A Representational Intervention to Promote Preparation for End-of-life Decision Making (SPIRIT)
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|ClinicalTrials.gov Identifier: NCT01259011|
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Behavioral: the SPIRIT intervention||Not Applicable|
Dialysis is central to survival for 450,000 Americans with end-stage renal disease (ESRD). Yet patients on dialysis have significant comorbidities and high mortality rates (24% annually). One out of four ESRD patient deaths occurs after a decision to stop dialysis. However, when persons have lost their decision capacity if there has been no prior discussion between the patient and surrogate regarding goals of care, the issue of whether to continue dialysis can pose an ethical impasse and cause profound psychological distress for surrogate decision makers. Using the representational approach to patient education, we developed and pilot tested 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. SPIRIT is a 6-step, 2-session, face-to-face intervention presented to both patient and surrogate by a trained interventionist in an interview format.
The proposed randomized controlled trial will test the effects of the SPIRIT intervention in improving preparedness for end-of-life decision making among ESRD patients and their surrogates and reducing surrogates' conflict during decision making and psychosocial morbidities. Subjects will be 200 Caucasian and African-American patients with ESRD recruited from outpatient dialysis clinics and their chosen surrogate decision makers. Preparedness outcomes (dyad congruence, patient decisional conflict, and surrogate decision making confidence) will be measured at 2, 6, and 12 months post-intervention. Surrogate decisional conflict and psychosocial morbidities (anxiety, depression, and post-traumatic distress symptoms) will be measured 2 weeks after the patient's hospitalization that required surrogate decision making. To compare the effects of SPIRIT to those of standard care on surrogates after the patient's death, psychosocial morbidities will be measured at 3 and 6 months after the patient's death. We will also explore the potential impact of race on intervention effects and examine mediators and moderators of the intervention effects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Controlled Trial of SPIRIT: A Representational Intervention to Promote Preparation for End-of-Life Decision Making|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||April 2014|
No Intervention: control
Written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. A social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record.
Experimental: SPIRIT intervention
The SPIRIT intervention is a two-session, 1½ hour-long, structured intervention that is composed of six steps (assessing representations, identifying and exploring gaps and concerns, creating conditions for conceptual change, introducing replacement information, summarizing, and setting goals and planning), presented to both patient and surrogate by a trained nurse interventionist in a face-to-face interview format based on the representational approach.
Behavioral: the SPIRIT intervention
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
- Dyad Congruence [ Time Frame: 2, 6, 12 months ]patient and surrogate congruence on the goals of care
- Change Over Time: Hospital Anxiety and Depression Scale Scores [ Time Frame: 2 Weeks, and at 3 and 6 months post death ]Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.
- Change Over Time: Post-traumatic Distress Symptom Score [ Time Frame: 2 weeks and 3 and 6 months after patient death ]The Post-Traumatic Symptoms Scale-10 (PTSS-10) was used to assess the presence and intensity of PTSD symptoms during the preceding 7 days. This self-report scale consists of 10 statements that specifically mention symptoms related to PTSD criteria (e.g., sleep problems, nightmares, tension in the body, irritation, startle, etc.) rated on a 7-point Likert scale from 1 (Never/Rare) to 7 (Very often/Always). A total score (range 10 - 70) of > 35 is associated with a high probability that the person meets the diagnostic criteria for PTSD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259011
|United States, North Carolina|
|University of North Carolina, Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Mi-Kyung Song, PhD||University of North Carolina, Chapel Hill|