Trial Outcomes & Findings for An Effectiveness-Implementation Trial of SPIRIT in ESRD (NCT NCT03138564)

Last Updated: 2025-11-05

Results Overview

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 member of the dyad chose the same response (either comfort care only or continue aggressive care) in both scenarios. In all other cases, the dyad is assigned with "0", which includes: 1) the patient and surrogate responses are the same in one of the two scenarios, 2) the patient and surrogate responses differ in both scenarios, and 3) the patient and surrogate responses are both "I am not sure".

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

852 participants

Primary outcome timeframe

Baseline, Week 2

Results posted on

2025-11-05

Participant Flow

Participants were recruited from multiple dialysis centers in Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia, USA. Participant enrollment began on February 15, 2018, and follow-up assessments for the primary outcome measures at Week 2 were completed on March 24, 2022. Data collection for secondary outcome measures with surrogates three months after the patient's death was completed July 29, 2022.

42 clinics were enrolled with 23 randomized to the SPIRIT and 19 randomized to usual care. One SPIRIT clinic and 2 control clinics were excluded prior to study initiation. There were 557 eligible patients in SPIRIT clinics and 264 dyads consented to participate; of these, 33 dyads withdrew or became ineligible prior to the baseline visit. In control clinics there were 293 eligible patients and 210 dyads consented to participate; 15 dyads withdrew or became ineligible prior to the baseline visit.

Unit of analysis: dialysis clinics

Participant milestones

Participant milestones
Measure	SPIRIT Clinic Dialysis clinics randomized to deliver the SPIRIT 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. Patients receiving care at SPIRIT clinics were given the option to participate in this study with their surrogate decision-makers.	Comparison Condition Clinic Dialysis clinics randomized to the comparison condition control arm. The comparison condition is the usual care provided. As required by the Centers for Medicare and Medicaid Services (CMS), written information on advance directives (ADs) is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an AD. This typically takes about 10 minutes. Patients receiving care at the comparison condition clinics were given the option to participate in this study with their surrogate decision-makers.
Overall Study STARTED	462 22	390 17
Overall Study Patients Beginning the Study	231 22	195 17
Overall Study Surrogates Beginning the Study	231 22	195 17
Overall Study Patients Completing the Week 2 Assessment	182 22	192 17
Overall Study Surrogates Completing the Week 2 Assessment	183 22	189 17
Overall Study Surrogates Eligible for Post-bereavement Visit	54 22	35 17
Overall Study Surrogates Completing Post-bereavement Visit	46 22	31 17
Overall Study COMPLETED	365 22	381 17
Overall Study NOT COMPLETED	97 0	9 0

Reasons for withdrawal

Reasons for withdrawal
Measure	SPIRIT Clinic Dialysis clinics randomized to deliver the SPIRIT 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. Patients receiving care at SPIRIT clinics were given the option to participate in this study with their surrogate decision-makers.	Comparison Condition Clinic Dialysis clinics randomized to the comparison condition control arm. The comparison condition is the usual care provided. As required by the Centers for Medicare and Medicaid Services (CMS), written information on advance directives (ADs) is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an AD. This typically takes about 10 minutes. Patients receiving care at the comparison condition clinics were given the option to participate in this study with their surrogate decision-makers.
Overall Study Death of patient prior to the Week 2 assessment	14	2
Overall Study Lost to Follow-up	16	2
Overall Study Withdrawal by Subject	48	4
Overall Study No longer met eligibility criteria	2	0
Overall Study Withdrawal by investigator due to no availability of SPIRIT champion in the clinic	4	0
Overall Study Patient died before surrogate completed Week 2 assessment	12	0
Overall Study Surrogate declined to complete the Week 2 assessment but did not withdraw from study	0	1
Overall Study Death of surrogate prior to Week 2 assessment	1	0

Baseline Characteristics

An Effectiveness-Implementation Trial of SPIRIT in ESRD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPIRIT Clinic - Patients n=231 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	SPIRIT Clinic - Surrogates n=231 Participants Surrogates of patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=195 Participants Patients receiving care at clinics randomized to the control condition	Comparison Condition Clinic - Surrogates n=195 Participants Surrogates of patients receiving care at clinics randomized to the control condition	Total n=852 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	222 Participants n=15 Participants	225 Participants n=161 Participants	190 Participants n=100 Participants	185 Participants n=3 Participants	822 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	2 Participants n=3 Participants	2 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=15 Participants	1 Participants n=161 Participants	3 Participants n=100 Participants	1 Participants n=3 Participants	6 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	161 Participants n=15 Participants	159 Participants n=161 Participants	132 Participants n=100 Participants	132 Participants n=3 Participants	584 Participants n=8 Participants
Race (NIH/OMB) White	66 Participants n=15 Participants	64 Participants n=161 Participants	53 Participants n=100 Participants	57 Participants n=3 Participants	240 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	2 Participants n=161 Participants	3 Participants n=100 Participants	4 Participants n=3 Participants	9 Participants n=8 Participants
Region of Enrollment United States	231 participants n=15 Participants	231 participants n=161 Participants	195 participants n=100 Participants	195 participants n=3 Participants	852 participants n=8 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 12.8 • n=15 Participants	53.2 years STANDARD_DEVIATION 14.7 • n=161 Participants	62.4 years STANDARD_DEVIATION 12.5 • n=100 Participants	54.3 years STANDARD_DEVIATION 16.1 • n=3 Participants	57.8 years STANDARD_DEVIATION 14.6 • n=8 Participants
Sex: Female, Male Female	121 Participants n=15 Participants	168 Participants n=161 Participants	97 Participants n=100 Participants	152 Participants n=3 Participants	538 Participants n=8 Participants
Sex: Female, Male Male	110 Participants n=15 Participants	63 Participants n=161 Participants	98 Participants n=100 Participants	43 Participants n=3 Participants	314 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=15 Participants	6 Participants n=161 Participants	5 Participants n=100 Participants	8 Participants n=3 Participants	28 Participants n=8 Participants
Race (NIH/OMB) More than one race	2 Participants n=15 Participants	4 Participants n=161 Participants	4 Participants n=100 Participants	1 Participants n=3 Participants	11 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2

Population: The number of participants analyzed reflects the number of persons with ESRD and surrogate dyads (two persons per dyad). This analysis includes dyads who both completed the assessment at the indicated study visit.

Outcome measures

Outcome measures
Measure	SPIRIT Clinic - Patients n=231 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=195 Participants Patients receiving care at clinics randomized to the control condition
Dyad Congruence on Goals-of-Care Tool Number of Congruent Dyads at Baseline (assigned value = 1)	98 dyads	76 dyads
Dyad Congruence on Goals-of-Care Tool Number of Incongruent Dyads at Baseline (assigned value = 0)	133 dyads	119 dyads
Dyad Congruence on Goals-of-Care Tool Number of Congruent Dyads at 2 Weeks Post-Intervention (assigned value = 1)	111 dyads	94 dyads
Dyad Congruence on Goals-of-Care Tool Number of Incongruent Dyads at 2 Weeks Post-Intervention (assigned value = 0)	71 dyads	93 dyads

PRIMARY outcome

Timeframe: Baseline, Week 2

Population: This analysis includes patient participants who completed the DCS. One participant in the comparison condition study arm did not answer all items on the scale at the baseline visit and thus their total score could not be computed.

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.

Outcome measures

Outcome measures
Measure	SPIRIT Clinic - Patients n=231 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=194 Participants Patients receiving care at clinics randomized to the control condition
Patient's Decisional Conflict Scale (DCS) Score Baseline	25.6 score on a scale Standard Deviation 6.22	24.8 score on a scale Standard Deviation 5.82
Patient's Decisional Conflict Scale (DCS) Score Two Weeks Post-Intervention	23.4 score on a scale Standard Deviation 5.94	24.1 score on a scale Standard Deviation 5.78

PRIMARY outcome

Timeframe: Baseline, Week 2

Population: This analysis includes participants completing the indicated study visit.

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.

Outcome measures

Outcome measures
Measure	SPIRIT Clinic - Patients n=231 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=195 Participants Patients receiving care at clinics randomized to the control condition
Surrogate's Decision Making Confidence (DMC) Scale Score Baseline	18.2 Score on a scale Standard Deviation 2.73	18.3 Score on a scale Standard Deviation 2.59
Surrogate's Decision Making Confidence (DMC) Scale Score Two Weeks Post-Intervention	18.9 Score on a scale Standard Deviation 1.73	18.6 Score on a scale Standard Deviation 2.16

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	SPIRIT Clinic - Patients n=231 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=195 Participants Patients receiving care at clinics randomized to the control condition
Composite Outcome of Dyad Congruence and Surrogate DMC Score Number of Dyads Where Week 2 Post-Intervention Composite Outcome = 1	107 dyads	90 dyads
Composite Outcome of Dyad Congruence and Surrogate DMC Score Number of Dyads Where Week 2 Post-Intervention Composite Outcome = 0	75 dyads	97 dyads
Composite Outcome of Dyad Congruence and Surrogate DMC Score Number of Dyads Where Baseline Composite Outcome = 1	92 dyads	74 dyads
Composite Outcome of Dyad Congruence and Surrogate DMC Score Number of Dyads Where Baseline Composite Outcome = 0	139 dyads	121 dyads

SECONDARY outcome

Timeframe: Upon patient death (up to 21 months)

The use of intensive procedures during end-of-life treatment will be identified through the United States Renal Data System (USRDS). The use of mechanical ventilation as part of the patient's end-of-life (EOL) treatment will be documented (e.g., mechanical ventilation, feeding tube, dialysis, CPR). The EoL treatment intensity data acquisition will take at least two more years after the participant's death due to the 2-year gap in the administrative data release.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months after patient death (up to 24 months)

Population: This analysis includes surrogates from dyads where the patient died during the follow-up period. Per the intent to treat analysis, surrogates of 89 deceased patients were to be analyzed, and baseline values are presented for these participants. Twelve did not complete the post-bereavement survey due to being lost to follow-up or not consenting to participate in the extended follow-up. Baseline and post-bereavement scores are presented for the 77 who completed the post-bereavement assessment.

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.

Outcome measures

Outcome measures
Measure	SPIRIT Clinic - Patients n=54 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=35 Participants Patients receiving care at clinics randomized to the control condition
Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score Baseline for all surrogates where the patient died during the follow-up period	4.80 score on a scale Standard Deviation 2.99	4.89 score on a scale Standard Deviation 2.83
Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score Baseline for surrogates who completed the post-bereavement assessment	4.85 score on a scale Standard Deviation 3.07	4.61 score on a scale Standard Deviation 2.81
Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score Post-bereavement assessment (3 months after patient death)	5.59 score on a scale Standard Deviation 3.58	6.71 score on a scale Standard Deviation 3.72

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SPIRIT Clinic - Patients n=54 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=35 Participants Patients receiving care at clinics randomized to the control condition
Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score Baseline for all surrogates where the patient died during the follow-up period	3.28 score on a scale Standard Deviation 2.62	2.83 score on a scale Standard Deviation 2.80
Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score Baseline for surrogates who completed the post-bereavement assessment	3.04 score on a scale Standard Deviation 2.36	2.71 score on a scale Standard Deviation 2.76
Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score Post-bereavement assessment (3 months after patient death)	4.26 score on a scale Standard Deviation 2.94	4.23 score on a scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SPIRIT Clinic - Patients n=54 Participants Patients receiving care at clinics randomized to the SPIRIT intervention	Comparison Condition Clinic - Patients n=35 Participants Patients receiving care at clinics randomized to the control condition
Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score Baseline for all surrogates where the patient died during the follow-up period	19.96 score on a scale Standard Deviation 9.24	21.97 score on a scale Standard Deviation 9.87
Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score Baseline for surrogates who completed the post-bereavement assessment	19.30 score on a scale Standard Deviation 7.81	21.97 score on a scale Standard Deviation 10.26
Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score Post-bereavement assessment (3 months after patient death)	26.4 score on a scale Standard Deviation 12.2	29.3 score on a scale Standard Deviation 13.3

Adverse Events

Comparison Condition Clinic - Surrogates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SPIRIT Clinic - Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 54 deaths

SPIRIT Clinic - Surrogates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Comparison Condition Clinic - Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 35 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mi-Kyung Song, PhD, RN

Emory University

Phone: 404-727-3134

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place