An Effectiveness-Implementation Trial of SPIRIT in ESRD
Completed · Not applicable
Conditions studied: End Stage Renal Disease
In brief
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 facts
- Study ID
- NCT03138564
- Run by
- Emory University
- People needed
- 852
- Starts
- 2018-02-15
- Expected to finish
- 2025-11-21
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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