SPIRIT for Persons With Dementia and Complex Multimorbidity

April 27, 2023 updated by: Mi-Kyung Song, Emory University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Emory Dialysis at Northside
      • Atlanta, Georgia, United States, 30331
        • Emory Dialysis at Greenbriar
      • Decatur, Georgia, United States, 30033
        • Emory Dialysis at North Decatur
      • Decatur, Georgia, United States, 30034
        • Emory Dialysis at Candler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPIRIT-Dementia
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
Behavioral: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyad Congruence
Time Frame: Baseline, 2 Days Post-intervention
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
Time Frame: Baseline, 2 Days Post-intervention
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
Time Frame: Baseline, 2 Days Post-intervention
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)
Time Frame: 6 and 12 Months Post-intervention
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
Time Frame: Baseline, 1 Month after the Patient's Death
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
Time Frame: Baseline, 1 Month after the Patient's Death
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Nursing Research (NINR)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Mi-Kyung Song, RN, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Actual)

March 24, 2022

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00094859a
  • 3R01NR017018 (U.S. NIH Grant/Contract)
  • 5R01AG057714 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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