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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?

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

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