Вы находитесь на странице: 1из 9

Clinical Investigations

Barriers and Facilitators to Initiating and


Completing Time-Limited Trials in Critical Care*
Courtenay R. Bruce, JD, MA1,2; Cecilia Liang, BA1; Jennifer S. Blumenthal-Barby, PhD, MA1;
Janice Zimmerman, MD3,4; Andrea Downey, MS, RN5; Linda Pham, MSSW, LCSW6;
Lisette Theriot, LMSW6; Estevan D. Delgado, BA1; Douglas White, MD, MAS7

Objectives: A time-limited trial is an agreement between clinicians Interventions: None.


and patients or surrogate decision makers to use medical therapies Measurements and Main Results: Interviewees reported initiating
over a defined period of time to see if the patient improves or deteri- time-limited trials for three different purposes: to prepare surrogates
orates according to agreed-upon clinical milestones. Although time- and clinicians for discussion and possible shifts toward comfort-care
limited trials are broadly advocated, there is little empirical evidence only therapies, build consensus, and refine prognostic information.
of the benefits and risks of time-limited trials, when they are initiated, The main barriers to initiating time-limited trials involve clinicians’ or
when and why they succeed or fail, and what facilitates completion surrogate decision makers’ disagreement on setting a time limit.
of them. Our study objectives were to 1) identify the purposes for Barriers to completing time-limited trials include 1) requesting
which clinicians use time-limited trials and 2) identify barriers and more time; 2) communication breakdowns because of rotating call
facilitators to initiating and completing time-limited trials. schedules; and 3) changes in clinical course. Finally, facilitators to
Design: Semistructured interviews: We analyzed interviews using completing time-limited trials include 1) having defined goals about
qualitative description with constant comparative techniques. what could be achieved during an ICU stay, either framed in narrow,
Setting: Nine hundred-bed, academic, tertiary hospital in Hous- numeric terms or broad goals focusing on achievable activities of
ton, Texas. Interviewees were from open medical, surgical, neuro- daily living; 2) applying time-limited trials in certain types of cases;
surgical, and cardiovascular ICUs. and 3) taking ownership to ensure completion of the trial.
Subjects: Thirty healthcare professionals were interviewed (nine Conclusions: An understanding of barriers and facilitators to initi-
surgeons, 16 intensivists, three nurse practitioners, and two ating and completing time-limited trials is an essential first step
“other” clinicians). toward appropriate utilization of time-limited trials in the ICUs, as
well as developing educational or communication interventions
*See also p. 2676. with clinicians to facilitate time-limited trial use. We provide practi-
1
Department of Medicine, Center for Medical Ethics and Health Policy, cal suggestions on patient populations in whom time-limited trials
Baylor College of Medicine, Houston, TX. may be successful, the setting, and clinicians likely to benefit from
2
Department of Medicine, Houston Methodist Hospital System, Houston educational interventions, allowing clinicians to have a fuller sense
Methodist Hospital System Biomedical Ethics Program, Houston, TX.
of when and how to use time-limited trials. (Crit Care Med 2015;
3
Weill Cornell Medical College, New York, NY.
43:2535–2543)
4
Division of Critical Care, Department of Medicine, Houston Methodist
Hospital, Houston, TX.
Key Words: communication; decision making; end-of-life; ethics;
5
Division of Palliative Care, Department of Nursing, Houston Methodist
family meetings; substituted judgment; surrogates; time-limited
Hospital, Houston, TX. trials
6
Division of Social Work, Department of Social Work and Case Manage-
ment, Houston Methodist Hospital, Houston, TX.
7
Department of Critical Care Medicine, Program on Ethics and Decision Mak-
ing in Critical Illness, University of Pittsburgh Medical Center, Pittsburg, PA.

C
Supplemental digital content is available for this article. Direct URL citations linicians, patients, and surrogate decision makers fre-
appear in the printed text and are provided in the HTML and PDF versions quently engage in discussions and decision making
of this article on the journal’s website (http://journals.lww.com/ccmjournal). about whether to continue invasive life-prolonging
Dr. Zimmerman served as a board member for Decisio Health and is therapies for critically ill patients or, alternatively, to shift to
employed by Houston Methodist. The remaining authors have disclosed
that they do not have any potential conflicts of interest. palliative-only measures. Especially in the critical care envi-
For information regarding this article, E-mail: crbruce@bcm.edu ronment, patients (or more likely surrogate decision mak-
Copyright © 2015 by the Society of Critical Care Medicine and Wolters ers on behalf of incapacitated patients) are asked to make
Kluwer Health, Inc. All Rights Reserved. complex treatment and end-of-life decisions (1–3). Where
DOI: 10.1097/CCM.0000000000001307 outcomes are uncertain, patients, surrogates, and clinicians

Critical Care Medicine www.ccmjournal.org 2535


Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Bruce et al

have to balance tensions between shifting to full comfort- wanted to cover the interpersonal context in which clinicians
care measures at a time they feel is too early in the course of operate, making qualitative methodologies ideal.
patients’ illnesses versus continuing burdensome treatments
for a time they perceive as too long (1, 4). To accommodate Study Design and Participants
this tension, a third strategy has been proposed as an alterna- We used purposive sampling to recruit a diverse sample of clini-
tive to all-or-nothing approaches, often referred to as a “time- cians, with a particular emphasis on recruiting intensivists in dif-
limited trial” (TLT). ferent ICUs (surgical ICU [SICU], cardiovascular ICU [CVICU],
A TLT is defined as “an agreement between clinicians medical ICU [MICU], and neurosurgical ICU [NICU]). Our ratio-
and patient/surrogate decision makers to use medical ther- nale for focusing on intensivists was that they would likely have
apies—such as mechanical ventilation, enteral feeding, or robust experience initiating and completing TLTs because they
dialysis—over a defined period of time to observe if the coordinate care and frequently organize and participate in family
patient improves or deteriorates according to agreed-upon conferences. To allow for some preliminary comparisons, we also
clinical outcomes” (1). Quill and Holloway (1) proposed purposively sampled surgeons. The other interviewees (one pallia-
a five-step framework for initiating TLTs, consisting of a tive care specialist and one neurologist) were purposively selected
meeting between the care team and patient/surrogate deci- because of their experience and familiarity with TLTs.
sion makers to 1) define the patient’s acute care needs and
prognosis; 2) clarify the patient’s goals and preferences; 3) Interview Guide Development and Interviews
identify objective markers for improvement or deteriora- Between December 2014 and March 2015, C.R.B., C.L., L.T.,
tion; 4) suggest a time frame, ranging from a few days to a A.D., and L.P. conducted in-person interviews using a struc-
month or more, for reevaluation of the patient’s condition; tured interview guide. Five investigators reviewed the initial
and 5) define potential actions to take at the end of the trial interview guide based on an extensive literature review, expert
to ensure its completion or, if complications arise during the opinion, and familiarity with medical decision making. Inter-
trial, actions that should be taken (1), with similar commu- view protocols were modified iteratively throughout the pro-
nication models being proposed by other authors (2). In this cess of data collection, so that questions with diminishing
informational returns were gradually replaced by questions
way, TLTs offer opportunities for reevaluation and iterative,
that emerged inductively from interviewees’ responses.
outcome-focused decision making within the broader con-
The final interview guide (Appendix 1, Supplemental
text of patient’s overall priorities, thereby alleviating some
Digital Content 1, http://links.lww.com/CCM/B444) consisted
of the burden of having to make discrete all-or-nothing deci-
of open-ended questions exploring five domains: 1) experi-
sions where outcomes are uncertain (5).
ences with TLTs; 2) attitudes about TLTs; 3) content of TLTs;
Although TLTs are broadly advocated (1, 2, 4–7), there
4) barriers and facilitators to initiating and completing TLTs;
is little empirical evidence of the benefits and risks of TLTs and 5) advice on interventions to promote appropriate use
(8, 9), when they are initiated, when and why they succeed or of TLTs and facilitate completion of them. C.R.B., C.L., L.T.,
fail, and what facilitates completion of them. An understanding A.D., and L.P. conducted all of the interviews after obtaining
of barriers and facilitators to initiating and completing TLTs is oral consent from interviewees. Interviews lasted between 20
an essential first step toward promoting appropriate utilization minutes and 45 minutes. Interviews were audiorecorded, tran-
of TLTs, as well as developing targeted educational or commu- scribed verbatim by an independent transcription agency, and
nication interventions with clinicians to encourage TLT use redacted. Audiorecordings were destroyed after transcription.
and ensure effectiveness. Without this foundational under-
standing, TLTs might continue, at best, to be used infrequently Analysis
(5) or, at worst, to be used inappropriately or ineffectively. C.R.B, J.B.B., and C.L. analyzed the interviews using qualitative
Our study objectives were to 1) identify the purposes for description with constant comparative techniques. Qualitative
which TLTs are used in four open ICUs with mandatory inten- descriptive studies aim to provide a comprehensive summary
sivist comanagement within one hospital and 2) identify bar- of events. Our aim is not to provide thick description (ethnog-
riers and facilitators to initiating and completing TLTs. To our raphy), theory development (grounded theory), nor interpre-
knowledge, this is the first qualitative study on TLTs, one of tative meaning of an experience (phenomenology); rather, our
only two empirical studies on the subject (5), and the first to goal is to provide a straight description of clinicians’ experi-
study barriers and facilitators. ences in using TLTs in a language similar to their own (11, 12).
To provide this description, we developed a codebook collab-
oratively through discussions between our research team members
MATERIALS AND METHODS to ensure consistent application of codes. To do this, C.R.B., J.B.B.,
The Baylor College of Medicine and Houston Methodist Hospi- and C.L. organized potential codes by the above domains after
tal Institutional Review Boards approved this study. We selected reviewing three transcripts. Code assignments to six preliminary
qualitative methodologies because the focus of this study is to transcripts were made independently by C.R.B., J.B.B., and C.L.,
answer the “how” and “why” questions (10). To explore the each generating new emergent codes as needed, and later com-
barriers and facilitators to initiating and completing TLTs, we pared and discussed until consensus in coding styles was reached.

2536 www.ccmjournal.org December 2015 • Volume 43 • Number 12

Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Clinical Investigations

After the codebook was developed and agreed upon, coding some circumstances, it was difficult to discretely classify a
for the remainder of the interviews was done independently clinician’s specialty. One full-time intensivist is board certi-
by members of the research team and later merged for analy- fied and trained in surgery (categorized as an “intensivist” for
sis. Throughout this process of coding, emergent patterns and the purposes of this project; Table 1), and some surgeons are
themes were stored electronically (using “Comments” and trained in several subspecialties, including surgical critical
“Memos,” in the language of ATLAS.ti [13]) as a way to pro- care. To provide clarity and consistency in reporting, we use
vide analytical depth, identify illustrative quotes, and highlight clinicians’ self-identified primary specialty for categorization
points for team discussion. Interrater reliability was assessed
purposes. Specifically, four surgeons function as intensivists in
on a random sample of 32 quotes taken from six transcripts.
the SICU in addition to performing surgery. They are identi-
fied as surgeons for reporting purposes, as are the remaining
RESULTS five surgeons who do not function as intensivists. Where there
The majority of intensivists that were approached agreed to are discernible differences between surgeons who function in
participate (16–18). Three nurse practitioners working in
an intensivist capacity some of the time and those who do not,
the ICUs were approached, and all agreed to participate. Ten
we distinguish them as intensivist surgeons and nonintensivist
surgeons were approached, and nine were able to participate
surgeons. Participant demographics are provided in Table 1.
(Table 1). All nine of them actively conduct surgery, four of
whom are transplant or vascular surgeons and five of whom We reached saturation of findings at 30 participants. This
are acute care/trauma surgeons. is a typical number for reaching saturation when variability
Specialties of our interviewees included internal medi- across participants is low (14). Below, themes are arranged
cine critical care (11 interviewees), surgery or surgical critical according to domains that were the focus of the interview
care (10 interviewees), anesthesia critical care (five inter- guide: purposes, barriers, and facilitators to TLTs. Illustrative
viewees), or other specialties (one interviewee) (Table 1). In quotes from the interviews are provided in Table 2.

Table 1. Participant Characteristics by Unit, Gender, and Experience


Nurse
Variables Total Intensivists Surgeons Practitioners Other

n (%)a 30 (100) 16 (53) 9 (30) 3 (10) 2 (7)


 Medical ICU 8 (27) 5 (31) 0 (0) 2 (67) 1 (50)
 Neurosurgery ICU 6 (20) 3 (19) 2 (22) 0 (0) 1 (50)
 Cardiovascular ICU 11 (37) 8 (50) 2 (22) 1 (33) 0 (0)
 Surgical ICU 5 (17) 0 (0)b 5 (56) 0 (0) 0 (0)
Specialty of physicians
 Surgery 10 (37) 1 (4) 9 (100) 0 (0)
 Internal medicine 11 (41) 10 (37) 0 (0) 1 (50)
 Anesthesia 5 (19) 5 (19) 0 (0) 0 (0)
 Other 1 (4) 0 (0) 0 (0) 1 (50)
Gender
 Female 10 (33) 4 (25) 2 (22) 3 (100) 1 (50)
 Male 20 (67) 12 (75) 7 (78) 0 (0) 1 (50)
Experience (yr) c

 0–5 5 (17) 2 (13) 3 (33) 0 (0) 0 (0)


 5–10 7 (23) 1 (6) 3 (33) 3 (100) 0 (0)
 10–15 9 (30) 7 (44) 1 (11) 0 (0) 1 (50)
 15–25 2 (7) 2 (13) 0 (0) 0 (0) 0 (0)
 25+ 7 (23) 4 (25) 2 (22) 0 (0) 1 (50)
In some instances, percentages may not equal 100 because of rounding.
a

b
Four surgeons in the surgical ICU also work as intensivists on a part-time basis. They are identified as surgeons for reporting purposes. All of them actively
perform surgeries.
Years” is calculated from time of residency completion for physicians and time of graduation for nurses.
c“

Critical Care Medicine www.ccmjournal.org 2537


Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Bruce et al

Table 2. Illustrative Quotes of Purposes, Barriers, and Facilitators to Initiating and


Completing Time-Limited Trials
Purposes Prepare surrogates Subject 027: “Those few days allow things to sink in, rather than just saying. ‘He’s not going
and surgeons to make it; we need to pull the plug today.’”
Subject 026: “Watchful waiting. It can help prepare families…gives them time, something
concrete to hold onto. Otherwise, you can just go along [for days]. This is more proactive.”
Subject 028: “It does give the family more opportunity for acceptance, but us, too. We can
swing toward the pendulum and agree. It allows for closure.”
Build consensus Subject 023: “I think you have to have the courage and the guts to recognize that you, as a
physician, don’t just have to order up people what they want like a short-order cook off the
drive-thru menu. Direct their thought process…set limits.”
Refine prognosis Subject 03: “I’m not 100% sure whether you’re going to get better or not, I do know that in
72 hours we are going to have some pretty good evidence that if they are not better by
that point, than the likelihood drops off significantly.”
Subject 017: “A specific one might be some type of neurologic injury, where a patient had a
cardiac arrest and there was a hypoxic brain injury. With those patients, usually the first 48
hours is the most critical time period in terms of assessing neurologic recovery.”
Barriers to Surrogates do not Subject 07: “More often than not, the family has different thoughts and their own
initiating TLTs agree prejudices… And that becomes very difficult to set timelines because they don’t want to
hear that, especially if they are in the mindset that the care will be abandoned.”
Clinicians do not Subject 026: “There is no data that all of my colleagues can agree upon. We will just re-
agree evaluate. It becomes more of an art than a science at some point. People have different
amounts of risks they are willing to tolerate.”
Barriers to Requesting more Subject 25: “Once it is crunch time, the family wants the estranged son to come in; the
completing time daughter from Colorado….They are looking for a flight next Tuesday. Even it is about time,
TLTs it isn’t time. The family is the biggest barrier.”
Subject 024: “You make this agreement at the zero hour when you start and, by the time
you get to hour 48, now the whole situation is contaminated by all these people who have
been on the Internet. Or they talked to someone. They said he would never speak again
and now he’s in college.”
Subject 007: “We may keep extending the time without really enforcing the decision that
was made 5 days ago. So we keep on changing or moving the goalpost. Is that right or
wrong? I don’t know.”
Communication Subject 010: “It would be helpful if before we even talk to the families…the teams
breakdown sit together and they decide—a team meeting without the families-- to know…our
expectations. Because if the expectations of the surgical team and the ICU team are not
the same, that is what creates problems.”
Clinical course Subject 026: “You have a plan in your head, but things change. Battle plans only last until the
changes first shot is fired. Cases are too individualized.”
Facilitators to Having a defined Broad goal
completing goal  Subject 002: “I go into a meeting and say, well, your mom isn’t waking up, so let’s give her 3
TLTs days and then we will reassess. But, in those 3 days, if she is opening her eyes…the family
will take this as a positive sign…So before you set a TLT, you have set specific goals that are
based on overall quality of life, like at the end of 3 days, is she able to interact?”
Narrow goal
 Subject 011: “If you tell them, okay, let’s give them a week and if by the end of the week,
they’re not off pressors…If they haven’t met these milestones then, it makes it easier to
take the next step...”
Applying TLTs in Subject 003: “Better outside of the ICU where there might be single-system failure. In
certain types of oncology, where you can start a patient on chemotherapy, you just repeat a biopsy and the
cases numbers tell you if the patient is better or worse.”
Taking ownership Subject 022: “The owners of the patients [are responsible]…the physicians of record. The
the people in the ICU are technically consultants. Those [admitting] folks have to buy-in.
Because I’m the physician of record and I’ve known this patient for the last 40 years...That
makes a whole bunch of difference.”
TLT = time-limited trial.

2538 www.ccmjournal.org December 2015 • Volume 43 • Number 12

Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Clinical Investigations

PURPOSES OF TLTs of interviewees. Only one surgeon (a nonintensivist transplant


Interviewees described using TLTs for three different purposes: surgeon) reported using TLTs to formulate agreement among
to prepare surrogates and clinicians for discussion and possible surgeons and intensivists about plans of care.
shift toward comfort-care only therapies, build consensus, and
refine prognostic information. Clinicians in every unit and Refine Prognosis
every specialty described using TLTs in these three ways, both A TLT may be used to gather more data where there is prog-
as a way to address family dynamics and clinician dynamics. nostic uncertainty. This was the most frequent use of TLT in
the NICU. Every interviewee in the NICU described using the
Preparation of Surrogates and Clinicians TLT after an acute brain injury to help refine prognostication
Every interviewee (and every specialty) in each ICU men- efforts, with the first 72 hours being the most critical. Within
tioned the utility of TLTs as a way to prepare surrogates and the day of admission or the day of the brain injury, interview-
families for likely negative outcomes, including discussion ees described the meeting with the family and frequently advo-
about pursuing comfort-related goals. By conceptualizing and cating nonescalation of aggressive measures for 48–72 hours
describing patients’ health incrementally over a period of days to assess the patient’s overall health condition and likelihood
or weeks, interviewees felt they were helping surrogates foster of recovery. Clinicians reported meeting again with the fam-
appropriate expectations in a gradual, anticipatory way. Inter- ily after this time period and, based on whether there was any
viewees described two distinct goals: provide surrogates com- improvement or deterioration during that 72-hour period,
passion and time to adjust (subject 013: “Approaching families recommended proceeding with invasive interventions or shift-
at the end when the patient is close to death doesn’t give them ing to full comfort-care measures.
any time to adjust.”) while simultaneously aligning expecta- Thirteen interviewees (every unit; each specialty) described
tions between clinicians and patients/surrogates. Specifically, using the TLT as means of prognostic refinement when a family
interviewees described receiving “unrealistic” responses from requested discontinuation or deescalation of aggressive thera-
surrogate decision makers whenever the foundation for end- pies at a time clinicians thought was too premature. This theme
of-life discussions was not properly introduced by clinicians in was particularly prominent among nonintensivist surgeons and
earlier conversations. Clinicians felt that surrogates perceived intensivist surgeons, surfacing in all surgeon interviews. There
end-of-life conversations as jarring and unexpected, resulting was a near equal distribution among the units. Subject 003:
in what clinicians perceived to be a misalignment between cli-
The patient said he never wanted to be on life-support.
nicians and surrogates regarding goals of care and expectations
He is going to be able to return to exactly the same level
of outcomes.
of functioning as before…With this potential for a very
TLTs could also be used to prepare clinicians, especially sur-
high level of recovery, I am OK pushing it a little. And I
geons, for a shift toward comfort-care measures (subject 027:
think a small amount of paternalism is OK.
“And it helps us. We, especially surgeons, have a history [with
the patient]. It changes your dynamic.”). Clinician prepared- By requesting more time, this clinician felt he would be bet-
ness was described in all but two surgeon interviews, one of ter positioned to assess the patient’s anticipated outcome. In this
whom is a nonintensivist, transplant surgeon. It was also men- case, the patient’s surrogate decision maker agreed to wait more
tioned in two intensivist interviews. time to reevaluate the patient’s condition in the context of his
overall priorities. However, two other clinicians who mentioned
Build Consensus using a TLT as a means of requesting more time reported that
Eleven interviewees described using a TLT to build consensus surrogate decision makers were not amenable to creating a TLT.
among family members who disagree with each other by estab-
lishing a timeframe for surrogates/families to make a decision,
BARRIERS TO INITIATING TLTs
subject 007: “The family… they’re divided. They go into a state
of inertia. That is the trial’s biggest value: it forces them to con- Surrogates Do not Agree
front and make decisions.” Using the TLT to formulate concor- One reported barrier to initiating a TLT that arose in approxi-
dance among divided families was mentioned in every unit, mately five interviews (mix of specialties and units) is that sur-
most especially in the MICU and the NICU. This was the most rogate decision makers may not be receptive to setting a time
frequent use of TLTs in the MICU. There were no discernible period or may interpret a timeline as a means of “pressuring”
differences between specialties. them to make a decision. Subject 003: “When the family isn’t
Conversely, six interviewees, all from the CVICU and SICU, ready, the family isn’t ready. If they aren’t ready for a trial,
described using the TLT to formulate agreement among divided pushing it or ‘insisting’ on it more often alienates the family…
clinicians, as opposed to divided family members. Subject 011: and [causes] more harm than good.” A related barrier is that in
“Sometimes, there is conflict within the team itself. If that is the the clinical context, it can often be difficult to build a rapport
case, you may wait a week to give the team a chance to accept with the family in the amount of time that would be necessary
what is going on with the patient.” Discordance between clini- to initiate dialogue about a TLT. Without this foundation of
cians was generally described as being disagreement between rapport, discussion about a timeline would only be met with
surgeons and intensivists, raised primarily by the latter group resistance.

Critical Care Medicine www.ccmjournal.org 2539


Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Bruce et al

Clinicians Do not Agree Communication Breakdown


Clinicians may not uniformly agree about whether to institute Rotating call schedules and frequent handoff among the team
a TLT trial or, alternatively, the amount of time that should be was cited in all but five interviews as a principal reason for TLT
set as a variable for the trial. Eleven clinicians (in the CVICU disintegration, with no notable differences between the units
and SICU; every specialty) discussed public reporting of surgi- or specialties. Subject 003, “There are too many teams involved
cal outcomes based on 30-day mortality and how this could with a patient in the ICU. Even among ourselves as the intensiv-
impact surgeons’ receptivity to initiating TLTs. Subject 017 ist group, it’s rare that the same doc sees the same patient more
(nurse practitioner): “If you have competing interests, it won’t than a few days in a row.” Twenty-three interviewees believed
work. Surgeons…want their patients to survive because they that rotating call schedules and block scheduling not only
need their numbers to look good. Intensivists are looking at affected their ability to assess whether a TLT is appropriate and
the bigger picture.” Surgeons (whether intensivist surgeons or feasible (e.g., building enough rapport to establish a TLT) but
nonintensivist surgeons) did not report a reluctance to initi- also impacted their ability to know whether a trial had been set,
ate TLTs, even when prompted during the interview, although if the goals or variables of the trial had been determined, and
two of them (both nonintensivist transplant surgeons) said whether there is a willingness to complete them.
outcomes matter (subject 27: “It will count as a death. Like it
or not, we have to pay attention to that stuff. But that doesn’t Clinical Course Changes
mean I will allow my patient to suffer or prolong it.”). Approximately half of clinicians (every unit; every specialty)
Eighteen clinicians reported that, even where there was described patients’ conditions changing so much that complet-
agreement with initiating a TLT in theory, it was difficult to ing TLTs was subject to disintegration, no matter how well for-
formulate agreement on the amount of time that should be set mulated the trial was at the outset. This was most prominent in
the MICU, surfacing in all but one interview. Subject 003: “You
as a variable, particularly when the patient had multilpe organ
tell a family that at the end of 7 days, if the ventilator doesn’t
failure or where there was little evidence to drive the analysis.
work, then we should transition to comfort care. But at day 7,
This was most salient in the MICU, a theme that arose in every
the patient is 60% better and trending up. But now they have an
interview, and least prominent in the NICU (whose clinicians
infection... How do you account for other problems that weren’t
uniformly reported 48- to 72-hr trials, with no disagreement
present at the initiation of the trial but come on after it started?”
among them). Given that all of the MICU clinicians have back-
grounds in internal medicine, this theme was most prominent
among this specialty, although it also arose in interviews with FACILITATORS TO TLTs
surgical specialties. Having a Defined Goal
Clinicians agreed that TLTs can only be successful insofar as
the goals were clearly defined and measurable, a theme aris-
BARRIERS TO COMPLETING A TLT
ing in all but two interviews. However, there was considerable
Requesting More Time variation on what constitutes an appropriate goal, with some
During a trial, a surrogate may request more time when a clinicians focusing quite narrowly on clinical, objective vari-
patient deteriorates rapidly, pointing to the original timeframe ables mapped to positive or negative trends in laboratory val-
as the point at which decision making should occur (subject ues or weaning efforts, whereas others focused more broadly
006, “Let’s say you gave them a week. In two or three days, the on outcomes in the context of a patient’s overall priorities.
patient may be deteriorating drastically, and you are coding “Broad” framing centered on whether a patient would be able
3–4 times a day and the family says: ‘But you said 7 days.’”). It is to achieve certain activities by a specific time frame, such as
unclear whether this clinician discussed with surrogates at the “wakefulness” or “mobility.” “Narrow” framing focused on
initiation of the trial what would happen if the patient rapidly numerical values: trending laboratory values or the amount of
deteriorated during the interim of the trial. ventilatory support to indicate increased or decreased depen-
Three interviewees (all in the CVICU) described TLTs as dence on specific therapies or improvement or deterioration of
lacking efficacy when clinicians extend timeframes without a particular organ.
any substantive change in clinical status, which they attributed There were discernable differences between units on
to a diffusion of responsibility among the team members or a whether they defined goals in terms of narrow goals or broad
general lack of desire to “be the one to call it quits” or “it can goals. The MICU and NICU intensivists focused on broad
just be passed to the oncoming team,” as reflected in this com- goals. All CVICU intensivists described mapping goals using
ment, subject 011: clinical variables, typically liver function tests and drips, and
only one intensivist from this unit described mapping goals
A TLT has backfired when we can’t stick to a timeline. using broad goals. Likewise, this finding could also be mapped
Let’s wait a week. Oh, there’s no improvement. Let’s wait to specialty. Internal medicine critical care specialties (MICU
another week. And no one is willing to step up and say, and NICU) focused on broad goals, whereas anesthesia and
we’ve waited long enough. We kick the can down the surgery critical care specialties (CVICU and SICU) focused on
road when there is high turnover among the team. narrow ones.

2540 www.ccmjournal.org December 2015 • Volume 43 • Number 12

Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Clinical Investigations

Applying TLTs in Certain Types of Cases of TLTs: 1) shift-based or block-scheduling staffing patterns
Seventeen interviewees reported that it is easier to initiate and impact clinicians’ assessments of whether a TLT would be
complete a TLT when there are few confounding variables, feasible, likely creating a reluctance to initiate a trial where it
most often attributed to cases where a patient has only one might be appropriate; 2) block scheduling impacts success-
organ-failing or one life-limiting condition rather than sys- ful communication of TLT variables between team members;
temic failure. In these cases, there may be more evidence to and 3) block scheduling impacts follow-through of the trial
guide the setting of variables. Subject 028: “Too many factors because of a diffusion of TLT-completion responsibilities
and variability…Any obstacles beyond isolated organ failure among off-going and oncoming service members.
are just so hard to overcome and hard to calculate.” A second implementation challenge we identified involves
Clinicians also reported that it is easier to complete a TLT intrateam discordance. This finding is related to observa-
when there is one life-limiting condition because they would tions previously described by others that surgeons may be less
likely defer to the consultant charged with addressing a partic- inclined to initiate postoperative goals-of-care discussions
ular health problem on whether and how to initiate a TLT. This than other clinicians (18–20), and, in the context of our study,
was a particularly prominent theme in the SICU and MICU these discussions would include initiating and completing
and most especially among internal medicine specialties. TLTs. However, we found differing perspectives between sur-
geons and intensivists about surgeons’ willingness to engage in
Taking Ownership goals-of-care conversations and TLTs. Specifically, our surgeon
A majority of clinicians claimed that someone taking “owner- interviewees (intensivists and nonintensivists) did not express
ship” of the trial and ensuring its completion was vital to its a reluctance to initiate TLTs, and they frequently touted the
success. However, there was significant disagreement about benefits of a TLT while simultaneously acknowledging a need
who should take ownership. Specifically, clinicians disagreed to monitor surgical outcomes, a finding that deviates from
about who should be responsible for initiating a trial or com- previous conceptual work on surgeon reporting and its impact
pleting a trial: ranging from the primary service, to the sur- on TLTs (6). Surgeons did not perceive TLTs and surgical out-
geon, to the person with the strongest relationship with the comes as necessarily competing in the way that intensivists did.
family. On some occasions, clinicians thought that the person Another major barrier to successful TLTs reported by
initiating the TLT should not necessarily be responsible for interviewees is the perception that changes in the patient’s
completing it. For instance, at least two interviewees thought clinical course sometimes made completing a TLT difficult, a
that the primary service or surgeon should be responsible for finding that, to our knowledge, has not been previously iden-
initiating it, but they also thought that support services (e.g., tified. We consider this an important finding because it may
social worker or palliative care specialists) should be charged signal an area in which more clinician education is needed
with ensuring trial follow-through. about how to operationalize TLTs, implications of which we
Despite this discordance, nearly all clinicians agreed that, describe further below.
in instances where there is isolated organ failure, the person Our work has potential implications regarding how clini-
charged with addressing that underlying issue (e.g., neurology cians should operationalize TLTs. First, rather than perceiving
for an acute brain injury) should drive the timing and content a change in clinical course to be an implementation barrier, it
of TLTs. should be viewed as integral to the clinical complexities and
uncertainties that make TLTs an appropriate alternative to
all-or-nothing treatment approaches. One way to appropri-
DISCUSSION ately align expectations between clinicians and surrogates is to
Our work extends and deepens our understanding of TLTs by describe the possible outcomes before the trial is implemented.
identifying additional purposes, core challenges to TLT imple- Potential outcomes would include the following: 1) the patient
mentation (initiation and completion), and potential strategies gets worse and is unable to successfully meet recovery-oriented
to overcome these challenges (Table 3). Below, we elaborate on milestones, and therefore, the comfort pathway is likely appro-
a few of our main findings concerning TLT implementation priate; 2) the patient improves and meets recovery-oriented
challenges, provide clinical implications for the use of TLTs, milestones, and therefore, life-prolonging measures are appro-
and suggest recommendations on how clinicians should oper- priate; 3) the patient’s likely outcome is still uncertain, and
ationalize TLTs. therefore, another conversation is needed, which could include
The most prominent TLT implementation challenge iden- establishing new milestones for the TLT.
tified in our study involves fragmented healthcare environ- As part of managing expectations, it is important for clini-
ments resulting from shift-based ICU or block-scheduling cians to recognize the limits of TLTs, employing them in cases
staffing patterns (15–17). Although Quill and Holloway (1) where they are most likely to be successful and not viewing
raised this as a theoretical concern, this is the first empiri- them as a panacea for all complex cases. The “ideal” TLT case,
cal evidence highlighting the degree to which rotating teams it seems, is one involving a medically straightforward situation,
and shifting responsibilities affect TLT. Although this is an such as single-organ failure, or involving a single life-limiting
exploratory study, there are preliminary data suggesting that illness, such as cancer (Table 3). The challenge in ICUs is that
staffing patterns have the potential to undermine the utility patients often have systemic failure. Perhaps, TLTs might be

Critical Care Medicine www.ccmjournal.org 2541


Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Bruce et al

Table 3. Summary of Practical, Clinically Based Recommendations for When


and How to Use Time-Limited Trials
Description Likely Facilitators to Effective TLT Use Likely Barriers to Effective TLT Use

Patient Single-organ failure Conditions without a strong evidence base


for formulating a recovery/deterioration
Single life-limiting illness timeline
Conditions with a strong, consensus-
driven evidence base for formulating a
recovery/deterioration timeframe
Setting Small or closed ICUs Large or open ICUs
ICU staffing models not based on shifts or Shift-based or block-scheduling staffing
blocks of time models

Post–acute care settings ICU team members who rotate or shift


responsibilities frequently
Families Preparation of surrogates or families for Surrogates or families who prefer taking
comfort-care discussions an active/lead role in decision making
Mitigation of intrafamily discordance about Surrogates or families who report feeling
prognostic information or plans of care pressured to make decisions
Clinicians Initiation by a clinician charged with Initiation by a clinician who is unable or
treating a primary life-limiting condition unwilling to close the trial
TLT = time-limited trial.

most appropriate outside the ICU setting, an area ripe for frequency and category frequency. Frequencies do not allow for
future study. definitive causal assertions and empirical comparisons because
Another clinical implication of our work is that we, like qualitative interviewing only allows for rich exploration of
others, believe that TLTs will only be successful insofar as they themes and topics (8, 12). Despite this, we believe that provid-
have discrete, achievable goals (1, 5). We build upon previous ing numbers in areas that can confidently be reported gives the
work by suggesting that narrow clinical variables will be used reader a sense of the prevalence and prominence of themes.
in ICUs where clinicians tend to be more anesthesia and surgi- Finally, because this study was done at one tertiary referral insti-
cally oriented (like the CVICU). These specialties are perhaps tution, results may not be generalizable. Preliminary findings,
more conducive to numerical values than other specialties, although modest, are important for directing further research.
which supports the use of narrow clinical variables. Broadly Future work should also assess surrogates’ or patients’ perspec-
focused goals, on the other hand, are used in ICUs where clini- tives on TLTs and their efficacy, as we only provide clinicians’
cians are often trained in internal medicine. Whether and how perspectives, a limitation we acknowledge.
clinicians’ backgrounds influence the content of TLTs, includ-
ing its goals, is worthy of further exploration to determine CONCLUSIONS
whether narrow or broad framing facilitates completing TLTs. Our study documents that clinicians perceive TLTs to be ver-
Our final clinically based, practical strategies for overcom- satile. They are used to build consensus among clinicians,
ing TLT implementation barriers focus on mitigating chal- among clinicians and family members, and among family
lenges associated with shift-based ICU staffing models. To this members. They also have several implementation challenges.
end, it would be helpful to ensure continuity of communica- By exploring barriers and facilitators to initiating and com-
tion among rotating teams, perhaps using a visible tool in the pleting TLTs in several different ICUs with clinicians of varied
patient’s chart to call attention to the creation of a trial or an backgrounds, we are able to provide practical, clinically based
added feature on handoff reports that accounts for whether a suggestions, allowing clinicians to have a fuller sense of when
TLT has been initiated and the variables of a trial. If communi- and how to use TLTs, as well as when there might be barriers
cation interventions and educational sessions are provided to to implementation.
foster clinicians’ skills in talking about TLTs, perhaps these pro-
grams should develop a phased-in approach for training inter- REFERENCES
ventions, prioritizing training for clinicians most often given 1. Quill TE, Holloway R: Time-limited trials near the end of life. JAMA
deference in creating trials (e.g., neurologists, oncologists, and 2011; 306:1483–1484
intensivists). 2. Workman S: A communication model for encouraging optimal care at
the end of life for hospitalized patients. QJM 2007; 100:791–797
This study has a number of limitations that are inherent to
3. Berger JT, DeRenzo EG, Schwartz J: Surrogate decision making:
qualitative methodologies and unit characteristics. For instance, Reconciling ethical theory and clinical practice. Ann Intern Med
we recognize that there are limitations in reporting word 2008; 149:48–53

2542 www.ccmjournal.org December 2015 • Volume 43 • Number 12

Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Clinical Investigations

4. Schenker Y, Crowley-Matoka M, Dohan D, et al: I don’t want to be the 13. Friese S. ATLAS. ti 7 User Guide and Reference. Berlin: ATLAS. ti
one saying ‘we should just let him die’: Intrapersonal tensions expe- Scientific Software Development GmbH, 2013
rienced by surrogate decision makers in the ICU. J Gen Intern Med 14. Strauss A, Corbin JM: Basics of Qualitative Research: Grounded
2012; 27:1657–1665 Theory Procedures and Techniques. Second Edition. Newbury Park:
5. Schenker Y, Tiver GA, Hong SY, et al: Discussion of treatment trials in SAGE Publications, Inc, 1990
intensive care. J Crit Care 2013; 28:862–869 15. Hysong SJ, Knox MK, Haidet P: Examining clinical performance feed-
6. Neuman MD, Allen S, Schwarze ML, et al: Using time-limited trials to back in patient-aligned care teams. J Gen Intern Med 2014; 29:
improve surgical care for frail older adults. Ann Surg 2015; 261:639–641 667–674
7. Bruce CR, Allen NG, Fahy BN, et al: Challenges in deactivating a 16. Crown DF, Rosse JG: Yours, mine, and ours: Facilitating group pro-
total artificial heart for a patient with capacity. Chest 2014; 145: ductivity through the integration of individual and group goals. Organ
625–631 Behav Hum Decis Process 1995; 64:138–150
8. Rinehart A: Beyond the futility argument: The fair process approach 17. Locke E: The nature and causes of job satisfaction. In: Handbook
and time-limited trials for managing dialysis conflict. Clin J Am Soc of Industrial and Organizational Psychology. Chicago: Rand McNally
Nephrol 2013; 8:2000–2006 Publishing Company, 1976, pp 1297–1349
9. Creutzfeldt CJ, Holloway RG: Treatment decisions after severe stroke: 18. Paul Olson TJ, Brasel KJ, Redmann AJ, et al: Surgeon-reported con-
Uncertainty and biases. Stroke 2012; 43:3405–3408 flict with intensivists about postoperative goals of care. JAMA Surg
10. Yin RK: Case Study Research: Design and Methods. Third Edition. 2013; 148:29–35
Thousand Oaks: SAGE Publications, Inc, 2002 19. Penkoske PA, Buchman TG: The relationship between the surgeon
11. Neergaard MA, Olesen F, Andersen RS, et al: Qualitative description - and the intensivist in the surgical intensive care unit. Surg Clin North
The poor cousin of health research? BMC Med Res Methodol 2009; Am 2006; 86:1351–1357
9:52 20. Bruce CR, Miller SM, Zimmerman JL: A qualitative study exploring
12. Sandelowski M: Whatever happened to qualitative description? Res moral distress in the ICU team: The importance of unit functionality
Nurs Health 2000; 23:334–340 and intrateam dynamics. Crit Care Med 2015; 43:823–831

Critical Care Medicine www.ccmjournal.org 2543


Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

Вам также может понравиться