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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 is a NA study that has completed, run by Emory University. The registered enrollment target is 852 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03138564
The ClinicalTrials.gov registry entry for NCT03138564 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 852 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SPIRIT is the first listed.
NCT03138564 reports 0 study locations.
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.
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