Trial Outcomes & Findings for SPIRIT for Persons With Dementia and Complex Multimorbidity (NCT NCT04108000)
NCT ID: NCT04108000
Last Updated: 2023-05-24
Results Overview
Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in 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 then compared to determine dyad congruence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline, 2 Days Post-intervention
Results posted on
2023-05-24
Participant Flow
Participants were recruited from multiple dialysis centers in Georgia, USA. Participant enrollment began on February 14, 2020, and follow-up assessments for the primary outcome measures were completed on March 24, 2023.
Research team chose individual randomization because intervention spillover to the control condition was very unlikely. Race was used (white vs non-white) as stratification factor to ensure equal allocation of race to each condition to control for race as a confounder. Intervention was delivered by a trained interventionist, in person, or virtually due to COVID-19, and thus it was nearly impossible for care providers to obtain the knowledge and skill related to SPIRIT to change their practice.
Participant milestones
| Measure |
SPIRIT-Dementia -Patients
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
SPIRIT-Dementia -Surrogate
Surrogates of patients randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care - Patients
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis.
Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
Usual Care - Surrogates
Surrogates of patients randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis.
Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
SPIRIT-Dementia -Patients
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
SPIRIT-Dementia -Surrogate
Surrogates of patients randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care - Patients
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis.
Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
Usual Care - Surrogates
Surrogates of patients randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis.
Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|---|---|
|
Overall Study
Death of patient
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
|
Overall Study
Death of surrogate partner
|
0
|
1
|
0
|
1
|
Baseline Characteristics
SPIRIT for Persons With Dementia and Complex Multimorbidity
Baseline characteristics by cohort
| Measure |
SPIRIT-Dementia -Patients
n=9 Participants
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
SPIRIT-Dementia -Surrogate
n=9 Participants
Surrogates of patients randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, an opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care - Patients
n=10 Participants
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis.
Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
Usual Care - Surrogates
n=10 Participants
Surrogates of patients randomized to this study arm will receive the standard information about advance directives that are provided at the time of diagnosis.
Usual Care: As required by the Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.44 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
57.56 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
63.40 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
53.20 years
STANDARD_DEVIATION 12.19 • n=4 Participants
|
58.42 years
STANDARD_DEVIATION 11.33 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
38 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 Days Post-interventionPopulation: The Unit of measure and analysis is a dyad (patient-surrogate pair). At 2 days post-intervention, 2 attrition in the SPIRIT group and 1 attrition in the Comparison group
Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in 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 then compared to determine dyad congruence.
Outcome measures
| Measure |
SPIRIT-Dementia
n=9 Participants
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care
n=10 Participants
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis.
Usual Care: As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|
|
Dyad Congruence
Congruent at Baseline
|
1 Dyads
|
5 Dyads
|
|
Dyad Congruence
Incongruent at Baseline
|
8 Dyads
|
5 Dyads
|
|
Dyad Congruence
Congruent at two (2) days post-intervention
|
1 Dyads
|
4 Dyads
|
|
Dyad Congruence
Incongruent at wo (2) days post-intervention
|
6 Dyads
|
5 Dyads
|
PRIMARY outcome
Timeframe: Baseline, 2 Days Post-interventionPopulation: This analysis includes participants (patients) who completed the indicated study visit. Two participants (patients) in the SPIRIT group and one participant (patient) in the Comparison group did not complete the 2-day post-intervention follow-up visit.
Patient decisional conflict will be 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 - 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making.
Outcome measures
| Measure |
SPIRIT-Dementia
n=9 Participants
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care
n=10 Participants
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis.
Usual Care: As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|
|
Patient's Decisional Conflict Scale (DCS) Score
Baseline
|
14.11 score on a scale
Standard Deviation 1.62
|
16.00 score on a scale
Standard Deviation 2.49
|
|
Patient's Decisional Conflict Scale (DCS) Score
Two (2) Days Post-Intervention
|
15.29 score on a scale
Standard Deviation 2.21
|
16.67 score on a scale
Standard Deviation 3.84
|
PRIMARY outcome
Timeframe: Baseline, 2 Days Post-interventionPopulation: This analysis includes participants who completed study visits. There were two attrition (surrogates) in the SPIRIT group and one (surrogate) attrition in the Comparison group At 2 days post-intervention
Surrogate decision-making confidence will be 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 (5) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.
Outcome measures
| Measure |
SPIRIT-Dementia
n=9 Participants
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care
n=10 Participants
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis.
Usual Care: As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|
|
Surrogate's Decision Making Confidence (DMC) Scale Score
Baseline
|
18.44 score on a scale
Standard Deviation 1.42
|
17.00 score on a scale
Standard Deviation 6.01
|
|
Surrogate's Decision Making Confidence (DMC) Scale Score
Two (2) Days Post-Intervention
|
17.57 score on a scale
Standard Deviation 4.79
|
18.67 score on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: 6 and 12 Months Post-interventionPopulation: At both 6 and 12 months post-intervention, 2 attrition in the SPIRIT group and 2 attrition in the Comparison group
The proportion of decisions (participants who withdrew from dialysis, Do not resuscitate (DNR), or chose hospice enrollment) will be compared between study arms.
Outcome measures
| Measure |
SPIRIT-Dementia
n=9 Participants
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care
n=10 Participants
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis.
Usual Care: As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|
|
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
6 months post-intervention: Participants who withdrew from dialysis
|
0 Participants
|
0 Participants
|
|
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
6 months post-intervention: Participants who chose Do Not Resuscitate (DNR)
|
0 Participants
|
0 Participants
|
|
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
6 months post-intervention: Participants who chose Hospice enrollment
|
0 Participants
|
0 Participants
|
|
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
12 months post-intervention: Participants who withdrew from dialysis
|
0 Participants
|
1 Participants
|
|
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
12 months post-intervention Participants who chose Do Not Resuscitate (DNR)
|
0 Participants
|
1 Participants
|
|
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
12 months post-intervention: Participants who chose Hospice enrollment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 Month after the Patient's DeathPopulation: The surrogate in the SPIRIT group did not complete the post-bereavement assessment.
Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). 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). The separate anxiety and depression subscale scores 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 or depression.
Outcome measures
| Measure |
SPIRIT-Dementia
n=1 Participants
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care
n=2 Participants
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis.
Usual Care: As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|
|
Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score
Anxiety at Baseline
|
2.00 score on a scale
Standard Deviation NA
Unable to provide standard deviation (SD) on the score of only one (1) participant.
|
4.00 score on a scale
Standard Deviation 0.00
|
|
Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score
Anxiety - 1 Month after patient' death
|
—
|
7.50 score on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, 1 Month after the Patient's DeathPopulation: The surrogate in the SPIRIT group did not complete the post-bereavement assessment.
Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). 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). The separate anxiety and depression subscale scores 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 or depression.
Outcome measures
| Measure |
SPIRIT-Dementia
n=1 Participants
Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention.
SPIRIT-Dementia: The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
|
Usual Care
n=2 Participants
Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis.
Usual Care: As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives 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 advance directive.
|
|---|---|---|
|
Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score
Depression at Baseline
|
7.00 score on a scale
Standard Deviation NA
Unable to provide standard deviation (SD) on the score of only one (1) participant.
|
7.00 score on a scale
Standard Deviation 4.24
|
|
Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score
Depression - 1 Month after patient' death
|
—
|
9.50 score on a scale
Standard Deviation 2.12
|
Adverse Events
SPIRIT-Dementia- Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
SPIRIT-Dementia- Surrogates
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care - Surrogates
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place