NCT03138564

An Effectiveness-Implementation Trial of SPIRIT in ESRD

Completed NA Results posted Last updated 23 February 2026

What this trial tests

NA trial testing SPIRIT in End Stage Renal Disease in 852 participants. Completed in 21 November 2025.

Timeline

15 February 2018

Primary endpoint
24 March 2022

21 November 2025

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	852
Start date	15 February 2018
Primary completion	24 March 2022
Estimated completion	21 November 2025
Sites	39 locations across United States

Drugs / interventions tested

• SPIRIT
• Comparison Condition

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Emory University

Who can join

18 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dyad Congruence on Goals-of-Care Tool Primary · Baseline, Week 2

The Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in end-stage renal disease (ESRD) patients. Possible responses to the scenarios are: "The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis", and "I am not sure". Patients and surrogates complete this tool independently and their responses are compared to determine dyad congruence. A dyad is assigned with "1" if each

Number of Congruent Dyads at Baseline (assigned value = 1)

Group	Value	95% CI
SPIRIT Clinic - Dyads	98
Comparison Condition Clinic - Dyads	76

Number of Incongruent Dyads at Baseline (assigned value = 0)

Group	Value	95% CI
SPIRIT Clinic - Dyads	133
Comparison Condition Clinic - Dyads	119

Number of Congruent Dyads at 2 Weeks Post-Intervention (assigned value = 1)

Group	Value	95% CI
SPIRIT Clinic - Dyads	111
Comparison Condition Clinic - Dyads	94

Number of Incongruent Dyads at 2 Weeks Post-Intervention (assigned value = 0)

Group	Value	95% CI
SPIRIT Clinic - Dyads	71
Comparison Condition Clinic - Dyads	93

Patient's Decisional Conflict Scale (DCS) Score Primary · Baseline, Week 2

Patient decisional conflict is measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 to 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making.

Baseline

Group	Value	95% CI
SPIRIT Clinic - Patients	25.6	± 6.22
Comparison Condition Clinic - Patients	24.8	± 5.82

Two Weeks Post-Intervention

Group	Value	95% CI
SPIRIT Clinic - Patients	23.4	± 5.94
Comparison Condition Clinic - Patients	24.1	± 5.78

Surrogate's Decision Making Confidence (DMC) Scale Score Primary · Baseline, Week 2

Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) "Not confident at all" to (4) "Very confident". Total scores range from 0 to 20, with higher scores indicating greater confidence.

Baseline

Group	Value	95% CI
SPIRIT Clinic - Surrogates	18.2	± 2.73
Comparison Condition Clinic - Surrogates	18.3	± 2.59

Two Weeks Post-Intervention

Group	Value	95% CI
SPIRIT Clinic - Surrogates	18.9	± 1.73
Comparison Condition Clinic - Surrogates	18.6	± 2.16

Composite Outcome of Dyad Congruence and Surrogate DMC Score Primary · Baseline, Week 2

The composite outcome combines dyad congruence on Goals-of-Care scenarios and surrogate DMC scores. If the dyad congruence is 1 and the surrogate's DMC \>=3, then the composite outcome value for the dyad is "1". In all other cases, the dyad's composite outcome value is "0".

Number of Dyads Where Baseline Composite Outcome = 1

Group	Value	95% CI
SPIRIT Clinic - Dyads	92
Comparison Condition Clinic - Dyads	74

Number of Dyads Where Baseline Composite Outcome = 0

Group	Value	95% CI
SPIRIT Clinic - Dyads	139
Comparison Condition Clinic - Dyads	121

Number of Dyads Where Week 2 Post-Intervention Composite Outcome = 1

Group	Value	95% CI
SPIRIT Clinic - Dyads	107
Comparison Condition Clinic - Dyads	90

Number of Dyads Where Week 2 Post-Intervention Composite Outcome = 0

Group	Value	95% CI
SPIRIT Clinic - Dyads	75
Comparison Condition Clinic - Dyads	97

Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score Secondary · Baseline, 3 months after patient death (up to 24 months)

Surrogate post-bereavement anxiety symptoms were measured with the Hospital Anxiety and Depression Scale (HADS) Anxiety subscale. Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). Scores for the anxiety subscale range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety.

Baseline for all surrogates where the patient died during the follow-up period

Group	Value	95% CI
SPIRIT Clinic - Surrogates	4.80	± 2.99
Comparison Condition Clinic - Surrogates	4.89	± 2.83

Baseline for surrogates who completed the post-bereavement assessment

Group	Value	95% CI
SPIRIT Clinic - Surrogates	4.85	± 3.07
Comparison Condition Clinic - Surrogates	4.61	± 2.81

Post-bereavement assessment (3 months after patient death)

Group	Value	95% CI
SPIRIT Clinic - Surrogates	5.59	± 3.58
Comparison Condition Clinic - Surrogates	6.71	± 3.72

Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score Secondary · Baseline, 3 months after patient death (up to 24 months)

Surrogate post-bereavement symptoms of depression were measured with the Hospital Anxiety and Depression Scale (HADS) Depression subscale. Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). Total scores of the depression subscale range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of depression.

Baseline for all surrogates where the patient died during the follow-up period

Group	Value	95% CI
SPIRIT Clinic - Surrogates	3.28	± 2.62
Comparison Condition Clinic - Surrogates	2.83	± 2.80

Baseline for surrogates who completed the post-bereavement assessment

Group	Value	95% CI
SPIRIT Clinic - Surrogates	3.04	± 2.36
Comparison Condition Clinic - Surrogates	2.71	± 2.76

Post-bereavement assessment (3 months after patient death)

Group	Value	95% CI
SPIRIT Clinic - Surrogates	4.26	± 2.94
Comparison Condition Clinic - Surrogates	4.23	± 2.69

Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score Secondary · Baseline, 3 months after patient death (up to 24 months)

Surrogate post-bereavement traumatic distress was measured with the Post-Traumatic Symptoms Scale-10 (PTSS-10). Surrogates indicate how often they have experienced symptoms of post-traumatic stress by responding to 10 symptoms on a scale of 1 to 7 where 1 = "never" and 7 = "always". Total scale scores range from 10 to 70 and higher scores indicate more intense symptoms.

Baseline for all surrogates where the patient died during the follow-up period

Group	Value	95% CI
SPIRIT Clinic - Surrogates	19.96	± 9.24
Comparison Condition Clinic - Surrogates	21.97	± 9.87

Baseline for surrogates who completed the post-bereavement assessment

Group	Value	95% CI
SPIRIT Clinic - Surrogates	19.30	± 7.81
Comparison Condition Clinic - Surrogates	21.97	± 10.26

Post-bereavement assessment (3 months after patient death)

Group	Value	95% CI
SPIRIT Clinic - Surrogates	26.4	± 12.2
Comparison Condition Clinic - Surrogates	29.3	± 13.3

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for interpersonal communication about end of life care between health practitioners and affected people.
   Ryan RE, Connolly M, Bradford NK, Henderson S, et al · · 2022 · cited 33× · PMID 35802350 · DOI 10.1002/14651858.cd013116.pub2
2. Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families: A Cluster Randomized Clinical Trial.
   Song MK, Manatunga A, Plantinga L, Metzger M, et al · · 2024 · cited 20× · PMID 38289604 · DOI 10.1001/jamanetworkopen.2023.51511
3. SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.
   Song MK, Unruh ML, Manatunga A, Plantinga LC, et al · · 2018 · cited 19× · PMID 28993286 · DOI 10.1016/j.cct.2017.10.005