SPIRIT Advance Care Planning for Kidney Failure

Recruiting at 38 trial locations

Overseen By Mi-Kyung Song, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: No surrogate, Hospice, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

852 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the SPIRIT Advance Care Planning intervention safe for humans?

The SPIRIT intervention, which focuses on advance care planning for patients with kidney failure, has been tested in trials and shown to improve preparedness for end-of-life decision making without any reported safety concerns. ^{1 2 3 4 5}

How is the SPIRIT treatment for kidney failure different from other treatments?

The SPIRIT treatment is unique because it focuses on advance care planning, which involves discussions to help patients with kidney failure understand their illness, set goals, and make informed decisions about their care. Unlike traditional treatments that focus on medical interventions, SPIRIT emphasizes patient-centered communication and planning to improve end-of-life care. ^{5 6 7 8 9}

What data supports the effectiveness of the SPIRIT treatment for kidney failure?

Advance care planning (ACP), which is part of the SPIRIT treatment, helps patients with kidney failure by ensuring their treatment preferences are known and respected at the end of life. Studies show that ACP can improve end-of-life care by aligning medical interventions with patients' wishes, potentially leading to a more dignified and preferred end-of-life experience. ^{6 7 9 10 11}

Who Is on the Research Team?

Mi-Kyung Song, PhD, RN

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients with end-stage renal disease (ESRD) on dialysis who can speak and understand English, along with their chosen surrogates capable of decision-making. It excludes those too ill or cognitively impaired, without a surrogate, already in hospice care, or surrogates unable to complete questionnaires.

Inclusion Criteria

I am currently on dialysis.

Paid caregivers who will not be participating in medical decisions for the patient

I have chosen someone to make decisions for me.

Exclusion Criteria

People who do not have someone who can act as a substitute for them.

You are already receiving care in a hospice program.

My doctor thinks I am too sick or not mentally sharp enough to join.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

SPIRIT is a two-session, 60-minute, structured psychoeducational intervention targeting both patient and surrogate.

2 weeks

2 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments at baseline and two weeks after the intervention.

9 months

Regular monitoring until patient death or end of observation period

Post-bereavement Assessment

Surrogates complete a post-bereavement assessment three months after the death of the patient.

3 months after patient death

Optional Extension

Optional extension of the observational period for an additional 12 months, for up to 21 months of observation.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Comparison Condition
• SPIRIT

Trial Overview The study tests 'SPIRIT', an advance care planning intervention aimed at preparing ESRD patients and their surrogates for end-of-life decisions. It compares SPIRIT delivered by dialysis providers against usual care plus delayed implementation of SPIRIT in outpatient clinics.

How Is the Trial Designed?

Group I: SPIRIT Clinic Experimental Treatment 1 Intervention

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 II: Comparison Condition Clinic Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The study developed an advance care planning intervention for patients with chronic kidney disease, emphasizing a collaborative approach that involved patients, families, and healthcare professionals to address their needs and preferences.

Key components of the intervention include a conversation process that focuses on everyday life, illness, and treatment, along with an advance care planning tool designed to improve communication and support shared decision-making among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning to patients with chronic kidney disease and their families: An intervention development study. Frandsen, CE., Dieperink, H., Trettin, B., et al.[2023]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

Advance Care Planning. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Kidney failure end-of-life care: impact of advance care planning - retrospective observational study. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

Case-control study of end-of-life treatment preferences and costs following advance care planning for adults with end-stage kidney disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Advance care planning to patients with chronic kidney disease and their families: An intervention development study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A practical guide for the care of patients with end-stage renal disease near the end of life. [2019]

6. Belgium pubmed.ncbi.nlm.nih.gov

Caring for people who are dying on renal wards: a retrospective study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Advance Care Planning Training for Renal Social Workers. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Predictive Modelling Risk Calculators and the Non Dialysis Pathway. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Serious Illness Conversations in advanced kidney disease: a mixed-methods implementation study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Advance care planning for adults with CKD: a systematic integrative review. [2019]