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

NCT01259011 | Completed Results DMC

• 2 other identifiers: 09-1190R01NR011464
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

end stage renal disease; dialysis; end of life decision making; surrogate psychological morbidities

Outcome Measures

Primary Outcomes (1)

• Dyad Congruence

  patient and surrogate congruence on the goals of care

  2, 6, 12 months

Secondary Outcomes (2)

• Change Over Time: Hospital Anxiety and Depression Scale Scores

  2 Weeks, and at 3 and 6 months post death

• Change Over Time: Post-traumatic Distress Symptom Score

  2 weeks and 3 and 6 months after patient death

Study Arms (2)

control

NO INTERVENTION

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.

SPIRIT intervention

EXPERIMENTAL

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

Interventions

the SPIRIT intervention BEHAVIORAL

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 intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

• 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.

  PMID: 26141307 RESULT

• 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.

  PMID: 26840848 RESULT

• 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.

  PMID: 26982909 RESULT

• 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.

  PMID: 27272317 RESULT

• 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.

  PMID: 24519843 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Mi-Kyung Song
• Organization: Emory University

mi-kyung.song@emory.edu

404-727-3134

Study Officials

• Mi-Kyung Song, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 13, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-07

Locations

US (1)