First Trial of LCP for Dying Cancer Patients Finds Little Benefit

Zosia Chustecka

October 17, 2013

The Liverpool Care Pathway (LCP), which outlines end-of-life care, has been widely used in England for over a decade, but has been controversial and is now being phased out. Now, the first-ever randomized clinical trial of the pathway, which compared it with standard healthcare practice in an Italian study involving dying cancer patients, shows that it offers little clinical benefit.

The findings should "be used to inform strategies to care for dying patients," say the researchers, headed by Massimo Costantini, MD, from the Research Institute S Maria Nuova in Reggio Emilia, Italy. The trial was published online October 15 in the Lancet.

"The results of [this], the only adequately powered study of the LCP so far, have not shown clinically meaningful differences for patients — the ultimate measure of useful health policy," comment David Currow, BMed, MPH, FRACP, chair of palliative and supportive services at Flinders University, Adelaide, Australia, and Amy Abernethy, MD, from Duke Clinical Research Institute, Durham, North Carolina, in an accompanying comment.

LCP Aims for Dignified Death

The LCP was developed in the late 1990s at the Royal Liverpool University Hospital and Marie Curie Hospice Liverpool, and has been widely adopted in England and also some other European countries.

However, after years of controversy and widespread criticism in the British press, an independent review was conducted by the British government, and this review, published in July 2013, has recommended phasing out the LCP, and instead using individualized end-of-care plans.

The LCP aims to provide the best quality of care for patients in their final days of life, and transfers many of the best practices of hospices to the hospital setting. Steps involve reviewing whether further medications or tests would be helpful, keeping the patient as comfortable as possible, assessing whether artificial fluids should be given when a patient has stopped eating or drinking, and reviewing the patient's spiritual or religious needs.

While the British review concluded that the LCP works well when carried out by well trained and resourced staff, it also found "many serious cases of unacceptable care where the LCP had been incorrectly implement. Examples include leaving patients without adequate nutrition, hydration, and inappropriately sedated." In some cases, care for the dying had been "practiced as a tick box exercise," and the LCP had been misused and misunderstood leading to problems. In addition, "it was simply too generic in its approach for the needs of some people." As a result, the review concluded that the LCP should be phased out, and that it should be replaced by a more personalized and clinically sensitive approach.

Lessons For Going Forward

"Any future strategy for improvement should take into account what we have learned about the LCP program, from the results of this and other studies," say the researchers reporting the first randomized trial to test the pathway.

Although there was no significant difference in overall quality of care for dying cancer patients who were cared for under the LCP compared with those under standard care, "we did see a small improvement," lead author Dr. Costantini commented in a statement.

It does appear that the LCP has the "potential to close the gap between hospice care and hospital care," he continued, adding: "We know families rate quality of hospice care more highly."

"There could be fundamental components of the LCP that might be beneficial, and the next steps are to establish this," he said.

Coauthor on the study, Irene Higginson, PhD, OBE, director of the Cicely Saunders Institute at King's College London, United Kingdom, adds: "Our findings demonstrate just how important it is for any initiative that replaces the LCP in England to be grounded in scientific evidence and tested in controlled trials before being rolled out across the board."

Randomized Trial in Italy

The study was conducted in Italy with a version of the LCP that had been translated and adapted to the Italian context (LCP-I). Previously, Dr. Costantini and colleagues had tested it is a small phase 2 trial, and found that it significantly improved some aspects of end-of-life care for patients dying in the hospital. They note that the effects of LCP-I that they saw in that trial were greater than they found in the randomized study they now report.

The current study was carried out in 16 Italian general medicine hospital wards, which were randomly allocated to care for patients under the LCP or according to standard healthcare practice.

The team identified 308 patients who had died from cancer (147 under LCP, 161 in control wards) and interviewed relatives of the deceased (81% of relatives of patients cared for in LCP-I wards, 70% of those in control wards).

Relatives were interviewed using questions from a toolkit developed to measure quality of care at the end of life from the perspective of family members. Items covered issues such as being informed and making decisions; questions about respect, dignity, and kindness; and also an overall rating of patient-focused family-centered care.

The results showed no significant difference in the distribution of the overall quality-of-care toolkit scores between the wards in which the LCP-I had been implemented (score, 70.5 of 100) and the control wards (63 of 100; P = .186).

However, there were some differences. Two of the secondary outcomes had higher scores in the LCP-I group — respect, dignity, and kindness; and control of breathlessness. In addition, there was a higher probability of receiving potentially appropriate medications, specifically drugs for pulmonary secretions, as well as opioids and morphine.

There were no negative effects from the LCP-I, and the study was underpowered, the researchers note.

Also, the median time of care under the LCP-I program was 35 hours (which is similar to the 27 hours reported in a 2001 UK audit), they note. "This period is too short to control symptoms, ensure good communication, and support families," they comment. To achieve better results, earlier palliative care may be needed, they suggest.

The study was funded by the Italian Ministry of Health and Maruzza Lefebvre D'Ovidio Foundation-Onlus. Dr. Costantini, the study coauthors, and Dr. Curow have disclosed no relevant financial relationships. Dr. Abernethy reports receiving research funding from several pharmaceutical companies, and honoraria from Novartis, Bristol-Myers Squibb, and Pfizer.

Lancet. Published online October 16, 2013. Abstract, Comment

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