N/A
N=210
A Representational Intervention to Promote Preparation for End-of-life Decision Making
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01259011 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Dyad Congruence — 48; 64 percentage of congruent dyads — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- the SPIRIT intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyad Congruence |
48; 64 | <.05 sig |
| SECONDARY Change Over Time: Hospital Anxiety and Depression Scale Scores |
6.1; 6.1; 6.6; 6.3; 6.4; 5.1 | 0.12 |
| SECONDARY Change Over Time: Post-traumatic Distress Symptom Score |
17.3; 20.2; 27.0; 23.6; 22.5; 19.3 | 0.21 |
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.
Eligibility Criteria
Inclusion Criteria
for patients,
- self-identified Caucasian or African American;
- receiving either center-hemodialysis or home-peritoneal dialysis for at least 6 months prior to enrollment;
- availability of an individual chosen by the patient who can be present during the intervention as a surrogate decision maker;
- age 18 years or older;
- ability to participate in health care decisions as evidenced by less than 3 errors on the Short Portable Mental Status Questionnaire (SPMSQ), suggesting normal mental functioning;
- ability to read, write, and speak English.
- a CCI score of ≥6;
- hospitalization in the last 6 months, a CCI score of 5, including congestive heart failure (CHF).
for surrogates,
- age 18 years or older (to serve as a surrogate decision maker, the individual must be an adult);
- willingness to serve as the surrogate decision maker and participate in the intervention with the patient;
- ability to read, write, and speak English.
Exclusion Criteria
-Patients who are too sick to participate in an hour-long interview, who require special care and assistance, who would not be able to care for their needs will be excluded.
Data sourced from ClinicalTrials.gov (NCT01259011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.