Clinical trial NCT01259011: A Representational Intervention to Promote Preparation for End-of-life Decision Making
Official title: A Randomized Controlled Trial of SPIRIT: A Representational Intervention to Promote Preparation for End-of-Life Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: end stage renal disease
dialysis
end of life decision making
surrogate psychological morbidities
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2010-12-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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.

Primary outcomes:
measure: Dyad Congruence
timeFrame: 2, 6, 12 months
Secondary outcomes:
measure: Change Over Time: Hospital Anxiety and Depression Scale Scores
timeFrame: 2 Weeks, and at 3 and 6 months post death
measure: Change Over Time: Post-traumatic Distress Symptom Score
timeFrame: 2 weeks and 3 and 6 months after patient death
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mi-Kyung Song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song MK, Ward SE, Fine JP, Hanson LC, Lin FC, Hladik GA, Hamilton JB, Bridgman JC. Advance care planning and end-of-life decision making in dialysis: a randomized controlled trial targeting patients and their surrogates. Am J Kidney Dis. 2015 Nov;66(5):813-22. doi: 10.1053/j.ajkd.2015.05.018. Epub 2015 Jun 30.
citation: Song MK, Ward SE, Lin FC, Hamilton JB, Hanson LC, Hladik GA, Fine JP. Racial Differences in Outcomes of an Advance Care Planning Intervention for Dialysis Patients and Their Surrogates. J Palliat Med. 2016 Feb;19(2):134-42. doi: 10.1089/jpm.2015.0232.
citation: Song MK, Ward SE, Hanson LC, Metzger M, Kim S. Determining Consistency of Surrogate Decisions and End-of-Life Care Received with Patient Goals-of-Care Preferences. J Palliat Med. 2016 Jun;19(6):610-6. doi: 10.1089/jpm.2015.0349. Epub 2016 Mar 16.
citation: Song MK, Metzger M, Ward SE. Process and impact of an advance care planning intervention evaluated by bereaved surrogate decision-makers of dialysis patients. Palliat Med. 2017 Mar;31(3):267-274. doi: 10.1177/0269216316652012. Epub 2016 Jul 10.
citation: Song MK, Ward SE. The extent of informed decision-making about starting dialysis: does patients' age matter? J Nephrol. 2014 Oct;27(5):571-6. doi: 10.1007/s40620-014-0061-4. Epub 2014 Feb 12.