A Representational Intervention to Promote Preparation for End-of-life Decision Making

End Stage Renal Disease Clinical Trial

— SPIRIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259011
• Other study ID #: 09-1190
• Secondary ID: R01NR011464
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: July 28, 2017
• Start date: March 2010
• Est. completion date: April 2014

Study information

• Verified date: July 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

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

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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):81 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyad Congruence	patient and surrogate congruence on the goals of care	2, 6, 12 months
Secondary	Change Over Time: Hospital Anxiety and Depression Scale Scores	Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.	2 Weeks, and at 3 and 6 months post death
Secondary	Change Over Time: Post-traumatic Distress Symptom Score	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.	2 weeks and 3 and 6 months after patient death