12033 Background: Management of patients with agitated terminal delirium is challenging as clinicians try to find a balance between adequate sedation to maximize comfort while retaining communication abilities. A novel approach to tailor care is to ask caregivers for a PDSG by setting an individualized target for sedation. In this study, we examined PDSG using (1) clinical vignettes and (2) as a clinical response criteria in patients enrolled onto a randomized clinical trial. Methods: This is a pre-planned secondary analysis of a double-blind randomized clinical trial examining the sedative effect of chlorpromazine and/or haloperidol in patients with agitated terminal delirium refractory to low dose haloperidol (clinicaltrials.gov: NCT03021486; Lancet Oncol 2020 21:7 989-998). At baseline, caregivers and bedside nurses were independently asked to select the PDSG for 6 patient vignettes that differed by level of agitation (high vs. moderate), ability to communicate (yes or no), and survival (days vs. weeks). There were 5 choices for PDSG, corresponding to RASS scores of 0 (no sedation), -1 to -2, -3, -4 and -5 (deep sedation). Respondents were also asked to select the PDSG for the enrolled study patient, which were assessed against actual RASS scores over the first 24 hours to determine a response. We examined the association between PDSG levels and various patient and respondent characteristics with multi-level cumulative logits models. Results: 68 patients were enrolled and 45 received the masked study interventions (median survival 73 h [95% CI 49,106 h]). 42 caregivers and 40 nurses provided PDSG data. For the case vignettes, 7-31% of caregivers and 20-55% of nurses chose RASS -4 or -5 as PDSG. PDSG was significantly lower for patients who were unable to communicate (odds ratio [OR] 3.1-4.4, P < 0.0001), patients with only days of survival vs. weeks (OR 1.7, 95% confidence interval [CI] 1.2-2.5; P = 0.002) and if the respondent was a bedside nurse (OR = 2.5, 95% CI 1.8-3.6; P < 0.0001). For study patients, 12 (29%) of caregivers and 13 (33%) of nurses selected RASS -4 or -5 as PDSG. After the first 2 hours, 40-61% of patients achieved RASS scores that were within ±1 point of caregiver’s PDSG, with no significant difference detected among treatment groups (P = 0.45). PDSG for study patients was significantly lower if the respondent perceived severe distress related to agitation (OR = 4.4, 95% CI 1.1-17.2; P = 0.03), particularly if the respondent was a bedside nurse (OR = 4.8, 95% CI 1.4-16.2; P = 0.01). Conclusions: PDSG represents a novel response criterion to tailor care for patients with agitated terminal delirium. Lighter sedation was preferred by caregivers compared to nurses, particularly for patients with less agitation, ability to communicate, and longer expected survival. These findings may allow clinicians to better tailor the level of sedation for patients with restlessness/agitation in the last days of life. Clinical trial information: NCT03021486.
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