Time-Limited Trials in Intensive Care Medicine

A Tool for Avoiding Inappropriate Treatment

Background: Approximately 16% of patients treated in intensive care units do not outlive the treatment. Among patients in intensive care units who undergo mechanical ventilation or dialysis, only half survive longer than six months. Prognostication is unreliable in the individual case. Time-limited trials (TLT) may help prevent inappropriate treatment, particularly for older and chronically ill patients.

Methods: This review is based on pertinent publications that were retrieved by a selective search in the PubMed and Scopus databases and the Google Scholar searching service.

Results: 19 empirical studies and 15 medical-ethical analyses on time-limited trials were identified, as well as expert opinions, guidelines, and review articles. If the prognosis of a patient in intensive care is poor or unclear, the patient or representative can agree with the treating team on a trial of predefined treatment, for a limited period of time, to attain objectifiable, individual therapeutic goals. These goals are set and assessed with the aid of scores used in intensive care medicine, along with the patient’s individual values and resources. TLTs enable more accurate prognostication based on the observed effect of treatment in the individual patient, so that a joint decision can be taken on whether to provide further treatment with curative intent or to switch to palliative care. In this way, inappropriate treatment can be avoided—both over- and undertreatment. Initial findings suggest that TLT can identify patients who will not benefit from continued intensive treatment.

Conclusion: TLTs are well founded in medical ethics and address a central problem in intensive care medicine, namely, the question of individual benefit. Only sparse empirical data on TLTs are available to date. TLTs should be standardized and evaluated in prospective studies to determine whether their expected benefit can truly be achieved in the complex real world of intensive care medicine.

Cite this as

Russwurm M: Time-limited trials in intensive care medicine: A tool for avoiding inappropriate treatment. Dtsch Arztebl Int 2025; 122: 180–5. DOI: 10.3238/arztebl.m2025.0016

Modern intensive care medicine can prolong the lives of patients suffering from almost all medical conditions, whether acute, acute-on-chronic, or chronic-progressive. For this reason, the intensive care unit is naturally the place where critically ill patients are initially treated if there is no contradictory expression of will on the part of the patient or if there is a lack of medical indication for treatment. The indication to treat depends on prognosis which is difficult to assess in intensive-care patients (1, 2, 3, 4, 5). This means that appropriate forms of treatment—i.e., those that pursue realistic therapeutic goals agreed by the patient, applying suitable means while taking the prognosis into account – can be difficult to define, especially in intensive care medicine. Inappropriate forms of treatment are those where a discrepancy is evident between prognosis and treatment intensity. This is either because it is not possible to achieve the therapeutic goals, even with a maximum of treatment intensity (overtreatment), or because treatment intensity cannot contribute (sufficiently) to achieving the therapeutic goal (undertreatment).

The reasons for the provision of inappropriate treatment lie conceptually in the difficulty of defining “realistic therapeutic goals”, i.e., patient prognosis. This is especially the case when caring for the critically ill patient. For example, a study on the care of critically ill patients with obstructive lung disease in intensive care demonstrated a large difference between clinicians’ estimate of the patient’s probability of survival (10%) and actual survival (40%) (6). This kind of discrepancy creates a considerable risk of undertreatment. However, inappropriate therapy in intensive care medicine in the form of overtreatment is also reported as being highly prevalent (7, 8). In a US American study, physicians considered 123 of 1136 critical care patients (11%) to be receiving futile treatment (9). These 123 patients demonstrated a six-month mortality of 85%, with the 15% survivors remaining in severely compromised health states (9). In a multinational survey, 27% (439 of 1651 respondents) of intensive care nurses and physicians reported perceiving inappropriateness of care, with 89% stating the amount of care was excessive (10).

But even modern methods for assessing prognosis are not precise enough. Although a recent holistic prediction model based on data from 20 000 intensive care patients achieved good prediction of mortality (area under the curve 0.85) after 48 hours (11), this cannot be considered sufficient to make decisions on the termination of life-sustaining therapies in specific individual cases. In this regard, a theoretical analysis has highlighted fundamental methodological, heuristic, and medical ethical problems concerning individual prognostication: For instance, it was shown that the applicability of data or data conglomerates and the modeling derived from them is in principle limited concerning the prognosis of the individual (12), i.e., no substantial improvements are to be expected in the future (for example, by using artificial intelligence). This inherent risk of the prognosis not being met is of particular concern where the decision is irreversible (cessation or failure to initiate therapy resulting in death).

Clear trends have been identified indicating that older people in particular are increasingly receiving intensive care treatment and are dying in intensive care units (13, 14, 15), yet at the same time the quality of the models for this patient group is poor (16). Data from Germany demonstrates that this is not only a qualitative problem, but also a quantitative one: in Germany, around one in two people die in hospital and one in ten in intensive care units (14, 17); one in four people who die in hospital have previously received intensive care treatment (14).

Dying in intensive care has its own particular problems, given that these patients suffer unique—because substantial—restrictions to their basic needs (personal freedom, privacy, oral nutrition, freedom from pain, night sleep, physical integrity) and are often no longer capable of making decisions themselves (analgosedation, coma, delirium). Around one in four patients develops delirium while in the intensive care unit (18). Furthermore, survival after being in intensive care is in part associated with serious long-term consequences, a complex of problems subsumed under the term “post-intensive care syndrome” (PICS) or the term PICS-F (PICS family) if the stay in the ICU subsequently negatively affects not only the patient but also their social environment (19).

These important implications of intensive care also apply to forms of long-term intensive care against the background of the growing sector of intensive care services provided in the outpatient setting (20). Although overall mortality in all intensive care units (neurological, surgical, medical) has fallen to 11% (21) or 16% (22) as reported in older, but comprehensive, North American studies, despite rising patient age and disease severity (a more recent study from Portugal reported similar results with an overall mortality of 16% during the period 2015 to 2019; [23]), the six-month mortality of patients who are either ventilated or receiving dialysis and/or vasopressors is around 50% (24, 25). Therefore, a key question in the intensive medical care of critically ill patients is: Who benefits?

Methods

In March 2024, a search of the literature was conducted in the databases Medline/PubMed and Scopus as well as via the Google Scholar search service using the search term “Time Limited Trial(s)”. The identified articles in the German and English languages and their references were scrutinized for their relevance to intensive care medicine. In addition, in the form of a narrative review, articles were identified which reflect the state of science and medical ethical analysis relevant to the present topic. During the primary literature search, 19 empirical investigations (see Table 1 for a synopsis of the relevant trials), 15 articles with medical analyses, and 38 expert opinions, guidelines, and recommendations as well as two reviews were identified and analyzed.

Table 1

Selection of studies relevant to TLTs

Results

Medical ethical concept and areas of application of time-limited trials

Time-limited trials (TLTs) were outlined and justified in the context of medical ethics in 1983 by the US-American “President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research” (26). In 2005, TLTs were proposed as an “ICU test” for patients admitted to the intensive care unit (ICU) (27) to address the problems of poor predictability combined with a high level of stress and mortality in ICUs. The commission argued that any benefit of treatment can be safely ruled out only after it has been attempted and deemed to have failed. A more solid and morally preferable justification to terminate intensive care is achieved by the confirmation of (non-)response to therapy gained over the course of the TLT than when it is not even started a priori due to uncertainty of its benefit (26). TLTs are therefore indicated where there is a high risk of providing inappropriate therapy. The German-speaking literature has pointed out certain features indicating when intensive care medicine is probably not appropriate (28). The presentation of these features led to a recently published recommendation on behalf of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) on implementing TLTs (29).

Apart from their benefit for cases with uncertain predictability, one core feature of TLTs is their ability to reinforce the mutual decision-making process—especially with respect to patients who can no longer decide for themselves. The—at times long-term—negative emotional burden on relatives or surrogates to authorize therapy decision-making on the part of the patient affects at least one third of these surrogates (30). TLTs can open up a time window to allow relatives to assess the effects of therapy on the patient, to process the situation emotionally, and to (re)align their decisions based upon this (31). This can possibly reduce the emotional burden, given that relatives often systematically overestimate the prognosis of patients in the intensive care unit (32, 33) and sometimes have their doubts about its accuracy (34).

TLTs can also promote consensus where there is disagreement between doctors and the patient’s surrogates about the therapeutic course (35, 36). For the relatives, this means that treatments will not be withheld a priori. They represent a compromise between unstarted and open-ended therapy because they provide all participants with an evidence base for the indication to continue treatment. One feature of TLTs is that they prepare surrogates and the treatment team for palliation (“hope for the best and prepare for the worst together” [37]) and can thus represent a gentler approach towards accepting a non-curative form of treatment for a severe condition (38). TLTs could also be useful where the views regarding prognosis vary between those treating the underlying disease and intensivists. Here, TLTs provide the opportunity to defuse conflicts and to facilitate shared decision making by gaining confidence.

The key to achieving these effects of TLTs is their correct implementation as a service provided by the entire intensive care team. Identified obstacles to this include staff rotations which can significantly delay or interrupt TLTs (38, 39) or when important elements of TLTs (for example, “What should be decided?”) are not, or not clearly, communicated (40). The correct choice of patients is particularly important in this respect: TLTs are of no value in treating patients with a dismal prognosis (e1), as this would be contrary to the medical ethical considerations underlying these trials.

Definition and features of TLTs

A TLT is conducted using all indicated procedures to save the patient. If this fails, then it serves to justify with greater medical certainty a generally irrevocable decision to change or terminate the therapeutic goal or, on the other hand, to increase confidence in the patient’s prognosis. According to a largely accepted definition, a TLT is an agreement between doctor and patient, or surrogate, to conduct for a set period treatments indicated in cases with very uncertain prognosis. The intention is to objectify the improvement or deterioration (or absence of change) of the condition as assessed by predefined therapeutic goals (29, e2). If the therapeutic goals are not achieved, then palliative therapy should be provided. Under exceptional circumstances, another TLT may be agreed if the prognosis remains uncertain (e2).

When planning a TLT (which can already be agreed upon prior to admission to the intensive care unit or during the course of ICU treatment [29]), medical and personal factors should be assessed together with the patient and their surrogate and converted to a concrete action plan (e2). Apart from ICU scoring systems, the TLT should gather information regarding prior medical history, personal (for example, motivational) and social resources (social network) as well as wishes and (for example, religious) values of the patient. After considering all these aspects, the treatment team should define a few objectifiable and realistic treatment goals (for example, freedom from vasopressors, extubation, ending dialysis, adequate wake-up response) that are considered to be prognostically favorable in a dedicated TLT discussion with the patient and/or surrogates and which should become apparent within a predefined period of time.

During the TLT, therapeutic measures—in particular with respect to any complications—should be re-assessed on a daily basis with particular attention to the uncertain prognosis and the agreements set out in the TLT. At the end of the trial period, a new meeting should be arranged to evaluate and decide which therapeutic goal is to be pursued.

A TLT is particularly indicated if the patient’s prognosis does not appear to be reliably predictable, which is usually the case in those with already reduced quality of life and physical function (35). How many patients are affected by this in reality is uncertain. As an example, prognostically unfavorable factors which would suggest conducting a TLT have been summarized under the mnemonic FRAIL (Table 2) (e3). Judging from the surveys available, TLTs have been used in some form or other in eight to 25% of patients in the intensive care unit (31, 38, e4, e5).

Table 2

FRAIL – mnemonic suggesting criteria for identifying patients who could be suitable for a TLT

Implementation and effects of TLTs

Communication strategy represents a key method used in a TLT (36, e6). As an aid for this, essential elements of communication have been proposed under the mnemonic TIME (Table 3) (e7), while on the other hand, the TLT course of action can be memorized using the mnemonic CARE (Table 4). It is crucial that information regarding prognosis should always be combined with an assessment of the patient’s values and goals (e8, e9) to justify the subsequent treatment recommendation using an individualized approach.

Table 3

TIME – mnemonic for essential elements of communication surrounding time-limited trials

Table 4

CARE – mnemonic for describing how to conduct a TLT

Another decisive question arises as to how long a limited period should reasonably be. Five investigations are available which show that prognostic uncertainty becomes less over time spent in the intensive care unit (11, e10, e11, e12, e13). Three of these investigations are expressly concerned with the implications for TLT. A study examining duration of a TLT after admission to the intensive care unit for patients with advanced solid tumors found an optimal trial duration of four days (e11). A study of oncology intensive care patients reported similar results and suggests the need for reappraisal of the therapeutic goal on day six (e10). Another study showed that prognostic certainty increases in patients over the age of 80 until day seven and then remains stable (e13). However, it must be pointed out that prognostic uncertainty still remains considerable at this point in time (around 30% residual uncertainty) (e13).

In conclusion, a prognosis made after a few days in the intensive care unit is more reliable than before admission (e14). Although the majority of recommendations based on expert opinions generally suggest a duration of around seven days for a TLT (e2, e15), there are no publications providing a robust answer with a sufficiently high level of evidence to the question of the optimal duration of a TLT. It may be reasonably assumed that the duration of a TLT depends on individual circumstances, primary illness, and any associated organ failure (e2), while bearing in mind that patients and surrogates should be involved in deciding the time frame (e6).

There is currently one prospective study available that has explicitly investigated the effects of TLT (36). It is a pre-post-study conducted at three public hospitals in California (USA). Specific quality characteristics were examined after intensive training of staff to conduct TLTs (especially in acquiring the necessary communication skills) as well as the mortality and invasiveness of the intensive care procedures before and after training. After training the staff and involving a total of 209 patients (113 before the intervention, 96 after), a significant increase was observed in the proportion of

• discussions with the families (60 versus 96%)
• relevant contents of discussions, such as risks and benefit of treatment (35 versus 95%)
• eliciting patients’ values and preferences (46 versus 98%)
• specifically identifying clinical markers of improvement (21  versus 88%).

On this basis, it was shown that, after training the staff, ICU length of stay was reduced (from 8.7 to 7.4 days) and the incidence of invasive procedures fell (86 versus 73%) (36). Remarkably, there was no difference in mortality before and after training (58.4 versus 58.3%), leading the authors to conclude that TLTs were able to precisely identify those patients who do not benefit from continuation of therapy.

It was already known that patient-centered communication can have positive effects on limiting length of stay in intensive care and continuation of so-called life-sustaining procedures (e16). It must be borne in mind, however, that earlier studies recruited external staff specializing in communication skills (e17). The present study was able to demonstrate for the first time that, after training, the team directly treating the patients can also achieve such results. Putting its—as yet still unanswered—questions and limitations aside (e18), the study by Chang et al. (36) is certainly an important milestone in the development and implementation of TLTs in intensive care around 40 years after their theoretical creation.

Conclusions

The discussion regarding which patients benefit from intensive care is as old as intensive care medicine itself. Scoring systems are inadequate for making a reliable prognosis for the individual patient. The rationales for the implementation of time-limited trials are theoretically plausible and to some extent proven. TLTs, as a shared service of the entire intensive care team, are recommended by national (29, e19, e20) and international committees of experts (e6) and guideline commissions (e21). At present, there is only one study available which has examined TLTs prospectively and whose results are promising. These results suggest that TLTs can identify those patients who will not benefit from continuation of intensive care. Efforts should be made to systemize TLTs and to examine their effects in a structured manner in order to assess and utilize to the full the anticipated benefits for patients, relatives, and staff.

Acknowledgments
I would like to thank Prof. Dr. Patrick Schramm (Dresden), Dr. Ingo Sagoschen, Dr. Sabrina Kopp (Mainz), and not least PD Dr. Johannes Wild (Marburg) for their uncomplicated and dynamic support as well as the valuable cooperation in establishing the TEst-ICU (TLT Establishment in the ICU) Study Group for the examination of TLTs on the intensive care unit. I would also like to thank Dr. Benjamin Klapdor (Marburg) for the many fruitful discussions which contributed to the development of the manuscript.

Funding
Clinician Scientist Program of the Faculty of Medicine of the Philipps University Marburg

Conflict of interest statement
The author declares that he has no conflicts of interests.

Manuscript received on 12 April 2024, revised version accepted on
23 January 2025.

Translated from the original German by Dr. Grahame Larkin

Corresponding author:
Dr. med. Martin Russwurm

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