Page 166 - Haematologica May 2022

C. DuMontier et al.
sions documented in the medical record during the 1-year follow- up period was also measured via chart review. EOL goals-of-care discussion was defined as a discussion regarding EOL preferences by any treating clinician including resuscitation/code status, hos- pice, and/or preferred location for dying.23 Finally, after completion of enrollment, a survey was administered to 65 Dana-Farber hematologic oncologists, physician assistants, and nurse practi- tioners who cared for patients in the geriatric consultation arm. This survey sought to gather clinicians’ opinions regarding the usefulness of consultation (on a Likert scale where 1 = “least” use- ful and 5 = “most” useful) in addressing geriatric domains of care and areas of management for specific age-related issues (see sur- vey instrument, Online Supplementary Figure S2).
Statistical analysis
For the primary analysis, the impact of geriatric consultation on 1-year overall survival was assessed using Kaplan-Meier analysis comparing the 1-year survival rate between patients receiving geriatric consultation plus standard oncologic care and patients receiving standard oncologic care alone. Differences in 1-year sur- vival rate and a corresponding 95% confidence interval (95% CI) were calculated to summarize the effect of geriatric consultation on 1-year overall survival.24,25 Multivariable Cox regression and weighted logistic regression models26 were also used to estimate the treatment effect, adjusting for any potential remaining imbal- ances after randomization related to age, sex, disease aggressive- ness (defined according to previous methods5-7), and frailty (pre- frail versus frail). Aggressive diseases included diffuse large B-cell lymphoma, mantle cell lymphoma, multiple myeloma, acute myeloid leukemia, and indolent diseases included marginal zone lymphoma, follicular lymphoma, chronic lymphocytic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm/myelo- proliferative disease, and hairy-cell leukemia.
For secondary analyses, the effects of geriatric consultation on emergency department visits, hospitalizations, and number of days in the hospital were assessed using separate negative binomi- al regression models, each adjusting for age, sex, disease aggres- siveness, and frailty. The impact of geriatric consultation on the likelihood of having documented EOL goals-of-care discussions during the follow-up period was assessed using multivariable logistic regression, adjusting for the aforementioned covariates. Exploratory analyses investigated any association between num- ber of geriatrician visits and mortality, as well as a subgroup analy- sis determining any difference in effect by frailty severity. All pri- mary and secondary analyses were performed as intention-to- treat analyses, followed by per-protocol analyses that excluded patients who, although assigned to the intervention, ended up not completing their geriatric visit. SAS (version 9.4, SAS Institute, Cary, NC, USA) and R (version 4.0,0, https://www.R-project.org, R foundation for Statistical Computing, Vienna, Austria) statistical software were used for all analyses.
Results
Patients’ characteristics
Between February 2015 and May 2018, 270 eligible patients with planned follow-up at Dana-Farber were approached for enrollment (Figure 1). Of these, 232 agreed to participate and underwent the screening GA, after which 72 patients were classified as robust and thus excluded from the trial. One hundred sixty pre-frail/frail patients were ran- domly assigned to receive geriatric consultation plus stan- dard oncologic care (n=60) or standard care alone (n=100). One patient in the standard care arm was lost to follow-up
because the patient never returned to Dana-Farber after ini- tial consult and vital status could not be confirmed. This patient was assumed to be alive at the end of the study peri- od and was included in the analyses. In the intervention arm, three patients died before receiving their consultation, three cancelled the consultation, and six did not return to Dana Farber (i.e., they continued their care at their local practice). The two study arms were overall balanced in terms of baseline characteristics (Table 1), with high rates of functional impairment (35.6% with dependency in instru- mental activities of daily living [IADL]), cognitive impair- ment (39.5% with impairment in executive function), and mobility impairment (60.6% with gait speed <0.8 meters/second). Online Supplementary Table S1 lists the latest active treatment regimens within 3 months of initial consul- tation.
Uptake of the embedded geriatric consultation
Of those randomized to geriatric consultation, 48 (80%) completed at least one visit with a geriatrician (95% CI: 68% to 88%). Of those 12 assigned to receive geriatric consultation who did not complete it, three died, three cancelled the consultation (although continued their cancer care at Dana-Farber), and six ended up not return- ing to Dana-Farber for further care. Among the 48 who completed at least one consultation, 26 completed one or more additional visits with a geriatrician (range of total visits per patient, 1-12). Patients enrolled toward the end of the study period tended to have more total visits than patients enrolled toward the beginning (Online Supplementary Figure S2).
Geriatric consultation and 1-year overall survival
After being randomized to the geriatric consultation arm, time to the initial visit with a geriatrician varied across patients with a median of 36 days (range, 0-224 days; interquartile range, 76 days). The median follow-up extend- ed beyond our outcome of 1-year survival. Among the 48 patients who were seen by the geriatrician in the consulta- tion arm, the median number of interventions recommend- ed for each patient was two, with a range of zero to four interventions. The most common interventions fell within the comorbidity/polypharmacy domain (39 [81.3%] patients receiving one or more interventions); followed by nutrition (26 [54.2%]); function/falls (23 [47.9%]); cognition (15 [31.3%]); and depression/mood (8 [16.7%]). Ninety- seven of these interventions were carried out by the geria- trician through counseling, non-pharmacological recom- mendations, or pharmacological prescriptions. Fourteen of these interventions were referrals or coordination with other disciplines, including physical therapists, social work- ers, and nutritionists. No control patients crossed over to the consultation arm in the 1-year follow-up period (i.e., no control patient received an embedded geriatric consulta- tion).
A cumulative total of 32 patients died in the year follow- ing their initial consultation, 11 (18.3%) in the geriatric con- sultation arm versus 21 (21.0%) in the standard care arm. Overall survival at 1 year was not significantly higher in patients receiving geriatric consultation (81.7%, 95% CI: 71.0% to 90.2%) in comparison with patients receiving standard care (78.8%, 95% CI: 69.7% to 85.7%; difference: 2.9%, 95% CI: -9.5% to 15.2%, P=0.65) (Figure 2A). Results were similar in the per-protocol analysis (Figure 2B), as were results after adjustment for covariates in the multi-
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