A Representational Intervention to Promote Preparation for End-of-life Decision Making (SPIRIT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
End Stage Renal Disease |
Behavioral: the SPIRIT intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- changes from baseline in dyad preparedness for end-of-life decision making over 12 months [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]patient and surrogate congruence on the goals of care; patient decisional conflict; surrogate decision making confidence
- changes from baseline in surrogate psychosocial morbidities over 6 months [ Time Frame: 3 and 6 month post death ] [ Designated as safety issue: No ]
- surrogate perspectives on decision making experience [ Time Frame: 2 weeks post death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: control | |
| Experimental: SPIRIT intervention |
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Mi-Kyung Song, Associate Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01259011 History of Changes |
| Other Study ID Numbers: | 09-1190, R01NR011464 |
| Study First Received: | December 6, 2010 |
| Last Updated: | May 5, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of North Carolina, Chapel Hill:
|
end stage renal disease dialysis end of life decision making surrogate psychological morbidities |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on June 17, 2013