Journal of palliative medicine
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Randomized Controlled Trial
Associations of Health Care Utilization and Therapeutic Alliance in Patients with Advanced Cancer.
Introduction: Therapeutic alliance (TA), or the extent to which patients feel a sense of caring and trust with their physician, may have an impact on health care utilization. We sought to determine if TA is associated with: (1) emergency department (ED) visits within 30 days of death and (2) hospice enrollment. Methods and Materials: This is a secondary analysis of data from a randomized clinical trial. ⋯ Conclusions: Higher TA was associated with decreased ED visits within 30 days of death. There was no association between TA and rates of hospice enrollment. Clinical Registration Number: NCT02712229.
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Randomized Controlled Trial
Effectiveness of an Algorithmic Approach to Ventilator Withdrawal at the End of Life: A Stepped Wedge Cluster Randomized Trial.
Background: The transition to spontaneous breathing puts patients who are undergoing ventilator withdrawal at high risk for developing respiratory distress. A patient-centered algorithmic approach could standardize this process and meet unique patient needs because a single approach (weaning vs. one-step extubation) does not capture the needs of a heterogenous population undergoing this palliative procedure. Objectives: (1) Demonstrate that the algorithmic approach can be effective to ensure greater patient respiratory comfort compared to usual care; (2) determine differences in opioid or benzodiazepine use; (3) predict factors associated with duration of survival. ⋯ Conclusions: The algorithm was effective in ensuring patient respiratory comfort. Surprisingly, more medication was given in the usual care arm; however, less may be needed when distress is objectively measured (RDOS), and treatment is initiated as soon as distress develops as in the algorithm. Clinical Trial Registration number: NCT03121391.
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Randomized Controlled Trial
Participant Safety in Multisite, Randomized, Double-Blind, Placebo-Controlled Clinical Trials in Hospice/Palliative Care: Data from the Contracted Studies of the Australian National Palliative Care Clinical Studies Collaborative.
Objective: To describe the harms in all arms of six consecutive multi-site, double-blind, placebo-controlled randomised clinical trials. Background: Controversies surround conduct of phase III clinical trials in palliative care. Concerns include risks to participants' safety, use of placebo arms, participants' burden, and justification when therapies are already widely used. ⋯ Results: Studies recruited 1,232 participants: 65/1,232 (5.3%) participants had serious adverse events of which none had a definite (blinded) attribution, all of which settled with ceasing the intervention; 49/1,232 (4.0%) participants had adverse events. No participants on placebo arms had adverse or serious adverse events with definite (blinded) attribution. Discussion: These studies are safe for participants and generate knowledge to support informed patient decision making.
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Randomized Controlled Trial
Impact of Animal-Assisted Interaction on Anxiety in Children With Advanced Cancer and Their Caregivers.
Background: Pediatric patients with advanced cancer and their caregivers have unique psychosocial needs. Anxiety often worsens throughout treatment for both patients and parents, and, if undertreated, can cause suffering. Animal-assisted interaction (AAI) incorporates animals into patient care in a structured manner for the purpose of therapeutic benefit. ⋯ The difference in initial STAI State anxiety scores for caregivers may indicate a positive effect of AAI in reducing anxiety surrounding appointments through anticipation of seeing a therapy dog. Conclusion: Further research is needed to determine the effectiveness of AAI in pediatric patients with advanced cancer and their caregivers, but results are promising that participation in AAI may lessen caregiver anxiety. Clinical Trial Registration Number is: NCT03765099.
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Randomized Controlled Trial
Reality of Family Caregiving for Hispanics With Alzheimer's Disease and Related Dementias: A Qualitative Analysis.
Background: Underserved Hispanic patients often experience unmet palliative care (PC) needs, particularly those with noncancer diagnoses such as Alzheimer's disease and related dementias. Most caregivers for Hispanic patients are family relatives who are less likely to use health care and community resources and experience high caregiver burden. We adapted a culturally tailored patient navigator (PN) intervention to provide support and improve PC outcomes for Hispanics with Alzheimer's disease and related dementias and their family caregivers (FCGs). ⋯ Conclusions: PNs helped FCGs and patients beyond the intervention's scope. Providing support and awareness to FCGs, and incorporating cultural beliefs, may improve PC access to disparate populations and guide future interventions. Clinical Trial Registration Number NCT03181750.