SPIRIT Advance Care Planning for Kidney Failure

Not currently recruiting at 39 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist patients with end-stage renal disease (ESRD) in making informed decisions about their care as they approach the end of life. It tests the effectiveness of a program called SPIRIT, which includes two sessions to prepare patients and their chosen surrogates for making difficult decisions about continuing dialysis or exploring other options, such as hospice care. The trial seeks patients currently on dialysis who can communicate in English, along with their surrogates, to aid in decision-making. Participants will be randomly assigned to either start the SPIRIT program immediately or delay it to observe differences in outcomes. As an unphased trial, this study offers participants the chance to contribute to research that could enhance decision-making support for others facing similar challenges.

Will I have to stop taking my current medications?

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

What prior data suggests that the SPIRIT intervention is safe for patients with kidney failure?

Research has shown that the SPIRIT program improves communication and is safe for patients and their families. In past studies, SPIRIT helped patients and their decision-makers feel more prepared for end-of-life choices without causing stress or harm. Participants in another study found the process easy to handle and would recommend it to others.

Although SPIRIT is a learning approach, not a drug or medical procedure, positive feedback from users supports its safety. Participants felt more prepared and reported better experiences in dealing with end-of-life situations. This suggests that the program is well-received and poses no known risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPIRIT Advance Care Planning technique for kidney failure because it offers a structured psychoeducational approach, unlike traditional treatments that primarily focus on medical management. Most current treatments for kidney failure emphasize medication, dialysis, or transplant. However, SPIRIT uniquely targets both patients and their surrogates through guided conversations that address the emotional and psychological aspects of living with kidney failure. By facilitating better communication and understanding between patients and their care providers, SPIRIT aims to improve decision-making and quality of life, offering a more holistic approach to care.

What evidence suggests that the SPIRIT intervention is effective for advance care planning in kidney failure?

Research has shown that the SPIRIT program, which participants in this trial may receive, helps patients with severe kidney disease and their families plan for future medical care. In a previous study, SPIRIT improved communication between patients and their decision-makers, making them better prepared for end-of-life choices. This program has successfully helped patients and their families understand the illness and treatment options. Studies have also found that participants felt the SPIRIT sessions were helpful and engaging, which made them more comfortable discussing tough topics about their care. Overall, evidence suggests SPIRIT is a promising tool for improving discussions about end-of-life care for those with kidney failure. ^{1 6 7 8 9}

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. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814337

Effectiveness of an Advance Care Planning Intervention in ... Results of this trial demonstrated that the advance care planning intervention by health care workers at dialysis centers improved patient and surrogate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11161133/

Building the Evidence for Advance Care Planning for Patients ... The trial by Song and colleagues offers some important lessons for implementing serious illness models of care in kidney failure. First, SPIRIT's robust reach ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03138564

An Effectiveness-Implementation Trial of SPIRIT in ESRD This study is a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of ...

4. ajkd.org ajkd.org/article/S0272-6386(25)00044-7/abstract

Implementation of An Advance Care Planning Intervention ... This study suggests that SPIRIT was delivered with high fidelity and was experienced positively by stakeholders. However, challenges such as ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714417304500

SPIRIT trial: A phase III pragmatic trial of an advance care ... This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5972830/

Advance Care Planning and End-of-Life Decision Making ... SPIRIT was associated with improvements in dyad preparation for end-of-life decision making and surrogate bereavement outcomes.

7. withpower.com withpower.com/trial/phase-kidney-failure-chronic-1-2018-ce7ce

SPIRIT Advance Care Planning for Kidney Failure 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 ...

8. journals.lww.com journals.lww.com/kidney360/fulltext/2022/10000/a_pilot_randomized_controlled_trial_of_integrated.11.aspx

A Pilot Randomized Controlled Trial of Integrated Palliative ... Eight respondents (62%) said they did not find the process cumbersome, whereas 12 (92%) said they would participate again and would encourage others to ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203056/

Advance Care Planning With Patients Who Have End-Stage ... Patients with end-stage kidney disease have a high disease burden and a mortality rate that exceeds age-matched individuals with cancer and cardiovascular ...