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NEW YORK (Reuters Health) – The Serious Illness Care Program helps oncologists have better serious-illness conversations with patients without creating anxiety or depression, according to results of a cluster-randomized clinical trial.

“I was most surprised to see the significant improvement in discussions about prognosis and illness understanding, as well as values and goals, that occurred as a result of the intervention,” said Dr. Rachelle Bernacki of Ariadne Labs at Brigham and Women’s Hospital in Boston.

“About 90% of patients in the intervention group had conversations with their oncology clinicians addressing these important issues, compared to fewer than half of patients in the control group,” she told Reuters Health by email.

Dr. Bernacki and her colleagues investigated the effects of the Serious Illness Care Program (SICP) on the occurrence, timing, quality and accessibility of documented serious-illness conversations between oncology clinicians and patients with advanced cancer. Their findings appear in two reports online March 14, one in JAMA Oncology and the other in JAMA Internal Medicine.

In the trial, 48 oncology clinicians were assigned to the SICP intervention and 43 were assigned to the control group. Ultimately, the team analyzed data on 134 patients of the intervention clinicians and 144 patients of the control clinicians.

The intervention included clinical tools, clinician training, and system changes. The main clinician tool was a structured communication guide, the Serious Illness Conversation Guide (SICG); the main system changes included patient identification, reminders and an SICG documentation template in an accessible advance-care-planning module in the electronic medical record.

Significantly more intervention patients (96%) than controls (79%) had at least one documented serious-illness conversation before death, and the timing of the first conversation was significantly earlier in the intervention group (median, 143 days before death) than in the control group (median, 71 days).

“This finding is important because earlier conversations give patients, families, and their clinicians more time to plan and prepare,” corresponding author Dr. Joanna Paladino, also of Ariadne Labs, told Reuters Health by email.

About twice as many intervention patients as control patients had a documented discussion about values or goals, prognosis or illness understanding, and life-sustaining treatment preferences. The fourth domain of the serious-illness conversation, end-of-life care planning, did not differ significantly between the groups.

Overall, conversations with intervention patients included significantly more of these domains on average (mean, 3.2 of four domains) than did conversations in the control group (mean, 1.9). There were also significantly more conversations per patient in the intervention group (3.1 vs. 2.1).

Goal-concordant care and peacefulness at the end of life did not differ significantly between the intervention and control groups.

On the other hand, the proportion of patients reporting moderate or severe anxiety symptoms was significantly lower in the intervention group at 14 weeks (5.0% vs. 10.2%) and at 24 weeks (4.2% vs. 10.4%, respectively), despite similar proportions reporting such symptoms at baseline (9.0% vs. 9.6%, respectively).

The proportion of patients reporting moderate or severe depression symptoms was also significantly lower in the intervention group at 14 weeks (10.6% vs. 20.8% among controls), but this difference was no longer significant at 24 weeks (12.5% vs. 17.8%).

“These outcomes are important because while clinicians want to have meaningful conversations about patients’ goals and wishes, they worry about making their patients’ emotional status worse,” Dr. Paladino said. “What this study shows is that timely, patient-centered serious-illness conversations can improve these mental health symptoms by a clinically meaningful amount, and reduce emotional suffering that many people face when living with a serious illness.”

Median two-year survival did not differ between the intervention (13.9 months) and control (13.6 months) groups.

“We showed that this intervention was feasible to implement in practice and demonstrated high adoption by oncology clinicians, leading to more, earlier, and better conversations,” Dr. Paladino said. “Since the program worked with oncology clinicians, this suggests that with tools, training, and support, other clinicians can do this and reach many more patients who would benefit from conversations.”

“Once you start a conversation, more conversations follow,” Dr. Bernacki said. “I believe those conversations can reduce anxiety for patients. Talking about the future and what to expect makes it less frightening. If we can provide anticipatory guidance for seriously ill patients and families, we can allay some of the burden of illness.”

Interested clinicians can find free materials at the group’s website, Dr. Paladino noted.

Dr. Martin R. Stockler, who co-authored an accompanying editorial, told Reuters Health by email, “It’s important to appreciate that the SICP improved the frequency, timeliness, depth, and documentation of these important discussions with no increase in anxiety or depression. It’s disappointing that the SICP had little effect on goal-concordant care or peacefulness, but I suspect this is because the trial was conducted with motivated clinicians who probably did a better-than-average job in the control group.”

“Physicians should invite, initiate, and document these difficult conversations with their patients because it’s the right thing to do, despite the absence of a demonstrable effect on goal-concordant care or peacefulness in this trial,” said Dr. Stockler, of Concord Cancer Center, in Concord, and the University of Sydney, in Camperdown, Australia. “Physicians should consider this intervention and trial carefully to determine the elements they should incorporate to improve their own practice.”


JAMA Oncol 2019.

JAMA Intern Med 2019.

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