Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03138564 · ClinicalTrials.gov registry record · NA
An Effectiveness-Implementation Trial of SPIRIT in ESRD
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 852
- Enrollment target
NCT03138564: Completed NA study, sponsored by Emory University.
NCT03138564 is a NA study that has completed, run by Emory University. The registered enrollment target is 852 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03138564, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 852 participants
- Enrollment target
Study 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.
Primary Outcome
The Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in end-stage renal disease (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 independentl
Interventions
- BEHAVIORAL SPIRIT
- BEHAVIORAL Comparison Condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 852 participants |
| Start Date | 2018-02-15 |
| Est. Completion | 2025-11-21 |
| Phase | NA |
What the finished NCT03138564 record still lists
NCT03138564 is an interventional study that assigns participants to a tested intervention. The registered 852 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which SPIRIT is the first listed.
NCT03138564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03138564 about?
NCT03138564 is a clinical study titled "An Effectiveness-Implementation Trial of SPIRIT in ESRD". 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 s...
What is the current status of trial NCT03138564?
This trial is currently completed. It is a NA study. The enrollment target is 852 participants. The study started on 2018-02-15. Estimated completion is 2025-11-21.
What interventions are being tested in trial NCT03138564?
The interventions under investigation include: SPIRIT (BEHAVIORAL), Comparison Condition (BEHAVIORAL).
Who is sponsoring clinical trial NCT03138564?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03138564's enrollment target sits among peer trials
852 131st of 2000 higher than 1,870 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06237452 · 852 participants · Phase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
- NCT06422143 · 851 participants · Phase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
- NCT07005102 · 854 participants · Phase 2
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
- NCT07290491 · 854 participants · Phase 3
Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI