An Effectiveness-Implementation Trial of SPIRIT in ESRD

NCT ID: NCT03138564

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 852 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2025-12-31

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.

Detailed Description

End-stage renal disease (ESRD) currently affects nearly 662,000 people in the U.S. While dialysis is the treatment of choice for over 90% of patients with ESRD and is universally covered by Medicare regardless of patient age or means, the likelihood that dialysis can restore health or prolong life is limited; only 50% of dialysis patients are alive 3 years after the onset of ESRD. Thus many dialysis patients and their family members or surrogate decision-makers have to face difficult end-of-life decisions. Although advance care planning (ACP), in which patients and surrogate decision-makers discuss future health states and treatment options, is a central tenet of dialysis care, the vast majority of dialysis patients (>90%) report never engaging in ACP discussions with their care providers. The lack of effective ACP to prepare patients and their surrogates for end-of-life decision making with sufficient time before death has deleterious consequences at all levels of society. Consequences have been well documented: prolonged use of futile treatment at the end of life, which misuses the healthcare system, high levels of surrogate distress during decision making, which emanates from not having a clear understanding of the patient's wishes, and surrogates experiencing later sequelae of psychosocial morbidities, such as depression and family discord.

"Sharing Patient's Illness Representation to Increase Trust" (SPIRIT), a patient and family-centered ACP intervention based on the Representational Approach to Patient Education, was designed by the research team to establish a testable model of how end-of-life care discussions could occur between a dialysis patient and his/her chosen surrogate (usually a spouse or adult child). The discussions, which are facilitated by a trained care provider, are framed around addressing each individual's representations of (beliefs about) the illness and views of life-sustaining measures at the end of life. SPIRIT follows a six-step learning objective over two-sessions, which together take about 60 minutes. The care provider, who is value-neutral, guides the patient in examining his/her values related to end-of-life care, helps the surrogate understand the patient's illness progression, and prepares the surrogate for his/her role as a surrogate in a highly emotionally charged medical setting. Over the last decade, SPIRIT has been tested to establish feasibility, patient-surrogate acceptability, and efficacy. In these explanatory trials carried out in dialysis clinics, SPIRIT was delivered by trained research nurses. Patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, including the extent to which: a) the patient and surrogate agreed on end-of-life care goals, b) the patient had reduced conflict about the benefits and burdens of life-sustaining treatments, and c) the surrogate had increased confidence about the role of surrogate. Key to establishing the utility of this approach for broader generalizability, surrogates who received SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to those who did not. The logical, critical next step is to ask: Will SPIRIT be effective as part of routine care in real-world clinical settings with less control? To address this very issue, the researchers will conduct a real-world effectiveness-implementation study, an essential step prior to widespread implementation of SPIRIT.

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. Simultaneously, the researchers will evaluate the implementation of SPIRIT, including sustainability. This study will use a Type I effectiveness-implementation hybrid approach that combines testing intervention effectiveness and gathering information about implementation of an efficacious intervention in a real world setting. To maximize data on the implementation process and sustainability, the researchers chose a delayed intervention design in which clinics are randomized either to implement SPIRIT immediately after randomization (i.e., initial implementation) or to maintain usual care for a comparison condition and then implement the intervention in control clinics following conclusion of this clinical trial (i.e., delayed implementation). The intent of the delayed implementation group was provide descriptive data for translation of the intervention into clinical practice (versus data collected on dyad participants in this current study), however, this portion of the study could not be performed due to the coronavirus disease 2019 (COVID-19) pandemic.

The short-term goal is to generate sufficient evidence to accelerate the integration of SPIRIT into dialysis practice and policy. This study will recruit 400 dyads of patients at high risk of death in the next year and their surrogates (a total of 800 individuals) from dialysis clinics in four states. The dialysis clinics will be randomized to implement SPIRIT or to maintain usual care to serve as a control to the intervention. Participants will complete a follow-up assessment two weeks after the the study intervention. They will then be observed for 9 months (or until the death of the patient) with an optional extension of the observational period for an additional 12 months, for up to 21 months of observation. Individual patient participation will end after the observation period (9 or 21 months) or death, whichever occurs first; surrogate participation will end after the observation period (9 or 21 months) or at the completion of the post-bereavement surveys which are administered 3-months after the death of the patient (up to 24 months).

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SPIRIT Clinic

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.

Group Type: EXPERIMENTAL

SPIRIT

Intervention Type: 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.

Comparison Condition Clinic

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.

Group Type: ACTIVE_COMPARATOR

Comparison Condition

Intervention Type: 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.

Interventions

SPIRIT

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.

Intervention Type: BEHAVIORAL

Comparison Condition

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Sharing Patient's Illness Representation to Increase Trust; Usual care

Eligibility Criteria

Inclusion Criteria

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

• are chosen as a surrogate by the patient
• paid caregivers who will not be participating in medical decisions for the patient

Exclusion Criteria

• lack of an available surrogate
• too ill or cognitively impaired to participate based on clinicians' judgment
• already enrolled in hospice

• Unable to complete questionnaires due to physical or cognitive limitations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Mi-Kyung Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi-Kyung Song, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Dialysis at Northside

Atlanta, Georgia, United States

Emory Dialysis at Greenbriar

Atlanta, Georgia, United States

Emory Dialysis at Candler

Decatur, Georgia, United States

Emory Dialysis Center

North Decatur, Georgia, United States

Dialysis Clinic, Inc - Acoma Canoncito Laguna

Acoma Pueblo, New Mexico, United States

Dialysis Clinic, Inc - Albuquerque

Albuquerque, New Mexico, United States

Dialysis Clinic, Inc - Albuquerque South

Albuquerque, New Mexico, United States

Dialysis Clinic, Inc - Albuquerque East

Albuquerque, New Mexico, United States

Dialysis Clinic, Inc - Carlsbad

Carlsbad, New Mexico, United States

Dialysis Clinic, Inc - Cuba

Cuba, New Mexico, United States

Dialysis Clinic, Inc - Grants

Grants, New Mexico, United States

Dialysis Clinic, Inc - Raton

Raton, New Mexico, United States

Dialysis Clinic, Inc - Rio Rancho

Rio Rancho, New Mexico, United States

Dialysis Clinic, Inc - Santo Domingo

Santo Domingo Pueblo, New Mexico, United States

Dialysis Clinic, Inc - Silver City

Silver City, New Mexico, United States

Dialysis Clinic, Inc - Taos

Taos, New Mexico, United States

Carolina Dialysis - Carrboro

Carrboro, North Carolina, United States

Carolina Dialysis - Mebane

Mebane, North Carolina, United States

Carolina Dialysis - Pittsboro

Pittsboro, North Carolina, United States

Fresenius Kidney Care - Raleigh

Raleigh, North Carolina, United States

Carolina Dialysis-Sanford Lee County

Sanford, North Carolina, United States

Carolina Dialysis-Sanford Main

Sanford, North Carolina, United States

Carolina Dialysis - Siler City

Siler City, North Carolina, United States

Dialysis Clinic, Inc - Harmar Village

Cheswick, Pennsylvania, United States

Dialysis Clinic, Inc - Monroeville/Five Points

Monroeville, Pennsylvania, United States

Dialysis Clinic, Inc - North Versailles

North Versailles, Pennsylvania, United States

Dialysis Clinic, Inc - Oakland

Pittsburgh, Pennsylvania, United States

Dialysis Clinic, Inc - Banksville

Pittsburgh, Pennsylvania, United States

Dialysis Clinic, Inc - Wilkinsburg

Pittsburgh, Pennsylvania, United States

Dialysis Clinic, Inc - North Hills

Pittsburgh, Pennsylvania, United States

UVA Dialysis Altavista Clinic

Altavista, Virginia, United States

UVA Dialysis Amherst Clinic

Amherst, Virginia, United States

Kidney Center Outpatient Dialysis Clinic

Charlottesville, Virginia, United States

UVA Dialysis Clinic Farmville

Farmville, Virginia, United States

UVA Augusta Dialysis

Fishersville, Virginia, United States

UVA Dialysis Zion Crossroads

Gordonsville, Virginia, United States

UVA Dialysis Lynchburg

Lynchburg, Virginia, United States

UVA Dialysis Orange Clinic

Orange, Virginia, United States

UVA Dialysis Clinic Staunton

Staunton, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28993286 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38289604 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NR017018-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00094859

Identifier Type: -

Identifier Source: org_study_id