SPIRIT for Persons With Dementia and Complex Multimorbidity

End Stage Renal Disease Clinical Trial

Official title: SPIRIT for Persons With Dementia and Complex Multimorbidity

Status Completed

Clinical Trial Summary

In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on preparedness outcomes. Additional follow up with caregivers will occur 6 months later.

Clinical Trial Description

Cognitive impairment or dementia, usually vascular dementia or Alzheimer's, co-occur in approximately 38% of patients with end stage renal disease (ESRD). When dementia is superimposed on ESRD, the risk for poor outcomes, including disability, hospitalization and death, sharply increases. Similarly, initiating dialysis in older adults with multiple comorbidities, including dementia, does not offer survival benefit. However, advance care planning (ACP) discussions with dialysis patients rarely occur. The reality of ESRD plus dementia is that most of these patients are likely to die or progress to advanced dementia without ever engaging in ACP discussions before the cognitive window of opportunity closes. Moreover, persons with dementia (regardless of their cognitive impairment level) are routinely excluded from clinical trials of ACP, largely because investigators assume that these people do not have the cognitive capability to appreciate the complexity of ACP. In an on-going study ("SPIRIT in Dementia") the researchers carefully adapted SPIRIT for persons with mild to moderate dementia (mostly due to Alzheimer's) and their surrogates. In a sample of 23 dementia patients without complex multimorbidity and their surrogates, the researchers were able to conclude that meaningful ACP conversations were possible even for individuals with moderate dementia. Based on these findings, this supplement study will leverage the infrastructure of the parent SPIRIT in ESRD trial to pilot test the adapted SPIRIT intervention for patients with ESRD plus dementia as a model for determining whether patients with dementia superimposed on complex multimorbidity can fully participate in ACP discussion.

This purpose of this pilot randomized controlled trial with 30 patient and caregiver dyads is to:

• estimate the effects of the SPIRIT-dementia intervention on: (a) preparedness outcomes for end-of-life decision making (defined as dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) 2-3 days post-intervention, and (b) care decisions (withdrawal from dialysis, Do-Not-Resuscitate order, hospice enrollment) assessed at 6 months post-intervention, or the patient's death, whichever occurs first,

• estimate the effects of the SPIRIT-dementia intervention on surrogates' post-bereavement distress (anxiety and depression symptoms) at 1 month after the patient's death, and

• explore the relationships among patients' cognitive status, decision-making capacity and their ability to express end-of-life wishes. ;

Related Conditions & MeSH terms

• Dementia
• End Stage Renal Disease
• Kidney Failure, Chronic

• NCT number: NCT04108000
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Completion date: March 23, 2023