SPIRIT for Persons With Dementia and Complex Multimorbidity

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2023-03-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

30 pairs of patients and their caregivers (surrogates) will be randomized to either receive the SPIRIT intervention or standard of care.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SPIRIT-Dementia

Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.

Group Type EXPERIMENTAL

SPIRIT-Dementia

Intervention Type BEHAVIORAL

The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.

Usual Care

Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive.

Interventions

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SPIRIT-Dementia

The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.

Intervention Type BEHAVIORAL

Usual Care

As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* receiving in-center hemodialysis
* diagnosed with dementia or having mild to moderate cognitive impairment based on a Montreal Cognitive Assessment (MoCA) score 13-25 or a Saint Louis University Mental Status (SLUMS) score \< 27 (high school education) or \< 25 (less than high school education)
* able to understand and speak English
* a University of California San Diego Brief Assessment of Capacity to Consent (UBACC) score of 11 or higher

* 18 years or older
* be chosen by the patient
* able to understand and speak English