# An Effectiveness-Implementation Trial of SPIRIT in ESRD

> **NIH NIH R01** · EMORY UNIVERSITY · 2020 · $685,506

## Abstract

Abstract
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, we have developed and
iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a patient and family-
centered advance care planning intervention based on the Representational Approach to Patient Education.
We have established feasibility, patient-surrogate acceptability, and efficacy. 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. 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, and surrogates in SPIRIT reported significantly improved post-
bereavement psychological outcomes after the patient's death compared to a no treatment comparison
condition. The logical, critical next step is to ask: Will SPIRIT be effective as part of routine care in real-world
settings with less control? To address this very issue, we will conduct a real-world effectiveness-
implementation study. We propose 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, we will evaluate
the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of
death in the next year and their surrogates from 30 dialysis clinics in 4 states to accomplish the following aims:
Aim 1. Examine the effectiveness of SPIRIT compared to usual care on preparedness outcomes for end-of-life
decision making (defined as dyad congruence on goals of care, patient decisional conflict, and surrogate
decision-making confidence) at 2 weeks post-intervention; Aim 2. Evaluate the process outcomes of SPIRIT
implementation: acceptability, fidelity, intervention costs, and sustainability during the initial and delayed
implementation of SPIRIT; Aim 3. Examine the effectiveness of SPIRIT and usual care on surrogates' post-
bereavement distress (anxiety, depression, and post-traumatic distress symptoms) at 3 months after the
patient's death; and Aim 4. Secondary Aim: Examine the effectiveness of SPIRIT and usual care on end-of-
life treatment intensity (percentages of patients hospitalized, having ICU admission, and having intensive
procedures and length of hospital stay) during the final month of life. This real...

## Key facts

- **NIH application ID:** 9890004
- **Project number:** 5R01NR017018-04
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** MI-KYUNG SONG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $685,506
- **Award type:** 5
- **Project period:** 2017-06-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9890004

## Citation

> US National Institutes of Health, RePORTER application 9890004, An Effectiveness-Implementation Trial of SPIRIT in ESRD (5R01NR017018-04). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9890004. Licensed CC0.

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