An Effectiveness-Implementation Trial of SPIRIT in ESRD

NCT03138564 | Completed Results DMC

• 2 other identifiers: IRB000948591R01NR017018-01
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 39

Brief Summary

Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by patients and their surrogates with sufficient time to consider alternatives such as hospice or dying at home. Over the last decade, the researchers have developed and iteratively tested a patient and family-centered advance care planning intervention based on the Representational Approach to Patient Education called "Sharing Patient's Illness Representation to Increase Trust" (SPIRIT). SPIRIT is a 6-step, 2-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. This study is a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics compared to usual care plus delayed SPIRIT implementation. The researchers will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from dialysis clinics in four states. Patients and surrogates will complete questionnaires at baseline and two weeks after the intervention. Surrogates will complete a post-bereavement assessment three months after the death of the patient.

Conditions

End Stage Renal Disease

Keywords

Nursing; Nephrology; Behavioral Research; Social Research

Outcome Measures

Primary Outcomes (4)

• Dyad Congruence on Goals-of-Care Tool

  The Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in end-stage renal disease (ESRD) patients. Possible responses to the scenarios are: "The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis", and "I am not sure". Patients and surrogates complete this tool independently and their responses are compared to determine dyad congruence. A dyad is assigned with "1" if each member of the dyad chose the same response (either comfort care only or continue aggressive care) in both scenarios. In all other cases, the dyad is assigned with "0", which includes: 1) the patient and surrogate responses are the same in one of the two scenarios, 2) the patient and surrogate responses differ in both scenarios, and 3) the patient and surrogate responses are both "I am not sure".

  Baseline, Week 2

• Patient's Decisional Conflict Scale (DCS) Score

  Patient decisional conflict is measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 to 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making.

  Baseline, Week 2

• Surrogate's Decision Making Confidence (DMC) Scale Score

  Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) "Not confident at all" to (4) "Very confident". Total scores range from 0 to 20, with higher scores indicating greater confidence.

  Baseline, Week 2

• Composite Outcome of Dyad Congruence and Surrogate DMC Score

  The composite outcome combines dyad congruence on Goals-of-Care scenarios and surrogate DMC scores. If the dyad congruence is 1 and the surrogate's DMC \>=3, then the composite outcome value for the dyad is "1". In all other cases, the dyad's composite outcome value is "0".

  Baseline, Week 2

Secondary Outcomes (4)

• End-of-life Treatment Intensity

  Upon patient death (up to 21 months)

• Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score

  Baseline, 3 months after patient death (up to 24 months)

• Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score

  Baseline, 3 months after patient death (up to 24 months)

• Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score

  Baseline, 3 months after patient death (up to 24 months)

Study Arms (2)

SPIRIT Clinic

EXPERIMENTAL

Patients at clinics that have been randomized to the SPIRIT arm will be given the option to participate in the intervention. SPIRIT is a two-session, 60-minute, structured psychoeducational intervention, targeting both patient and surrogate. Using a provider manual, the care provider follows six steps: 1) assessing illness presentation, 2) identifying gaps and concerns, 3) creating conditions for conceptual change, 4) introducing replacement information, 5) summarizing, and 6) setting goals and planning.

Behavioral: SPIRIT

Comparison Condition Clinic

ACTIVE COMPARATOR

Patients at clinics that have been randomized to the control arm will be given the option to participate as a study control. The control clinics will have delayed implementation of the SPIRIT intervention.

Behavioral: Comparison Condition

Interventions

SPIRIT BEHAVIORAL

SPIRIT is a two-session, structured psychoeducational intervention assisting patients clarify their end-of-life preferences and helping surrogates understand the patient's wishes and prepare for the surrogate role. During the first session (about 45 minutes) individualized information is provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the care provider will assist the patient to examine his/her values about life-sustaining treatment. The surrogate will receive help preparing for end-of-life decision-making and the emotional burden of decision-making. A Goals-of-Care document will be completed to indicate the patient's preferences. Two weeks later, the second session (about 15 minutes) addresses remaining or new concerns. The patient's Goals-of-Care document will be reviewed. The patient's end-of-life preferences and surrogate's name and relationship to the patient will be documented in the medical record.

Also known as: Sharing Patient's Illness Representation to Increase Trust

SPIRIT Clinic

Comparison Condition BEHAVIORAL

As required by Centers for Medicare and Medicaid Services (CMS), written information on advance directives (ADs) is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an AD. This typically takes about 10 minutes.

Also known as: Usual care

Comparison Condition Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• on either hemodialysis or peritoneal dialysis
• able to understand and speak English

You may not qualify if:

• lack of an available surrogate
• too ill or cognitively impaired to participate based on clinicians' judgment
• already enrolled in hospice
• are chosen as a surrogate by the patient
• paid caregivers who will not be participating in medical decisions for the patient
• Unable to complete questionnaires due to physical or cognitive limitations

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (39)

Emory Dialysis at Northside

Atlanta, Georgia, 30318, United States

Location

Emory Dialysis at Greenbriar

Atlanta, Georgia, 30331, United States

Location

Emory Dialysis at Candler

Decatur, Georgia, 30034, United States

Location

Emory Dialysis Center

North Decatur, Georgia, 30033, United States

Location

Dialysis Clinic, Inc - Acoma Canoncito Laguna

Acoma Pueblo, New Mexico, 87034, United States

Location

Dialysis Clinic, Inc - Albuquerque

Albuquerque, New Mexico, 87102, United States

Location

Dialysis Clinic, Inc - Albuquerque South

Albuquerque, New Mexico, 87105, United States

Location

Dialysis Clinic, Inc - Albuquerque East

Albuquerque, New Mexico, 87110, United States

Location

Dialysis Clinic, Inc - Carlsbad

Carlsbad, New Mexico, 88220, United States

Location

Dialysis Clinic, Inc - Cuba

Cuba, New Mexico, 87013, United States

Location

Dialysis Clinic, Inc - Grants

Grants, New Mexico, 87020, United States

Location

Dialysis Clinic, Inc - Raton

Raton, New Mexico, 87740, United States

Location

Dialysis Clinic, Inc - Rio Rancho

Rio Rancho, New Mexico, 87124, United States

Location

Dialysis Clinic, Inc - Santo Domingo

Santo Domingo Pueblo, New Mexico, 87052, United States

Location

Dialysis Clinic, Inc - Silver City

Silver City, New Mexico, 88061, United States

Location

Dialysis Clinic, Inc - Taos

Taos, New Mexico, 87571, United States

Location

Carolina Dialysis - Carrboro

Carrboro, North Carolina, 27510, United States

Location

Carolina Dialysis - Mebane

Mebane, North Carolina, 27302, United States

Location

Carolina Dialysis - Pittsboro

Pittsboro, North Carolina, 27312, United States

Location

Fresenius Kidney Care - Raleigh

Raleigh, North Carolina, 27610, United States

Location

Carolina Dialysis-Sanford Lee County

Sanford, North Carolina, 27332, United States

Location

Carolina Dialysis-Sanford Main

Sanford, North Carolina, 27332, United States

Location

Carolina Dialysis - Siler City

Siler City, North Carolina, 27344, United States

Location

Dialysis Clinic, Inc - Harmar Village

Cheswick, Pennsylvania, 15024, United States

Location

Dialysis Clinic, Inc - Monroeville/Five Points

Monroeville, Pennsylvania, 15146, United States

Location

Dialysis Clinic, Inc - North Versailles

North Versailles, Pennsylvania, 15137, United States

Location

Dialysis Clinic, Inc - Oakland

Pittsburgh, Pennsylvania, 15213, United States

Location

Dialysis Clinic, Inc - Banksville

Pittsburgh, Pennsylvania, 15216, United States

Location

Dialysis Clinic, Inc - Wilkinsburg

Pittsburgh, Pennsylvania, 15221, United States

Location

Dialysis Clinic, Inc - North Hills

Pittsburgh, Pennsylvania, 15237, United States

Location

UVA Dialysis Altavista Clinic

Altavista, Virginia, 24517, United States

Location

UVA Dialysis Amherst Clinic

Amherst, Virginia, 24521, United States

Location

Kidney Center Outpatient Dialysis Clinic

Charlottesville, Virginia, 22903, United States

Location

UVA Dialysis Clinic Farmville

Farmville, Virginia, 23901, United States

Location

UVA Augusta Dialysis

Fishersville, Virginia, 22939, United States

Location

UVA Dialysis Zion Crossroads

Gordonsville, Virginia, 22942, United States

Location

UVA Dialysis Lynchburg

Lynchburg, Virginia, 24501, United States

Location

UVA Dialysis Orange Clinic

Orange, Virginia, 22960, United States

Location

UVA Dialysis Clinic Staunton

Staunton, Virginia, 24401, United States

Location

Related Publications (2)

• Song MK, Unruh ML, Manatunga A, Plantinga LC, Lea J, Jhamb M, Kshirsagar AV, Ward SE. SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD. Contemp Clin Trials. 2018 Jan;64:188-194. doi: 10.1016/j.cct.2017.10.005. Epub 2017 Oct 6.

  PMID: 28993286 BACKGROUND

• Song MK, Manatunga A, Plantinga L, Metzger M, Kshirsagar AV, Lea J, Abdel-Rahman EM, Jhamb M, Wu E, Englert J, Ward SE. Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2351511. doi: 10.1001/jamanetworkopen.2023.51511.

  PMID: 38289604 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

ligroin

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: Mi-Kyung Song, PhD, RN
• Organization: Emory University

mi-kyung.song@emory.edu

404-727-3134

Study Officials

• Mi-Kyung Song, PhD, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Dialysis clinics are randomized to provide the intervention or usual care. Patients of those clinics will be given the opportunity to participate in the study and will receive the intervention or usual care based on which clinic they attend.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: February 15, 2018
• Primary Completion: March 24, 2022
• Study Completion: November 21, 2025
• Last Updated: February 23, 2026
• Results First Posted: September 18, 2023

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (39)