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SPIRIT Advance Care Planning for Kidney Failure

N/A

Waitlist Available

Led By Mi-Kyung Song, PhD, RN

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients on either hemodialysis or peritoneal dialysis

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months after patient death (up to 24 months)

Awards & highlights

Study Summary

This trial will test whether a patient and family-centered advance care planning intervention called SPIRIT, which is designed to help patients with end-stage renal disease (ESRD) and their surrogates prepare for end-of-life decision making, is effective when delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since SPIRIT is a communication-focused intervention rather than a medical treatment, it does not have traditional side effects. However, participants may experience emotional distress when discussing end-of-life preferences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months after patient death (up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months after patient death (up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months after patient death (up to 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Outcome of Dyad Congruence and Surrogate DMC Score

Dyad Congruence on Goals-of-Care Tool

Patient's Decisional Conflict Scale (DCS) Score

+1 more

Secondary outcome measures

End-of-life Treatment Intensity

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

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

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SPIRIT ClinicExperimental Treatment1 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 ClinicActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,559,844 Total Patients Enrolled

3 Trials studying Kidney Failure

1,551 Patients Enrolled for Kidney Failure

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,375,709 Total Patients Enrolled

2 Trials studying Kidney Failure

2,145 Patients Enrolled for Kidney Failure

Mi-Kyung Song, PhD, RNPrincipal Investigator - Emory University

Emory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian healthcare facilities participating in this investigation?

"There are 20 different study sites currently partaking in the trial, located across Farmville, Pittsboro and Decatur as well as other locales. We recommend you choose a nearby centre to reduce any necessary travelling obligations if participating."

Answered by AI

Is access to this research opportunity still available for participants?

"According to clinicaltrials.gov, this study is no longer enrolling patients; the initial post was made on February 15th 2018 and the most recent update occured in May 9th 2022. Despite this trial's closure, there are 180 other clinical trials actively recruiting right now."

Answered by AI