SPIRIT for Persons With Dementia and Complex Multimorbidity

NCT04108000 | Completed Results DMC

• 3 other identifiers: IRB00094859a3R01NR0170185R01AG057714
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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.

Conditions

End Stage Renal Disease

Keywords

Dementia; Nursing; Nephrology; Behavioral research; Social research

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)

  6 and 12 Months Post-intervention

• Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score

  Baseline, 1 Month after the Patient's Death

• Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score

  Baseline, 1 Month after the Patient's Death

Study Arms (2)

SPIRIT-Dementia

EXPERIMENTAL

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

Behavioral: SPIRIT-Dementia

Usual Care

ACTIVE COMPARATOR

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

Interventions

SPIRIT-Dementia 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.

SPIRIT-Dementia

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• lack of an available surrogate
• uncompensated hearing deficits
• already enrolled in hospice
• years or older
• be chosen by the patient
• able to understand and speak English

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Emory Dialysis at Northside

Atlanta, Georgia, 30318, United States

Location

Emory Dialysis at Greenbriar

Atlanta, Georgia, 30331, United States

Location

Emory Dialysis at North Decatur

Decatur, Georgia, 30033, United States

Location

Emory Dialysis at Candler

Decatur, Georgia, 30034, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Dementia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Professor Mi-Kyung Song, PhD, RN
• Organization: Emory University

mi-kyung.song@emory.edu

404-727-3134

Study Officials

• Mi-Kyung Song, RN, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 27, 2019
• Study Start: February 14, 2020
• Primary Completion: March 24, 2022
• Study Completion: March 23, 2023
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)