Monday, January 3, 2011

RCT of Palliative Medicine Consultations on Admission

In the current issue of Archives of Internal Medicine, under the category, "Health Care Reform" is a Research Letter entitled, Hospital-Based Palliative Medicine Consultation: A Randomized Controlled Trial. It is brought to you by the good folks at UCSF. It was a 2-year, randomized, prospective, clinical trial of patients 65 years or older with heart failure, cancer, chronic obstructive pulmonary disease, or cirrhosis, who were able to give informed consent, and who spoke English.


Patients were randomly assigned to the intervention or usual care group. The intervention group received a physician-based palliative medicine consultation (PMC) on enrollment and was followed up every weekday during hospitalization. The patients were routinely assessed for symptoms as well as psychosocial and spiritual needs. The PMC physician discussed treatment preferences, and consulted a pharmacist and chaplain as needed. The PMC physician communicated with the patient's team via a medical chart note and by telephone. The usual care group received a brief visit from the PMC physician who gave them a packet of information on diet and exercise. Patients were rated as dependent or independent for Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales, and were rated on the 15-item Geriatric Depression Scale (GDS-15) for depression. Pain, dyspnea, and anxiety were assessed daily by a research assistant who was blinded to group assignment. All patients completed a telephone survey 2 weeks after discharge to reassess symptoms, rate physician and nursing care, and recall discussions of preferences. Medical records were reviewed to determine patients' primary diagnosis on admission.

107 patients were enrolled; 81 patients completed follow-up surveys. Most patients were male (62%) and white (71%) and had some college education (56%). The mean (SD) age was 76 (7.5) years, and 45% were married or partnered. The primary diagnoses were heart failure (51%); cancer (22%); chronic obstructive pulmonary disease (20%); and cirrhosis (6%). The mean (SD) hospital length of stay was 5.5 (5.8) days. Most participants were dependant in 1 or more ADL (71%), and 21% had a GDS-IS score of 6 or higher. The groups differed in mean age (77 and 74 years in the intervention and usual care groups, respectively; P = .007) but not in other characteristics.

Symptom scores for all subjects improved from baseline to follow-up for pain (4.2 vs 2.3; P <.001), dyspnea (3.8 vs 2.0; P <.001), and anxiety (4.8 vs 2.4; P <.001). There was no additional improvement in pain (P = .30), dyspnea (P = .50), or anxiety (P = .08) for patients assigned to the intervention at any assessment period. At follow-up, most patients believed that the staff understood what they were going through and that physicians and nurses listened to their hopes, fears, and beliefs. However, a minority of patients reported that the physician discussed their preferences for care (43%), their chance of surviving hospitalization (42%), or their religious beliefs (31%). There were no differences between groups for any of these items. The writers point out that the subjects, of this single-institution study, were not those that would otherwise be referred for PMCs and thus may have lacked issues that a PMC would affect. They wondered whether palliative care may have an impact on different outcomes or require ongoing engagement. Also, the intervention was not by interdisciplinary team.



Some thoughts:
I agree that the physician-based intervention made over a short-course with patients who were not necessarily into end-stage disease was not likely to make significant effect over usual care. Right patient, right treatment, right dose, right time, etc. What we seem to have here is equivalence or a failure to show inferiority for inclusion of PMCs, at least with respect to the trial design and tested parameters. But they present and discuss pooled data for symptom-levels and then note that there is no significant additional improvement for PMC, rather than testing the difference between group means.

Now, in the category of retrospective data-mining:
According to the Figure there were no significant intergroup differences (with respect to 95% CIs) between usual care and PMC for interval-matched measurements of pain, dyspnea and anxiety. However, I did note that for the usual-care group, between baseline to follow-up, there was no significant difference (with respect to 95% CIs) in the levels of pain [3.5 (2.4 - 4.8) vs. 2.1 (1.1 - 3.1)], dyspnea [3.0 (1.8 - 4.2) vs. 1.6 (0.6 - 2.5)] and anxiety [3.8 (2.7 - 5.0) vs. 2.5 (1.3 - 3.6)]. One could suggest that for these patients their usual-care admissions had no effect on these symptoms.

Alternatively, for the PMC group, between baseline to follow-up, there was significant difference in the levels of pain [4.9 (3.8 - 6.0) vs. 2.4 (1.4 - 3.4)], dyspnea showed equivalence at the lower and upper values of the 95% CI [4.4 (3.3 - 5.5) vs. 2.4 (1.5 - 3.3)], and again there was significant difference for anxiety [5.5 (4.2 - 5.5) vs. 2.5 (1.5 - 3.6)].

I think there is food for thought here in terms of future trial design. Is this difference real? For these chronically ill patients, from admission to follow-up, do hospitalizations with PMCs show significant decreases in symptoms compared to no significant difference in symptoms with usual-care admissions? Do admissions with PMCs using interdisciplinary-team interventions show significant differences over usual-care admissions?
ResearchBlogging.org




Pantilat, S., O'Riordan, D., Dibble, S., & Landefeld, C. (2010). Hospital-Based Palliative Medicine Consultation: A Randomized Controlled Trial Archives of Internal Medicine, 170 (22), 2038-2040 DOI: 10.1001/archinternmed.2010.460

6 Responses to “RCT of Palliative Medicine Consultations on Admission”

Drew Rosielle MD said...
January 05, 2011

I left these comments, slightly modified, on the Geripal post about the same trial:

My reaction to this was mostly a shrug. No arguments with the authors about what they were trying to study - it's a relevant question - but a shrug to the finding that undifferentiated PC consultation didn't do anything measurable. This was not anything like a trial of palliative care as actually practiced, and to me just underlines the very important question of what palliative specialists are supposed to be doing. While all the patients in this study needed to have 'palliative concerns' addressed, this does not mean that they needed or would benefit from specialty palliative care. Specialist palliative care is not for everyone: as underlined by this study (may not add anything to most patients) and professionally we'd all be bored and disillusioned if we saw a bunch of patients like this. We've created this problem for ourselves to an extent - beating the 'palliative care for everyone drum' ...'upstream' etc. All of that true - all patients with serious, life-limiting illness should have symptom management, quality of life, and care planning needs addressed, but I firmly believe this does not mean *specialist* palliative care for everyone. The reason why Mass Gen RCT for lung cancer made an impact is b/c those patients were much sicker. Imagine the spectrum of 65 yo patients admitted with CHF - that's a lot more diverse group of patients (w/r/t prognosis, care planning needs) than patients with incurable lung cancer.

All of this fancy talk is not to say that I can say who should be seen by us specialists (and I should add I'm talking about palliative consultation here not the distinct-ish but very important specialist services delivered by hospice teams). It's not everyone (as this study reinforces; it's not even everyone who is close to death - many oncologists, primary docs, cardiologists, surgeons, etc. do just fine with straight-forward cases and the help of hospice services, etc.) and it seems to have a lot to do with 1) magnitude and complexity of patient symptom/psychoexistential/decision-making needs and 2) competence of the clinicians requesting us to get involved. Clearly there is a lot of variation there. I've thought about this a lot over the years and have recently given up on it, actually defining patient characteristics of who should be seen by us specialists, especially since #2 is so variable (even though yes yes I agree that many nonPC specialists overestimate their skills). Part of me wonders if what 'needs to be done' is to help all docs/clinicians understand and recognize and value what excellent communication, symptom control, psychosocial support, and care planning look like and to recognize when their patients aren't getting it and to refer appropriately. If you're the superstar oncologist who can do it all - swell! - if not, you should know when you're not meeting your patients needs and collaborate with teams who can.


Sean said...
January 07, 2011

Fair warning, my comments are an editorial & only indirectly related to the paper.

I agree with a lot you wrote Drew. When I was a fellow, our team was involved in a consult trigger project. The aim of it was wise and proactive. But I recall being involved in several awkward and uncomfortable situations -- "now who are you? what is palliative care?" Then I tried to engage the patient and family in a conversation they had non interest in starting. Perhaps the patient and family would then pepper me with questions I couldn’t answer regarding the primary team’s plan of care. I remember experiencing boundary issues and feeling darn right silly at other times. Why am I so anxious to get involved in a medical situation I wasn’t invited to participate in?

When I think about the systems based practice of palliative care consultations, perhaps the vital cog is the primary provider who asks for the consult. If he/she is not invested in the palliative care consult and neither is the patient/family and the patient mortality isn't immediately at stake, then I worry about practices such as these becoming larger boundary issues for our field. I realize in systems based approaches to improving care, you wish to take the human element out of solutions. But I don't think it's possible to do that for palliative care consults or probably any consult service for that matter. I agree with Drew, there will always be considerable variation in how one decides whether to get a pall care consult or not. This gives many of us distress b/c it’s so hard to influence other providers behaviors regarding this and we so desperately want to improve the medical culture of practice in end of life care. But in a reductionist viewpoint of our clinical role, we provide a needed service to providers asking for our help.


Brian McMichael, M.D. said...
January 07, 2011

Thank you both, Drew and Sean, very much for your comments.

Sean, I think that your comment, like Drew's, is the very kind of comment we're after here at Pallimed.

I think that the questions of nuance for the field as it establishes itself are where do we stand between no one gets PC and everyone gets PC, as well as why, when, and how?


Sean said...
March 27, 2011

Fair warning, my comments are an editorial & only indirectly related to the paper.

I agree with a lot you wrote Drew. When I was a fellow, our team was involved in a consult trigger project. The aim of it was wise and proactive. But I recall being involved in several awkward and uncomfortable situations -- "now who are you? what is palliative care?" Then I tried to engage the patient and family in a conversation they had non interest in starting. Perhaps the patient and family would then pepper me with questions I couldn’t answer regarding the primary team’s plan of care. I remember experiencing boundary issues and feeling darn right silly at other times. Why am I so anxious to get involved in a medical situation I wasn’t invited to participate in?

When I think about the systems based practice of palliative care consultations, perhaps the vital cog is the primary provider who asks for the consult. If he/she is not invested in the palliative care consult and neither is the patient/family and the patient mortality isn't immediately at stake, then I worry about practices such as these becoming larger boundary issues for our field. I realize in systems based approaches to improving care, you wish to take the human element out of solutions. But I don't think it's possible to do that for palliative care consults or probably any consult service for that matter. I agree with Drew, there will always be considerable variation in how one decides whether to get a pall care consult or not. This gives many of us distress b/c it’s so hard to influence other providers behaviors regarding this and we so desperately want to improve the medical culture of practice in end of life care. But in a reductionist viewpoint of our clinical role, we provide a needed service to providers asking for our help.


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April 05, 2011

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