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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259011
First Posted: December 13, 2010
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Mi-Kyung Song, PhD, RN, FAAN, University of North Carolina, Chapel Hill
  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
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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Further study details as provided by Mi-Kyung Song, PhD, RN, FAAN, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Dyad Congruence [ Time Frame: 2, 6, 12 months ]
    patient and surrogate congruence on the goals of care


Secondary Outcome Measures:
  • 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.
Enrollment: 210
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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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:

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

Responsible Party: Mi-Kyung Song, PhD, RN, FAAN, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01259011     History of Changes
Other Study ID Numbers: 09-1190
R01NR011464 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2010
First Posted: December 13, 2010
Results First Submitted: September 29, 2016
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mi-Kyung Song, PhD, RN, FAAN, 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