SPIRIT for Persons With Dementia and Complex Multimorbidity

Study Overview
=================
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.

Official Title
-----------------
SPIRIT for Persons With Dementia and Complex Multimorbidity

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Behavioral: SPIRIT-Dementia
* Behavioral: Usual Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 30 pairs of patients and their caregivers (surrogates) will be randomized to either receive the SPIRIT intervention or standard of care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPIRIT-Dementia<br>Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention. | Behavioral: SPIRIT-Dementia<br>* 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.<br>|
| Active Comparator: Usual Care<br>Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis. | Behavioral: Usual Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyad Congruence | Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in ESRD patients. Possible responses to the scenarios are: The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment, The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis, and I am not sure. Patients and surrogates complete this tool independently and their responses are then compared to determine dyad congruence. | Baseline, 2 Days Post-intervention | 
| Patient's Decisional Conflict Scale (DCS) Score | Patient decisional conflict will be measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 - 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making. | Baseline, 2 Days Post-intervention | 
| Surrogate's Decision Making Confidence (DMC) Scale Score | Surrogate decision-making confidence will be measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) Not confident at all to (5) Very confident. Total scores range from 0 - 20, with higher scores indicating greater confidence. | Baseline, 2 Days Post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | The proportion of decisions (participants who withdrew from dialysis, Do not resuscitate (DNR), or chose hospice enrollment) will be compared between study arms. | 6 and 12 Months Post-intervention | 
| Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score | Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates normal, 8-10 indicates borderline abnormal, and 11-21 indicates abnormal levels of anxiety or depression. | Baseline, 1 Month after the Patient's Death | 
| Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score | Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates normal, 8-10 indicates borderline abnormal, and 11-21 indicates abnormal levels of anxiety or depression. | Baseline, 1 Month after the Patient's Death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Nursing, Nephrology, Behavioral research, Social research