CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 210 enrolled
Drug / intervention
the SPIRIT interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01259011
NCT01259011N/ACompleted

A Randomized Controlled Trial of SPIRIT: A Representational Intervention to Promote Preparation for End-of-Life Decision Making

University of North Carolina, Chapel Hill·interventional·Posted Dec 13, 2010·Updated Sep 25, 2017

In Brief

A clinical study evaluating the SPIRIT intervention for End Stage Renal Disease. Completed, enrolled 210 participants across 1 site.

Detailed Summary

The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness Representations to Increase Trust) intervention designed to improve discussions about end-of-life care between patients and their surrogate decision makers. Subjects will be 200 Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that (1) SPIRIT will lead to significantly less patient decisional conflict and significantly greater dyad congruence and surrogate decision making confidence than the standard care control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate decisional conflict and psychosocial morbidities at 2 weeks after the patient's hospitalization requiring surrogate decision making significantly more than the standard care control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2010
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.6 years ago

Interventions

the SPIRIT interventionbehavioral

the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers