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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Mi-Kyung Song, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01259011
First received: December 6, 2010
Last updated: January 7, 2015
Last verified: January 2015
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
Enrollment: 420
Study Start Date: March 2010
Study Completion Date: April 2014
Primary Completion Date: February 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259011

Locations
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Mi-Kyung Song, PhD University of North Carolina, Chapel Hill
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: January 7, 2015
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
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 28, 2016