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An Effectiveness-Implementation Trial of SPIRIT in ESRD
Sponsor: Emory University
Summary
Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by patients and their surrogates with sufficient time to consider alternatives such as hospice or dying at home. Over the last decade, the researchers have developed and iteratively tested a patient and family-centered advance care planning intervention based on the Representational Approach to Patient Education called "Sharing Patient's Illness Representation to Increase Trust" (SPIRIT). SPIRIT is a 6-step, 2-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. This study is a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics compared to usual care plus delayed SPIRIT implementation. The researchers will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from dialysis clinics in four states. Patients and surrogates will complete questionnaires at baseline and two weeks after the intervention. Surrogates will complete a post-bereavement assessment three months after the death of the patient.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
852
Start Date
2018-02-15
Completion Date
2025-11-21
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
SPIRIT
SPIRIT is a two-session, structured psychoeducational intervention assisting patients clarify their end-of-life preferences and helping surrogates understand the patient's wishes and prepare for the surrogate role. During the first session (about 45 minutes) individualized information is provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the care provider will assist the patient to examine his/her values about life-sustaining treatment. The surrogate will receive help preparing for end-of-life decision-making and the emotional burden of decision-making. A Goals-of-Care document will be completed to indicate the patient's preferences. Two weeks later, the second session (about 15 minutes) addresses remaining or new concerns. The patient's Goals-of-Care document will be reviewed. The patient's end-of-life preferences and surrogate's name and relationship to the patient will be documented in the medical record.
Comparison Condition
As required by Centers for Medicare and Medicaid Services (CMS), written information on advance directives (ADs) 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 AD. This typically takes about 10 minutes.
Locations (39)
Emory Dialysis at Northside
Atlanta, Georgia, United States
Emory Dialysis at Greenbriar
Atlanta, Georgia, United States
Emory Dialysis at Candler
Decatur, Georgia, United States
Emory Dialysis Center
North Decatur, Georgia, United States
Dialysis Clinic, Inc - Acoma Canoncito Laguna
Acoma Pueblo, New Mexico, United States
Dialysis Clinic, Inc - Albuquerque
Albuquerque, New Mexico, United States
Dialysis Clinic, Inc - Albuquerque South
Albuquerque, New Mexico, United States
Dialysis Clinic, Inc - Albuquerque East
Albuquerque, New Mexico, United States
Dialysis Clinic, Inc - Carlsbad
Carlsbad, New Mexico, United States
Dialysis Clinic, Inc - Cuba
Cuba, New Mexico, United States
Dialysis Clinic, Inc - Grants
Grants, New Mexico, United States
Dialysis Clinic, Inc - Raton
Raton, New Mexico, United States
Dialysis Clinic, Inc - Rio Rancho
Rio Rancho, New Mexico, United States
Dialysis Clinic, Inc - Santo Domingo
Santo Domingo Pueblo, New Mexico, United States
Dialysis Clinic, Inc - Silver City
Silver City, New Mexico, United States
Dialysis Clinic, Inc - Taos
Taos, New Mexico, United States
Carolina Dialysis - Carrboro
Carrboro, North Carolina, United States
Carolina Dialysis - Mebane
Mebane, North Carolina, United States
Carolina Dialysis - Pittsboro
Pittsboro, North Carolina, United States
Fresenius Kidney Care - Raleigh
Raleigh, North Carolina, United States
Carolina Dialysis-Sanford Lee County
Sanford, North Carolina, United States
Carolina Dialysis-Sanford Main
Sanford, North Carolina, United States
Carolina Dialysis - Siler City
Siler City, North Carolina, United States
Dialysis Clinic, Inc - Harmar Village
Cheswick, Pennsylvania, United States
Dialysis Clinic, Inc - Monroeville/Five Points
Monroeville, Pennsylvania, United States
Dialysis Clinic, Inc - North Versailles
North Versailles, Pennsylvania, United States
Dialysis Clinic, Inc - Oakland
Pittsburgh, Pennsylvania, United States
Dialysis Clinic, Inc - Banksville
Pittsburgh, Pennsylvania, United States
Dialysis Clinic, Inc - Wilkinsburg
Pittsburgh, Pennsylvania, United States
Dialysis Clinic, Inc - North Hills
Pittsburgh, Pennsylvania, United States
UVA Dialysis Altavista Clinic
Altavista, Virginia, United States
UVA Dialysis Amherst Clinic
Amherst, Virginia, United States
Kidney Center Outpatient Dialysis Clinic
Charlottesville, Virginia, United States
UVA Dialysis Clinic Farmville
Farmville, Virginia, United States
UVA Augusta Dialysis
Fishersville, Virginia, United States
UVA Dialysis Zion Crossroads
Gordonsville, Virginia, United States
UVA Dialysis Lynchburg
Lynchburg, Virginia, United States
UVA Dialysis Orange Clinic
Orange, Virginia, United States
UVA Dialysis Clinic Staunton
Staunton, Virginia, United States