An Effectiveness-Implementation Trial of SPIRIT in ESRD
Public ClinicalTrials.gov record NCT03138564. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03138564
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 852 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2018
- Primary completion
- Mar 23, 2022
- Completion
- Nov 20, 2025
- Last update posted
- May 6, 2026
2018 – 2025
United States locations
- U.S. sites
- 39
- U.S. states
- 5
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory Dialysis at Northside | Atlanta | Georgia | 30318 | — |
| Emory Dialysis at Greenbriar | Atlanta | Georgia | 30331 | — |
| Emory Dialysis at Candler | Decatur | Georgia | 30034 | — |
| Emory Dialysis Center | North Decatur | Georgia | 30033 | — |
| Dialysis Clinic, Inc - Acoma Canoncito Laguna | Acoma Pueblo | New Mexico | 87034 | — |
| Dialysis Clinic, Inc - Albuquerque | Albuquerque | New Mexico | 87102 | — |
| Dialysis Clinic, Inc - Albuquerque South | Albuquerque | New Mexico | 87105 | — |
| Dialysis Clinic, Inc - Albuquerque East | Albuquerque | New Mexico | 87110 | — |
| Dialysis Clinic, Inc - Carlsbad | Carlsbad | New Mexico | 88220 | — |
| Dialysis Clinic, Inc - Cuba | Cuba | New Mexico | 87013 | — |
| Dialysis Clinic, Inc - Grants | Grants | New Mexico | 87020 | — |
| Dialysis Clinic, Inc - Raton | Raton | New Mexico | 87740 | — |
| Dialysis Clinic, Inc - Rio Rancho | Rio Rancho | New Mexico | 87124 | — |
| Dialysis Clinic, Inc - Santo Domingo | Santo Domingo Pueblo | New Mexico | 87052 | — |
| Dialysis Clinic, Inc - Silver City | Silver City | New Mexico | 88061 | — |
| Dialysis Clinic, Inc - Taos | Taos | New Mexico | 87571 | — |
| Carolina Dialysis - Carrboro | Carrboro | North Carolina | 27510 | — |
| Carolina Dialysis - Mebane | Mebane | North Carolina | 27302 | — |
| Carolina Dialysis - Pittsboro | Pittsboro | North Carolina | 27312 | — |
| Fresenius Kidney Care - Raleigh | Raleigh | North Carolina | 27610 | — |
| Carolina Dialysis-Sanford Lee County | Sanford | North Carolina | 27332 | — |
| Carolina Dialysis-Sanford Main | Sanford | North Carolina | 27332 | — |
| Carolina Dialysis - Siler City | Siler City | North Carolina | 27344 | — |
| Dialysis Clinic, Inc - Harmar Village | Cheswick | Pennsylvania | 15024 | — |
| Dialysis Clinic, Inc - Monroeville/Five Points | Monroeville | Pennsylvania | 15146 | — |
| Dialysis Clinic, Inc - North Versailles | North Versailles | Pennsylvania | 15137 | — |
| Dialysis Clinic, Inc - Oakland | Pittsburgh | Pennsylvania | 15213 | — |
| Dialysis Clinic, Inc - Banksville | Pittsburgh | Pennsylvania | 15216 | — |
| Dialysis Clinic, Inc - Wilkinsburg | Pittsburgh | Pennsylvania | 15221 | — |
| Dialysis Clinic, Inc - North Hills | Pittsburgh | Pennsylvania | 15237 | — |
| UVA Dialysis Altavista Clinic | Altavista | Virginia | 24517 | — |
| UVA Dialysis Amherst Clinic | Amherst | Virginia | 24521 | — |
| Kidney Center Outpatient Dialysis Clinic | Charlottesville | Virginia | 22903 | — |
| UVA Dialysis Clinic Farmville | Farmville | Virginia | 23901 | — |
| UVA Augusta Dialysis | Fishersville | Virginia | 22939 | — |
| UVA Dialysis Zion Crossroads | Gordonsville | Virginia | 22942 | — |
| UVA Dialysis Lynchburg | Lynchburg | Virginia | 24501 | — |
| UVA Dialysis Orange Clinic | Orange | Virginia | 22960 | — |
| UVA Dialysis Clinic Staunton | Staunton | Virginia | 24401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03138564, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03138564 live on ClinicalTrials.gov.