Clinical trial NCT04108000: SPIRIT for Persons With Dementia and Complex Multimorbidity
Official title: SPIRIT for Persons With Dementia and Complex Multimorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Dementia
Nursing
Nephrology
Behavioral research
Social research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Institute on Aging (NIA)
First posted: 2019-09-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 pairs of patients and their caregivers (surrogates) will be randomized to either receive the SPIRIT intervention or standard of care.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Patient 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

Exclusion Criteria:

* lack of an available surrogate
* uncompensated hearing deficits
* already enrolled in hospice

Surrogate Inclusion Criteria:

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

Primary outcomes:
measure: Dyad Congruence
timeFrame: Baseline, 2 Days Post-intervention
measure: Patient's Decisional Conflict Scale (DCS) Score
timeFrame: Baseline, 2 Days Post-intervention
measure: Surrogate's Decision Making Confidence (DMC) Scale Score
timeFrame: Baseline, 2 Days Post-intervention
Secondary outcomes:
measure: Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
timeFrame: 6 and 12 Months Post-intervention
measure: Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline, 1 Month after the Patient's Death
measure: Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline, 1 Month after the Patient's Death
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Dialysis at Northside
state: Georgia
city: Atlanta
country: United States
facility: Emory Dialysis at Greenbriar
state: Georgia
city: Decatur
country: United States
facility: Emory Dialysis at North Decatur
state: Georgia
city: Decatur
country: United States
facility: Emory Dialysis at Candler
state: Georgia
Study officials:
affiliation: Emory University
name: Mi-Kyung Song, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: