control group (ES of difference in overall
congruence index = 0.43) (Figure 2). Respecting Choices participants also demonstrated a greater
increase in knowledge about ACP (ES = 0.22), and their health care agents
demonstrated a greater degree of comfort with their potential responsibility
than did those in the control group (ES = 0.31) (Table 2).
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Figure 2. Patients and health care agents
in the Respecting Choices intervention group demonstrated greater
congruence in reporting the patient's goals for treatments at the end of life
compared with controls receiving nondirective standard care (effect size = -0.43).
Ms represent the mean of the distribution, and open circles represent the
distribution.
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Table 2. Effect Sizes of Trial Outcomes*
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RESPONSE SHIFT EFFECTS
Comparing the results of preintervention and postintervention assessments,
participants in the Respecting Choices intervention
became less willing to undergo life-sustaining treatments for a new serious
medical problem (ES = -0.25) and more willing to undergo such treatments
for an incurable progressive disease (ES = 0.24), suggesting a response shift
in values (Table 2). The intervention
group also became less willing to tolerate poor health states (ES = 0.78),
suggesting a response shift in conceptualization of quality of life (Table 2). There were no small, medium,
or large ESs for comparisons of change during follow-up on the visual analog
scale items for pain, anxiety, or alertness, and there were no significant
then-test minus baseline differences on these items, suggesting that participants
in both arms did not make response shifts in internal standards (data not
shown). Thus, patients did not seem to recalibrate their standards for quality-of-life
outcomes but rather to reflect on and define their own values after having
a better understanding of benefits and burdens of end-of-life care. This in
turn led to different wishes with respect to potential end-of-life medical
decision making.
FEASIBILITY
Our experience suggests that performing a larger randomized trial is
feasible and desirable for statistical validation of the Respecting Choices intervention. All of the participants in this pilot
trial completed the Respecting Choices interview
in one session that lasted 1 to 2 hours. We also believe that specific steps
can be taken to improve the design of the trial reported herein and that this
would enhance the results obtained. By modifying study procedures over the
course of the pilot trial, we increased enrollment and reduced the risk of
attrition. One significant modification included offering interviews in the
patient's home. Once we moved data collection from the medical school to the
patient's home, half of the patients who initially refused to participate
because of transportation problems enrolled in the study. For a larger trial
to recruit participants easily, it will be important to conduct interviews
in the home. A second significant modification involved contacting patients'
health care agents in person regarding the need for follow-up participation
rather than relying on the patient to inform the agent of his or her participation.
We were able to increase the agents' response rates from 33% to 95% when we
made personal contact with the agents.
COMMENT
We conclude that the Respecting Choices intervention
seems to have a beneficial effect on patient-agent congruence in understanding
the patient's goals for end-of-life care. This intervention also improves
the patient's knowledge about ACP and the agent's level of comfort with the
role of health care agent. Furthermore, it seems that the Respecting Choices intervention led to appropriate changes in patient
desires for specific treatments based on their own values of quality of life
and on a better understanding of the burdens and benefits associated with
these medical decisions. It led to specific changes in preferences for life-sustaining
treatments in some hypothetical health state scenarios. These changes may
reflect response shifts in values and clearer concepts of quality of life.
These values and concepts became clarified as patients were given the opportunity
to reflect on their personal priorities and to discuss them at length with
their health care agent, usually the family member closest to them. They sometimes
modified their wishes as they became more knowledgeable about the true benefits
and burdens of life-sustaining treatments based on their own current and likely
future health states.
There was a notable discrepancy in intervention participants' preferences
for life-sustaining treatments: there was increasing conservatism regarding
life-sustaining treatments for a new serious medical problem, but patients
became less conservative in their preferences for life-sustaining treatments
in the context of a progressive chronic disease. Increasing conservatism has
been documented in health care providers, compared with laypeople, and has
been postulated to reflect a better understanding of the true advantages and
disadvantages of such treatments by health care professionals.35
This explanation could account for the greater reluctance of intervention
patients to undergo life-sustaining treatment for a new serious medical problem.
However, the greater acceptance of life-sustaining treatment for a progressive
chronic disease suggests that a better understanding of the benefits and burdens
of treatments does not always lead to more conservative treatment preferences.
This discrepancy in the intervention patients' treatment preferences between
new and chronic disease may reflect how rational principles of weighing the
benefits and burdens of treatments may have less impact in situations that
are emotionally salient. Research on cognitive-experiential self theory and
other dual-mode processing theories suggests that rational and experiential
modes of decision making operate in tandem.36
The situational context determines which system prevails. The same rational
principles can operate in 2 different situations, but the decisions reached
may be different if one situation is more emotionally meaningful than the
other. In the present study, patients were perhaps more experienced with a
chronic progressive disease situation. They may have already suffered a good
deal to sustain life but found life still to be worth living. They might accordingly
have been less willing to forego life-sustaining treatments for a more familiar
situation. With a new disease, on the other hand, a patient would simply be
choosing between the benefits and burdens of treatments emphasizing the rational
rather than the emotional mode of processing. It may thus have been easier
to apply their new knowledge to the new problem. On a purely rational basis,
dealing with a hypothetical (and therefore less emotionally salient) situation,
their decision did not favor life-sustaining treatment.
The Respecting Choices intervention seems to
have a beneficial effect on short-term outcomes with respect to patients'
wishes being understood by their health care agents. Thus, it should help
ensure that any ultimate decision by the health care agent will be more consistent
with the patient's wishes. The intervention also helps to clarify the patients'
wishes in their own minds and in their agents' minds. This clarification seems
to be based on thoughtful reflection and better understanding of the issues
involved. The effects noted in this study were all moderate in magnitude and
lacked compelling statistical validity owing to the small size of the study
population. Although we believe that actual end-of-life care will be more
consistent with the patients' wishes for many of the study participants, it
was impossible to document this in a small study with only a 2-month follow-up.
There were no deaths among our study participants.
We were surprised to find as high as 55% "absolute congruence" between
patient and health care agent in the control group. We wondered if the necessary
constraints of our research study—and especially the need for informed
consent—may have constituted an inadvertent form of intervention. To
recruit patients for the study required explanation of its importance. To
obtain informed consent required a more detailed discussion of the importance
of patient/family dialogue about end-of-life decision making, including the
potential need for a facilitator. When randomized to the control group, patients
may have believed that they had missed out on a potentially important benefit.
They may have had a greater sense of the need for patient/family dialogue.
This may have increased their desire to have a thorough discussion with their
health care agent. If so, the benefits of the intervention we documented might
have been more striking compared with a more typical (ie, nonresearch study)
patient group.
The feasibility of implementing this trial in a larger population was
assessed by investigating the recruitment response rate and the follow-up
response rate and by identifying any procedures that might be modified to
improve the results of the larger trial. Our experience thus far suggests
that performing a large randomized trial is feasible and that specific steps
can be taken that will enhance its results. During the pilot trial, we modified
our mode of data collection from paper-and-pencil self-reporting conducted
primarily at research offices in the medical school setting by the patients
to semistructured interviews performed by facilitators in the home. We also
modified the intake and randomization procedures so that they were conducted
by impartial research staff rather than trained Respecting
Choices facilitators who had an emotional commitment to the facilitated
discussion intervention. These changes enhanced the patient response rate
in the pilot trial and also led to an improved study design for a larger trial.
In addition, these changes are also likely to have added random error to our
measured outcomes, reducing our statistical power for the pilot trial analyses.
This situation provides further justification for relying on clinical ES analyses
rather than inferential statistics (ie, reliance on P
values) for the outcomes evaluation of the pilot trial.
Findings from the pilot trial also convinced us of the need to implement
a communitywide intervention to change the cultural norms about ACP. Despite
the apparent simplicity of the La Crosse intervention, our experience has
been that its implementation is complex. There are significant barriers to
promoting advance directives despite addressing deficits in information and
access.15 Increasing public awareness of the
need for ACP would assist in recruiting patients into an advance directive
initiative. Many patients and families are reluctant to discuss such issues.
There needs to be encouragement of such discussions on the part of patients
and families by civic and religious groups and the medical profession. Furthermore,
there seemed to be a general misunderstanding among potential participants
that simply designating a health care agent constitutes adequate ACP. People
need to understand that the agent must be thoroughly informed about the patient's
wishes. Discussing end-of-life care touches on many sensitive matters, including
medical, psychosocial, spiritual and religious, and socioeconomic issues.
These sensitive and often difficult discussions between patient and health
care agent usually do not happen if left to chance. Also, patients and agents
often lack the specific information needed to make truly well-informed decisions.
Although many physicians make an effort to provide such information, often
the time required and the complexity of the issues makes it unrealistic to
expect the physician to facilitate a thorough discussion between patients
and their health care agents. Having a trained nonphysician facilitator, usually
a nurse or social worker with considerable experience in end-of-life care,
helps ensure that an adequate dialogue occurs between patients and their health
care agents or family members. It would also be worthwhile to implement the
La Crosse intervention in community settings with significant numbers of elderly
people, such as independent living facilities. Successfully influencing the
end-of-life experience for an entire community entails recognizing and anticipating
such complexities and developing culturally sensitive approaches for outreach,
recruitment, and intervention.
Implementation of procedural improvements identified during this study
would enhance results, but it is still advisable that a subsequent trial be
powered to detect a moderate ES (ie, at least 62 patients per study arm).
It would also be desirable to carry out long-term follow-up so that the ultimate
impact of the intervention on actual end-of-life experience can be documented.
We conclude that performing a randomized trial comparing the Respecting Choices intervention is feasible and that procedural modifications
identified in this trial would enhance its results. Pending further study,
this preliminary randomized trial confirms the benefit of a facilitated discussion
of ACP, as first described in a retrospective clinical study from La Crosse,
Wis.12
AUTHOR INFORMATION
Accepted for publication November 29, 2001.
Dr Hammes receives a royalty on any net profits from sales of the Respecting Choices training manuals.
This work was supported by the Fairlawn Foundation, the UMass Memorial
Foundation, and the Stoddard Charitable Trust (Worcester, Mass).
We thank Linda Briggs, RN, MS, MA, for her assistance in facilitator
training and Kathryn Gendreau, BA, for data management support.
Intervention flowchart available from the authors.
Corresponding author and reprints: Carolyn E. Schwartz, ScD, University
of Massachusetts Medical School, 31 Mitchell Rd, Concord, MA 01742 (e-mail: carolyn.schwartz{at}umassmed.edu).
From the Departments of Family Medicine and Community Health (Dr Schwartz)
and Surgery (Dr Wheeler), the Office of Medical Ethics (Ms Edmunds), the Department
of Medicine, Divisions of Preventive and Behavioral Medicine (Drs Schwartz,
Reed, and Yanko and Mr Ma) and General Medicine, Primary Care, and Geriatrics
(Dr Li), University of Massachusetts Medical School, Worcester; the Department
of Medical Humanities, Gundersen Lutheran Medical Foundation, La Crosse, Wis
(Dr Hammes); Visiting Nurse Association Care Network Inc, Worcester (Ms Basque);
and Boston College School of Nursing, Chestnut Hill, Mass (Dr Tabloski). Members
of the UMass End-of-Life Working Group (Worcester, Mass) are Eileen Griffin,
RN; Thomas G. Landry III, DMin; Flo Leclair, RN, BSN, CNRH; Sarah McGee, MD,
MPH; Sarah Reiff-Hekking, PhD; and Joanne Spurr, LCSW.
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