End Stage Renal Disease
Conditions
Keywords
Dementia, Nursing, Nephrology, Behavioral research, Social research
Brief summary
In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on preparedness outcomes. Additional follow up with caregivers will occur 6 months later.
Detailed description
Cognitive impairment or dementia, usually vascular dementia or Alzheimer's, co-occur in approximately 38% of patients with end stage renal disease (ESRD). When dementia is superimposed on ESRD, the risk for poor outcomes, including disability, hospitalization and death, sharply increases. Similarly, initiating dialysis in older adults with multiple comorbidities, including dementia, does not offer survival benefit. However, advance care planning (ACP) discussions with dialysis patients rarely occur. The reality of ESRD plus dementia is that most of these patients are likely to die or progress to advanced dementia without ever engaging in ACP discussions before the cognitive window of opportunity closes. Moreover, persons with dementia (regardless of their cognitive impairment level) are routinely excluded from clinical trials of ACP, largely because investigators assume that these people do not have the cognitive capability to appreciate the complexity of ACP. In an on-going study (SPIRIT in Dementia) the researchers carefully adapted SPIRIT for persons with mild to moderate dementia (mostly due to Alzheimer's) and their surrogates. In a sample of 23 dementia patients without complex multimorbidity and their surrogates, the researchers were able to conclude that meaningful ACP conversations were possible even for individuals with moderate dementia. Based on these findings, this supplement study will leverage the infrastructure of the parent SPIRIT in ESRD trial to pilot test the adapted SPIRIT intervention for patients with ESRD plus dementia as a model for determining whether patients with dementia superimposed on complex multimorbidity can fully participate in ACP discussion. This purpose of this pilot randomized controlled trial with 30 patient and caregiver dyads is to: * estimate the effects of the SPIRIT-dementia intervention on: (a) preparedness outcomes for end-of-life decision making (defined as dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) 2-3 days post-intervention, and (b) care decisions (withdrawal from dialysis, Do-Not-Resuscitate order, hospice enrollment) assessed at 6 months post-intervention, or the patient's death, whichever occurs first, * estimate the effects of the SPIRIT-dementia intervention on surrogates' post-bereavement distress (anxiety and depression symptoms) at 1 month after the patient's death, and * explore the relationships among patients' cognitive status, decision-making capacity and their ability to express end-of-life wishes.
Interventions
BEHAVIORALSPIRIT-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.
BEHAVIORALUsual 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.
Sponsors
National Institute of Nursing Research (NINR)
National Institute on Aging (NIA)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
30 pairs of patients and their caregivers (surrogates) will be randomized to either receive the SPIRIT intervention or standard of care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * receiving in-center hemodialysis * diagnosed with dementia or having mild to moderate cognitive impairment based on a Montreal Cognitive Assessment (MoCA) score 13-25 or a Saint Louis University Mental Status (SLUMS) score \< 27 (high school education) or \< 25 (less than high school education) * able to understand and speak English * a University of California San Diego Brief Assessment of Capacity to Consent (UBACC) score of 11 or higher
Exclusion criteria
* lack of an available surrogate * uncompensated hearing deficits * already enrolled in hospice Surrogate Inclusion Criteria: * 18 years or older * be chosen by the patient * able to understand and speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyad Congruence | Baseline, 2 Days Post-intervention | 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. |
| Patient's Decisional Conflict Scale (DCS) Score | Baseline, 2 Days Post-intervention | 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. |
| Surrogate's Decision Making Confidence (DMC) Scale Score | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 6 and 12 Months Post-intervention | The proportion of decisions (participants who withdrew from dialysis, Do not resuscitate (DNR), or chose hospice enrollment) will be compared between study arms. |
| Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score | Baseline, 1 Month after the Patient's Death | 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. |
| Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score | Baseline, 1 Month after the Patient's Death | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 9 |
| 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. | 10 |
| 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. | 10 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death of patient | 1 | 0 | 1 | 0 |
| Overall Study | Death of surrogate partner | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | SPIRIT-Dementia -Patients | Total | Usual Care - Surrogates | Usual Care - Patients | SPIRIT-Dementia -Surrogate |
|---|---|---|---|---|---|
| Age, Continuous | 58.44 years STANDARD_DEVIATION 8.35 | 58.42 years STANDARD_DEVIATION 11.33 | 53.20 years STANDARD_DEVIATION 12.19 | 63.40 years STANDARD_DEVIATION 11.43 | 57.56 years STANDARD_DEVIATION 11.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 35 Participants | 9 Participants | 8 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 34 Participants | 8 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 9 participants | 38 participants | 10 participants | 10 participants | 9 participants |
| Sex: Female, Male Female | 6 Participants | 23 Participants | 5 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 15 Participants | 5 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 9 | 1 / 9 | 1 / 10 | 1 / 10 |
| other Total, other adverse events | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Dyad Congruence
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.
Time frame: Baseline, 2 Days Post-intervention
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPIRIT-Dementia | Dyad Congruence | Congruent at Baseline | 1 Dyads |
| SPIRIT-Dementia | Dyad Congruence | Incongruent at Baseline | 8 Dyads |
| SPIRIT-Dementia | Dyad Congruence | Congruent at two (2) days post-intervention | 1 Dyads |
| SPIRIT-Dementia | Dyad Congruence | Incongruent at wo (2) days post-intervention | 6 Dyads |
| Usual Care | Dyad Congruence | Incongruent at wo (2) days post-intervention | 5 Dyads |
| Usual Care | Dyad Congruence | Congruent at Baseline | 5 Dyads |
| Usual Care | Dyad Congruence | Congruent at two (2) days post-intervention | 4 Dyads |
| Usual Care | Dyad Congruence | Incongruent at Baseline | 5 Dyads |
Primary
Patient's Decisional Conflict Scale (DCS) Score
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.
Time frame: Baseline, 2 Days Post-intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPIRIT-Dementia | Patient's Decisional Conflict Scale (DCS) Score | Baseline | 14.11 score on a scale | Standard Deviation 1.62 |
| SPIRIT-Dementia | Patient's Decisional Conflict Scale (DCS) Score | Two (2) Days Post-Intervention | 15.29 score on a scale | Standard Deviation 2.21 |
| Usual Care | Patient's Decisional Conflict Scale (DCS) Score | Baseline | 16.00 score on a scale | Standard Deviation 2.49 |
| Usual Care | Patient's Decisional Conflict Scale (DCS) Score | Two (2) Days Post-Intervention | 16.67 score on a scale | Standard Deviation 3.84 |
Primary
Surrogate's Decision Making Confidence (DMC) Scale Score
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.
Time frame: Baseline, 2 Days Post-intervention
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPIRIT-Dementia | Surrogate's Decision Making Confidence (DMC) Scale Score | Baseline | 18.44 score on a scale | Standard Deviation 1.42 |
| SPIRIT-Dementia | Surrogate's Decision Making Confidence (DMC) Scale Score | Two (2) Days Post-Intervention | 17.57 score on a scale | Standard Deviation 4.79 |
| Usual Care | Surrogate's Decision Making Confidence (DMC) Scale Score | Baseline | 17.00 score on a scale | Standard Deviation 6.01 |
| Usual Care | Surrogate's Decision Making Confidence (DMC) Scale Score | Two (2) Days Post-Intervention | 18.67 score on a scale | Standard Deviation 1.94 |
Secondary
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
The proportion of decisions (participants who withdrew from dialysis, Do not resuscitate (DNR), or chose hospice enrollment) will be compared between study arms.
Time frame: 6 and 12 Months Post-intervention
Population: At both 6 and 12 months post-intervention, 2 attrition in the SPIRIT group and 2 attrition in the Comparison group
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPIRIT-Dementia | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 6 months post-intervention: Participants who withdrew from dialysis | 0 Participants |
| SPIRIT-Dementia | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 6 months post-intervention: Participants who chose Do Not Resuscitate (DNR) | 0 Participants |
| SPIRIT-Dementia | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 6 months post-intervention: Participants who chose Hospice enrollment | 0 Participants |
| SPIRIT-Dementia | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 12 months post-intervention: Participants who withdrew from dialysis | 0 Participants |
| SPIRIT-Dementia | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 12 months post-intervention Participants who chose Do Not Resuscitate (DNR) | 0 Participants |
| SPIRIT-Dementia | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 12 months post-intervention: Participants who chose Hospice enrollment | 0 Participants |
| Usual Care | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 12 months post-intervention Participants who chose Do Not Resuscitate (DNR) | 1 Participants |
| Usual Care | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 6 months post-intervention: Participants who withdrew from dialysis | 0 Participants |
| Usual Care | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 12 months post-intervention: Participants who withdrew from dialysis | 1 Participants |
| Usual Care | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 6 months post-intervention: Participants who chose Do Not Resuscitate (DNR) | 0 Participants |
| Usual Care | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 12 months post-intervention: Participants who chose Hospice enrollment | 0 Participants |
| Usual Care | Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) | 6 months post-intervention: Participants who chose Hospice enrollment | 0 Participants |
Secondary
Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score
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.
Time frame: Baseline, 1 Month after the Patient's Death
Population: The surrogate in the SPIRIT group did not complete the post-bereavement assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPIRIT-Dementia | Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score | Anxiety at Baseline | 2.00 score on a scale | — |
| Usual Care | Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score | Anxiety at Baseline | 4.00 score on a scale | Standard Deviation 0 |
| Usual Care | 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
Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score
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.
Time frame: Baseline, 1 Month after the Patient's Death
Population: The surrogate in the SPIRIT group did not complete the post-bereavement assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPIRIT-Dementia | Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score | Depression at Baseline | 7.00 score on a scale | — |
| Usual Care | 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 4.24 |
| Usual Care | 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 |